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Source: IRS e-Filed Form 990 (from the IRS e-File system), Tax Year 2024
Total Revenue
▼$199.1K
Program Spending
37%
of total expenses go to program services
Total Contributions
$106.6K
Total Expenses
▼$199.4K
Total Assets
$350.7K
Total Liabilities
▼$263.8K
Net Assets
$86.9K
Officer Compensation
→N/A
Other Salaries
$72K
Investment Income
$0
Fundraising
▼$37K
Source: USAspending.gov · Searched by organization name
VA/DoD Awards
$7.1M
VA/DoD Award Count
5
Funding from the Department of Veterans Affairs and/or Department of Defense.
Total Federal Funding (partial)
$366.2M
Awards Found
200+
Additional awards may exist. View all on USAspending.gov →
| Awarding Agency | Description | Amount | Fiscal Year | Period |
|---|---|---|---|---|
| Department of Health and Human Services | LIFESPAN/TUFTS/BROWN CENTER FOR AIDS RESEARCH (CFAR) | $37.1M | FY1998 | Sep 1998 – Jun 2028 |
| Department of Health and Human Services | LOOK AHEAD: ACTION FOR HEALTH IN DIABETES | $10.2M | FY1999 | Sep 1999 – Jan 2022 |
| Department of Health and Human Services | COBRE FOR STRESS, TRAUMA AND RESILIENCE (STAR) - PROJECT SUMMARY / ABSTRACT THERE IS INCREASING EVIDENCE FOR A PROFOUND AND PERSISTENT IMPACT OF CHILDHOOD STRESS AND TRAUMA ON PSYCHO- LOGICAL AND PHYSICAL HEALTH OUTCOMES OVER THE LIFESPAN. THE STRENGTH AND CONSISTENCY OF THESE ASSOCIATIONS HAS LED TO A PARADIGM SHIFT IN APPROACHING ADULT DISEASE IN WHICH ADDRESSING THE EARLY CHILDHOOD ORIGINS OF HEALTH AND DISEASE IS CONSIDERED TO BE EQUAL TO IF NOT MORE CRITICAL THAN INTERVENTION EFFORTS WITH ADULTS. HOWEVER, DE- SPITE THE MAGNITUDE OF RISK ASSOCIATED WITH ADVERSE CHILDHOOD EXPERIENCES, THERE IS LIMITED UNDERSTANDING OF THE PRECISE MECHANISMS BY WHICH EARLY ADVERSITY IMPACTS HEALTH. WE PROPOSE TO ESTABLISH A PHASE I CENTER OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE) FOR STRESS, TRAUMA, AND RESILIENCE (STAR) AT THE MIRIAM HOSPITAL TO ADDRESS THIS CRITICAL GAP. THE STAR COBRE IS UNIFIED BY A CONCEPTUAL FRAMEWORK FOCUSED ON (A) ISOLATING/DISENTANGLING SPECIFIC STRESS EXPOSURES AND TRAUMAS, AND (B) IDENTIFYING PROXIMAL MECHANISMS OF RISK AND RESILIENCE WITH IN-VIVO ECOLOGICAL SAMPLING THAT WILL LEAD RAPIDLY TO NOVEL AND ACTIONABLE INTER- VENTION TARGETS TO IMPROVE HEALTH. THE COBRE INCORPORATES A LIFE COURSE APPROACH, WITH AN EMPHASIS ON SENSITIVE PERIODS OF DEVELOPMENT—PREGNANCY, CHILDHOOD, AND YOUNG ADULTHOOD. THREE PROMISING, EARLY CA- REER PROJECT LEADERS, A JUNIOR FACULTY RECRUIT WITH EXPERTISE IN STAR FROM AN UNDER-REPRESENTED MINORITY GROUP, AND A DIVERSITY-FOCUSED PILOT PROJECT PROGRAM FUNDED BY THE MIRIAM HOSPITAL FORM THE NEXUS OF THE STAR CO- BRE. CO-MENTORSHIP BY TWO LEADING NIH-FUNDED SCIENTISTS WITH COMPLEMENTARY EXPERTISE WILL CATALYZE THE TRAN- SITION OF THE PROJECT LEADERS TO INDEPENDENT FUNDING. DR. BUBLITZ WILL UTILIZE CUTTING-EDGE ECOLOGICAL METHODS TO UNDERSTAND LINKS BETWEEN MATERNAL HISTORY OF CHILDHOOD SEXUAL ABUSE AND HYPERTENSIVE DISORDERS OF PREG- NANCY. DR. EVANS WILL CONDUCT A NATURALISTIC EXPERIMENT IN CHILDREN TO ELUCIDATE THE SPECIFIC IMPACT OF FOOD IN- SECURITY FROM OTHER POVERTY-RELATED STRESSORS ON DIET, INFLAMMATORY AND METABOLIC BIOMARKERS AND SUMMER WEIGHT GAIN; DR. VERGARA-LOPEZ WILL UTILIZE A NOVEL DIMENSIONAL APPROACH TO CHILDHOOD MALTREATMENT TO CONTRAST THE IMPACT OF DEPRIVATION (NEGLECT) VS. THREAT (ABUSE) ON YOUNG ADULT EMOTION REGULATION STRATEGIES AND MENTAL HEALTH SYMPTOMS. TO SUPPORT PROJECT LEADERS AND THE STAR COBRE, WE WILL ESTABLISH AN ADMINISTRATIVE CORE, INCLUDING A COMMUNITY ADVISORY BOARD AND A STATE-OF-THE ART MENTORING AND EDUCATION PROGRAM, AND TWO RESEARCH CORES: THE TECHNOLOGY, ASSESSMENT, DATA, AND ANALYSIS (TADA) CORE WILL SUPPORT METHODS HAR- NESSING CUTTING-EDGE TECHNOLOGY, DATA MANAGEMENT AND STATISTICS; THE HUMAN SUBJECTS AND VULNERABLE POP- ULATIONS (VP) CORE WILL SUPPORT RECRUITMENT/RETENTION OF VULNERABLE AND DIVERSE POPULATIONS AND COMMUNITY PARTNERSHIPS. THE STAR COBRE WILL SERVE AS THE ONLY RESEARCH CENTER IN RHODE ISLAND FOCUSED ON STRESS, TRAUMA, AND RESILIENCE. OUR LONG-TERM GOAL IS TO DEVELOP AND SUSTAIN A CRITICAL MASS OF INVESTIGATORS TO ESTABLISH THE MIRIAM HOSPITAL AS A VIBRANT REGIONAL AND NATIONAL HUB FOR TRANSFORMATIVE RESEARCH INTO MECHA- NISMS OF RISK AND RESILIENCE FOLLOWING CHILDHOOD EXPOSURE TO STRESS, TRAUMA, AND ADVERSITY. | $10.1M | FY2021 | Sep 2021 – Jul 2027 |
| Department of Health and Human Services | COBRE CENTER FOR ANTIMICROBIAL RESISTANCE AND THERAPEUTIC DISCOVERY | $9.3M | FY2018 | Sep 2018 – Jul 2024 |
| Department of Health and Human Services | OP EARLY INTERVENTION SVCS W/RESPECT TO HIV DISEASE | $8.5M | FY1994 | May 1994 – Dec 2020 |
| Department of Health and Human Services | HIV AND OTHER INFECTIOUS CONSEQUENCES OF SUBSTANCE ABUSE | $7.1M | FY2001 | Jul 2001 – Jun 2028 |
| Department of Health and Human Services | THUMB CMC BIOMECHANICS AND EARLY OA PROGRESSION | $6.4M | FY2011 | Jul 2011 – Aug 2022 |
| Department of Health and Human Services | RYAN WHITE PART C OUTPATIENT EIS PROGRAM | $6.4M | FY1994 | May 1994 – Dec 2027 |
| Department of Health and Human Services | COBRE CENTER FOR CANCER RESEARCH DEVELOPMENT | $6.3M | FY2015 | May 2015 – Apr 2021 |
| Department of Health and Human Services | BIOLOGICALLY ENHANCED HEALING OF AUTOGRAFT ACL RECONSTRUCTION. | $5.8M | FY2009 | Feb 2009 – Aug 2020 |
| Department of Health and Human Services | CARE CORRECTIONS: TECHNOLOGY FOR JAIL HIV/HCV TESTING LINKAGE AND CARE (TLC) | $4.9M | FY2010 | Sep 2010 – Jun 2017 |
| Department of Health and Human Services | TRAINING IN BEHAVIORAL & PREVENTIVE MEDICINE | $4.8M | FY2006 | Apr 2006 – Dec 2027 |
| Department of Health and Human Services | PREVENTION OF WEIGHT GAIN IN YOUNG ADULTS | $4.6M | FY2009 | Aug 2009 – May 2015 |
| Department of Health and Human Services | INCREASING SLEEP DURATION: A NOVEL APPROACH TO WEIGHT CONTROL | $4.4M | FY2009 | Sep 2009 – Aug 2015 |
| Department of Health and Human Services | IMPROVING LINKAGE TO HIV CARE FOLLOWING RELEASE FROM INCARCERATION | $4M | FY2010 | Sep 2010 – Jun 2017 |
| Department of Health and Human Services | ADDRESSING HIV DRUG RESISTANCE RESEARCH GAPS IN A COHORT OF PERINATALLY INFECTED KENYAN CHILDREN AND ADOLESCENTS | $3.9M | FY2019 | Jun 2019 – May 2026 |
| Department of Health and Human Services | FACILITATING HIV/AIDS AND HIV TESTING LITERACY FOR EMERGENCY DEPARTMENT PATIENTS | $3.5M | FY2014 | Jul 2014 – Apr 2020 |
| Department of Health and Human Services | PRENATAL MARIJUANA: IMPACT ON INFANT NEUROBEHAVIOR, STRESS, & EPIGENETIC MECHANISMS | $3.5M | FY2017 | Sep 2017 – Jul 2025 |
| Department of Health and Human Services | THE LIFESPAN/BROWN CRIMINAL JUSTICE RESEARCH PROGRAM ON SUBSTANCE USE AND HIV | $3.5M | FY2014 | Jun 2014 – Dec 2029 |
| Department of Health and Human Services | REAL TIME PHYLOGENY AND CONTACT TRACING TO DISRUPT HIV TRANSMISSION | $3.4M | FY2018 | Mar 2018 – Feb 2025 |
| Department of Health and Human Services | TARGETING COGNITIVE FUNCTION AND INTEROCEPTIVE AWARENESS TO IMPROVE SELF-MANAGEMENT IN PATIENTS WITH CO-MORBID HEART FAILURE AND COGNITIVE IMPAIRMENT. - PROJECT SUMMARY/ABSTRACT DUE TO POPULATION AGEING, HEART FAILURE (HF) IS REACHING PANDEMIC PROPORTIONS AND IS NOW THE MOST COMMON HOSPITAL DISCHARGE DIAGNOSIS AMONG OLDER ADULTS IN THE UNITED STATES. HF CARRIES AN UNFAVORABLE PROGNOSIS, WITH BOTH 6-MONTH HOSPITAL READMISSIONS AND 5-YEAR MORTALITY RATES REACHING 50%. TO IMPROVE CLINICAL OUTCOMES, IT IS CRITICAL THAT PATIENTS IMPLEMENT ADEQUATE SELF-CARE, I.E., THEY ADHERE TO PHARMACOLOGICAL AND LIFESTYLE RECOMMENDATIONS AND MONITOR THEIR SYMPTOMS TO ENSURE THEY RECEIVE MEDICAL ATTENTION IN A TIMELY FASHION. MILD COGNITIVE IMPAIRMENT (MCI) AFFECTS UP TO TWO-THIRDS OF PATIENTS WITH HF AND IS A KEY BARRIER TO THEIR ABILITY TO EFFECTIVELY IMPLEMENT SELF-CARE. DESPITE ITS NEGATIVE IMPACT ON SELF-CARE AND ON CLINICAL OUTCOMES, ONLY A SMALL NUMBER OF SELF-CARE INTERVENTION STUDIES SPECIFICALLY ADDRESS MCI AND INTERVENTIONS TARGETING THIS IMPORTANT COMORBIDITY ARE SORELY NEEDED. THERE IS PRELIMINARY EVIDENCE THAT MINDFULNESS TRAINING (MT) CAN IMPROVE COGNITIVE FUNCTION IN INDIVIDUALS WITH MCI. MT HAS ALSO BEEN SHOWN TO IMPROVE INTEROCEPTIVE AWARENESS, A SKILL WHICH COULD INCREASE THE PATIENT’S ABILITY TO RECOGNIZE WORSENING OF HF SYMPTOMS IN A TIMELY FASHION, RECEIVE TREATMENT SOONER, AND POTENTIALLY PREVENT RE-ADMISSIONS. FINALLY, BY ELICITING THE RELAXATION RESPONSE, MT ENHANCES VAGAL CONTROL, WHICH HAS BEEN ASSOCIATED WITH BETTER COGNITIVE FUNCTION. THIS APPLICATION, DESIGNED IN RESPONSE TO PAR-20-180 “IDENTIFYING INNOVATIVE MECHANISMS OR INTERVENTIONS THAT TARGET MULTIMORBIDITY AND ITS CONSEQUENCES” AND IN LINE WITH NIA INTERESTS, WILL LEVERAGE OUR EXPERTISE WITH REMOTE MT FOR PATIENTS WITH CHRONIC CONDITIONS TO CONDUCT A PHASE II MECHANISTIC RCT WITH THE FOLLOWING OBJECTIVES: A) TO STUDY THE EFFECTS OF MT ON COGNITIVE FUNCTION AND INTEROCEPTIVE AWARENESS IN PATIENTS WITH CO- MORBID MCI AND HF, B) TO ASSESS WHETHER IMPROVEMENTS IN THESE PROXIMAL FACTORS COULD POSITIVELY IMPACT SELF- CARE AND C) TO STUDY THE UNDERLYING PHYSIOLOGICAL MECHANISMS BY WHICH MT COULD IMPROVE COGNITION IN THIS POPULATION. STABLE OUTPATIENTS (N=176) WITH HF AND MCI WILL BE RANDOMLY ASSIGNED TO PHONE-DELIVERED MT (A WEEKLY, 30-MINUTE SESSION FOR 8 WEEKS INTEGRATED WITH A 20-MIN GUIDED DAILY INDIVIDUAL PRACTICE VIA DIGITAL RECORDINGS) PLUS ENHANCED USUAL CARE (EUC) OR TO EUC ALONE. CONSISTENT WITH CURRENT RECOMMENDATIONS, USUAL CARE WILL BE ENHANCED IN BOTH GROUPS WITH SELF-CARE EDUCATION MATERIALS. AT BASELINE, 3 MONTHS (END OF TREATMENT), AND 9 MONTHS SINCE BASELINE PARTICIPANTS WILL UNDERGO COMPREHENSIVE ASSESSMENTS OF COGNITIVE FUNCTION, INTEROCEPTIVE AWARENESS, HF SELF-CARE AND OTHER PSYCHO-BEHAVIORAL FACTORS, CARDIAC VAGAL CONTROL, AND HF BIOMARKERS. THIS IS THE FIRST RIGOROUS INVESTIGATION OF THE EFFECTS OF MT ON COGNITIVE FUNCTION, INTEROCEPTIVE AWARENESS, AND SELF-CARE IN PATIENTS WITH CO-MORBID MCI AND HF. DEMONSTRATING THAT, BY IMPROVING COGNITIVE PERFORMANCE AND INTEROCEPTIVE AWARENESS, MT PROMOTES SELF-CARE IN PATIENTS WITH CO-MORBID HF AND MCI WILL PAVE THE WAY TO THE INTEGRATION OF MT INTO REHABILITATION PROGRAMS AND SELF-CARE INTERVENTIONS TO IMPROVE CLINICAL OUTCOMES IN THIS VULNERABLE POPULATION. | $3.4M | FY2022 | May 2022 – Apr 2027 |
| Department of Health and Human Services | ETHANOL INSULIN/IGF SIGNALING AND NEURONAL MIGRATION | $3.3M | FY1996 | Sep 1996 – Aug 2020 |
| Department of Health and Human Services | FETAL BEHAVIOR, BRAIN & STRESS RESPONSE: ULTRASOUND MARKERS OF MATERNAL SMOKING | $3.3M | FY2013 | Aug 2013 – Apr 2022 |
| Department of Health and Human Services | CHARACTERIZING THE HIV PRE-EXPOSURE PROPHYLAXIS CARE CONTINUUM FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN | $3.3M | FY2017 | Sep 2017 – Jun 2024 |
| Department of Health and Human Services | ELECTRONIC CIGARETTES DURING PREGNANCY: IMPACT ON FETAL DEVELOPMENT | $3.3M | FY2018 | Aug 2018 – May 2027 |
| Department of Health and Human Services | ENHANCING EMOTION REGULATION TO SUPPORT WEIGHT CONTROL EFFORTS IN ADOLESCENTS WITH OVERWEIGHT AND OBESITY | $3M | FY2020 | Sep 2020 – Jun 2026 |
| Department of Health and Human Services | HIV PREVENTION FOR STD CLINIC PATIENTS | $2.9M | FY2003 | Jul 2003 – Jun 2014 |
| Department of Health and Human Services | STUDY OF NOVEL APPROACHES TO WEIGHT GAIN PREVENTION - EXTENSION (SNAP-E) | $2.9M | FY2015 | Sep 2015 – May 2020 |
| Department of Health and Human Services | EFFICACY OF YOGA AS AN ALTERNATIVE THERAPY FOR SMOKING CESSATION | $2.9M | FY2012 | Jul 2012 – Mar 2018 |
| Department of Health and Human Services | PACKAGING AND DISSEMINATING THE JOIN FOR ME PROGRAM IN LOW-INCOME SETTINGS | $2.9M | FY2019 | Apr 2019 – Mar 2025 |
| Department of Health and Human Services | HETEROGENEITY AND PREDICTORS OF STRESS REACTIVITY IN TAKOTSUBO SYNDROME | $2.9M | FY2020 | Mar 2020 – Feb 2025 |
| Department of Health and Human Services | MOTIVATING SMOKERS WITH MOBILITY IMPAIRMENTS TO QUIT SMOKING | $2.8M | FY2009 | Jul 2009 – May 2015 |
| Department of Health and Human Services | MATERNAL SMOKING: HPA AND EPIGENETIC PATHWAYS TO INFANT NEUROBEHAVIORAL DEFICITS | $2.8M | FY2011 | Aug 2011 – Apr 2020 |
| VA/DoDDepartment of Defense | SEXUAL ASSAULT PREVENTION FOR MEN IN THE MILITARY | $2.8M | FY2015 | Sep 2015 – Sep 2024 |
| Department of Health and Human Services | MECHANISMS OF MINDFULNESS TRAINING TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY - ABSTRACT HYPERTENSIVE DISORDERS OF PREGNANCY ARE THE MOST COMMON MEDICAL CONDITION AFFECTING PREGNANCY AND A LEADING CAUSE OF MATERNAL MORBIDITY AND MORTALITY IN THE UNITES STATES. HYPERTENSIVE DISORDERS OF PREGNANCY INCREASE LIFETIME CARDIAC DISEASE RISK IN WOMEN AND INFANTS EXPOSED DURING PREGNANCY AND ARE CONSIDERED AN INDEPENDENT, GENDER-SPECIFIC CARDIOVASCULAR RISK FACTOR BY THE AMERICAN HEART ASSOCIATION. CURRENT INTERVENTIONS TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY ARE EXTREMELY LIMITED AND MINIMALLY EFFECTIVE. MINDFULNESS-BASED INTERVENTIONS HOLD SIGNIFICANT PROMISE AS A NON-PHARMACOLOGICAL INTERVENTION TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY; MINDFULNESS-BASED INTERVENTIONS SIGNIFICANTLY REDUCE BLOOD PRESSURE IN ADULTS WITH HYPERTENSION AND PREHYPERTENSION. HOWEVER, PRENATAL CLINICAL TRIALS OF MINDFULNESS-BASED INTERVENTIONS HAVE EXCLUDED WOMEN AT RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY FROM PARTICIPATING, AND HAVE NOT EXAMINED EFFECTS OF MINDFULNESS ON MATERNAL CARDIOVASCULAR PARAMETERS. OUR PILOT RCT OF PRENATAL MINDFULNESS TRAINING FOR WOMEN AT RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY DEMONSTRATED MEDIUM TO LARGE EFFECTS ON MATERNAL CARDIOVASCULAR PARAMETERS OF RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY, INCLUDING LOWER AMBULATORY BLOOD PRESSURE AND ACCELERATED FETAL GROWTH VELOCITY. HOWEVER, THE MECHANISMS EXPLAINING EFFECTS OF PRENATAL MINDFULNESS TRAINING ON INDICATORS OF RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY ARE UNKNOWN. BUILDING UPON THESE PROMISING PRELIMINARY FINDINGS, THE PROPOSED RCT WILL HARNESS SUBJECTIVE AND OBJECTIVE ECOLOGICAL MOMENTARY ASSESSMENT (EMA) METHODOLOGIES (IN VIVO REPEATED ASSESSMENTS) IN COMBINATION WITH WEARABLE BIOSENSOR TECHNOLOGY TO CAPTURE RICH EPOCHS OF ECOLOGICALLY-VALID PSYCHOLOGICAL (AIM 1), PHYSIOLOGICAL (AIM 2), AND INTERPERSONAL (AIM 3) PROCESSES THROUGH WHICH MINDFULNESS TRAINING MAY LEAD TO IMPROVED MATERNAL CARDIOVASCULAR PARAMETERS AND REDUCED RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY. N=150 PREGNANT WOMEN AT RISK FOR HDP WILL BE RANDOMIZED TO AN 8-WEEK PHONE-DELIVERED MINDFULNESS INTERVENTION OR USUAL CARE. FOR EVERY PARTICIPANT, WE WILL MEASURE MATERNAL CARDIOVASCULAR PARAMETERS (24-HOUR BLOOD PRESSURE AND UTERINE ARTERY RESISTANCE VALUES BY ULTRASOUND DOPPLER) BEFORE AND AFTER THE RCT. ALL PARTICIPANTS WILL COMPLETE EMA FOR 2 WEEKS ‘BURSTS’ BEFORE AND AFTER THE RCT TO EVALUATE MECHANISMS OF MINDFULNESS TRAINING ON MATERNAL CARDIOVASCULAR PARAMETERS. EMA WILL INCLUDE SMARTPHONE-APP BASED EXPERIENCE SAMPLING OF PSYCHOLOGICAL PROCESSES; SMARTPHONE-APP BASED AMBIENT AUDIO SAMPLING (I.E. THE ELECTRONICALLY ACTIVATED RECORDER [EAR] METHOD) AND WEARABLE WRIST-WORN BIOSENSOR MONITORING (HEART RATE AND HEART RATE VARIABILITY) OF PHYSIOLOGICAL RESPONSES TO EVERYDAY EXPERIENCES. RESULTS WILL PROVIDE NEW INSIGHTS INTO 1) EFFECTS OF MINDFULNESS TRAINING ON CARDIOVASCULAR PARAMETERS IN PREGNANCY, 2) PATHOPHYSIOLOGICAL MECHANISMS OF HYPERTENSIVE DISORDERS OF PREGNANCY, AND 3) NEW TARGETS FOR PREVENTION STRATEGIES. | $2.8M | FY2021 | Sep 2021 – Jun 2027 |
| Department of Health and Human Services | HPA & NEURAL RESPONSE TO PEER REJECTION: BIOMARKERS OF ADOLESCENT DEPRESSION RISK | $2.7M | FY2011 | Jun 2011 – Feb 2019 |
| Department of Health and Human Services | PLACENTAL ROLE IN MEDIATING ADVERSE OUTCOMES IN OBSTRUCTIVE SLEEP APNEA | $2.7M | FY2014 | Sep 2014 – Aug 2020 |
| Department of Health and Human Services | A NOVEL CYCLIC PEPTIDE-BASED TREATMENT FOR TBI | $2.6M | FY2016 | Jul 2016 – Jun 2022 |
| Department of Health and Human Services | PLACENTAL GENOMICS IN THE DEVELOPMENTAL CONSEQUENCES OF MARIJUANA USE IN PREGNANCY - PROJECT SUMMARY/ABSTRACT THIS APPLICATION IS RESPONSIVE TO NOT-DA-20-039: EFFECTS OF CANNABIS USE AND CANNABINOIDS ON THE DEVEL- OPING BRAIN. PRENATAL CANNABIS USE IS COMMON AND INCREASING, WITH RATES AS HIGH AS 1 IN 4 IN POOR, YOUNG, UNDERSERVED WOMEN. EXPANDING LEGALIZATION OF CANNABIS HAS LED TO INCREASING AVAILABILITY, USE, PERCEPTIONS OF SAFETY AS WELL AS INCREASED POTENCY. HOWEVER, DATA IS LACKING REGARDING THE IMPACT OF PRENATAL USE OF INCREASE- ED-POTENCY CANNABIS ON OFFSPRING NEURODEVELOPMENT. OUR GROUP IS CURRENTLY CONDUCTING AN INTENSIVE, PROSPECTIVE INVESTIGATION OF THE IMPACT OF MATERNAL PRENATAL CANNABIS USE ON INFANT NEURODEVELOPMENT (R01DA044504). OUR ONGOING STUDY HAS YIELDED PRELIMINARY EVIDENCE FOR AN IMPACT OF PRENATAL CANNABIS ON OFFSPRING GROWTH AND NEURODEVELOPMENT, BUT DOES NOT INVOLVE A COMPREHENSIVE INTERROGATION OF GENOMIC PATHWAYS UNDERLYING THESE ASSOCIATIONS. PINPOINTING GENOMIC PATHWAYS WILL ALLOW US TO IDENTIFY BIOMARKERS OF FETAL HARM AND DEVELOP NOVEL SCREENING TOOLS AND INTERVENTION TARGETS TO PROTECT AND TREAT EXPOSED OFFSPRING. THE PLACENTA IS A UNIQUE ORGAN THAT REGULATES THE INTRAUTERINE ENVIRONMENT, MATERNAL-FETAL COMMUNICATION--INCLUDING PASSAGE OF CANNABINOIDS--AND PLAYS A CRITICAL ROLE IN SUPPORTING FETAL GROWTH AND NEURODEVELOPMENT. SEMINAL WORK BY OUR GROUP HAS REVEALED THAT THE PRENATAL ENVIRONMENT IMPACTS PLACENTA FUNCTION, THAT ALTERATIONS IN PLACENTA FUNCTION CAN BE INFORMED BY GENOMIC PROFILING OF THE PLACENTA, AND THAT ALTERATIONS IN PLACENTA GENOMIC PROFILES ARE LINKED TO NEWBORN GROWTH AND NEUROBEHAVIOR. MICRORNAS (MIRNAS) ARE AN UNDERSTUDIED ASPECT OF PLACENTA EPIGENETIC REGULATION; MIRNAS ARE SHORT NON-CODING RNAS THAT REGULATE GENE EXPRESSION POST-TRANSCRIPTIONALLY AND ARE CRIT- ICAL REGULATORS OF PLACENTAL- AND NEURO-DEVELOPMENT. A RECENT INITIAL STUDY SUPPORTS THE HYPOTHESIS THAT MATERNAL CANNABIS MAY IMPACT PLACENTA IMMUNE GENE NETWORKS, AND OFFSPRING ANXIETY, BUT WAS NOT DESIGNED TO INVESTIGATE PRENATAL CANNABIS, ONLY INCLUDED A SMALL NUMBER OF CANNABIS USERS, AND DID NOT INCLUDE MIRNA. WE PROPOSE A COMPREHENSIVE PLACENTA MIRNA AND MRNA PROFILING STUDY TO DEFINE THE IMPACT OF PRENATAL CANNABIS EXPOSURE ON PLACENTA GENOMIC ACTIVITY AND INFANT NEURODEVELOPMENT. WE TEST THE CENTRAL HYPOTHESIS THAT PRENATAL CANNABIS EXPOSURE LEADS TO UNIQUE ALTERATIONS IN PLACENTA ENDOCANNABINOID, NEURONAL DEVELOPMENT, IMMUNE, AND STRESS SIGNALING PATHWAYS, AND THAT THESE FUNCTIONAL GENOMIC FEATURES WILL ALSO IMPACT INFANT DE- VELOPMENT. WE LEVERAGE OUR ONGOING COHORT (N=100 CANNABIS USERS, N=100 NON-USERS) DESIGNED TO ASSESS THE IMPACT OF PRENATAL CANNABIS ON INFANT NEURODEVELOPMENT AND INCLUDING PLACENTA COLLECTION FOR CANDIDATE METHYL- ATION ASSAYS. OUR PROPOSED GENOMIC MECHANISMS STUDY INVOLVES THE ADDITION OF STATE-OF-THE-ART WHOLE TRANSCRIP- TOME RNA-SEQUENCING (MRNA AND MIRNA) TO DELINEATE THE FUNCTIONAL IMPACTS OF PRENATAL CANNABIS EXPOSURE AND LINKS TO INFANT DEVELOPMENT. DETERMINING GENOMIC PROFILES UNDERLYING THE IMPACT OF PRENATAL CANNABIS ON INFANT DEVELOPMENT IS TIMELY AND OFFERS POTENTIAL TO IDENTIFY BIOMARKERS OF EXPOSURE AND OFFSPRING RISK AS WELL AS MOLECULAR TARGETS FOR FUTURE INTERVENTION EFFORTS. | $2.6M | FY2023 | Jun 2023 – Mar 2028 |
| Department of Health and Human Services | OPTIMIZING JUST-IN-TIME ADAPTIVE INTERVENTION TO IMPROVE DIETARY ADHERENCE IN BEHAVIORAL OBESITY TREATMENT: A MICRO-RANDOMIZED TRIAL | $2.6M | FY2020 | Aug 2020 – May 2026 |
| Department of Health and Human Services | COMMUNITY- AND CLINIC-BASED SUBSTANCE USE TREATMENT AND HIV PREVENTION FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN | $2.6M | FY2018 | Sep 2018 – Mar 2024 |
| Department of Health and Human Services | PREDICTORS OF DE NOVO DEVELOPMENT OF OBSTRUCTIVE SLEEP APNEA IN PREGNANCY | $2.6M | FY2016 | Aug 2016 – Jun 2022 |
| Department of Health and Human Services | MATERNAL DEPRESSION PLACENTAL HPA REGULATION & FETAL-NEONATAL STRESS RESPONSE | $2.6M | FY2007 | Sep 2007 – Jul 2012 |
| Department of Health and Human Services | PRAGMATIC TRIAL OF TECHNOLOGY-SUPPORTED BEHAVIORAL OBESITY TREATMENT IN THE PRIMARY CARE SETTING: A MULTIPHASE EFFECTIVENESS AND IMPLEMENTATION HYBRID DESIGN | $2.6M | FY2017 | Sep 2017 – Jun 2023 |
| Department of Health and Human Services | A RANDOMIZED TRIAL OF CONTINUED METHADONE MAINTENANCE VS. DETOXIFICATION IN JAIL | $2.5M | FY2009 | Aug 2009 – May 2014 |
| Department of Health and Human Services | EFFICACY OF EXERCISE VIDEOGAMES FOR PHYSICAL ACTIVITY ADOPTION AND MAINTENANCE | $2.5M | FY2011 | Sep 2011 – May 2018 |
| Department of Health and Human Services | USING MULTIMODAL REAL-TIME ASSESSMENT TO PHENOTYPE DIETARY NON-ADHERENCE BEHAVIORS THAT CONTRIBUTE TO POOR OUTCOMES IN BEHAVIORAL OBESITY TREATMENT - PROJECT SUMMARY/ABSTRACT BEHAVIORAL OBESITY TREATMENT (BOT) PRODUCES CLINICALLY SIGNIFICANT WEIGHT LOSS AND REDUCED DISEASE RISK/SEVERITY FOR MANY INDIVIDUALS WITH OVERWEIGHT/OBESITY. YET, MANY PATIENTS FALL SHORT OF EXPECTED OUTCOMES, WHICH CAN BE LARGELY ATTRIBUTED TO LAPSES FROM THE RECOMMENDED DIET. OUR WORK HAS SHOWN THAT DIETARY LAPSES (SPECIFIC INSTANCES OF NONADHERENCE TO THE PRESCRIBED CALORIE TARGET(S) IN BOT) ARE FREQUENT DURING WEIGHT LOSS ATTEMPTS, AND ARE ASSOCIATED WITH POORER WEIGHT LOSSES AND HIGHER DAILY ENERGY INTAKE. DESPITE THE POTENTIAL FOR LAPSES TO INFLUENCE BOT OUTCOMES AND HEALTH, POORLY UNDERSTOOD VARIABILITY IN TYPES OF LAPSE BEHAVIORS AND THEIR MECHANISMS INTERFERES WITH OUR ABILITY TO INTERVENE ON THEM. IN OUR RESEARCH, PARTICIPANTS HAVE IDENTIFIED DISTINCT BEHAVIORS ASSOCIATED WITH LAPSE (E.G., EATING AN OFF-PLAN FOOD, EATING TOO LARGE A PORTION OF FOOD). ACROSS SEVERAL STUDIES, WE HAVE ESTABLISHED THE CONCEPT OF “DIETARY LAPSE TYPES” (I.E., SPECIFIC EATING BEHAVIOR(S) AND CONTEXTUAL FACTORS UNDERLYING A DIETARY LAPSE). WE HAVE SHOWN THAT BEHAVIORAL, PSYCHOSOCIAL, AND CONTEXTUAL MECHANISMS MAY DIFFER ACROSS DIETARY LAPSE TYPES, AND THAT SOME LAPSE TYPES APPEAR TO BE MORE DETRIMENTAL THAN OTHERS FOR WEIGHT CONTROL. ELUCIDATING CLEAR DIETARY LAPSE TYPES THEREFORE HAS MAJOR POTENTIAL FOR UNDERSTANDING AND IMPROVING ADHERENCE IN BOT, BUT WE HAVE BEEN UNABLE TO DO SO BECAUSE OUR WORK IS LIMITED TO SECONDARY ANALYSES OF DATA FROM LARGER TRIALS THAT HAVE INCOMPLETE MEASURES OF LAPSE TYPES, POTENTIAL MECHANISMS, AND CLINICAL OUTCOMES. WE PROPOSE TO EXTEND OUR RESEARCH BY USING BEHAVIORAL PHENOTYPING (I.E., DATA-DRIVEN IDENTIFICATION OF UNDERLYING BEHAVIORAL, PSYCHOLOGICAL, AND CONTEXTUAL FACTORS OF A HEALTH BEHAVIOR) TO ESTABLISH LAPSE PHENOTYPES, AND UNDERSTAND THEIR IMPACT ON CLINICAL OUTCOMES. WHILE TYPICAL PHENOTYPING STUDIES CLUSTER INDIVIDUALS VIA UNIQUE CHARACTERISTICS, WE AIM TO UNDERSTAND PHENOTYPES OF LAPSES AS A SPECIFIC BEHAVIOR WITHIN INDIVIDUALS. WE WILL USE MULTIMODAL REAL-TIME ASSESSMENT TOOLS WITHIN A MULTI-LEVEL FACTOR ANALYSIS FRAMEWORK TO UNCOVER PHENOTYPES WHILE ACCOUNTING FOR BEHAVIORS OCCURRING WITHIN INDIVIDUALS AND WITHIN DAYS. ADULTS WITH OVERWEIGHT/OBESITY (N=150) WILL PARTICIPATE IN A WELL-ESTABLISHED 12-MO. ONLINE BOT AND 6-MO. WEIGHT LOSS MAINTENANCE PERIOD. PARTICIPANTS WILL COMPLETE A 14-DAY LAPSE PHENOTYPING ASSESSMENT BATTERY AT BASELINE, 4, 8, 12 AND 18 MONTHS. EMA AND PASSIVE SENSING TOOLS (I.E., WRIST DEVICES, GEOLOCATION) WILL ASSESS DIETARY LAPSES AND RELEVANT PHENOTYPING CHARACTERISTICS IDENTIFIED FROM OUR PRIOR WORK. PARTICIPANT ENERGY INTAKE WILL BE ASSESSED WITH 24-HOUR DIETARY RECALLS AND WEIGHT WILL BE MEASURED PRE- AND POST- ASSESSMENT. RESULTS WILL YIELD A SET OF LAPSE PHENOTYPES AND KNOWLEDGE OF THEIR UNDERLYING MECHANISMS, WHICH WILL CAN INFORM NOVEL INTERVENTIONS TO IMPROVE DIETARY ADHERENCE IN BOT (AND IN OTHER TREATMENTS FOR WHICH DIETARY ADHERENCE IS CRITICAL). THIS INNOVATIVE APPROACH WILL ADVANCE THE SCIENCE OF ADHERENCE MORE BROADLY BY SUPPORTING THE DEVELOPMENT OF SOPHISTICATED THEORETICAL MODELS OF ADHERENCE BEHAVIOR AND GIVE RISE TO NOVEL PHENOTYPING METHODS THAT CAN BE LEVERAGED TO BETTER UNDERSTAND AND TREAT NON-ADHERENCE TO OTHER HEALTH BEHAVIORS (E.G., MEDICATIONS, ACTIVITY). | $2.5M | FY2022 | May 2022 – Apr 2027 |
| Department of Health and Human Services | SYSTEM-BASED TRACKING AND TREATMENT FOR EMERGENCY PATIENTS WHO SMOKE: STTEPS | $2.5M | FY2011 | Aug 2011 – Jun 2017 |
| Department of Health and Human Services | EFFICACY OF RESISTANCE TRAINING AS AN AID TO SMOKING CESSATION TREATMENT | $2.4M | FY2013 | Apr 2013 – Mar 2019 |
| Department of Health and Human Services | RAPID EVALUATION OF INNOVATIVE INTERVENTION COMPONENTS TO MAXIMIZE THE HEALTH BENEFITS OF BEHAVIORAL OBESITY TREATMENT DELIVERED ONLINE: AN APPLICATION OF MULTIPHASE OPTIMIZATION STRATEGY | $2.4M | FY2019 | Jun 2019 – Dec 2024 |
| Department of Health and Human Services | CARDIAC UBIQUITIN LIGASES: REGULATION AND ROLE IN MODULATING CARDIAC EXCITATION. | $2.4M | FY2017 | Jul 2017 – Jun 2022 |
| Department of Health and Human Services | TEACHING NOVEL VALUES-BASED SKILLS TO IMPROVE LONG-TERM WEIGHT LOSS: A RANDOMIZED TRIAL EXAMINING THE EFFICACY OF A WEIGHT LOSS MAINTENANCE INTERVENTION BASED ON ACCEPTANCE AND COMMITMENT THERAPY | $2.3M | FY2019 | Sep 2019 – Aug 2025 |
| Department of Health and Human Services | ADAPTING EPISODIC FUTURE THINKING FOR BEHAVIORAL WEIGHT LOSS: COMPARING STRATEGIES AND CHARACTERIZING TREATMENT RESPONSE - PROJECT SUMMARY/ABSTRACT OBESITY IS ONE OF THE MOST IMPORTANT PUBLIC HEALTH ISSUES TODAY, CONTRIBUTING TO MANY OF THE LEADING CAUSES OF MORBIDITY AND MORTALITY IN THE UNITED STATES. DESPITE STRONG DESIRES TO ACHIEVE LONG-TERM WEIGHT LOSS GOALS, INDIVIDUALS WITH OBESITY TEND TO OVERVALUE IMMEDIATE REWARDS AND DISCOUNT THE FUTURE. EPISODIC FUTURE THINKING (EFT), A COGNITIVE STRATEGY IN WHICH INDIVIDUALS ENVISION THEMSELVES IN THE FUTURE AND SIMULATE POTENTIAL EXPERIENCES, HAS BEEN SHOWN TO HELP SHIFT ATTENTION TO THE FUTURE, IMPROVE FOOD CHOICES, AND REDUCE INTAKE. MOST PREVIOUS STUDIES HAVE USED PROMOTION-FOCUSED EFT, IN WHICH PARTICIPANTS ENVISION THEMSELVES EXPERIENCING POSITIVE FUTURE OUTCOMES. HOWEVER, THEORIES SUGGEST IT IS POSSIBLE EFT-BASED STRATEGIES MAY BE ALTERNATIVELY FOCUSED ON PREVENTION, GUIDING PARTICIPANTS TO CONSIDER FUTURE CONSEQUENCES OF UNHEALTHY CHOICES. OUR RECENT PILOT (R03 DK106405) RANDOMIZED CONTROLLED TRIAL IMPLEMENTED THESE APPROACHES IN A 3-MONTH INTERNET-DELIVERED BEHAVIORAL WEIGHT LOSS PROGRAM (IBWL). PARTICIPANTS (N=95) WERE RANDOMIZED TO EITHER: (1) STANDARD IBWL (NO EFT-BASED STRATEGIES), (2) PREVENT (IBWL + EFT-BASED STRATEGIES FOCUSED ON PREVENTING LONG-TERM NEGATIVE CONSEQUENCES OF UNHEALTHY CHOICES), OR (3) PROMOTE (IBWL + EFT-BASED STRATEGIES FOCUSED ON PROMOTING LONG-TERM BENEFITS OF HEALTHY CHOICES). PREVENT WAS SUPERIOR TO STANDARD IBWL PRODUCING THE GREATEST OVERALL WEIGHT LOSS, WHICH WAS COUPLED WITH REDUCED FOOD REWARD DRIVE AND INCREASED SELF-CONTROL. THIS IS CONSISTENT WITH OUR PREVIOUS WORK IN WHICH USE OF THE PREVENT STRATEGY WAS ASSOCIATED WITH REDUCED CRAVING AND INCREASED INHIBITORY CONTROL NEURAL ACTIVITY. ALTHOUGH PREVENT PRODUCED THE GREATEST WEIGHT LOSS, VARIABILITY SUGGESTS INDIVIDUAL DIFFERENCES MAY MODERATE SUCCESS IN EACH TREATMENT. FOR INSTANCE, INDIVIDUALS HIGH IN PROMOTION-FOCUS WERE MORE LIKELY TO HAVE GREATER WEIGHT LOSS IN PROMOTE. WE NOW PROPOSE A FULLY POWERED RANDOMIZED CONTROLLED TRIAL (RCT) TO TEST IF EITHER OF THESE NOVEL APPROACHES MAY PROVIDE BENEFIT OVER STANDARD TREATMENT. FURTHER, THE PROPOSED STUDY WILL SEEK TO IDENTIFY MODERATORS THAT PREDICT SUCCESS, DETERMINING FOR WHOM EACH STRATEGY IS BEST. INDIVIDUALS WITH OVERWEIGHT/OBESITY (N=360) WILL BE RANDOMIZED TO 12 MONTHS OF EITHER (1) STANDARD IBWL, (2) PREVENT, OR (3) PROMOTE. ALL PARTICIPANTS WILL HAVE AN INTRODUCTORY TRAINING SESSION, DURING WHICH PREVENT AND PROMOTE GROUPS WILL RECEIVE TRAINING IN THEIR SPECIFIC EFT-BASED STRATEGY. IBWL LESSONS WILL THEN BE WEEKLY FOR 3 MONTHS FOLLOWED BY A ‘REFRESHER’ TRAINING SESSION FOR ALL GROUPS, AND MONTHLY IBWL FOR THE REMAINING 9 MONTHS. IN PREVENT AND PROMOTE IBWL LESSONS AND FEEDBACK MESSAGES WILL CONTINUOUSLY FEATURE EXERCISES AND REMINDERS TO UTILIZE THE ASSIGNED EFT-BASED STRATEGIES. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, DURING TREATMENT AT 3 AND 6 MONTHS, AT THE END OF TREATMENT (12 MONTHS), AND 6 MONTHS POST-TREATMENT (18 MONTHS). THE PRIMARY OUTCOME IS WEIGHT CHANGE. THIS RCT WILL PROVIDE CRITICAL INSIGHT INTO NOVEL TREATMENT STRATEGIES FOR IMPROVING WEIGHT LOSS AND MAY LEAD TO FUTURE OPTIMIZATION OF WEIGHT LOSS VIA INDIVIDUALLY TAILORED TREATMENT. | $2.3M | FY2021 | Sep 2021 – Aug 2027 |
| Department of Health and Human Services | PHONE COACHING AS A RESCUE STRATEGY FOR EARLY NON-RESPONDERS ENROLLED IN AN INTERNET-DELIVERED WEIGHT LOSS PROGRAM | $2.3M | FY2018 | Sep 2018 – Sep 2023 |
| Department of Health and Human Services | NON-TRIBOLOGIC BIOACTIVITY OF LUBRICIN | $2.2M | FY2016 | May 2016 – Apr 2022 |
| Department of Health and Human Services | LIVE SMART: SMARTPHONE INTERVENTION FOR WEIGHT CONTROL | $2.2M | FY2012 | Jul 2012 – Jun 2017 |
| Department of Health and Human Services | ESTABLISHING MULTI-SITE FEASIBILITY AND FIDELITYOF YOGA TO IMPROVE MANAGEMENT OF TYPE-2 DIABETES - PROJECT ABSTRACT/SUMMARY EFFECTIVE INTERVENTIONS ARE URGENTLY NEEDED TO HELP ADULTS WITH TYPE 2 DIABETES (T2DM) ACHIEVE AND MAINTAIN A HEALTHY LIFESTYLE. A SIGNIFICANT AND GROWING PROPORTION OF AMERICANS, NEARLY 1 IN 10, HAVE T2DM.[1] UNCONTROLLED DIABETES CAUSES SERIOUS DAMAGE TO KIDNEYS, EYES AND NERVES, AND INCREASES RISK OF HEART DISEASE AND STROKE.[2,3] CONTROLLING BLOOD GLUCOSE IS CRUCIAL TO AVOID THESE COMPLICATIONS. ACHIEVING GLYCEMIC CONTROL REQUIRES ATTENTION TO MULTIPLE LIFESTYLE BEHAVIORS INCLUDING HEALTHY EATING AND REGULAR PHYSICAL ACTIVITY.[4-7] HOWEVER, ONLY 39% OF ADULTS WITH DIABETES ARE PHYSICALLY ACTIVE.[8] TRADITIONAL (WESTERN) EXERCISE (E.G., WALKING, CYCLING) IMPROVES BLOOD GLUCOSE LEVELS IN ADULTS WITH T2DM.[9,10] LONG-TERM ADHERENCE IS ESSENTIAL TO MAINTAIN HEALTH BENEFITS. HOWEVER, INDIVIDUALS WITH T2DM FACE GREATER BARRIERS TO SUSTAINING PHYSICAL ACTIVITY COMPARED TO THEIR HEALTHY PEERS DUE TO THE PREVALENCE OF OVERWEIGHT AND OBESITY AMONG THOSE WITH T2DM AND THE CO- MORBIDITIES OF DIABETES (E.G., POOR CIRCULATION, FOOT CARE ISSUES) THAT CREATE MORE DISCOMFORT DURING EXERCISE. YOGA IS SIMILAR TO TRADITIONAL EXERCISE IN ITS ABILITY TO IMPROVE PHYSICAL FITNESS BUT CAN BE HIGHLY ACCOMMODATING TO THOSE WITH PHYSICAL LIMITATIONS.[11] MOREOVER, AS A MINDFULNESS PRACTICE, WITH EMPHASIS ON RELAXATION, MEDITATION, AND DEEP BREATHING, YOGA’S EFFECTS ON STRESS REDUCTION MAY HAVE SPECIAL RELEVANCE TO PEOPLE WITH T2DM.[12-14] INCREASED MINDFULNESS LEADS TO IMPROVED SELF-CARE BEHAVIORS INCLUDING PHYSICAL ACTIVITY. RECENT META-ANALYSES SUGGEST A BENEFICIAL EFFECT OF YOGA ON GLYCEMIC OUTCOMES.[15,16] HOWEVER, EXISTING STUDIES HAVE GENERALLY BEEN OF LOW QUALITY AND CONDUCTED WITH NON-US POPULATIONS. THIS U01 APPLICATION IS THE NEXT LOGICAL STEP FOLLOWING SUCCESSFUL CONCLUSION OF OUR PILOT YOGA INTERVENTION FOR ADULTS WITH T2DM (R21AT008830). FEASIBILITY AND ACCEPTABILITY WERE HIGH AS MEASURED BY PROGRAM ATTENDANCE (>80% OF SESSIONS), STUDY COMPLETION (92% OF PARTICIPANTS) AND PARTICIPANT SATISFACTION (M=4.6 ±0.57, 1-5 SCALE; SECTION 4.1.2). YOGA ALSO IMPROVED DIABETES SELF-CARE, QUALITY OF LIFE AND LED TO REDUCTIONS IN EMOTIONAL DISTRESS AND HBA1C.[17,18] THE PROPOSED STUDY WILL BUILD ON THESE EFFORTS BY RANDOMIZING A DIVERSE SAMPLE OF 90 ADULTS WITH T2DM FROM THREE DIFFERENT STATES (RI, MA, AND AL) TO A 12-WEEK PROGRAM OF EITHER (1) YOGA OR (2) STANDARD EXERCISE (SE) WITH FOLLOW UP AT 3 AND 6-MONTHS POST-TREATMENT. RESULTS OF THIS STUDY WILL DETERMINE OUR ABILITY TO DELIVER THESE INTERVENTIONS WITH STRONG RIGOR AND FIDELITY ACROSS MULTIPLE SITES AND WILL ESTABLISH THE FEASIBILITY AND ACCEPTABILITY OF THIS INTERVENTION ACROSS RACIALLY AND ETHNICALLY DIVERSE POPULATIONS. WE WILL ALSO EXAMINE FACTORS (E.G., OUTCOME EXPECTATIONS, BARRIERS TO HOME PRACTICE) THAT PROMOTE LONG-TERM ADHERENCE TO YOGA/PHYSICAL ACTIVITY. SUCCESSFUL CONCLUSION OF THIS U01 WILL STRENGTHEN FUTURE APPLICATIONS FOR A MULTI-SITE RCT TO RIGOROUSLY TEST THE EFFICACY OF YOGA FOR IMPROVING HBA1C AND DIABETES MANAGEMENT. IF SUPPORTED, YOGA COULD OFFER AN ATTRACTIVE, SUSTAINABLE FORM OF PHYSICAL ACTIVITY FOR FUTURE DIABETES MANAGEMENT PROGRAMS. | $2.1M | FY2021 | Jun 2021 – Nov 2025 |
| Department of Health and Human Services | USE OF BIOMIMICRY TO DETERMINE THE EFFECT OF SEPSIS ON NEUTROPHIL TRACTION | $2.1M | FY2016 | Dec 2015 – Nov 2021 |
| Department of Health and Human Services | BEHAVIORAL WEIGHT LOSS AS A TREATMENT FOR MIGRAINE IN OBESE WOMEN | $2.1M | FY2012 | Jul 2012 – Jun 2017 |
| Department of Health and Human Services | PSYCHOSOCIAL, IMMUNOLOGICAL AND BIOBEHAVIORAL BENEFITS OF STRESS MANAGEMENT INTERVENTIONS FOR CHRONIC DISEASES: COMPREHENSIVE SYSTEMATIC REVIEW AND M | $2M | FY2016 | Apr 2016 – Mar 2021 |
| VA/DoDDepartment of Defense | INTRA-ARTICULAR INJECTION OF ALPHA-2 MACROGLOBULIN PREVENTS POST-TRAUMATIC OSTEOARTHRITIS | $1.9M | FY2019 | Aug 2019 – Feb 2024 |
| Department of Health and Human Services | ACCEPTANCE BASED BEHAVIORAL INTERVENTION FOR WEIGHT LOSS: A RANDOMIZED TRIAL | $1.9M | FY2011 | Apr 2011 – Mar 2017 |
| Department of Health and Human Services | CONTROL SYSTEMS ENGINEERING TO ADDRESS THE PROBLEM OF WEIGHT LOSS MAINTENANCE: A SYSTEM IDENTIFICATION EXPERIMENT TO MODEL BEHAVIORAL & PSYCHOSOCIAL FACTORS MEASURED BY ECOLOGICAL MOMENTARY ASSESSMENT - PROJECT SUMMARY/ABSTRACT THE MOST MAJOR AND CRITICAL BARRIER TO THE TREATMENT OF OBESITY AND COMORBID CONDITIONS IS WEIGHT LOSS MAINTENANCE. A RANGE OF ESTABLISHED TREATMENTS RELIABLY PRODUCE CLINICALLY SIGNIFICANT INITIAL WEIGHT LOSSES OF 3- 30% OF BODY WEIGHT, WHICH SUBSTANTIALLY REDUCE RISK AND SEVERITY OF DISEASE, EVEN WHEN THE WEIGHT LOSS IS MODEST. HOWEVER, WEIGHT LOSS MAINTENANCE IS UNIFORMLY POOR, WITH MOST PATIENTS REGAINING AT LEAST SOME WEIGHT AND BEHAVIORALLY TREATED PATIENTS RETURNING TO BASELINE WEIGHT WITHIN 5 YEARS, THEREBY RENEWING RISK FOR WEIGHT-RELATED ILLNESS. WHILE REGAIN IS COMMON, IT IS DIFFICULT TO PREDICT WHEN OR WHY AN INDIVIDUAL WILL BEGIN TO REGAIN LOST WEIGHT. WE THEREFORE PROPOSE AN EXPERIMENT THAT WILL ENABLE A FUTURE JUST-IN-TIME ADAPTIVE INTERVENTION (JITAI) THAT PASSIVELY MONITORS TRIGGERS FOR LAPSE, IDENTIFIES WHICH TRIGGERS ARE MOST LIKELY TO CONTRIBUTE TO LAPSE FOR EACH PATIENT, ACCURATELY PREDICTS WHEN A PATIENT IS ENTERING A PERIOD OF HEIGHTENED RISK FOR LAPSE, DETERMINES THE TYPE(S) OF INTERVENTION(S) THAT ARE LIKELY TO PREVENT THE LAPSE, ADMINISTERS INTERVENTION FOR AS LONG AS NEEDED TO REESTABLISH HEALTHY BEHAVIORAL PATTERNS FOR WEIGHT MAINTENANCE, AND THEN RETURNS TO PASSIVE MONITORING. THIS AUTOMATED INTERVENTION IS NEARLY WITHIN REACH VIA A COMBINATION OF MOBILE TECHNOLOGIES, ANALYTICS, AND BEHAVIORAL INTERVENTION TECHNIQUES THAT OUR TEAM HAS ALREADY ESTABLISHED, INCLUDING: (A) AN ECOLOGICAL MOMENTARY ASSESSMENT PLATFORM TO MEASURE DAILY WEIGHT AND RELATED BEHAVIORAL AND PSYCHOSOCIAL INFLUENCES; (B) AN ANALYTIC FRAMEWORK, CONTROL SYSTEMS ENGINEERING, CAPABLE OF MODELING COMPLEX PATTERNS OF BEHAVIORAL AND PSYCHOSOCIAL INFLUENCES ON WEIGHT, AND DETERMINING HOW BEST TO INTERVENE ON THIS “SYSTEM” TO FACILITATE WEIGHT LOSS MAINTENANCE; AND (C) A TOOLBOX OF EMPIRICALLY VALIDATED BEHAVIORAL INTERVENTION STRATEGIES KNOWN TO BE EFFECTIVE FOR ADDRESSING COMMON CAUSES OF WEIGHT REGAIN. THIS PROPOSAL AIMS TO SUPPORT OUR MULTIDISCIPLINARY TEAM IN COMBINING OUR AREAS OF EXPERTISE AND PRIOR WORK TO ENABLE A “SYSTEM IDENTIFICATION (ID) EXPERIMENT” WITH N=120 PARTICIPANTS WHO HAVE RECENTLY LOST =3% OF INITIAL BODY WEIGHT IN A 6-MONTH BEHAVIORAL OBESITY TREATMENT (N=180 WILL UNDERGO BEHAVIORAL OBESITY TREATMENT TO PRODUCE THIS SAMPLE), WHO WILL BE STUDIED OVER A 12-MONTH MAINTENANCE PERIOD. THE DATA WILL BE USED TO VALIDATE AND REFINE A THEORETICAL MODEL OF WEIGHT LOSS MAINTENANCE. DURING THE STUDY, 4 INTERVENTIONS FROM THE BEHAVIORAL TOOLBOX WILL BE ADMINISTERED RANDOMLY, THUS PROVIDING NECESSARY DATA ON: (A) HOW LAPSE TRIGGERS ARE RELATED TO EACH OTHER AND WEIGHT, AND (B) WHICH INTERVENTIONS ARE EFFECTIVE FOR ADDRESSING WHICH TRIGGERS, FOR WHOM, AND UNDER WHAT CIRCUMSTANCES. THE END RESULT OF THIS PROJECT WILL BE A CONTROL SYSTEMS ALGORITHM THAT CAN PREDICT WHEN, FOR WHOM, AND HOW TO INTERVENE TO PREVENT WEIGHT REGAIN, AND A MOBILE PLATFORM THAT CAN BE USED TO DELIVER JITAI IN THE NEXT PHASE OF RESEARCH. THIS HIGHLY INNOVATIVE APPROACH TO WEIGHT LOSS MAINTENANCE COULD ULTIMATELY PREVENT REGAIN IN LARGE NUMBERS OF INDIVIDUALS AT LOW COST USING SMARTPHONE TECHNOLOGY THAT IS ALREADY UBIQUITOUS. | $1.9M | FY2023 | Sep 2023 – Jun 2028 |
| Department of Health and Human Services | OPTIMIZING ANTIMICROBIAL USE IN MAINTENANCE DIALYSIS UNITS (OPTIMUS) | $1.8M | FY2020 | Jul 2020 – Jun 2026 |
| Department of Health and Human Services | A REMOTE-BASED YOGA INTERVENTION FOR IMPROVING LONG-TERM WEIGHT LOSS - PROJECT SUMMARY EFFECTIVE INTERVENTIONS WITH STRONG DISSEMINATION POTENTIAL ARE CRITICAL FOR ADDRESSING THE OBESITY EPIDEMIC. INTERNET-DELIVERED WEIGHT LOSS (IDWL) PROGRAMS OVERCOME MANY OF THE BARRIERS COMMON TO FACE-TO-FACE INTERVENTIONS (E.G., GEOGRAPHICAL CONSTRAINTS, LACK OF CHILDCARE, HIGH COST), BUT WEIGHT LOSSES ARE APPROXIMATELY HALF OF THAT OBSERVED WITHIN IN-PERSON TREATMENT. NOVEL APPROACHES FOR IMPROVING LONG-TERM WEIGHT LOSS (WL) WITHIN IDWL PROGRAMS ARE NEEDED. YOGA HAS BEEN FOUND TO BE AN EFFECTIVE STRATEGY FOR TREATING A VARIETY OF HEALTH CONDITIONS (E.G., CVD RISK FACTORS, DEPRESSION, PAIN SYNDROMES), BUT HAS BEEN LARGELY OVERLOOKED WITHIN THE CONTEXT OF OBESITY MANAGEMENT. YOGA HAS ALSO BEEN SHOWN TO STRENGTHEN SELF-REGULATORY SKILLS (E.G., EMOTION REGULATION, COGNITIVE REGULATION, AND SELF-RELATED PROCESSES) WHICH ARE IMPORTANT FOR KEEPING WL OFF LONG-TERM. NONETHELESS, ONLY TWO RANDOMIZED TRIALS TO DATE HAVE COMBINED YOGA AND BEHAVIORAL WL TREATMENT. WHILE FINDINGS ARE INITIALLY PROMISING, SIGNIFICANT LIMITATIONS INCLUDE A LACK OF A CONTROL GROUP AND SMALL SAMPLE SIZE IN ONE STUDY AND A SHORT FOLLOW-UP (12 WEEKS) IN THE OTHER. ALSO, MECHANISMS THROUGH WHICH YOGA IMPACTS WL WITHIN A WEIGHT MANAGEMENT PROGRAM HAVE NOT BEEN EXPLORED. IN OUR PILOT STUDY, WE FOUND THAT PROVIDING YOGA FOLLOWING THREE MONTHS OF BEHAVIORAL WL TREATMENT LED TO FAVORABLE EFFECTS ON DIETARY LAPSES (I.E., DISCRETE EPISODES OF DIETARY NON-ADHERENCE WHICH THREATEN WL), IMPROVED AFFECT, AND INCREASED ABILITY TO RESIST DIETARY TEMPTATIONS COMPARED TO A CONTACT-MATCHED CONTROL. FURTHER, YOGA HAD A SIGNIFICANT EFFECT ON WL AND MEASURES OF SELF-REGULATION (DISTRESS TOLERANCE, MINDFULNESS, AND SELF-COMPASSION) AMONG INDIVIDUALS WHO LOST MORE WEIGHT WITHIN THE FIRST THREE MONTHS OF TREATMENT. ADHERENCE TO THE YOGA INTERVENTION, RETENTION, AND PROGRAM SATISFACTION RATINGS WERE HIGH. THE PROPOSED TRIAL EXPANDS UPON THESE PROMISING PRELIMINARY FINDINGS BY INCREASING THE LENGTH OF YOGA TREATMENT (3 TO 9 MONTHS), ASSESSING PARTICIPANTS OVER A LONGER, 18-MONTH PERIOD, BROADENING PARTICIPANT CHARACTERISTICS (INCLUDING MEN AND INCREASING RACIAL/ETHNIC DIVERSITY), AND INCREASING THE SAMPLE SIZE, SO THAT IT IS SUFFICIENTLY POWERED TO EXAMINE PRIMARY (WL) AND SECONDARY OUTCOMES (DIETARY LAPSES AND OTHER UNCOMFORTABLE EXPERIENCES WHICH COULD TRIGGER A DIETARY LAPSE) AT 12 MONTHS. FURTHER, IT SEEKS TO FILL AN IMPORTANT GAP IN THE LITERATURE BY FORMALLY ASSESSING THE MECHANISMS THROUGH WHICH YOGA IMPACTS WL. ALL INDIVIDUALS WILL RECEIVE A 12-MONTH INTERNET-DELIVERED WL PROGRAM AND WILL BE RANDOMIZED AT THE END OF MONTH 3 TO A 9-MONTH YOGA PROGRAM (DELIVERED VIA VIDEOCONFERENCE) OR 9-MONTH HEALTH AND WELLNESS PROGRAM (CONTACT-MATCHED CONTROL). PARTICIPANTS WILL BE FOLLOWED FOR 6 MONTHS BEYOND THE END OF TREATMENT (FINAL ASSESSMENT AT 18 MONTHS). THIS FULLY REMOTE TRIAL HAS GREAT POTENTIAL TO IMPACT BOTH THE YOGA AND WEIGHT CONTROL FIELDS AND IS PARTICULARLY RELEVANT GIVEN EMERGING RESEARCH INDICATING THAT MANY INDIVIDUALS NOW PREFER ONLINE HEALTHCARE PROGRAMS VS. IN-PERSON PROGRAMS. | $1.8M | FY2023 | Jul 2023 – Jun 2028 |
| Department of Health and Human Services | HEPATITIS B VIRUS VACCINE ESCAPE MUTANTS | $1.8M | FY2015 | Feb 2015 – Jul 2020 |
| Department of Health and Human Services | A STATE-WIDE INITIATIVE TO SPREAD EFFECTIVE BEHAVIORAL WEIGHT LOSS STRATEGIES | $1.8M | FY2010 | Jul 2010 – Jun 2014 |
| Department of Health and Human Services | A RANDOMIZED TRIAL TESTING LAY HEALTH COACHES FOR OBESITY TREATMENT | $1.8M | FY2012 | Jul 2012 – May 2017 |
| Department of Health and Human Services | PREVENTING SEXUAL AGGRESSION AMONG HIGH SCHOOL BOYS | $1.7M | FY2014 | Sep 2014 – Sep 2019 |
| Department of Health and Human Services | MIDCAREER INVESTIGATOR AWARD IN PATIENT ORIENTED RESEARCH | $1.7M | FY2008 | Aug 2008 – Nov 2018 |
| Department of Health and Human Services | RESEARCH TRAINING IN CHILDHOOD STRESS, TRAUMA, AND RESILIENCE | $1.7M | FY2020 | May 2020 – Apr 2025 |
| Department of Health and Human Services | DIFFERENTIAL THROMBOGENESIS EFFECTS OF EPA AND DHA MEDIATED BY HDL - PROJECT SUMMARY EPIDEMIOLOGICAL STUDIES SUGGEST THAT THE CONSUMPTION OF OMEGA-3 POLYUNSATURATED FATTY ACIDS (N-3 PUFAS) DERIVED FROM FISH OIL, MAINLY CONSISTING OF EICOSAPENTAENOIC ACID (EPA; 20:5 N-3) AND DOCOSAHEXAENOIC ACID (DHA; 22:6 N-3), IS ASSOCIATED WITH LOWER CARDIOVASCULAR RISK. HOWEVER, INTERVENTIONAL CLINICAL TRIALS AIMED AT REDUCING CARDIOVASCULAR INCIDENTS BY SUPPLEMENTATION WITH N-3 PUFAS HAVE YIELDED INCONSISTENT RESULTS. THE MECHANISMS RESPONSIBLE FOR THE BENEFIT OF N-3 PUFAS ON CARDIOVASCULAR RISK ARE STILL NOT COMPLETELY UNDERSTOOD. MOUNTING EVIDENCE SUGGESTS THAT IN ADDITION TO LOWERING TRIGLYCERIDES, THE TRIGLYCERIDE-INDEPENDENT EFFECTS OF N-3 PUFAS ALSO CONTRIBUTE TO THEIR CARDIOVASCULAR BENEFITS. IT IS LIKELY THAT DIFFERENTIAL EFFECTS OF EPA AND DHA ALSO CONTRIBUTE TO THE INCONSISTENT CLINICAL RESULTS. A HEAD-TO-HEAD COMPARISON OF THE BIOLOGICAL EFFECTS OF EPA AND DHA IN A RELEVANT POPULATION IS URGENTLY REQUIRED. BASED ON OUR PRELIMINARY DATA, WE HYPOTHESIZE THAT EPA AND DHA HAVE DIFFERENTIAL EFFECTS ON THROMBOGENESIS IN PATIENTS WITH ATHEROGENIC DYSLIPIDEMIA THAT ARE MEDIATED BY THE MODIFICATION OF HDL PARTICLE FUNCTION. WE PROPOSE A PROOF-OF-CONCEPT CLINICAL STUDY COMPARING THE BIOLOGICAL EFFECTS, PARTICULARLY THE THROMBOGENESIS AND ANTIPLATELET EFFECTS, OF AN ADEQUATE DOSE OF EPA AND DHA HEAD-TO- HEAD IN ATHEROGENIC DYSLIPIDEMIA SUBJECTS. WE WILL ALSO EXAMINE THE MECHANISM OF HOW HDL PARTICLES MEDIATE THESE ANTITHROMBOTIC EFFECTS. SPECIFIC AIM1: TO TEST THE HYPOTHESIS THAT EPA AND DHA DIFFERENTIALLY AFFECT PLATELET ACTIVATION AND THROMBOSIS IN VIVO IN SUBJECTS WITH ATHEROGENIC DYSLIPIDEMIA. HUMAN SUBJECTS WITH ATHEROGENIC DYSLIPIDEMIA WILL BE RANDOMIZED TO DIETARY SUPPLEMENTATION WITH FOUR GRAMS OF EITHER EPA OR DHA N-3 PUFAS IN A SINGLE-BLINDED FASHION FOR EIGHT WEEKS. AT BASELINE AND AFTER THE SUPPLEMENTATION, VARIOUS MARKERS OF THROMBOGENESIS WILL BE ASSESSED. SPECIFIC AIM 2: TO TEST THE HYPOTHESIS THAT THE EFFECTS OF N-3 PUFAS ON PLATELETS ARE MEDIATED BY THE MODULATION OF HDL PARTICLE FUNCTION. AT BASELINE AND POST N-3 PUFA SUPPLEMENTATION, HDL PARTICLE COMPOSITION AND HDL FUNCTIONS WILL BE ANALYZED, RESPECTIVELY. WE WILL FURTHER TEST OUR HYPOTHESIS MECHANISTICALLY IN AN HDL-DEFICIENT MOUSE MODEL. HDL-DEPENDENT BIOACTIVE LIPID PRODUCTION WILL BE CHARACTERIZED IN BOTH HUMAN AND MOUSE STUDIES. THESE STUDIES WILL PROVIDE INSIGHT INTO A NEW PARADIGM OF UNDERSTANDING THE PUZZLING CLINICAL EVIDENCE OF N-3 PUFAS AND MAY ULTIMATELY LEAD TO THE DEVELOPMENT OF NOVEL THERAPIES TO COMBAT CARDIOMETABOLIC RISK. | $1.6M | FY2023 | Apr 2023 – Mar 2028 |
| Department of Health and Human Services | MICRORANDOMIZED TRIAL TO OPTIMIZE USE OF BURDEN-REDUCING SELF-MONITORING APPROACHES IN BEHAVIORAL OBESITY TREATMENT - PROJECT SUMMARY ABSTRACT SELF-MONITORING (SM) IS AN ESSENTIAL COMPONENT GOLD-STANDARD BEHAVIORAL TREATMENT OF OBESITY (BOT) – THE MOST PREVALENT CAUSE OF MORBIDITY AND MORTALITY IN THE US. ADHERENCE TO DIETARY SELF-MONITORING IS ONE OF THE STRONGEST CONSISTENT PREDICTORS OF TREATMENT OUTCOMES. HOWEVER, ADHERENCE TO DIETARY SM IS GENERALLY POOR DUE TO THE BURDEN OF THE GOLD-STANDARD SM APPROACH (I.E., DETAILED TRACKING OF ALL FOOD & DRINK CONSUMED). DISCONTINUATION OF DIETARY SM IS DIRECTLY CORRELATED WITH AN END TO WEIGHT LOSS, AND IT INCREASES RISK OF WEIGHT REGAIN. IMPROVING ADHERENCE TO DIETARY SM IS THUS ONE OF THE MOST CRITICAL STRATEGIES FOR TREATING OBESITY. ALTERNATIVE SM APPROACHES HAVE BEEN DEVELOPED TO REDUCE BURDEN OF DIETARY SM AND THEREBY IMPROVE ADHERENCE. PRIOR WORK SHOWS THAT THESE SM ALTERNATIVES HAVE THE POTENTIAL TO SUSTAIN SM ADHERENCE AND IMPROVE WEIGHT LOSS IN BOT. HOWEVER, THERE IS NO SCIENTIFIC CONSENSUS IN HOW OR WHEN TO APPLY SM ALTERNATIVES FOR MAXIMUM BENEFIT. TO ADDRESS THIS CRITICAL GAP, WE WILL CONDUCT A MICRO-RANDOMIZED TRIAL (MRT) TO DETERMINE WHICH SM STRATEGY TO APPLY FOR WHOM, AND AT WHAT POINT DURING BOT, TO MAXIMIZE SM ADHERENCE AND WEIGHT LOSS. MRT INVOLVES REPEATED RANDOMIZATIONS AT SPECIFIC DECISION POINTS, WHICH ENABLES DATA-DRIVEN OPTIMIZATION OF THE COMPOSITION, TAILORING, AND TIMING OF BEHAVIORAL INTERVENTIONS. BY USING MRT TO COMPARE SM STRATEGIES OVER TIME WITHIN INDIVIDUALS AND EVALUATING FACTORS THAT INFLUENCE THEIR EFFICACY, WE CAN ENABLE BROADLY-APPLICABLE SM RECOMMENDATIONS TO IMPROVE BOT. WE CAN THEN USE THESE DATA TO DEVELOP ALGORITHMS THAT CAN REPEATEDLY AND AUTOMATICALLY ADAPT SM RECOMMENDATIONS BASED ON EACH INDIVIDUAL’S PERFORMANCE AND NEEDS. OUR MRT WILL TEST THE EFFECTS OF GOLD- STANDARD DIETARY SM AND 4 SM ALTERNATIVES ON SM ADHERENCE AND WEIGHT LOSS DURING A 24-WEEK BOT. A DIVERSE SAMPLE OF ADULTS WITH OVERWEIGHT/OBESITY WILL RECEIVE OUR ESTABLISHED, ONLINE BOT FOR 24 WEEKS. AT PROGRAM START, AND EVERY 2 WEEKS THEREAFTER, PARTICIPANTS WILL BE RANDOMIZED TO ONE OF FIVE SM APPROACHES, FOR A TOTAL OF 12 INDEPENDENT RANDOMIZATIONS PER PERSON. THE SM APPROACHES TO BE TESTED ARE: GOLD-STANDARD FULL DIETARY SM OF ALL FOODS/DRINKS AND THEIR KCALS; REDUCED-FREQUENCY FULL DIETARY SM (3 D/WK); SM OF DIETARY LAPSES ONLY; SMARTWATCH-BASED MONITORING OF ENERGY INTAKE; AND SM OF BODY WEIGHT ONLY VIA SMART SCALE. DATA FROM THIS MRT WILL HAVE TREMENDOUS SCIENTIFIC AND PRACTICAL IMPACTS; WE WILL EVALUATE THE EFFICACY OF ALTERNATIVE SM APPROACHES ON SM ADHERENCE AND WEIGHT LOSS AS WELL AS HOW EACH STRATEGY WORKS ACROSS INDIVIDUAL DIFFERENCES (E.G., SEX), SOCIAL DETERMINANTS OF HEALTH (E.G., FINANCIAL RESOURCE STRAIN), AND TIME-VARYING TREATMENT (E.G., WEEK OF TREATMENT) FACTORS. WE WILL USE REINFORCEMENT LEARNING, A MACHINE LEARNING APPROACH, TO CREATE AN ADAPTIVE SM-SELECTION ALGORITHM THAT AUTOMATICALLY DETERMINES THE SM APPROACH MOST LIKELY TO MAXIMIZE OUTCOMES FOR A GIVEN INDIVIDUAL THROUGHOUT TREATMENT. THIS PROPOSAL WILL ACHIEVE BOTH SCIENTIFIC AND PRACTICAL PUBLIC HEALTH BENEFIT BY USING A SOPHISTICATED DATA-DRIVEN APPROACH TO UNDERSTAND THE FACTORS THAT INFLUENCE SM ADHERENCE DURING BEHAVIORAL OBESITY TREATMENT, AND PROVIDE AN ALGORITHM TO OPTIMIZE SM IN FUTURE CLINICAL AND RESEARCH APPLICATIONS. | $1.6M | FY2024 | May 2024 – Mar 2029 |
| Department of Health and Human Services | SNRK(SUCROSE NON-FERMENTING RELATED KINASE)AND ADIPOSE ENERGY HOMEOSTASIS | $1.6M | FY2015 | Aug 2015 – Jul 2020 |
| Department of Health and Human Services | SUB-CELLULAR TARGETING OF ENDOTHELIAL ROS IN MYOCARDIAL ISCHEMIA | $1.6M | FY2017 | Aug 2017 – Sep 2022 |
| Department of Health and Human Services | COMMUNITY-LEVEL PRIMARY PREVENTION OF DATING AND SEXUAL VIOLENCE IN MIDDLE SCHOOLS | $1.6M | FY2015 | Sep 2015 – Sep 2020 |
| Department of Health and Human Services | IMPACT OF FLAVORS AND DESIGN FEATURES ON PATTERNS OF WATERPIPE USE AND TOXICITY IN PREGNANT MOTHERS | $1.6M | FY2016 | Aug 2016 – Jun 2022 |
| Department of Health and Human Services | METABOLIC REGULATION OF SKCA/IKCA CHANNELS AND ENDOTHELIAL FUNCTION | $1.5M | FY2016 | Sep 2016 – May 2022 |
| Department of Health and Human Services | EFFECTS OF ENDOGENOUS AND EXOGENOUS OVARIAN HORMONES ON ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) USE - ABSTRACT IN 2018 THE U.S. SURGEON GENERAL DECLARED ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) USE A YOUTH EPIDEMIC. ENDS USE CONTINUES TO SOAR, ESPECIALLY AMONG YOUNG ADULTS (AGES 18-24) WHO USE MORE THAN ANY OTHER COHORT. ENDS USE IS ASSOCIATED WITH NEGATIVE CARDIOVASCULAR, IMMUNOLOGIC, AND NEURODEVELOPMENTAL ILLNESS. YOUNG WOMEN ARE DISPROPORTIONATELY IMPACTED BY ENDS USE, DUE TO MORE NICOTINE WITHDRAWAL SYMPTOMS, GREATER CUE INDUCED CRAVINGS, AND POORER TREATMENT RESPONSE. YET, LITTLE IS KNOWN ABOUT FACTORS THAT CAN INFORM SEX-SPECIFIC ENDS TREATMENTS. VARIATION IN EXPOSURE TO OVARIAN HORMONES EITHER ENDOGENOUSLY VIA THE MENSTRUAL CYCLE OR EXOGENOUSLY VIA ORAL CONTRACEPTIVES MAY BE CRITICAL SEX-SPECIFIC FACTORS IMPACTING ENDS USE. THERE IS A DEARTH OF STUDIES FOCUSED ON ENDS; HOWEVER, BURGEONING ANIMAL AND HUMAN RESEARCH ON COMBUSTIBLE CIGARETTES SUGGESTS THAT THERE MAY BE THREE PATHWAYS LINKING OVARIAN HORMONES TO NICOTINE USE. ENDOGENOUS ESTRADIOL AND PROGESTERONE ARE OVARIAN HORMONES THAT FLUCTUATE ACROSS THE MENSTRUAL CYCLE. BASED ON THE POSITIVE REINFORCEMENT PATHWAY NATURALLY OCCURRING INCREASES IN ESTRADIOL PAIRED WITH DECREASES IN PROGESTERONE DURING THE FOLLICULAR PHASE ENHANCE THE REWARDING EFFECTS OF NICOTINE LEADING TO USE. BASED ON THE NEGATIVE REINFORCEMENT PATHWAY WE EXPECT THAT INDIVIDUALS WHO EXPERIENCE AFFECTIVE REACTIVITY IN RESPONSE TO NATURALLY OCCURRING DROPS IN ESTRADIOL AND PROGESTERONE DURING THE LUTEAL PHASE USE NICOTINE TO COPE WITH DISTRESS. LASTLY, ETHINYL ESTRADIOL (A SYNTHETIC FORM OF ESTROGEN COMMON IN ORAL CONTRACEPTIVES) INCREASES NICOTINE METABOLISM (I.E., QUICKER ELIMINATION OF NICOTINE) RESULTING IN MORE USE TO “REPLENISH” NICOTINE CONCENTRATIONS. DESPITE PROMISING STUDIES SUPPORTING THESE THREE PATHWAYS, META-ANALYTIC FINDINGS SHOW THAT SEVERAL STUDIES SHOW NO EFFECTS. THIS MAY BE BECAUSE MOST STUDIES DO NOT DIRECTLY MEASURE OVARIAN HORMONES OR INCLUDE BIOMARKERS OF NICOTINE METABOLISM, RELY ON CROSS-SECTIONAL BETWEEN-SUBJECT DESIGNS, AND INFER A DICHOTOMIZED MENSTRUAL CYCLE PHASE, RATHER THAN CAPTURE HORMONAL VARIATION. THIS PROJECT WILL UTILIZE A 35-DAY EXPERIENCE-SAMPLING METHODS PROTOCOL THAT PROSPECTIVELY TRACKS MENSTRUAL CYCLE DAY, ORAL CONTRACEPTIVE USE, ENDS USE, PERCEIVED NICOTINE REWARD, AND AFFECT. OVARIAN HORMONES AND A RATIO OF TRANS 3'-HYDROXYCOTININE TO COTININE (AN ESTABLISHED BIOMARKER OF NICOTINE METABOLISM) WILL BE ASSESSED FROM DRIED BLOOD SPOTS. WE WILL RECRUIT ENDS USERS WITH NATURALLY OCCURRING MENSTRUAL CYCLES (N=100) AND THOSE ON COMBINED-TYPE ORAL CONTRACEPTIVES (N=100). THIS PROJECT EXPANDS RESEARCH ON BIOLOGICAL SEX-SPECIFIC MECHANISMS AND WILL GENERATE DATA THAT CAN GUIDE TAILORED INTERVENTIONS. | $1.5M | FY2025 | Aug 2025 – Apr 2030 |
| Department of Health and Human Services | SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE | $1.5M | FY2007 | Sep 2007 – Aug 2013 |
| Department of Health and Human Services | COMMUNITY VOLUNTEERS PROMOTING PHYSICAL ACTIVITY AMONG CANCER SURVIVORS | $1.5M | FY2009 | Jan 2009 – May 2014 |
| Department of Health and Human Services | ALCOHOL CONSUMPTION AND HIV BEHAVIOR: EVALUATING THE EVIDENCE | $1.5M | FY2012 | Sep 2012 – Aug 2017 |
| Department of Health and Human Services | REAL TIME PHYLOGENY AND CONTACT TRACING TO DISRUPT HIV TRANSMISSION - REAL TIME PHYLOGENY AND CONTACT TRACING TO DISRUPT HIV TRANSMISSION KANTOR, RAMI MD SUMMARY HIV TRANSMISSION REMAINS A GLOBAL CHALLENGE, AND INNOVATIVE APPROACHES WITHIN CONSTRAINED PUBLIC HEALTH SYSTEMS ARE NEEDED FOR ITS DISRUPTION. THOUGH ACTUAL TRANSMISSION NETWORKS ARE UNKNOWN, CHARACTERIZING SOCIAL AND PHYLOGENETIC NETWORKS CAN GUIDE PUBLIC HEALTH INTERVENTIONS TOWARDS PREVENTING HIV TRANSMISSION. CONTACT TRACING IS THE CURRENT PUBLIC HEALTH TOOL TO DERIVE AND CHARACTERIZE SOCIAL NETWORKS AND IDENTIFY, NOTIFY, TEST AND LINK TO CARE PARTNERS OF THOSE NEWLY DIAGNOSED. ANALYSIS OF MOLECULAR HIV CLUSTERS BY GENETIC DISTANCE-BASED METHODS IS NOW RECOMMENDED IN THE US TO DETECT OUTBREAKS AS PART OF ENDING THE HIV EPIDEMIC. HOWEVER, THE ADDED VALUE OF PHYLOGENETIC (BEYOND DISTANCE-BASED) CLUSTER ANALYSES AND HOW THEY MAY FOCUS AND BENEFIT ROUTINE (BEYOND OUTBREAKS) PUBLIC HEALTH ACTIVITIES TO REDUCE TRANSMISSION IS AN EXISTING KNOWLEDGE GAP. IN THE PRIOR CYCLE WE STARTED TO ADDRESS THIS GAP, ESTABLISHED A STRONG ACADEMIC-GOVERNMENTAL PARTNERSHIP IN RHODE ISLAND, DEVELOPED A BIOINFORMATICS PIPELINE TO SHARE AND ANALYZE STATEWIDE DATA, AND FOR THE FIRST-TIME ROUTINELY AND IN NEAR-REAL-TIME CONDUCTED CLUSTER ANALYSES, IDENTIFIED RECENT HIV DIAGNOSES WHO WERE PART OF MOLECULAR CLUSTERS, AND ATTEMPTED TO RE-INTERVIEW ALL OF THEM, TO INCREASE THEIR MOTIVATION AND ENHANCE CONTACT TRACING. THE IMPORTANT FINDING THAT DESPITE BETTER CLUSTER DETECTION A RE-INTERVIEW WAS NOT BENEFICIAL, TOGETHER WITH OUR ACHIEVEMENTS IN THE PRIOR CYCLE, INFORMED AND REFOCUSED THIS RENEWAL, GUIDING ITS RESTRUCTURED SCOPE. IN THIS RENEWAL, LEVERAGING THE PARTNERSHIP WE ESTABLISHED AND OUR GAINED EXPERIENCE, WE PROPOSE TO REDESIGN OUR BIOINFORMATICS PIPELINE TO ROUTINELY AND IN NEAR-REAL-TIME CONDUCT CLUSTER ANALYSES AND INTEGRATE MOLECULAR DATA WITH TYPICALLY SILOED CLINICAL AND PUBLIC HEALTH DATA, USE THEM TO PRIORITIZE ALL INDIVIDUALS AND CLUSTERS WITH NEW SEQUENCES, USE THIS PRIORITIZATION TO INFORM TAILORED AND INTENSIVE PUBLIC HEALTH INTERVENTIONS, AND EVALUATE THE IMPACT OF THESE PROCESSES, WHILE IMPROVING REPRESENTATION AND PHYLOGENETIC INFERENCE OF THE LOCAL AND REGIONAL EPIDEMIC. WE HYPOTHESIZE THAT THESE INNOVATIVE APPROACHES WILL FOCUS RESTRICTED PUBLIC HEALTH EFFORTS AND MORE EFFICIENTLY IDENTIFY AND LINK TO CARE PERSONS UNAWARE OF THEIR HIV STATUS, PERSONS AWARE BUT NOT LINKED TO CARE, OR PERSONS AT HIGH RISK OF GETTING INFECTED. THE SPECIFIC AIMS TO ADDRESS THIS HYPOTHESIS ARE TO: (1) REDESIGN THE PIPELINE AND CONDUCT NEAR-REAL-TIME CLUSTER ANALYSES IN AND BEYOND RHODE ISLAND; (2) LEVERAGE THE REDESIGNED PIPELINE TO EVALUATE THE ADDED VALUE OF ROUTINE, NEAR-REAL-TIME INTEGRATION OF CLUSTER ANALYSES PRIORITIZING PUBLIC HEALTH INTERVENTIONS; AND (3) AUGMENT PHYLOGENETIC INFERENCE BY INCREASED SEQUENCE AVAILABILITY AND MORE COMPREHENSIVE ANALYSES. OUR APPROACH IS STRENGTHENED BY A MULTIDISCIPLINARY EXPERIENCED TEAM OF PUBLIC HEALTH OFFICIALS, ETHICISTS, CLINICIANS, STATISTICIANS, BIOINFORMATICIANS, BEHAVIORAL SCIENTISTS, EVOLUTIONARY AND MOLECULAR BIOLOGISTS, WITH INFRASTRUCTURE AND EXPERTISE DEVELOPED IN THE PRIOR CYCLE. THIS RENEWAL, BUILT ON A STRONG ETHICS PLATFORM, WILL HAVE HIGH IMPACT ON THE CARE CONTINUUM; BRING RHODE ISLAND CLOSER TO ZERO NEW HIV INFECTIONS; AND SERVE AS A MODEL FOR LARGER JURISDICTIONS, AS WE AIM TO END THE HIV EPIDEMIC IN RHODE ISLAND AND BEYOND. | $1.5M | FY2018 | Mar 2018 – Apr 2030 |
| Department of Health and Human Services | AN APPLICATION OF SMART METHODOLOGY TO OPTIMIZE AN INTERVENTION TO MAINTAIN IMPROVEMENTS IN HEALTH BEHAVIORS IN UNDER-RESOURCED PATIENTS AFTER PHASE II CARDIAC REHABILITATION - PROJECT SUMMARY/ABSTRACT CARDIOVASCULAR DISEASE (CVD) IS THE LEADING CAUSE OF DEATH IN THE UNITED STATES. CARDIAC REHABILITATION (CR) IS AN EVIDENCE-BASED, COST-EFFECTIVE, AND WIDELY AVAILABLE MULTIDISCIPLINARY PROGRAM THAT COMBINES SUPERVISED EXERCISE WITH PSYCHOEDUCATION ON HEALTH BEHAVIOR CHANGE AIMED AT IMPROVING OVERALL HEALTH AND REDUCING CARDIOVASCULAR RISK IN INDIVIDUALS WITH ESTABLISHED CVD. HOWEVER, UNDER-RESOURCED AND UNDERSERVED CVD PATIENTS (E.G., WOMEN, RACIAL AND ETHNIC MINORITIES, LOW SOCIOECONOMIC STATUS, DISABLED) ARE LESS LIKELY TO MAINTAIN THEIR ADHERENCE TO KEY CARDIOPROTECTIVE BEHAVIORS (WEIGHT MANAGEMENT, PHYSICAL ACTIVITY [PA], AND MEDICATION ADHERENCE) AFTER CR AND ARE UNDER-REPRESENTED IN POST-CR RESEARCH; THESE FACTORS COMBINED INCREASE THE HEALTH DISPARITIES IN CVD CARE THAT THESE SUB-POPULATIONS EXPERIENCE, ESPECIALLY SINCE MANY CANNOT COMPLETE SELF-PAY PHASE III MAINTENANCE PROGRAMS. IN THE PI’S PREVIOUS WORK, UNDER-RESOURCED AND UNDER-REPRESENTED PATIENTS INDICATED THAT THEY WANT TECHNOLOGY-BASED MAINTENANCE SUPPORT INTERVENTIONS THAT UTILIZE TECHNOLOGY THEY ALREADY OWN, ARE MINIMAL BURDEN, OFFER A FLEXIBLE SCHEDULE, OFFER MORE SUPPORT FOR PATIENT NEEDS WITHOUT OVERWHELMING THEM WITH PROGRAM REQUIREMENTS BEFORE DEMONSTRATING THAT A LOWER LEVEL OF SUPPORT WAS INSUFFICIENT, AND PRODUCE DESIRED RESULTS. PATIENTS FELT RESISTANT TO INITIATING A DEMANDING, TIME- INTENSIVE, OR IN-PERSON MAINTENANCE INTERVENTION IMMEDIATELY FOLLOWING CR. THE PRESENT APPLICATION UTILIZES A SEQUENTIAL, MULTIPLE ASSIGNMENT, RANDOMIZED TRIAL (SMART) DESIGN TO CREATE A STEPPED CARE MODEL THAT ADAPTS TO PATIENT NEEDS AND MINIMIZES PATIENT BURDEN. PARTICIPANTS (N=400) WILL BE RANDOMIZED TO RECEIVE EITHER A LOW-INTENSITY TEXT MESSAGING INTERVENTION OR AN AUTOMATED ONLINE PROGRAM FOR 2 MONTHS AND DETERMINE WHICH PRODUCES SUPERIOR ADHERENCE (AIM 1). FOLLOWING CLASSIFICATION AS INTERVENTION RESPONDERS OR NON- RESPONDERS, RESPONDERS WILL CONTINUE RECEIVING THEIR INITIAL LOW-INTENSITY INTERVENTION. WE WILL THEN DETERMINE WHETHER LOW- OR HIGH-INTENSITY HOME-BASED CR (WITH OR WITHOUT CASE MANAGEMENT) FOR 3 MONTHS PRODUCES BETTER BEHAVIORAL ADHERENCE FOLLOWING FAILURE OF A LOW-INTENSITY INTERVENTION FAILURE (AIM 2). WE WILL THEN FINALIZE THE IDEAL ADAPTIVE INTERVENTION BASED ON AIMS 1 AND 2 RESULTS AND MODERATOR ANALYSES (AIM 3). PATIENTS WILL COMPLETE POST-INTERVENTION ASSESSMENTS AT 6 MONTHS AND EXPLORATORY OUTCOMES ASSESSMENT (DEATH, REHOSPITALIZATION, QUALITY OF LIFE). THIS RESEARCH WILL RESULT IN A STEPPED CARE MODEL FOR UNDER-RESOURCED PATIENTS’ BEHAVIORAL ADHERENCE MAINTENANCE FOLLOWING CR. THIS PROJECT ADVANCES THE SCIENCE OF CVD TREATMENT AND POST-CR CARE, AND IT WILL DIRECTLY IMPACT CVD PATIENT OUTCOMES BY EXTENDING THE BENEFITS OF EVIDENCE-BASED, EFFECTIVE CARE AS WELL AS TARGET HEALTH DISPARITIES AMONG LESS-RESOURCED CVD PATIENTS. | $1.4M | FY2024 | Aug 2024 – Apr 2029 |
| Department of Health and Human Services | LINKING BIOPHYSICAL FUNCTIONS OF MICROBICIDES TO USER PERCEPTION & ACCEPTABILITY | $1.4M | FY2006 | Sep 2006 – Aug 2011 |
| Department of Health and Human Services | HIV DRUG RESISTANCE IN THE NEW ANTIRETROVIRAL THERAPY ERA IN KENYA - HIV DRUG RESISTANCE IN THE NEW ART ERA IN KENYA RAMI KANTOR, MD SUMMARY SINCE THE EMERGENCE OF RESISTANCE TO ZIDOVUDINE IN THE LATE 1980’S, WE HAVE BEEN IN A RACE: AN HIV DRUG IS DEVELOPED AND USED, FOLLOWED BY THE INEVITABLE EMERGENCE OF VIRAL RESISTANCE TO IT, ANOTHER DRUG IS DEVELOPED AND USED, AND SO ON. THIS LARGELY RESISTANCE-DRIVEN PROCESS HAS INFORMED ANTIRETROVIRAL DRUG DEVELOPMENT SINCE ITS INCEPTION. HOWEVER, TREATMENT MONITORING, INCLUDING DRUG RESISTANCE TESTING AND AT TIMES VIRAL LOAD TESTING, ARE LIMITED IN RESOURCE LIMITED SETTINGS, WHERE HIV BURDEN IS GREATEST, CREATING THE GLOBAL PARADOX: WE TEST FOR AND KNOW LESS ABOUT HIV DRUG RESISTANCE IN LOCATIONS WHERE OUR UNDERSTANDING OF IT IS MOST CRUCIAL. SUCH SETTINGS MAY BE MORE PRONE FOR RESISTANCE DUE TO RESTRICTED MONITORING IN CLINICAL CARE, HIGHER TREATMENT FAILURE THRESHOLDS, LIMITED AVAILABILITY OF ADVANCED MEDICATIONS AND FORMULATIONS, CIRCULATING DIVERSE HIV-1 SUBTYPES, AND SPECIAL CIRCUMSTANCES LIKE HIV-TB COINFECTION. SUCH SITUATIONS MIGHT FURTHER ENHANCE THE RISK TO DEVELOP RESISTANCE AND EXACERBATE THE COMPLEXITY OF ADDRESSING IT. THIS PARADOX IS EVEN GREATER NOW THAT WE ARE IN THE NEW GLOBAL ANTIRETROVIRAL THERAPY (ART) ERA. REMARKABLE PROGRESS IN ANTIRETROVIRALS LIKE DOLUTEGRAVIR (DTG), WITH ENHANCED EFFICACY, REDUCED TOXICITY, HIGH BARRIER TO RESISTANCE, AND IMPORTANTLY, GLOBAL ACCESSIBILITY, ALL INSTILL A PROFOUND CONFIDENCE, SUGGESTING THAT WE MAY HAVE ACHIEVED A PIVOTAL MILESTONE IN THE ONGOING RACE AGAINST HIV. HOWEVER, THE WIDESPREAD UTILIZATION OF DTG IN ALL LINES OF ART, ESPECIALLY IN SETTINGS WITH IMPERFECT MONITORING AND LIMITED MEDICATION AVAILABILITY, RAISES CONCERNS ABOUT CONTINUING THE DRUG RESISTANCE RACE. EMERGING DATA CONFIRM THESE CONCERNS AND HIGHLIGHT RESEARCH GAPS RELATED TO RESISTANCE DEVELOPMENT TO CURRENT ERA DRUGS AND THEIR MAGNITUDE AND CONSEQUENCES. THIS PROPOSAL IS DESIGNED TO ADDRESS THESE GAPS. LEVERAGING OUR LONG-STANDING NORTH- SOUTH COLLABORATION, WE PROPOSE TO COMPREHENSIVELY AND PROSPECTIVELY INVESTIGATE THE EXTENT AND IMPACT OF TRANSMITTED AND ACQUIRED RESISTANCE IN A LARGE HIV CARE PROGRAM IN KENYA, ONE OF THE EARLIER COUNTRIES TO ENTER THE NEW ART ERA IN 2017. WE HYPOTHESIZE THAT THE SCALE-UP OF DTG-BASED REGIMENS ACROSS ALL LINES OF TREATMENT IN RESOURCE LIMITED SETTINGS IS LEADING TO A GRADUAL ESCALATION OF DRUG RESISTANCE OVER TIME, IMPACTING CARE. TO ADDRESS THIS HYPOTHESIS, WE WILL ENROLL AND PROSPECTIVELY FOLLOW 1,840 KENYAN PERSONS WITH HIV ACROSS THE HIV, ART AND RESISTANCE TIMELINES. WE WILL CHARACTERIZE TRANSMITTED RESISTANCE (AIM 1) AND INVESTIGATE ACQUIRED RESISTANCE (AIM 2) OF 1ST-LINE DTG-BASED ART (AIM 2A), 2ND-LINE ART (AIM 2B), BEYOND 2ND-LINE ART (AIM 2C), AND SPECIAL POPULATIONS (AIM 3). OUR UNDERSTANDING OF RESISTANCE DEVELOPMENT IN THE NEW ART ERA IS LIMITED, YET CRUCIAL TO ENSURE ITS SUSTAINABLE SUCCESS. THIS TIMELY PROPOSAL WILL GENERATE HYPOTHESIS-DRIVEN DATA TO ADDRESS EXISTING GAPS AND INFORM PATIENT CARE TOWARDS ENDING THE HIV EPIDEMIC. WE EXPECT TO HAVE A HIGH AND DIRECT IMPACT ON GUIDING FUTURE ART STRATEGIES TO MINIMIZE RESISTANCE. THE NEW ART ERA HAS BEEN ROLLED OUT FOR ~5 YEARS, PROVIDING A UNIQUE OPPORTUNITY TO CONDUCT THIS RESEARCH. THE RIGHT TIME TO COMPREHENSIVELY INVESTIGATE RESISTANCE IN THE NEW ART ERA IS NOW, TO ENSURE THAT WE DON’T LOSE THE RACE, IN KENYA AND BEYOND. | $1.3M | FY2024 | Sep 2024 – Jul 2029 |
| Department of Health and Human Services | HIV DRUG RESISTANCE, MONITORING AND TRANSMISSION | $1.3M | FY2018 | Mar 2018 – Dec 2028 |
| Department of Health and Human Services | ECOLOGICAL MOMENTARY ASSESSMENT OF BEHAVIORAL AND PSYCHOSOCIAL PREDICTORS OF WEIGHT LOSS FOLLOWING BARIATRIC SURGERY | $1.3M | FY2015 | Sep 2015 – Jul 2019 |
| Department of Health and Human Services | SUSTAINING CESSATION IN SMOKERS WITH KIDS WITH ASTHMA | $1.2M | FY1999 | Aug 1999 – Jan 2010 |
| Department of Health and Human Services | THE ROLE OF NPR-C IN MODULATION OF ACUTE LUNG INJURY | $1.2M | FY2015 | Jul 2015 – Sep 2020 |
| Department of Health and Human Services | MECHANISMS OF MINDFULNESS TRAINING TO REDUCE MATERNAL AND INFANT CARDIOVASCULAR DISEASE RISK - ABSTRACT HYPERTENSIVE DISORDERS OF PREGNANCY ARE THE MOST COMMON MEDICAL CONDITION AFFECTING PREGNANCY AND A LEADING CAUSE OF MATERNAL MORBIDITY AND MORTALITY IN THE UNITES STATES. FIFTY PERCENT OF WOMEN WITH PRENATAL HYPERTENSIVE DISORDERS WILL CONTINUE TO EXPERIENCE HYPERTENSION IN THE POSTPARTUM PERIOD. MORE THAN HALF OF ALL PREGNANCY-RELATED DEATHS OCCUR IN THE POSTPARTUM PERIOD, AND OVER 30% OF MATERNAL DEATHS ARE COMPLICATED BY HYPERTENSIVE DISORDERS. CONSEQUENCES OF HYPERTENSIVE DISORDERS EXTEND WELL PAST THE PERINATAL PERIOD; WOMEN WITH PRENATAL HYPERTENSIVE DISORDERS ARE TWICE AS LIKELY TO DEVELOP HEART DISEASE IN THEIR LIFETIME, AND OFFSPRING EXPOSED TO HYPERTENSIVE DISORDERS IN UTERO FACE SIGNIFICANT LIFETIME CARDIOVASCULAR DISEASE RISK. THEREFORE, PREVENTION OF PRENATAL HYPERTENSIVE DISORDERS IS CRITICAL TO REDUCING RISK FOR POSTPARTUM OBSTETRIC COMPLICATIONS AND LIFELONG CARDIOVASCULAR DISEASE. MINDFULNESS-BASED INTERVENTIONS HOLD SIGNIFICANT PROMISE AS A NON- PHARMACOLOGICAL INTERVENTION TO PREVENT THESE DISORDERS AS MINDFULNESS-BASED INTERVENTIONS REDUCE BLOOD PRESSURE IN ADULTS WITH HYPERTENSION AND PREHYPERTENSION, AND RESULTS FROM OUR PILOT RCT INDICATING THAT PRENATAL MINDFULNESS TRAINING WAS ASSOCIATED WITH REDUCED BLOOD PRESSURE AND RISK FOR HYPERTENSIVE DISORDERS IN AT-RISK WOMEN. NOW, OUR TEAM IS CONDUCTING A 5-YEAR RCT INVESTIGATING THE DAILY MECHANISMS OF PRENATAL MINDFULNESS TRAINING ON PRENATAL MARKERS OF CARDIOVASCULAR RISK (R01HL157288). TO DATE, WE HAVE RECRUITED A RACIALLY AND ETHNICALLY DIVERSE SAMPLE OF WOMEN AT RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY, WITH >90% PARTICIPANT RETENTION, AND 89% OF PARTICIPANTS WHO COMPLETED THE PARENT STUDY REPORTED INTEREST IN PARTICIPATING IN THE PROPOSED ANCILLARY STUDY. HOWEVER, THE MOST SEVERE AND FATAL CARDIOVASCULAR COMPLICATIONS OCCUR IN THE POSTPARTUM PERIOD, AND IT IS NOT YET KNOWN WHETHER THE CARDIOVASCULAR BENEFITS OF PRENATAL MINDFULNESS TRAINING EXTEND INTO THE POSTPARTUM PERIOD. THUS, IN RESPONSE TO THE NOTICE OF SPECIAL INTEREST (NOSI): “HEART, LUNG, BLOOD AND SLEEP FOCUSED ANCILLARY STUDIES TO ONGOING CLINICAL STUDIES,” WE PROPOSE TO TEST THE LONG-TERM EFFECTS OF PRENATAL MINDFULNESS TRAINING ON POSTPARTUM MECHANISMS OF RISK FOR MATERNAL AND INFANT CARDIOVASCULAR DISEASE. THE PROPOSED ANCILLARY STUDY WILL FOLLOW N=130 PARTICIPANTS AND INFANTS THAT ARE ENROLLED IN THE PARENT RCT ACROSS THE FIRST POSTPARTUM YEAR. AT 4-, 6-, AND 12-MONTHS POSTPARTUM, WE WILL MEASURE EFFECTS OF PRENATAL MINDFULNESS TRAINING ON: 1) POSTPARTUM MATERNAL CARDIOVASCULAR DISEASE BIOMARKERS, 2) POSTPARTUM PHYSIOLOGICAL AND PSYCHOLOGICAL RESPONSES TO ECOLOGICALLY VALID DAILY EXPERIENCES, AND 3) INFANT GROWTH TRAJECTORIES THAT CONFER RISK FOR LIFETIME CVD. RESULTS WILL HAVE A SIGNIFICANT IMPACT ON THE FIELD BY IDENTIFYING MODIFIABLE MECHANISMS IN THE PRE AND POSTNATAL PERIODS TO REDUCE RATES OF HYPERTENSIVE DISORDERS AND DECREASE LIFELONG BURDEN OF CVD IN WOMEN AND THEIR OFFSPRING. CONSISTENT WITH NHLBI’S OBJECTIVES, RESULTS FROM THIS STUDY WILL HELP TO DEVELOP AND OPTIMIZE NOVEL THERAPEUTIC STRATEGIES TO PREVENT HEART, LUNG, AND BLOOD DISEASES IN WOMEN AND INFANTS. | $1.2M | FY2024 | May 2024 – Apr 2029 |
| Department of Health and Human Services | COMPARISON OF BEHAVIORALLY-BASED REMOTE APPROACHES TO OPTIMIZE WEIGHT LOSS AND IDENTIFICATION OF FACTORS WHICH CHARACTERIZE TREATMENT RESPONSE - PROJECT SUMMARY IN-PERSON BEHAVIORAL WEIGHT LOSS (WL) PROGRAMS ARE THE GOLD STANDARD OF OBESITY TREATMENT, BUT REMOTE-BASED INTERVENTIONS ARE BECOMING INCREASINGLY UTILIZED AS THEY OVERCOME BARRIERS COMMON TO IN-PERSON PROGRAMS (E.G., GEOGRAPHICAL, TIME, AND TRAVEL CONSTRAINTS) AND REPRESENT A MORE TRANSLATABLE INTERVENTION MODEL. YET, REMOTE WL INTERVENTIONS CAN VARY SUBSTANTIALLY, AND QUESTIONS REMAIN REGARDING WHICH TYPE IS MOST EFFECTIVE AND WHETHER THERE ARE CERTAIN GROUPS OF INDIVIDUALS WHO RESPOND BEST TO ONE TYPE OVER ANOTHER. FOR EXAMPLE, OUR FULLY AUTOMATED, ONLINE PROGRAM PRODUCES A 4.5% WL ON AVERAGE AND ABOUT HALF OF PARTICIPANTS ACHIEVE A WL ≥5%. WHILE THIS LOW-TOUCH INTERVENTION IS EFFECTIVE FOR MANY, OTHERS HAVE LIMITED SUCCESS AND MAY BENEFIT FROM A DIFFERENT TYPE OF REMOTE INTERVENTION (E.G., GROUP-BASED VIDEOCONFERENCE PROGRAM, RESEMBLING IN-PERSON TREATMENT) OR MORE INDIVIDUAL SUPPORT (E.G., VIA COACHING). THIS TRIAL UTILIZES A 2X2 FACTORIAL DESIGN TO COMPARE TWO REMOTE-DELIVERY FORMATS (AUTOMATED ONLINE PROGRAM VS. GROUP-BASED VIDEOCONFERENCE PROGRAM) AND THE ADDED EFFECT OF COACHING (VS. NO COACHING) ON 12-MONTH WL. DIRECT COMPARISONS OF THESE APPROACHES HAVE BEEN LIMITED. FROM A PERSONALIZED MEDICINE PERSPECTIVE, IT IS ALSO IMPORTANT TO UNDERSTAND FOR WHOM EACH REMOTE APPROACH SHOULD BE RECOMMENDED. THUS, AN ADDITIONAL AIM IS TO DEVELOP TWO ALGORITHMS WHICH COULD BE USED TO REFER PATIENTS INTO REMOTE WL PROGRAMS. THE ‘WIDELY-APPLICABLE’ ALGORITHM WILL USE METRICS COMMON TO ELECTRONIC MEDICAL RECORDS (SEX, BMI, AGE, RACE, ETHNICITY), AND THE ‘MORE COMPREHENSIVE’ ALGORITHM WILL FURTHER INCLUDE ADDITIONAL BASELINE CHARACTERISTICS (E.G., EDUCATION, HOUSEHOLD INCOME, HEALTH LITERACY, GROUP PREFERENCE, ETC). PARTICIPANTS WILL BE RANDOMIZED AT BASELINE (OUT OF 4 POSSIBLE COMBINATIONS) AND RECEIVE A 12- MONTH, REMOTE-BASED BEHAVIORAL WL PROGRAM. ALL PROGRAMS INCLUDE DAILY SELF-MONITORING OF DIET, EXERCISE, AND WEIGHT AND THE PROVISION OF AUTOMATED FEEDBACK. THOSE RECEIVING THE ONLINE PROGRAM WILL ALSO BE INSTRUCTED TO VIEW VIDEO LESSONS (24 IN TOTAL, 10-15 MIN EACH) WHICH FOCUS ON BEHAVIORAL STRATEGIES FOR CHANGING DIET AND EXERCISE. INDIVIDUALS RANDOMIZED TO THE VIDEOCONFERENCE PROGRAM WILL PARTICIPATE IN 24 GROUP SESSIONS (1 HOUR EACH) DESIGNED TO MIMIC IN-PERSON TREATMENT AND ALLOW FOR PARTICIPANT INTERACTION VIA LARGE AND SMALL GROUP DISCUSSIONS. COACHING CALLS (10-15 MIN EACH) WILL BE MONTHLY AND FOCUS ON INDIVIDUAL BARRIERS, PROBLEM SOLVING, GOAL SETTING, AND FOSTERING SUPPORT AND ACCOUNTABILITY. ASSESSMENTS WILL OCCUR AT BASELINE, 6 (MID-TREATMENT), 12 (POST-TREATMENT), AND 18 MONTHS (FOLLOWING 6 MONTHS OF NO INTERVENTION). SECONDARY AIMS WILL EXAMINE THE EFFECTS OF DELIVERY FORMAT AND COACHING ON INTERVENTION ENGAGEMENT (E.G., FREQUENCY OF SELF-MONITORING), PSYCHOSOCIAL OUTCOMES (E.G., PERCEIVED SUPPORT, SELF-EFFICACY, AND MOTIVATION), 18-MONTH WL, AND THE COST PER KILOGRAM OF WL (TO EXAMINE WHETHER THE ADDITION OF HUMAN SUPPORT IS COST-EFFECTIVE). STUDY FINDINGS HAVE THE POTENTIAL TO INFORM PATIENT REFERRALS AND INSURANCE COVERAGE DECISIONS FOR REMOTE WL TREATMENT. | $1.2M | FY2024 | Aug 2024 – May 2029 |
| Department of Health and Human Services | TRANSDISCIPLINARY CANCER CONTROL RESEARCH TRAINING GRANT | $1.2M | FY2000 | Sep 2000 – Aug 2011 |
| Department of Health and Human Services | A MULTIDISCIPLINARY APPROACH TO INTEGRATE HIV PREVENTION SERVICES INTO CLINICAL CARE SETTINGS FOR PEOPLE WITH OPIOID USE DISORDER - PROJECT SUMMARY OPIOID USE CONTINUES TO BE A PUBLIC HEALTH CRISIS IN THE UNITED STATES (US). AN ESTIMATED 2.7 MILLION PEOPLE HAD OPIOID USE DISORDER (OUD) WITH OVER 107,000 OVERDOSE DEATHS IN 2022 IN THE US. OUD IS ALSO A MAJOR RISK FACTOR FOR HIV INFECTION DUE TO INJECTION AND HIGH-RISK SEXUAL BEHAVIORS. DESPITE THE HIGHER RISK OF HIV, OUD PATIENTS HAVE HAD VERY LIMITED ENGAGEMENT WITH HIV PREVENTION SERVICES, INCLUDING HIV SCREENING, HIV PRE- EXPOSURE PROPHYLAXIS (PREP), AND MEDICATION FOR OUD (MOUD) SERVICES, WHICH ARE HIGHLY EFFECTIVE IN PREVENTING HIV INFECTION. NOVEL APPROACHES ARE NEEDED TO EXPLORE HOW TO ENGAGE PEOPLE WITH OUD IN HIV PREVENTION SERVICES WITH THE LONG-TERM GOAL OF REDUCING HIV INCIDENCE. THE INTEGRATION OF HIV PREVENTION SERVICES INTO CARE SETTING (E.G. EMERGENCY DEPARTMENTS, PRIMARY CARE, MENTAL HEALTH CLINICS, AND SUBSTANCE TREATMENT CENTERS) WHERE PEOPLE WITH OUD ALREADY SEEK CARE IS PROMISING. AS THE INTEGRATION OF HIV PREVENTION SERVICES INTO CARE SETTINGS IS COMPLICATED DUE TO THE INDIVIDUAL-, SOCIAL- AND STRUCTURAL-LEVEL BARRIERS, WE WILL USE INNOVATION AND MULTIDISCIPLINARY APPROACHES TO ACHIEVE THIS GOAL. IN THIS PROPOSAL, WE WILL CONDUCT A SYSTEMATIC ASSESSMENT OF HEALTHCARE UTILIZATION IN GENERAL, HIV PREVENTION SERVICES, AND MOUD USING THE ALL PAYERS CLAIMS DATABASE (APCD) AND STATE EMERGENCY DEPARTMENT DATABASE (SEDD) (SPECIFIC AIM (SA) 1), USE THE EVIDENCE-BASED QUALITY IMPROVEMENT (EBQI) - A COLLABORATIVE STAKEHOLDER-GUIDED INTERVENTION/STRATEGY DEVELOPMENT PROCESS TO DETERMINE THE OPTIMAL CARE SETTING AND IDENTIFY IMPLEMENTATION STRATEGIES OF INTEGRATING HIV PREVENTION SERVICES AND MOUD (SA 2), AND THEN TEST THEIR EFFECTS ON REDUCING HIV INCIDENCE AT THE POPULATION LEVEL USING AGENT-BASED MODELING (SA3). THIS INNOVATIVE STUDY WILL IDENTIFY CARE SETTINGS TO MAXIMUM HIV PREVENTION EFFORTS, TEST MULTIPLE PROMISING IMPLEMENTATION STRATEGIES, AND IDENTIFY THE MOST EFFECTIVE IMPLEMENTATION STRATEGY, WHICH IS READY FOR REAL-WORLD IMPLEMENTATION. | $1.2M | FY2024 | Sep 2024 – Jul 2029 |
| Department of Health and Human Services | USING A YMCA EXERCISE PROGRAM TO ENHANCE NICOTINE DEPENDENCE TREATMENT FOR WOMEN | $1.2M | FY2006 | Sep 2006 – Apr 2010 |
| Department of Health and Human Services | PREVENTION OF WEIGHT GAIN IN YOUNG ADULTS | $1.2M | FY2009 | Aug 2009 – May 2014 |
| Department of Health and Human Services | PRENATAL SMOKING, FETAL BEHAVIOR, AND INFANT WITHDRAWAL | $1.1M | FY2005 | Jun 2005 – Nov 2011 |
| VA/DoDDepartment of Defense | ENGINEERED NEUTROPHILS FOR INTRATUMORAL DELIVERY AND TARGETING | $1.1M | FY2023 | Sep 2023 – Sep 2026 |
| Department of Health and Human Services | ADDRESSING BODY IMAGE IN WEIGHT MANAGEMENT: AN OVERLOOKED RISK FACTOR FOR POOR TREATMENT OUTCOME AMONG WOMEN | $1M | FY2020 | Aug 2020 – Apr 2025 |
| Department of Health and Human Services | DEVELOPMENT OF A VALUES-AFFIRMATION INTERVENTION TARGETING MEDICATION ADHERENCE IN OLDER ADULTS WITH HEART FAILURE COMPLETING CARDIAC REHABILITATION | $999.5K | FY2019 | Aug 2019 – Aug 2025 |
| Department of Health and Human Services | COMMUNITY-BASED SUBSTANCE USE TREATMENT AND HIV PREVENTION FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN - THE PURPOSE OF OUR PROPOSED PROJECT, "COMMUNITY-AND CLINIC-BASED SUBSTANCE USE TREATMENT AND HIV PREVENTION FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN" IS TO INCREASE STATUS NEUTRAL ACCESS TO AND ENGAGEMENT IN CARE FOR RACIAL AND ETHNIC MEDICALLY UNDERSERVED INDIVIDUALS AT RISK FOR OR LIVING WITH SYNDEMIC CONDITIONS INCLUDING SUBSTANCE USE, MENTAL ILLNESS, HIV, VIRAL HEPATITIS, AND MINORITY STRESS. WITH NEARLY 1.1 MILLION RESIDENTS, RHODE ISLAND HAS ONE OF THE HIGHEST PERCENTAGES OF LGBTQ+ RESIDENTS OF ANY STATE IN THE COUNTRY AND THE MAJORITY RESIDE IN PROVIDENCE, THE CAPITAL CITY. PROVIDENCE IS THE EPICENTER OF SUBSTANCE USE IN RHODE ISLAND AND HAS AMONG THE HIGHEST RATES OF ILLICIT DRUG USE IN THE UNITED STATES. DISPARITIES EXIST BETWEEN THE GENERAL POPULATION AND THE LGBTQ+ COMMUNITY WITH HIGHER RATES AND SEVERITY OF SUBSTANCE USE DISORDERS (SUDS) AND CO-OCCURRING MENTAL HEALTH DISORDERS (CODS) AND LOWER RATES OF ACCESS TO- AND ENGAGEMENT IN- SUBSTANCE USE TREATMENT AMONG RACIAL AND ETHNIC MINORITIES WITH INTERSECTIONAL LGBTQ+ IDENTITIES.DESPITE THE LARGE PERCENTAGE OF UNDERSERVED INDIVIDUALS AND THE KNOWLEDGE OF THESE DISPARITIES, RHODE ISLAND DOES NOT HAVE A DEDICATED TREATMENT PROGRAM THAT ADDRESSES THE IMPORTANT AND UNIQUE NEEDS OF RACIAL AND ETHNIC MEDICALLY UNDERSERVED INDIVIDUALS WITH INTERSECTIONAL LGBTQ+ IDENTITIES WHO SUFFER DISPROPORTIONATE RATES OF SYNDEMIC SUBSTANCE USE, CO-OCCURRING MENTAL HEALTH, MEDICAL, AND SOCIAL CONCERNS. . OUR PROPOSED COMMUNITY- AND CLINIC-BASED PROJECT WILL AIM TO ADDRESS THESE UNMET NEEDS BY PROVIDING AFFIRMING, EVIDENCE-BASED, STATUS NEUTRAL, AND INCLUSIVE OUTREACH AND TREATMENT FOR SUD AND CODS FOR 225 INDIVIDUALS FROM THIS UNDERSERVED COMMUNITY IN RHODE ISLAND. ALIGNED WITH OUR PURPOSE, THE GOALS FOR OUR PROJECT INCLUDE: 1) INCREASING ACCESS TO AND ENGAGEMENT IN CULTURALLY CONGRUENT SUD CARE, 2) DECREASING SUBSTANCE USE AND MENTAL HEALTH SYMPTOMS AMONG CLIENTS WHO ENGAGE IN AND COMPLETE OUR PROJECT SERVICES, 3) INCREASING KNOWLEDGE OF MEDICAL STATUSES OF HIV, VIRAL HEPATITIS, AND STDS, 4) DECREASING HIV INFECTIONS, AND 5) PROMOTING PERSONAL AND ORGANIZATIONAL HEALTH LITERACY TO PREVENT THE PERPETUATION OF MINORITY STRESS, STIGMA, AND DISCRIMINATION WHICH CONTRIBUTE TO SUDS AND CODS. OUR PROGRAM GOALS AND DESIGN ARE DERIVED FROM OUR PROCESS OF CENTERING THE VOICES OF THOSE WITH LIVED EXPERIENCES. WE PLAN TO USE A STATUS NEUTRAL APPROACH BY BRAIDING TOGETHER EXISTING RESOURCES WITH THE NEW PROGRAM SERVICES ACROSS SITES TO DECREASE DISPARITIES IN HEALTH AND ATTEND TO "WHOLE PERSON" HEALTH CARE. TO MEET THE NEEDS OF OUR COMMUNITY AND ACCOMPLISH OUR GOALS, THE OBJECTIVES OF OUR PROJECT INCLUDE:) SCREENING AT LEAST 800 RACIAL AND ETHNIC MEDICALLY UNDERSERVED INDIVIDUALS WITH INTERSECTIONAL LGBTQ+ IDENTITIES IN COMMUNITY AND CLINIC SETTINGS; 2) PROVIDING COLLABORATIVE, CULTURALLY CONGRUENT, STATUS NEUTRAL MULTIDISCIPLINARY CARE TO 225 INDIVIDUALS TO ADDRESS THE SYNDEMIC OF SUD, CODS, MEDICAL CONCERNS, AND SOCIAL DETERMINANTS OF HEALTH NEEDS, 3) TESTING FOR HIV, VIRAL HEPATITIS, AND STDS IN THE COMMUNITY AND CLINICS, 4) PROVIDING EDUCATION ABOUT UNDETECTABLE = UNTRANSMISSIBLE AND SUPPORT FOR ADHERENCE AND PREP CARE, AND 5) COLLABORATIVELY CREATING AND ENGAGING IN A DYNAMIC EDUCATIONAL CURRICULUM TO SUPPORT DIVERSITY, EQUITY, INCLUSION, BELONGING, AND ANTI-RACISM ACROSS THE THREE PROGRAM SITES.IN SUMMARY, THE PROJECT WILL PROVIDE CRITICAL SERVICES FOR THE SCREENING AND TREATMENT OF SUBSTANCE USE AND OTHER CO-OCCURRING DISORDERS AMONG RACIAL AND ETHNIC UNDERSERVED INDIVIDUALS WITH INTERSECTIONAL LGBTQ+ IDENTITIES IN THE STATE OF RHODE ISLAND WHICH HAS AMONG THE HIGHEST RATES OF ILLICIT DRUG USE IN THE COUNTRY. | $998K | FY2024 | Sep 2024 – Sep 2029 |
| Department of Health and Human Services | DEVELOPING A BEHAVIORAL WEIGHT LOSS INTERVENTION FOR EMERGING ADULTS IMPLEMENTED WITHIN COLLEGE HEALTH SERVICE CENTERS - PROJECT SUMMARY/ABSTRACT FORTY PERCENT OF EMERGING ADULTS (AGE 18-25) HAVE OVERWEIGHT OR OBESITY, WHICH IS UNLIKELY TO REMIT AND HAS SIGNIFICANT HEALTH CONSEQUENCES. HOWEVER, EMERGING ADULTS ARE UNDERREPRESENTED IN TRADITIONAL WEIGHT LOSS PROGRAMS, DROP-OUT AT HIGH RATES, AND HAVE BLUNTED WEIGHT LOSS OUTCOMES. ONE POTENTIAL WAY TO IMPROVE PARTICIPATION IS TO OFFER BWLIS IN COLLEGE HEALTH SERVICE CENTERS TO REDUCE BARRIERS TO PARTICIPATION. APPROXIMATELY 40% OF EMERGING ADULTS ARE ENROLLED IN A POSTSECONDARY INSTITUTION AND COLLEGE HEALTH CENTERS ARE USED WIDELY BY STUDENTS. MOREOVER, DELIVERING AN INTERVENTION WITH DESIGN FEATURES THAT ARE RESPONSIVE TO EMERGING ADULT PREFERENCES AND LIFESTYLES MAY ALSO IMPROVE INTERVENTION EFFECTIVENESS AND ATTRACTIVENESS. THE “SMALL CHANGE” (SC) APPROACH TO WEIGHT LOSS ADDRESSES EMERGING ADULT BARRIERS TO ENGAGEMENT BY FOCUSING ON REDUCING CALORIES THROUGH A FEW SELF-SELECTED, SPECIFIC CHANGES TO CURRENT OBESOGENIC BEHAVIORS, REQUIRING LESS TIME AND EFFORT THAN TRADITIONAL BEHAVIORAL WEIGHT LOSS INTERVENTIONS (BWLI) AND PROMOTING AUTONOMY AND SELF- EFFICACY. THE SC APPROACH HAS BEEN USED EFFECTIVELY FOR WEIGHT LOSS IN OTHER POPULATIONS. THE GOAL OF THIS K23 IS TO DEVELOP AND REFINE A NOVEL AND EFFECTIVE BWLI BASED ON A SC APPROACH THAT IS DESIGNED FOR EMERGING ADULTS AND FOR IMPLEMENTATION IN COLLEGE HEALTH CENTERS, AN ACCESSIBLE CARE SETTING. TO ACHIEVE THIS RESEARCH GOAL, I WILL DEVELOP A PROTOTYPE BWLI FOR EMERGING ADULT COLLEGE STUDENTS (BWLI-COLLEGE) THAT WILL INTEGRATE 1) RESULTS FROM QUALITATIVE INTERVIEWS WITH COLLEGE STAKEHOLDER GROUPS REGARDING PERCEIVED BARRIERS AND FACILITATORS OF IMPLEMENTATION IN HEALTH CENTERS AND 2) PREVIOUS FINDINGS REGARDING EMERGING ADULT PREFERENCES FOR WEIGHT LOSS INTERVENTIONS (AIM 1A & 1B). NEXT, I WILL ITERATIVELY ADAPT THE BWLI-COLLEGE PROTOTYPE THROUGH 2-3 UNCONTROLLED PILOT TRIALS WITH FEEDBACK FROM EMERGING ADULT STUDENTS WITH OVERWEIGHT/OBESITY (N=10/TRIAL) TO MAXIMIZE FEASIBILITY, ACCEPTABILITY, AND WEIGHT LOSS (AIM 2). FINALLY, I WILL TEST BWLI-COLLEGE AGAINST A ONE-SESSION PSYCHOEDUCATIONAL CONTROL GROUP IN A SMALL RANDOMIZED-CONTROLLED PILOT TRIAL (N=60; AIM 3). THIS PROJECT WILL FILL A CRITICAL NEED FOR AN EVIDENCE-BASED WEIGHT MANAGEMENT INTERVENTION FOR EMERGING ADULTS THAT CAN BE DELIVERED VIA COLLEGE CAMPUSES. TO COMPLETE THIS K23 RESEARCH STUDY, I PROPOSE TO RECEIVE TRAINING IN 1) DESIGNING AND TESTING OBESITY INTERVENTIONS, 2) THE UNIQUE FEATURES OF EMERGING ADULT POPULATIONS, 3) IMPLEMENTATION PRINCIPLES AND METHODS FOR THE TRANSLATION OF OBESITY INTERVENTIONS TO REAL- WORLD SETTINGS AND 4) ADVANCED STATISTICAL METHODS FOR LONGITUDINAL DATA FROM EFFICACY AND EFFECTIVENESS TRIALS. WITH THIS TRAINING AND RESEARCH PLAN, THE COMPREHENSIVE TEAM OF MENTORS I HAVE ASSEMBLED TO FACILITATE MY PROGRESS, AND THE RIGOROUS ACADEMIC AND TRAINING ENVIRONMENT OF BROWN UNIVERSITY AND THE MIRIAM HOSPITAL, I WILL BE WELL-POSITIONED TO LAUNCH MY CAREER AS AN INDEPENDENT INVESTIGATOR DEDICATED TO DEVELOPING, TESTING, AND IMPLEMENTING NOVEL OBESITY INTERVENTIONS TO PROVIDE EARLY TREATMENT OF OBESITY AND PREVENT THE ASSOCIATED DOWNSTREAM HEALTH CONSEQUENCES IN LATER ADULTHOOD. | $993.7K | FY2022 | Jan 2022 – Nov 2026 |
| Department of Health and Human Services | AGE EFFECTS ON HIV-ASSOCIATED BRAIN DYSFUNCTION | $992.1K | FY2006 | Sep 2006 – Aug 2011 |
| Department of Health and Human Services | THE EFFECT OF ANTENATAL MATERNAL CANNABIS USE ON PARENTING BEHAVIOR - PROJECT SUMMARY AS UNITED STATES CANNABIS POLICY SHIFTS TOWARD LIBERALIZATION, NORMS AND BEHAVIORS AROUND ADULT USE HAVE SHIFTED IN KIND. THIS INCLUDES PARENT USE, WHICH IS INCREASING IN FREQUENCY AND PREVALENCE. WHILE CERTAIN DEFICITS HAVE BEEN FOUND IN CHILDREN OF PARENTS WHO USE CANNABIS, THESE ASSOCIATIONS ARE INHERENTLY SUBJECT TO CONFOUNDING BY PARENTS AND CHILDREN’S SOCIAL ENVIRONMENTS, AND POTENTIAL FOR CAUSAL INFERENCE HAS BEEN LIMITED. PARENTS REPORT USING FOR STRESS-COPING, BUT THE RELATIONSHIP BETWEEN CANNABIS AND STRESS IS COMPLEX AND HIGHLY DEPENDENT ON SOCIAL CONTEXT. PATTERNS OF CANNABIS USE AMONG PARENTS MIRROR EXISTING HEALTH INEQUITIES. THEORETICAL SOCIAL EPIDEMIOLOGIC MODELS SUGGEST THAT DRUG USE AS A STRESS-COPING MECHANISM IS BOTH A REFLECTION OF HEALTH INEQUITIES AND CAUSE OF HEALTH DISPARITIES, WHICH MAY BE FURTHER EXACERBATED IN THE CONTEXT OF INTERGENERATIONAL EFFECTS. THEORETICAL MODELS AND EMPIRICAL EVIDENCE FROM DEVELOPMENTAL PSYCHOLOGY UNDERLINE THE IMPORTANT AND INTERACTING ROLES OF SUBSTANCE USE, STRESS AND THE SOCIAL ENVIRONMENT ON PARENTING. THIS MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) WILL SUPPORT THE CANDIDATE’S CAREER DEVELOPMENT AS AN INDEPENDENT INTERDISCIPLINARY RESEARCHER IN MODIFIABLE FACTORS THAT PRODUCE DISPARITIES AND INEQUITIES IN SUBSTANCE USE, TREATMENT AND CONSEQUENCES ACROSS THE LIFE COURSE. THE AWARD WILL SUPPORT THE CANDIDATE’S SHORT-TERM GOAL OF UNDERSTANDING THE INTERGENERATIONAL TRANSMISSION OF CANNABIS-RELATED HARM. THIS APPLICATION AIMS TO CONTRIBUTE A CLEARER UNDERSTANDING OF THE COMPLEX RELATIONSHIPS BETWEEN DIVERSE FAMILIES’ SOCIAL ENVIRONMENTS, MATERNAL CANNABIS USE, PARENTING BEHAVIORS, AND THE MATERNAL-INFANT RELATIONSHIP IN THE SIX MONTHS POSTPARTUM. SPECIFIC AIMS ARE TO 1) UNDERSTAND THE IMPACT OF MATERNAL CANNABIS USE IN THE FIRST SIX MONTHS POSTPARTUM ON PARENTING BEHAVIORS AND MATERNAL-INFANT INTERACTION; 2) UNDERSTAND THE INFLUENCE OF DISCRIMINATION IN THE RELATIONSHIP BETWEEN STRESS, CANNABIS USE AND PARENTING; AND 3) CHARACTERIZE MOTIVATIONS FOR MATERNAL CANNABIS USE THROUGH QUALITATIVE INTERVIEWS. RESEARCH AIMS WILL BE EXPLORED IN A PROSPECTIVE LONGITUDINAL COHORT OF PREGNANT WOMEN WHO USE CANNABIS, FOLLOWING MOTHERS AND INFANTS UNTIL ONE YEAR POSTPARTUM. OUTCOMES WILL BE ASSESSED USING QUALITATIVE AND QUANTITATIVE TECHNIQUES, INCLUDING INTERVIEWS, SURVEYS, BEHAVIORAL OBSERVATION, AND BIOMARKER MEASUREMENT. BY FOCUSING ON MULTIPLE LEVELS OF MODIFIABLE INFLUENCE ON MATERNAL CANNABIS USE, PARENTING AND THE MATERNAL-INFANT RELATIONSHIP, INCLUDING BEHAVIORAL AND BIOLOGICAL PATHWAYS, RESULTS FROM THIS RESEARCH HAVE THE POTENTIAL TO PROVIDE UNIQUE OPPORTUNITIES TO ADDRESS MATERNAL AND CHILD HEALTH IN THE CONTEXT OF SHIFTING SOCIAL AND LEGAL NORMS SURROUNDING ADULT CANNABIS USE. THIS RESEARCH IS DESIGNED TO ADDRESS THE OBJECTIVE 4.1 OF NIDA’S STRATEGIC PLAN TO DETERMINE THE IMPACT OF DRUG USE AND ADDICTION ON INDIVIDUALS, FAMILIES, PEERS AND SOCIETY. THE TRAINING PLAN IS DESIGNED TO PREPARE THE CANDIDATE FOR A CAREER AS AN INTERDISCIPLINARY RESEARCHER IN SUBSTANCE USE BY SUPPLEMENTING HER BACKGROUND IN SOCIAL EPIDEMIOLOGY AND SECONDARY DATA ANALYSIS WITH TRAINING IN STRESS RESEARCH AND PRIMARY DATA COLLECTION. | $930.9K | FY2022 | Apr 2022 – Mar 2027 |
| Department of Health and Human Services | INNOVATIVE TECHNOLOGY TO IMPROVE PATIENT ADHERENCE TO WEIGHT LOSS RECOMMENDATIONS | $930.3K | FY2009 | Sep 2009 – Jul 2011 |
| Department of Health and Human Services | OPTIMIZATION AND EVALUATION OF A TAILORED BEHAVIORAL EHEALTH/MHEALTH WEIGHT LOSS INTERVENTION FOR CARDIAC REHABILITATION PATIENTS USING THE MULTIPHASE OPTIMIZATION STRATEGY | $930K | FY2018 | Feb 2018 – Feb 2024 |
| Department of Health and Human Services | MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH | $885.4K | FY2016 | Mar 2016 – Feb 2022 |
| Department of Health and Human Services | BUPRENORPHINE AS A BRIDGE TO HCV TREATMENT FOR HIV/HCV COINFECTED OPIOID USERS | $882.4K | FY2008 | Jul 2008 – Jun 2013 |
| Department of Health and Human Services | BASIC ASPECTS OF HEMATOPOIETIC STEM CELLS AND AGING | $865.2K | FY2017 | Sep 2017 – Jun 2022 |
| Department of Health and Human Services | USING NOVEL BEHAVIORAL APPROACHES TO IMPROVE LONG-TERM WEIGHT LOSS OUTCOMES | $863.1K | FY2013 | Sep 2013 – Jul 2019 |
| Department of Health and Human Services | ACHIEVING PHYSICAL ACTIVITY GUIDELINES THROUGH AN ENHANCED PRINT INTERVENTION | $860.9K | FY2000 | Aug 2000 – Oct 2010 |
| Department of Health and Human Services | STRESS RESPONSE, COGNITIVE CONTROL & "REAL TIME" RUMINATION: SHARED MECHANISMS UNDERLYING SUBSTANCE USE AND DEPRESSION | $860.8K | FY2018 | Aug 2018 – Jul 2023 |
| Department of Health and Human Services | ADDRESSING WEIGHT BIAS INTERNALIZATION TO IMPROVE ADOLESCENT WEIGHT MANAGEMENT OUTCOMES - PROJECT SUMMARY/ABSTRACT WEIGHT BIAS INTERNALIZATION (WBI), OR SELF-DIRECTED WEIGHT-BASED STIGMA, HAS BEEN ASSOCIATED WITH A NUMBER OF NEGATIVE PHYSICAL AND MENTAL HEALTH CONSEQUENCES FOR ADOLESCENTS WITH OBESITY, INCLUDING NEGATIVE WEIGHT- RELATED OUTCOMES (E.G., INCREASED CALORIE CONSUMPTION, POORER WEIGHT LOSS OUTCOMES). THE PREVALENCE AND SALIENCE OF WBI AS A STRESSOR IMPACTING WEIGHT-RELATED OUTCOMES IN ADOLESCENTS PAIRED WITH THE HETEROGENEOUS RESPONSE TO INTERVENTIONS FOR ADOLESCENTS WITH OBESITY HIGHLIGHTS THE POTENTIAL UTILITY OF COMBINED INTERVENTION FOR WBI AND OBESITY IN YOUTH TO PROMOTE IMPROVED WEIGHT MANAGEMENT OUTCOMES DURING THIS CRITICAL DEVELOPMENTAL PERIOD. THIS K23 AWARD IS DESIGNED TO FILL GAPS IN MY TRAINING AND SUPPORT A RESEARCH STUDY THAT WILL PROVIDE NEXT STEPS IN IMPROVING THE HEALTH OF ADOLESCENTS WITH OBESITY. THE FIRST PHASE OF THE RESEARCH PROJECT WILL EMPLOY FOCUS GROUPS AND AN OPEN PILOT TRIAL TO DEVELOP AND TEST FEASIBILITY OF AN INTEGRATED INTERVENTION THAT COMBINES TREATMENT FOR WBI WITH AN EVIDENCE-BASED ADOLESCENT BEHAVIORAL WEIGHT CONTROL (BWC). I WILL THEN CONDUCT A SMALL RCT TO TEST THE EFFECTS OF THE NEWLY DESIGNED WBI+BWC INTERVENTION ON WBI AND MECHANISMS OF WEIGHT- STIGMA STRESS INDUCED WEIGHT GAIN, SPECIFICALLY PHYSIOLOGICAL MARKERS OF STRESS (DIURNAL CORTISOL) AND INFLAMMATION (C-REACTIVE PROTEIN, INTERLEUKIN-6), AND DYSREGULATED EATING BEHAVIORS (EMOTIONAL EATING, LOSS OF CONTROL, UNHEALTHY WEIGHT CONTROL BEHAVIORS). I HYPOTHESIZE THAT BWC COMBINED WITH INTERVENTION FOR WBI, WILL LEAD TO IMPROVEMENTS IN MECHANISMS OF WEIGHT-STIGMA STRESS INDUCED WEIGHT GAIN, IN TURN PROMOTING IMPROVED WEIGHT LOSS OUTCOMES. THIS RESEARCH PROJECT HAS SIGNIFICANT CLINICAL IMPLICATIONS FOR THE IMPROVEMENT OF ADOLESCENT BWC AND REDUCTION OF THE NEGATIVE EFFECTS OF WEIGHT-BASED STIGMA IN ADOLESCENTS. TO CONDUCT THIS RESEARCH AND FILL CRITICAL GAPS IN MY TRAINING THAT WILL FACILITATE BECOMING AN INDEPENDENT INVESTIGATOR FOCUSED ON BEHAVIORAL TREATMENT OF OBESITY IN ADOLESCENTS, I WILL COMPLETE A RIGOROUS, TARGETED TRAINING PROGRAM. THE PROPOSED TRAINING PLAN INCLUDES DEVELOPING EXPERTISE IN 1) CONDUCTING RCTS TO DEVELOP AND TEST BWC INTERVENTIONS FOR ADOLESCENTS; 2) THEORETICAL AND CONCEPTUAL MODELS OF WEIGHT-BASED STIGMA AND WBI; 3) INTEGRATION OF MECHANISMS IN CLINICAL TRIALS FOCUSED ON BIOLOGICAL MARKERS AND DYSREGULATED EATING BEHAVIORS; AND 4) PROFESSIONAL DEVELOPMENT. THIS TRAINING WILL BE CONDUCTED UNDER THE PRIMARY MENTORSHIP OF DR. ELISSA JELALIAN, WITH CO-MENTORS DRS. REBECCA PUHL, STEPHANIE PARADE, ANDREA GOLDSCHMIDT, AND CONTRIBUTOR DR. DAVID BARKER. THE SKILLS I WILL ACQUIRE MAP DIRECTLY ONTO THE PROPOSED RESEARCH PROJECT AND PROVIDE THE KNOWLEDGE AND EXPERTISE NECESSARY TO PREPARE A SUCCESSFUL R01 APPLICATION BY THE END OF THE AWARD PERIOD. THE MENTORSHIP TEAM, IN COMBINATION WITH THE RIGOROUS ACADEMIC AND TRAINING ENVIRONMENT PROVIDED BY THE WEIGHT CONTROL AND DIABETES RESEARCH CENTER AT THE MIRIAM HOSPITAL AND BROWN UNIVERSITY, REPRESENT AN IDEAL ENVIRONMENT TO ACCOMPLISH THESE TRAINING AND RESEARCH GOALS. THROUGH THIS CAREER DEVELOPMENT AWARD, I WILL ESTABLISH MYSELF AS AN INDEPENDENT INVESTIGATOR DEDICATED TO THE DEVELOPMENT OF NOVEL INTERVENTIONS TO IMPROVE HEALTH OUTCOMES FOR ADOLESCENTS WITH OBESITY. | $827.2K | FY2023 | Jun 2023 – Feb 2028 |
| Department of Health and Human Services | USING THE MULTIPHASE OPTIMIZATION STRATEGY TO OPTIMIZE A CULTURALLY TAILORED ONLINE BEHAVIORAL WEIGHT LOSS INTERVENTION FOR SEXUAL MINORITY WOMEN | $826.5K | FY2020 | Jul 2020 – Apr 2025 |
| Department of Health and Human Services | DEVELOPMENT OF A TAI CHI PROGRAM TO OVERCOME BARRIERS TO CARDIAC REHABILITATION | $775.9K | FY2013 | Sep 2013 – May 2016 |
| Department of Health and Human Services | OPIATE REPLACEMENT THERAPY AT RELEASE FROM INCARCERATION | $753.5K | FY2005 | Jun 2005 – Mar 2010 |
| Department of Health and Human Services | LINKAGE TO COMMUNITY-BASED HIV PRE-EXPOSURE PROPHYLAXSIS CARE AMONG AT RISK WOMEN UPON RELEASE FROM INCARCERATION | $752.7K | FY2017 | Jul 2017 – Jun 2022 |
| VA/DoDDepartment of Defense | STIMULATING MENISCUS FIBROCARTILAGE HEALING BY BIOLOGIC CELL THERAPY | $750K | FY2020 | Sep 2020 – Mar 2024 |
| Department of Health and Human Services | ADAPTING AN ADOLESCENT WEIGHT MANAGEMENT PROGRAM FOR A TYPE 1 DIABETES POPULATION - PROJECT ABSTRACT COMORBID OVERWEIGHT/OBESITY (BMI>85TH PERCENTILE FOR SEX AND AGE) WAS RARE IN YOUTH WITH TYPE 1 DIABETES MELLITUS (T1DM) PRIOR TO THE 1990S, BUT THE PREVALENCE NOW EXCEEDS THAT OF YOUTH IN THE GENERAL POPULATION. BEHAVIORAL WEIGHT MANAGEMENT INTERVENTIONS ARE EVIDENCE-BASED, FIRST-LINE TREATMENTS FOR PEDIATRIC OBESITY. YET, THERE ARE UNIQUE CHALLENGES OF T1DM THAT REQUIRE THOUGHTFUL ADAPTATIONS TO THESE INTERVENTIONS. EXAMPLES INCLUDE REDUCED EXERCISE AND EXCESS CALORIE CONSUMPTION DUE TO HYPOGLYCEMIA. ADOLESCENTS WITH T1DM AND COMORBID OVERWEIGHT/OBESITY ARE ALSO AT HIGH RISK OF DEVELOPING DISORDERED EATING BEHAVIORS. THERE IS A CRITICAL NEED FOR BEHAVIORAL WEIGHT MANAGEMENT INTERVENTIONS THAT ADDRESS BARRIERS SPECIFIC TO T1DM AND INCORPORATE ATTENTION TO EATING DISORDER PREVENTION IN THIS AT-RISK POPULATION. THE OBJECTIVE OF THIS K23 PROJECT IS TO ADAPT THE PRIMARY MENTOR’S (DR. ELISSA JELALIAN) ESTABLISHED 16-WEEK ADOLESCENT WEIGHT MANAGEMENT INTERVENTION FOR A T1DM POPULATION. USING THE OBESITY-RELATED BEHAVIORAL INTERVENTION TRIALS (ORBIT) MODEL, A FRAMEWORK FOR INTERVENTION DEVELOPMENT, THIS PROJECT WILL DESIGN, REFINE, AND TEST AN ADAPTED BEHAVIORAL WEIGHT MANAGEMENT INTERVENTION FOR ADOLESCENTS WITH COMORBID T1DM AND OVERWEIGHT/OBESITY USING TWO RELATED YET DISTINCT STUDIES. STUDY 1 WILL ENSURE FEASIBILITY (I.E., PARTICIPANT ATTENDANCE) AND ACCEPTABILITY OF INTERVENTION MATERIALS BY ADOLESCENTS WITH COMORBID T1DM AND OVERWEIGHT/OBESITY USING AN OPEN-TRIAL DESIGN WITH 2-3 SMALL GROUPS (N=5 ADOLESCENTS/GROUP). PARTICIPANTS WILL COMPLETE VALIDATED MEASURES OF ACCEPTABILITY AFTER EACH WEEKLY SESSION AND AN EXIT SURVEY POST-INTERVENTION. THE CANDIDATE WILL ITERATIVELY REFINE THE INTERVENTION BASED UPON STUDY 1 RESULTS. STUDY 2 WILL COMPARE THE ADAPTED WEIGHT MANAGEMENT INTERVENTION TO A USUAL CARE CONTROL GROUP USING A PILOT RANDOMIZED CONTROLLED TRIAL DESIGN (N=50 TOTAL ADOLESCENTS) TO VERIFY THAT THE ADAPTED INTERVENTION REDUCES PARTICIPANT BMI AND INCREASES THE PERCENT TIME SPENT IN THE TARGET BLOOD GLUCOSE RANGE (70-180MG/DL; PRIMARY OUTCOMES). PARTICIPANTS IN STUDY 2 WILL COMPLETE ECOLOGICAL MOMENTARY ASSESSMENTS (EMA) AT BASELINE AND 16-WEEKS TO DETERMINE EVENTS OF MALADAPTIVE EATING AND WEIGHT CONTROL BEHAVIORS OVER TIME (SECONDARY OUTCOMES). EXPLORATORY ANALYSES WILL EVALUATE CORRELATES OF THESE MALADAPTIVE EATING AND WEIGHT CONTROL BEHAVIORS IN REAL-WORLD SETTINGS. THIS K23 PROJECT BUILDS UPON THE CANDIDATE’S PRIOR WORK IN PEDIATRIC OBESITY AND T1DM. THE HIGHLY QUALIFIED AND EXPERT MENTORSHIP TEAM WILL PROVIDE SUPPORT AND OVERSIGHT, ALLOWING THE CANDIDATE TO ACQUIRE THE NECESSARY SKILLS TO LAUNCH AN INDEPENDENT RESEARCH CAREER AIMED AT IMPROVING WEIGHT MANAGEMENT FOR ADOLESCENTS WITH COMORBID T1DM AND OVERWEIGHT/OBESITY. RESULTS WILL PROVIDE DATA FOR A SUBSEQUENT APPLICATION TO CONDUCT A FULLY POWERED RANDOMIZED CONTROLLED TRIAL TO TEST THE EFFICACY OF THE ADAPTED WEIGHT MANAGEMENT INTERVENTION. THE PROPOSED PROJECT ALIGNS WITH THE NIDDK’S MISSION TO MITIGATE DIABETES-RELATED CARDIOVASCULAR EVENTS AND HAS THE POTENTIAL TO BE AN IMPORTANT PUBLIC HEALTH INTERVENTION TO IMPROVE THE HEALTH OF ADOLESCENTS WITH T1DM AND OVERWEIGHT/OBESITY. | $749.9K | FY2022 | Sep 2022 – May 2027 |
| Department of Health and Human Services | CHILDHOOD ADVERSITY AND SUBSTANCE USE: INTEGRATING LABORATORY AND ECOLOGICAL APPROACHES TO UNDERSTAND THE ROLE OF AFFECT - PROJECT SUMMARY/ABSTRACT BY 12TH GRADE, OVER 50% OF ADOLESCENTS IN THE UNITED STATES ENDORSE LIFETIME SUBSTANCE USE. CHILDHOOD ADVERSITY IS A PREVALENT AND ROBUST RISK FACTOR FOR ADOLESCENT SUBSTANCE USE. APPROXIMATELY 54% OF ADOLESCENTS REPORT ADVERSE CHILDHOOD EXPERIENCES (ACES), MAKING THEM OVER 1.5 TIMES MORE LIKELY TO USE SUBSTANCES. YET, MANY ADOLESCENTS WITH ACES DENY SUBSTANCE USE ENGAGEMENT, IMPLYING THE EXISTENCE OF MODIFIABLE RISK FACTORS. USING AN INTEGRATIVE MODEL OF ECOLOGICAL AND LABORATORY APPROACHES, THE PROPOSED STUDY EXAMINES THE ROLE OF AFFECT IN THE LINK BETWEEN ACES AND ADOLESCENT SUBSTANCE USE. CANDIDATE: THE CANDIDATE IS A CLINICAL CHILD PSYCHOLOGIST WITH A LONG-STANDING COMMITMENT TO STUDYING RISK AND RESILIENCE ASSOCIATED WITH EARLY LIFE STRESS. HER PRIOR RESEARCH HAS FOCUSED ON ELUCIDATING MECHANISMS THAT CONTRIBUTE TO SUBSTANCE USE IN EMERGING ADULTS WITH ACES. SHE IS APPLYING FOR A FIVE-YEAR K08 CAREER DEVELOPMENT AWARD TO EXPAND HER EXPERTISE AND SUPPORT HER TRAINING, MENTORSHIP, AND RESEARCH IN ADOLESCENT SUBSTANCE USE. TRAINING: THE PROPOSED TRAINING PLAN INCLUDES FORMAL WORKSHOPS, SEMINARS, CONFERENCES, DIRECTED READINGS, AND MENTORED EXPERIENCES THAT WILL ADVANCE HER TRAJECTORY TOWARD RESEARCH INDEPENDENCE BY FOSTERING NEW EXPERTISE IN: (1) HIGHLY RIGOROUS AND CUTTING EDGE LABORATORY-BASED PHYSIOLOGICAL TECHNIQUES, INCLUDING EYE TRACKING, PUPIL DILATION, GALVANIC SKIN RESPONSE, AND HEART RATE MEASUREMENT, (2) THE COLLECTION, MANAGEMENT, AND ANALYSIS OF ECOLOGICAL MOMENTARY ASSESSMENT (EMA) DATA, (3) ADVANCED ANALYTICAL APPROACHES TO INTEGRATE MULTIMETHOD RESEARCH DESIGNS, (4) THE DESIGN AND IMPLEMENTATION OF ADOLESCENT SUBSTANCE USE RESEARCH, AND (5) ENHANCED PROFESSIONAL DEVELOPMENT. THE CANDIDATE IS INSTITUTIONALLY SUPPORTED BY THE MIRIAM HOSPITAL AND THE WARREN ALPERT MEDICAL SCHOOL OF BROWN UNIVERSITY. MENTORING: FIVE WELL-ESTABLISHED RESEARCHERS SERVE AS MENTORS ON THIS PROPOSAL. EACH MENTOR OFFERS COMPLEMENTARY EXPERTISE CONSISTENT WITH THE STUDY’S AIMS AND TRAINING OBJECTIVES, INCLUDING ADVANCED DATA ANALYTIC TECHNIQUES, EMA, CHILDHOOD TRAUMATIC STRESS, LABORATORY-BASED BIO-BEHAVIORAL ASSESSMENT, AND ADOLESCENT SUBSTANCE USE RESEARCH. RESEARCH: THE PROPOSED STUDY WILL RECRUIT ADOLESCENT PARTICIPANTS (N=100, AGES 13-18) FROM AN ACTIVE LONGITUDINAL STUDY (R01HD104187). USING EMA, EYE TRACKING, BEHAVIORAL TASK PERFORMANCE, AND TRADITIONAL SELF-REPORT DATA, THE AIMS OF THE PROPOSAL ARE TO: EXAMINE THE INDIRECT EFFECTS OF ACES ON SUBSTANCE USE VIA AFFECT BALANCE (AIM 1), TOLERANCE OF AFFECTIVE DISTRESS (AIM 2), AND ATTENTION/REACTIVITY TO AFFECTIVE STIMULI (AIM 3). | $746.8K | FY2022 | Sep 2022 – Aug 2027 |
| Department of Health and Human Services | DEVELOPMENT OF A NOVEL HIV RISK REDUCTION INTERVENTION FOR ABUSED WOMEN | $732.3K | FY2012 | Sep 2012 – Jan 2017 |
| Department of Health and Human Services | EXERCISE AS A BUFFER AGAINST STRESSED-INDUCED EATING | $728.1K | FY2014 | Jul 2014 – Mar 2019 |
| Department of Health and Human Services | LIFESTYLE INTERVENTION TO TREAT ERECTILE DYSFUNCTION (LITE) | $726.8K | FY2009 | Sep 2009 – Jul 2011 |
| Department of Health and Human Services | IMPLEMENTING A BRIEF SUICIDE INTERVENTION FOR HIGH RISK YOUTH WITH FRONT-LINE JUVENILE JUSTICE STAFF | $725.1K | FY2016 | Sep 2016 – May 2022 |
| Department of Health and Human Services | LONG-ACTING INJECTABLE ANTIRETROVIRAL TREATMENT TO IMPROVE HIV TREATMENT AMONG JUSTICE-INVOLVED PERSONS BEING RELEASED TO THE COMMUNITY - PERSONS WHO EXPERIENCE INCARCERATION IN THE UNITED STATES ARE DISPROPORTIONATELY IMPACTED BY HIV INFECTION AND SUBSTANCE USE DISORDERS (SUD) AND ARE AT INCREASED RISK OF HAVING POOR HEALTH OUTCOMES. THE TIME OF RELEASE FROM CARCERAL SETTINGS, KNOWN AS COMMUNITY RE-ENTRY, IS A PERIOD OF PARTICULARLY HIGH RISK FOR PERSONS WITH HIV (PWH). NEW AND CREATIVE APPROACHES TO SUSTAINING HIV TREATMENT AND VIRAL SUPPRESSION DURING COMMUNITY RE- ENTRY ARE URGENTLY NEEDED. ANTIRETROVIRAL TREATMENT (ART) IS HIGHLY EFFECTIVE IN CONTROLLING HIV AND CAN SIGNIFICANTLY REDUCE HIV TRANSMISSION. HOWEVER, JUSTICE INVOLVED PWH OFTEN STRUGGLE WITH DAILY ART ADHERENCE DURING COMMUNITY RE-ENTRY AND CONSEQUENTLY EXPERIENCE DISEASE PROGRESSION AND CONTRIBUTE TO HIV TRANSMISSION. LONG- ACTING INJECTABLE (LAI) ART IS A NEW ALTERNATIVE TO HELP OVERCOME THE CHALLENGES OF ADHERING TO DAILY PILLS. THE FIRST FDA-APPROVED LAI ART REGIMEN, CABOTEGRAVIR (CAB) AND RILPIVIRINE (RPV), IS ADMINISTERED BY INTRAMUSCULAR INJECTION EVERY FOUR WEEKS. THERE IS AN IMMEDIATE OPPORTUNITY TO INVESTIGATE WHETHER USING LAI ART, AS OPPOSED TO DAILY ORAL ART, HAS A UNIQUE AND IMPORTANT ROLE WHEN INITIATED IN CARCERAL SETTINGS AND CONTINUED DURING COMMUNITY RE-ENTRY WITH THE GOAL OF IMPROVING TREATMENT OUTCOMES. WE PROPOSE A MIXED METHODS STUDY THAT WILL DEVELOP AND PILOT TEST AN LAI ART PROTOCOL DESIGNED SPECIFICALLY FOR COMMUNITY RE-ENTRY. THIS STUDY WILL BE CONDUCTED IN COLLABORATION WITH THE MARYLAND DEPARTMENT OF PUBLIC SAFETY AND CORRECTIONAL SERVICES, CORIZON HEALTH (STATE PRISON MEDICAL CONTRACTOR), AND TOTAL HEALTH CARE, A FEDERALLY QUALIFIED HEALTH CENTER IN THE BALTIMORE METROPOLITAN AREA, AN ENDING THE HIV EPIDEMIC GEOGRAPHIC HOTSPOT. FRAMED BY THE BEHAVIORAL MODEL FOR VULNERABLE POPULATIONS, OUR AIMS INCLUDE: 1) CONDUCT INTERVIEWS WITH JUSTICE AND TREATMENT EXPERIENCED PWH (N=20), AND CARCERAL AND COMMUNITY KEY STAKEHOLDERS (N=20), TO OBTAIN GUIDANCE ON THE DEVELOPMENT AND IMPLEMENTATION OF A PROTOCOL TO TRANSITION PWH ON ORAL ART TO LAI ART IN PRISON WITH CONTINUATION DURING COMMUNITY RE-ENTRY. 2) DEVELOP AN INITIAL LAI ART COMMUNITY RE-ENTRY PROTOCOL AND CONDUCT AN OPEN LABEL PILOT STUDY THAT WILL FOLLOW 10 INCARCERATED PWH ELIGIBLE FOR LAI ART WHO ARE NEAR RELEASE FROM PRISON FOR THREE MONTHS IN ORDER TO OPTIMIZE PROTOCOL PROCEDURES AND TO PILOT STUDY RETENTION METHODS AND ASSESSMENTS. 3) FOLLOWING OPTIMIZATION OF PROTOCOL, CONDUCT A PILOT RANDOMIZED CONTROLLED TRIAL AMONG 50 INCARCERATED PWH ELIGIBLE FOR LAI ART AND SCHEDULED TO BE RELEASED FROM PRISON; PARTICIPANTS WILL BE RANDOMIZED 1:1 TO TRANSITION ART TO INJECTABLE CAB/RPV OR CONTINUE DAILY ORAL ART REGIMEN THROUGH A SIX-MONTH FOLLOW-UP PERIOD AFTER RELEASE. DURING THE FOLLOW-UP PERIOD, WE WILL ASSESS THE PRIMARY OUTCOME OF HIV VIRAL SUPPRESSION AND SECONDARY OUTCOMES INCLUDING CONTINUANCE OF THE ASSIGNED LAI OR ORAL ART REGIMEN, ART ADHERENCE, AND SUBSTANCE USE. THIS STUDY WILL PROVIDE PRELIMINARY DATA TO INFORM THE DESIGN OF A FUTURE MULTI-SITE FULLY POWERED CLINICAL TRIAL THAT WILL COMPARE LAI ART TO DAILY ORAL ART DURING COMMUNITY RE-ENTRY ON SUSTAINING HIV VIRAL SUPPRESSION AFTER RELEASE FROM PRISON. | $717.3K | FY2022 | Sep 2022 – Jul 2025 |
| Department of Health and Human Services | A SLEEP HYGIENE INTERVENTION TO IMPROVE SLEEP QUALITY IN URBAN, LATINO MIDDLE SCHOOL CHILDREN | $716.6K | FY2017 | Sep 2017 – Oct 2021 |
| Department of Health and Human Services | PREVENTION OF POSTPARTUM WEIGHT RETENTION | $706.4K | FY2006 | Sep 2006 – Aug 2010 |
| Department of Health and Human Services | AN AI-BASED BEHAVIORAL INTERVENTION TO IMPROVE PRE-EXPOSURE PROPHYLAXIS FOR HIV PREVENTION - HIV CONTINUES TO DISPROPORTIONATELY AFFECT MEN WHO HAVE SEX WITH MEN (MSM), PARTICULARLY THOSE LIVING IN THE ENDING THE HIV EPIDEMIC (EHE) JURISDICTIONS. DESPITE THE PROVEN EFFECTIVENESS OF HIV PRE-EXPOSURE PROPHYLAXIS (PREP) IN PREVENTING HIV INFECTIONS, ITS UPTAKE AMONG MSM IS NOTABLY INADEQUATE, PARTICULARLY AMONG THOSE LIVING IN EHE JURISDICTIONS. MOTIVATIONAL INTERVIEWING (MI) HAS SHOWN EFFECTIVENESS IN ENCOURAGING AT-RISK MSM TO ADOPT PREP; INTEGRATING THE TRANSTHEORETICAL MODEL (TTM) INTO MI ENABLES THE ASSESSMENT OF AN INDIVIDUAL'S READINESS FOR CHANGE AND THE DELIVERY OF TAILORED MI SESSIONS. HOWEVER, ITS LABOR-INTENSIVE NATURE, REQUIRING MULTIPLE SESSIONS, POSES A SIGNIFICANT CHALLENGE. THE POTENTIAL SOLUTION LIES IN HARNESSING GENERATIVE ARTIFICIAL INTELLIGENCE (AI) TO STREAMLINE AND MAKE MI MORE ACCESSIBLE. THIS PILOT STUDY AIMS TO LEVERAGE AI TECHNOLOGY TO OVERCOME THE LABOR-INTENSIVE ASPECTS OF MI, POTENTIALLY REACHING A BROADER AUDIENCE SIMULTANEOUSLY. IN THE STUDY, WE AIM TO TAILOR, REFINE, AND TEST AN AI-BASED CHATBOT CALLED CHIA (CHATBOT FOR HIV PREVENTION AND ACTION) WITH MI TECHNIQUES TO PROMOTE HIV PREP AMONG MSM LIVING IN THE EHE JURISDICTIONS. THE CHIA WILL BE TAILORED AND FINE-TUNED BASED ON THE LATEST CHAT GENERATIVE PRE-TRAINED TRANSFORMER (CHATGPT) MODEL TO EMPLOY MI TECHNIQUES TO ASSESS HIV RISK AND TTM STAGE, PROVIDE STAGE APPROPRIATE EDUCATION, AND MOTIVATE INDIVIDUALS TO INITIATE PREP (SPECIFIC AIM [SA] 1). IN AN OPEN PILOT TRIAL INVOLVING 15 PARTICIPANTS AGED 18 YEARS OR OLDER RECRUITED VIA VARIOUS SOCIAL MEDIA PLATFORMS, WE WILL RIGOROUSLY EVALUATE THE CHIA'S ACCURACY, PARTICIPANT SATISFACTION, AND RESPONSIVENESS TO INDIVIDUALS’ NEEDS WITH REFINEMENT MADE AS INDICATED IN SA2. THE REFINED CHIA WILL SUBSEQUENTLY UNDERGO EVALUATION IN A PILOT RANDOMIZED CONTROLLED TRIAL (SA3) TO ASSESS ITS ACCEPTABILITY, FEASIBILITY, AND PRELIMINARY EFFICACY IN PROMOTING PREP UPTAKE. WE WILL RANDOMLY ASSIGN PARTICIPANTS TO THE INTERVENTION (AT LEAST 60 MINUTES OF ENGAGEMENT WITH CHIA IN TWO OR MORE SESSIONS WITHIN TWO WEEKS OF ENROLLMENT, N=50) OR THE CONTROL ARMS (STANDARD OF CARE BY RESEARCH STAFF: RISK ASSESSMENT, PREP EDUCATION, RISK REDUCTION COUNSELING, AND PREP REFERRAL IF INTERESTED, N=50) WITH A 1:1 RATIO. PRIMARY OUTCOMES INCLUDE PRESCRIPTION RECEIPT, PHARMACY FILLING, AND DRUG CONCENTRATION LEVELS, PROVIDING DEFINITIVE MARKERS OF PREP UPTAKE. THE PROPOSED PILOT STUDY HAS THE POTENTIAL TO LEVERAGE THE POWER OF EMERGING AI TECHNOLOGIES TO INCORPORATE MI INTO HIV PREVENTION AND PREP PROMOTION. IF SUCCESSFUL, THE PROPOSED PILOT STUDY WILL HELP FACILITATE AI IN THE FIELD OF HIV PREVENTION AS WELL AS REDUCE HIV INCIDENCE AMONG MSM. | $705.3K | FY2025 | Sep 2025 – Sep 2028 |
| Department of Health and Human Services | MYSTYLE: ONLINE FAMILY-BASED HIV PREVENTION FOR NON-HETEROSEXUAL BLACK ADOLESCENT MALES IN THE SOUTH | $702.1K | FY2017 | Sep 2017 – Aug 2021 |
| Department of Health and Human Services | A BRIEF MOTIVATIONAL INTERVIEWING-BASED INTERVENTION TO IMPROVE HIV PRE-EXPOSURE PROPHYLAXIS UPTAKE AMONG MEN WHO HAVE SEX WITH MEN | $691.8K | FY2017 | May 2017 – Apr 2021 |
| Department of Health and Human Services | INTEGRATED SMOKING CESSATION AND MOOD MANAGEMENT FOR CARDIAC PATIENTS | $691.2K | FY2011 | Apr 2011 – Aug 2016 |
| Department of Health and Human Services | ADVANCING REPRODUCTIVE HEALTH: QUALITATIVE METHODS & INTERDISCIPLINARY MENTORSHIP | $689.3K | FY2012 | Apr 2012 – Mar 2018 |
| Department of Health and Human Services | MULTISITE FEASIBILITY OF BA-HD: AN INTEGRATED DEPRESSION AND BEHAVIORAL RISK FACTOR REDUCTION COACHING PROGRAM FOLLOWING ACUTE CORONARY SYNDROME - PROJECT ABSTRACT ACUTE CORONARY SYNDROME (ACS) IS AN URGENT PUBLIC HEALTH ISSUE WHICH CONTRIBUTES TO OVER ONE MILLION HOSPITALIZATIONS ANNUALLY. DEPRESSION UNDERMINES OPTIMAL RECOVERY FOLLOWING ACS, OFTEN AT LEAST PARTIALLY THROUGH INTERFERENCE WITH HEALTH BEHAVIORS. POST-ACS PATIENTS WITH DEPRESSION SMOKE MORE, ADHERE TO MEDICATIONS LESS OFTEN, ARE LESS PHYSICALLY ACTIVE, AND HAVE POORER DIET THAN POST-ACS PATIENTS WITHOUT DEPRESSION. THIS REDUCED ADHERENCE TO RECOMMENDED HEALTH BEHAVIORS, IN TURN, WORSENS CARDIOVASCULAR HEALTH AND INCREASES RISK OF ADDITIONAL MORBIDITY AND MORTALITY. OUR TEAM DEVELOPED BEHAVIORAL ACTIVATION FOR HEALTH AND DEPRESSION (BA-HD) WHICH IS A BEHAVIORAL ACTIVATION-BASED INTERVENTION THAT INTEGRATES TREATMENT FOR DEPRESSION AND MULTIPLE HEALTH BEHAVIOR CHANGE POST-ACS. THE OVERARCHING GOAL OF THIS R34 APPLICATION IS TO PILOT BA-HD ACROSS THREE DISTINCT REGIONS (NORTHEAST, MIDWEST, AND SOUTHEAST) IN PREPARATION FOR A SUBSEQUENT FULLY POWERED MULTISITE RANDOMIZED CONTROLLED EFFICACY TRIAL. SPECIFICALLY, THE RESEARCH TEAM WILL CONDUCT A MULTISITE PILOT RANDOMIZED CONTROLLED FEASIBILITY TRIAL OF BA-HD COMPARING THE INTERVENTION TO AN ENHANCED USUAL CARE (EUC) CONTROL GROUP. THIS TRIAL WILL ACCOMPLISH TWO AIMS: FIRST, WE WILL EXAMINE STUDY FEASIBILITY (E.G., RECRUITMENT, TREATMENT ENGAGEMENT, RETENTION) AND ACCEPTABILITY OF BOTH STUDY PROCEDURES AND THE BA-HD TREATMENT. SECOND, WE WILL EXAMINE THE PRELIMINARY EFFICACY OF BA-HD TO IMPROVE (1) DEPRESSED MOOD AND (2) CARDIOVASCULAR HEALTH ASSESSED VIA THE AMERICAN HEART ASSOCIATION’S LIFE’S SIMPLE 7 TOTAL SCORE. FINDINGS FROM THE PROPOSED RESEARCH ARE NECESSARY TO FINALIZE STUDY DESIGN IN PREPARATION FOR A SUBSEQUENT FULLY POWERED TRIAL TO EVALUATE THE EFFICACY OF BA-HD TO IMPROVE CARDIOVASCULAR HEALTH AND DEPRESSION | $681.5K | FY2023 | Aug 2023 – Jul 2026 |
| Department of Health and Human Services | A MOBILE INTERVENTION TO IMPROVE UPTAKE OF PREP FOR SOUTHERN BLACK MSM | $676.4K | FY2017 | Jun 2017 – Mar 2021 |
| Department of Health and Human Services | NEURODEVELOPMENTAL SUBSTRATES OF EMOTION REGULATION IN OBESE, BINGE EATING YOUTH | $672.6K | FY2015 | Jun 2015 – May 2020 |
| Department of Health and Human Services | THE NEURAL CORRELATES OF FOOD CHOICE DECISION-MAKING IN OBESITY AND WEIGHT LOSS | $668.4K | FY2011 | Sep 2011 – Nov 2016 |
| Department of Health and Human Services | PEER-DRIVEN INTERVENTION PROMOTING PRE-EXPOSURE PROPHYLAXIS UPTAKE AMONG AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN | $665K | FY2020 | Sep 2020 – Aug 2025 |
| Department of Health and Human Services | THE IMPACT OF MATERNAL S. JAPONICUM INFECTION ON FETAL METABOLISM AND GROWTH | $664.7K | FY2015 | Jan 2015 – Aug 2020 |
| Department of Health and Human Services | REDUCING ALCOHOL-RELATED HIV/STI RISK FOR WOMEN IN REPRODUCTIVE HEALTH CLINICS | $661.5K | FY2016 | Mar 2016 – Aug 2019 |
| Department of Health and Human Services | MINDFULNESS TRAINING TO IMPROVE ART ADHERENCE AND REDUCE RISK BEHAVIOR AMONG PERSONS LIVING WITH HIV | $656.8K | FY2015 | Aug 2015 – Jul 2019 |
| Department of Health and Human Services | UNDERNUTRITION-HELMINTH-ALCOHOL INTERACTIONS, PLACENTAL MECHANISMS, AND FASD RISK | $655.1K | FY2017 | Jan 2017 – Jun 2021 |
| Department of Health and Human Services | INCREASING PHYSICAL ACTIVITY AMONG INACTIVE BARIATRIC SURGERY PATIENTS | $653.5K | FY2009 | Mar 2009 – Feb 2014 |
| Department of Health and Human Services | MOLECULAR EPIDEMIOLOGY OF HIV TRANSMISSION NETWORKS | $650K | FY2011 | Sep 2011 – Dec 2016 |
| Department of Health and Human Services | EVALUATING THE IMPLEMENTATION AND IMPACT OF A NOVEL MEDICATION ASSISTED TREATMENT PROGRAM IN A UNIFIED JAIL AND PRISON SYSTEM | $645.1K | FY2017 | Sep 2017 – Aug 2020 |
| Department of Health and Human Services | IMPROVING ADHERENCE AND COGNITION IN SUBSTANCE-USING HIV PATIENTS | $644.9K | FY2010 | Sep 2010 – Aug 2012 |
| Department of Health and Human Services | TRAUMA-INFORMED OBSTETRIC CARE: DEVELOPMENT AND IMPLEMENTATION OF A STAKEHOLDER-INFORMED TOOLKIT FOR OBSTETRIC PROVIDERS AND PATIENTS - PROJECT SUMMARY/ABSTRACT MANY PREGNANT WOMEN HAVE EXPERIENCED TRAUMA, WHICH CAN MAKE PERINATAL CARE STRESSFUL AND INCREASE THE RISK OF PREGNANCY-RELATED HEALTH CONDITIONS. HOWEVER, OBSTETRIC PROVIDERS CAN MODIFY PROCEDURES TO REDUCE DISTRESS AND ENHANCE PATIENTS’ SENSE OF CONTROL AND SAFETY. ALTHOUGH OBSTETRIC PROVIDERS FREQUENTLY CARE FOR TRAUMA SURVIVORS, MOST ARE NOT TRAINED IN TRAUMA-INFORMED CARE (TIC). ADDITIONALLY, THERE ARE NO DATA ON FEASIBILITY, APPROPRIATENESS, OR ACCEPTABILITY OF TIC TOOLS AND INTERVENTIONS IN THE CONTEXT OF OBSTETRICS. THE GOAL OF THE PROPOSED K23 PROJECT IS TO DEVELOP THE FIRST, STAKEHOLDER-INFORMED OBSTETRIC TIC TOOLKIT COMPOSED OF TREATMENT PROTOCOLS, CLINICIAN TRAINING, TRAUMA AND VIOLENCE SCREENING TOOLS, AND OTHER RESOURCES TO HELP OBSTETRIC PROVIDERS APPLY TIC PRACTICES TO ALL CLINICAL INTERACTIONS IN ADDITION TO IDENTIFYING AND PROVIDING SUPPORT FOR TRAUMA SURVIVORS. THE OBSTETRIC TIC INTERVENTION TOOLKIT (OB-TIC) WILL BE DEVELOPED IN COLLABORATION WITH KEY STAKEHOLDERS (PREGNANT AND POSTPARTUM PATIENTS, NURSES, PHYSICIANS, AND ADMINISTRATORS) TO ENSURE THAT IT IS FEASIBLE, ACCEPTABLE, APPROPRIATE, COST-EFFECTIVE, AND CLINICALLY USEFUL. CURRENT PRACTICES AND PREFERENCES WILL BE CHARACTERIZED IN QUALITATIVE INTERVIEWS WITH STAKEHOLDERS WHICH WILL INFORM THE DEVELOPMENT OF OB-TIC IN COLLABORATION WITH A COMMUNITY WORKING GROUP OF STAKEHOLDERS. A PILOT IMPLEMENTATION TRIAL OF OB-TIC WILL BE CONDUCTED IN TWO OUTPATIENT OBSTETRICS CLINICS TO GATHER REAL-WORLD DATA THAT WILL INFORM THE FINAL INTERVENTION TOOLKIT, WHICH WILL BE TESTED ON A LARGER SCALE IN FUTURE (R01) STUDIES. THE K23 AWARD WILL FACILITATE THE CANDIDATE’S TRANSITION TOWARDS AN INDEPENDENT RESEARCH CAREER FOCUSED ON IMPROVING THE WELL-BEING OF WOMEN THROUGH TRAUMA-INFORMED PERINATAL HEALTHCARE AND IMPLEMENTATION SCIENCE, WHICH IS DIRECTLY IN LINE WITH THE NICHD PREGNANCY AND PERINATOLOGY PRIORITY OF “IMPROVING THE HEALTH OF WOMEN BEFORE, DURING, AND AFTER PREGNANCY.” TO DATE, THE CANDIDATE’S TRAINING HAS FOCUSED ON DEVELOPING CLINICAL EXPERTISE IN PERINATAL BEHAVIORAL MEDICINE, AND RESEARCH EXPERIENCE IN OBSTETRICS, PERINATAL STRESS, AND BEHAVIORAL INTERVENTIONS FOR STRESS AND DISCRIMINATION. THE K23 AWARD WILL PROVIDE PROTECTED TIME FOR TRAINING IN 1) IMPLEMENTATION SCIENCE METHODOLOGY FOCUSED ON THE DEVELOPMENT OF STAKEHOLDER INFORMED INTERVENTIONS AND SCALE-UP AND SPREAD OF EVIDENCE-BASED INTERVENTIONS; 2) QUALITATIVE RESEARCH METHODOLOGY, A FOUNDATIONAL COMPONENT OF IMPLEMENTATION SCIENCE AND STAKEHOLDER-BASED INTERVENTION DEVELOPMENT; 3) AND TRAUMA-INFORMED CARE IN OBSTETRICS, WHICH WILL PROVIDE A KNOWLEDGE BASE FOR OB-TIC. EXPERTS IN EACH OF THE KEY TRAINING DOMAINS WILL PROVIDE INDIVIDUAL MENTORSHIP IN ADDITION TO SPECIALIZED WORKSHOPS AND DIDACTICS. DURING THE PROPOSED K23 AWARD, THE CANDIDATE WILL BE A RESEARCH SCIENTIST AT THE MIRIAM HOSPITAL AND AN ASSISTANT PROFESSOR AT BROWN UNIVERSITY. THIS ENVIRONMENT IS RICH WITH INNOVATION AND COLLABORATION AND WILL ENHANCE THE CANDIDATE’S TRAINING AND FACILITATE THEIR RESEARCH GOALS. THE MENTORSHIP AND SKILLS GAINED AS PART OF THIS K23 AWARD, WILL PREPARE THE CANDIDATE TO PURSUE FUNDING FOR AN R01 FOCUSED ON A RANDOMIZED CONTROLLED TRIAL OF OB-TIC. | $644.4K | FY2022 | Sep 2022 – Aug 2027 |
| Department of Health and Human Services | IMPACT OF DYSFUNCTIONAL HDL ON PLATELET FUNCTION AND IN VIVO THROMBOSIS | $635K | FY2019 | Sep 2019 – Aug 2024 |
| Department of Health and Human Services | COMPREHENSIVE HIV TESTING STRATEGIES FOR JAILS | $629.3K | FY2007 | Aug 2007 – Jul 2012 |
| Department of Health and Human Services | DETERMINING THE ROLE OF RETROTRANSPOSON LINE-1 IN ALZHEIMERS DISEASE | $625.7K | FY2019 | Sep 2019 – Aug 2022 |
| VA/DoDDepartment of Defense | COLLAGEN VARIANTS SENSITIZE STOMACH TUMORS TO THERAPEUTICS | $573K | FY2020 | Jul 2020 – Jun 2023 |
| Department of Health and Human Services | ADAPTING ONLINE OBESITY TREATMENT FOR PRIMARY CARE PATIENTS IN POVERTY - PROJECT SUMMARY POVERTY AFFECTS OVER 37 MILLION INDIVIDUALS IN THE U.S., SUBJECTING THEM TO SYNDEMICS – CLUSTERED, MUTUALLY ENHANCING EPIDEMICS SUCH AS OBESITY, DIABETES, AND DEPRESSION THAT ARISE FROM AND PERPETUATE SOCIOECONOMIC INEQUALITY. SYNDEMIC THEORY UNDERSCORES A PATHWAY TO MITIGATE SYNDEMICS BY INTERVENING ON A SINGLE TARGET WITHIN THE CLUSTER. OBESITY’S HIGH PREVALENCE IN POVERTY; ROLE IN INCREASING LEADING CAUSES OF DEATH (E.G., CARDIOVASCULAR DISEASE, CANCER, DEMENTIA); AND ADVERSE PSYCHOSOCIAL EFFECTS (E.G., INCREASED DEPRESSION) MAKE IT A CRUCIAL, HIGH PRIORITY TARGET. WHILE STRUCTURAL AND SOCIAL FACTORS CONTRIBUTE TO OBESITY IN POVERTY, RESEARCH SHOWS THE EFFECTIVENESS OF INDIVIDUAL-LEVEL INTERVENTIONS IN IMPROVING HEALTH BEHAVIORS AND WEIGHT WHEN HIGHLY RESPONSIVE TO OVERBURDENED POPULATIONS’ NEEDS. AT THE SAME TIME, EVIDENCE GUIDING REFINEMENT OF INTERVENTIONS IS SPARSE AS PARTICIPANTS WITH SOCIOECONOMIC DISADVANTAGE ARE UNDERREPRESENTED IN OBESITY TREATMENT RESEARCH. REFLECTING THIS PHENOMENON, RX WEIGHT LOSS, A FULLY AUTOMATED ONLINE OBESITY TREATMENT, HAS SEEN LIMITED USE AMONG PATIENTS WITH LOW INCOME DESPITE PAST WORK SHOWING IT CAN BE DELIVERED EFFECTIVELY THROUGH PRIMARY CARE AT LOW COST. SINCE 72.8% OF ADULTS IN POVERTY HAVE A USUAL PRIMARY CARE PROVIDER, AND 83% HAVE INTERNET ACCESS, THIS GAP IN ADOPTION REPRESENTS A SIGNIFICANT OPPORTUNITY FOR PUBLIC HEALTH IMPACT THROUGH ADAPTATION OF RXWL THAT INCREASES RELEVANCE FOR TRADITIONALLY UNDERSERVED POPULATIONS. FURTHER, THIS RESEARCH IS POISED TO FILL A CRITICAL GAP IN OBESITY TREATMENT LITERATURE. THUS, THIS APPLICATION AIMS TO REVISE RXWL CONTENT AND THE PROCESS BY WHICH PRIMARY CARE PROVIDERS REFER PATIENTS TO THE PROGRAM (REFERENCED COLLECTIVELY AS THE “RXWL PACKAGE”) TO MAXIMIZE RESPONSIVENESS, REACH, AND EFFECTIVENESS FOR THOSE IN POVERTY. USING MIXED METHODS DATA COLLECTION, THIS PROJECT STRUCTURES RESEARCH ACTIVITIES USING THE SOCIAL MARKETING ASSESSMENT AND RESPONSE TOOL (SMART) AND EXAMINES IMPLEMENTATION OUTCOMES IDENTIFIED BY THE CONSOLIDATED FRAMEWORK FOR IMPLEMENTATION RESEARCH (CFIR). PRIMARY CARE PROVIDER (N = 23) AND PATIENT (N = 16) STAKEHOLDERS WILL PROVIDE FEEDBACK ON THE EXISTING RXWL PACKAGE (AIM 1); INSIGHTS AND SCIENTIFIC KNOWLEDGE WILL BE INTEGRATED TO PRODUCE A LOW-COST RXWL PACKAGE PROTOTYPE (I.E., A PDF WITH EMBEDDED LINKS APPROXIMATING THE INTENDED PROGRAM) FOR USABILITY TESTING (N = 8 PROVIDERS, 10 PATIENTS; AIM 2); AND DATA WILL DRIVE DEVELOPMENT OF A FINALIZED RXWL PACKAGE TO DISSEMINATE THROUGH PRIMARY CARE AND EVALUATE IN AN OPEN TRIAL (N = 12 PROVIDERS, 32 PATIENTS; AIM 3). AIM 3 WILL EXAMINE BOTH IMPLEMENTATION AND PRELIMINARY CLINICAL OUTCOMES, INCLUDING EFFECTS ON WEIGHT LOSS AND SYNDEMIC SEQUELAE; OBTAIN INSIGHTS FOR FURTHER REFINEMENT; AND INDICATE READINESS FOR A LARGER R- FUNDED CLINICAL TRIAL. REVISING RXWL HOLDS HIGH POTENTIAL TO REDUCE HEALTH DISPARITIES FOR THOSE FROM SOCIOECONOMICALLY DISADVANTAGED BACKGROUNDS. MOREOVER, FINDINGS WILL MAKE SIGNIFICANT CONTRIBUTIONS TO THE LITERATURE ON RECRUITMENT AND RETENTION OF PATIENTS IN POVERTY IN OBESITY TREATMENT RESEARCH; ADAPTATION OF OBESITY TREATMENT TO FIT THE UNIQUE NEEDS OF TRADITIONALLY UNDERSERVED POPULATIONS; AND IMPACT OF SOCIAL DETERMINANTS OF HEALTH ON THE COURSE OF OBESITY TREATMENT. | $564.6K | FY2023 | Sep 2023 – May 2028 |
| Department of Health and Human Services | EVALUATION AND ENHANCEMENT OF THE SUMMER FOOD SERVICE PROGRAM IN YOUTH FROM AN URBAN, LOW-RESOURCE COMMUNITY | $560.5K | FY2016 | Jul 2016 – May 2020 |
| Department of Health and Human Services | GENETIC AND BEHAVIORAL EFFECTS ON HIGH-DENSITY LIPOPROTEIN: THE LOOK AHEAD STUDY | $531.6K | FY2011 | Mar 2011 – Nov 2014 |
| Department of Health and Human Services | YOGA FOR WOMEN ATTEMPTING SMOKING CESSATION: AN INITIAL INVESTIGATION | $529.7K | FY2007 | Aug 2007 – Jul 2011 |
| Department of Health and Human Services | PEDIATRIC ASTHMA DISPARITIES: THE ROLE OF SLEEP AND IMMUNE BALANCE | $507.7K | FY2016 | Feb 2016 – Jul 2022 |
| Department of Health and Human Services | PHARMACOGENETICS AND DRUG-DRUG INTERACTIONS DURING HIV/TB THERAPY | $487.8K | FY2011 | Jun 2011 – May 2012 |
| Department of Health and Human Services | AN EMOTION REGULATION INTERVENTION FOR EARLY ADOLESCENT RISK BEHAVIOR PREVENTION | $467.5K | FY2017 | Aug 2017 – Jul 2020 |
| Department of Health and Human Services | PREDICTING THE IMPACT OF COST ON HIV PRE-EXPOSURE PROPHYLAXIS UPTAKE AND RACIAL/ETHNIC DISPARITIES AMONG MSM | $451.8K | FY2019 | Dec 2018 – Feb 2022 |
| Department of Health and Human Services | 1/5 THE CUMULATIVE RISK OF SUBSTANCE EXPOSURE AND EARLY LIFE ADVERSITY ON CHILD HEALTH DEVELOPMENT AND OUTCOMES | $450.1K | FY2019 | Sep 2019 – Mar 2022 |
| Department of Health and Human Services | TEEN JOIN: A SCALABLE WEIGHT CONTROL INTERVENTION FOR ADOLESCENTS | $436.2K | FY2014 | Jul 2014 – Jun 2017 |
| Department of Health and Human Services | TRANSLATING A DEMENTIA CAREGIVER INTERVENTION INTO A MOBILE APPLICATION | $432.5K | FY2019 | Sep 2019 – May 2022 |
| Department of Health and Human Services | ENTRY AND POST ENTRY EFFECT OF NTCP RECEPTOR ON HBV LIFE CYCLE | $429.1K | FY2019 | Nov 2018 – Jan 2021 |
| Department of Health and Human Services | EXPLORING THE ROLE OF MINDFULNESS TRAINING IN THE PROMOTION OF MEDICATION ADHERENCE IN HEART FAILURE OUTPATIENTS | $425.6K | FY2018 | May 2018 – Apr 2021 |
| Department of Health and Human Services | EVALUATING HIV PRE-EXPOSURE PROPHYLAXIS IMPLEMENTATION USING AN ALL PAYERS CLAIMS DATABASE | $425.4K | FY2017 | Apr 2017 – Mar 2020 |
| Department of Health and Human Services | HIV DRUG RESISTANCE MONITORING IN CHENNAI, INDIA | $417.3K | FY2013 | Aug 2013 – Jul 2016 |
| Department of Health and Human Services | YOGA AS A COMPLEMENTARY THERAPY FOR TYPE 2 DIABETES: AN INITIAL INVESTIGATION | $415.2K | FY2015 | Aug 2015 – May 2018 |
| Department of Health and Human Services | ROLE OF M6A RNA METHYLATION IN REGULATION OF TRANSLATION IN HUMAN GLIOBLASTOMA | $402.6K | FY2019 | Jul 2019 – Jun 2022 |
| Department of Health and Human Services | CARDIAC AUTONOMIC REGULATION ENHANCEMENT THROUGH EXERCISE (CARE-E) TRIAL | $390.9K | FY2008 | Sep 2008 – Jul 2010 |
| Department of Health and Human Services | CONCURRENT HAART AND TUBERCULOSIS TREATMENT: DRUG TO DRUG INTERACTIONS | $380.9K | FY2006 | Aug 2006 – Jun 2011 |
| Department of Health and Human Services | TEXT MESSAGING AS A NOVEL ALCOHOL INTERVENTION FOR COMMUNITY COLLEGE STUDENTS | $377.4K | FY2012 | Jul 2012 – Jun 2014 |
| Department of Health and Human Services | POSTTRAUMATIC STRESS AND STRESS REACTIVITY AFTER MYOCARDIAL INFARCTION - PROJECT SUMMARY/ABSTRACT IN THE US, AN ADULT SUFFERS A MYOCARDIAL INFARCTION (MI) EVERY 40 SECONDS. OVER 35% OF MI PATIENTS DEVELOP POSTTRAUMATIC STRESS DISORDER (PTSD) SYMPTOMS WITHIN 1 MONTH, INCREASING RISK OF 1-YEAR REHOSPITALIZATION AND MORTALITY IN A DOSE-RESPONSE MANNER. HOWEVER, BIOBEHAVIORAL PATHWAYS WHEREBY PTSD SYMPTOMS LEAD TO REHOSPITALIZATION AND MORTALITY HAVE YET TO BE IDENTIFIED. GIVEN PTSD SYMPTOMS POTENTIATE STRESS REACTIVITY AND PATIENTS SHOW GREATER STRESS REACTIVITY AFTER A MI, STRESS REACTIVITY IS A PROMISING MECHANISM TO STUDY IN THE ASSOCIATION BETWEEN PTSD SYMPTOMS AND PROXIMAL CARDIOVASCULAR HEALTH OUTCOMES SUCH AS AMBULATORY BLOOD PRESSURE (ABP). THE OBJECTIVE OF THIS MENTORED PATIENT-ORIENTED RESEARCH CAREER DEVELOPMENT AWARD (K23) IS TO PROVIDE DR. SHARON LEE, THE CANDIDATE, WITH NECESSARY TRAINING TO BECOME AN INDEPENDENT CLINICAL SCIENTIST WITH EXPERTISE IN THE BIOBEHAVIORAL MECHANISMS LINKING PTSD SYMPTOMS AND CARDIOVASCULAR DISEASE RISK. TO PREPARE DR. LEE TO BECOME AN INDEPENDENT INVESTIGATOR BY THE COMPLETION OF THIS AWARD, MENTORED TRAINING WILL ADDRESS FOUR DOMAINS: (1) PSYCHOPHYSIOLOGY OF CARDIOVASCULAR STRESS REACTIVITY, (2) METHODOLOGIES IN ECOLOGICAL MOMENTARY ASSESSMENT AND ABP MONITORING, (3) EPIDEMIOLOGY OF MI AND POST-MI CLINICAL OUTCOMES, AND (4) PROFESSIONAL DEVELOPMENT INTO AN INDEPENDENT CLINICAL SCIENTIST IN CARDIOVASCULAR BEHAVIORAL MEDICINE. THE PROPOSED INTENSIVE LONGITUDINAL STUDY FOCUSES ON THE POTENTIAL MECHANISTIC ROLE OF PSYCHOLOGICAL AND PHYSIOLOGICAL STRESS REACTIVITY IN THE ASSOCIATION BETWEEN PTSD SYMPTOMS AND 24-HOUR ABP IN MI PATIENTS. DR. LEE WILL LEVERAGE ECOLOGICAL MOMENTARY ASSESSMENT INCLUDING ABP MONITORING TO EXAMINE THE ASSOCIATION BETWEEN PTSD SYMPTOMS AND STRESS REACTIVITY (MOMENTARY PERCEIVED STRESS AND ABP REACTIVITY) AS IT UNFOLDS DURING THE 6-MONTH POST-MI ADJUSTMENT PERIOD. DATA COLLECTION WILL OCCUR AT THREE TIME POINTS, EACH CONSISTING OF A GOLD-STANDARD CLINICAL ASSESSMENT OF PTSD SYMPTOMS FOLLOWED BY A 7-DAY ECOLOGICAL MOMENTARY ASSESSMENT WITH A 24-HOUR PERIOD OF ABP MONITORING. THE FOLLOWING SPECIFIC AIMS WILL BE ACHIEVED: (1) TEST THE INTRAINDIVIDUAL ASSOCIATION BETWEEN PTSD SYMPTOMS AND STRESS REACTIVITY AND (2) TEST THE ROLE OF STRESS REACTIVITY IN THE INTRAINDIVIDUAL ASSOCIATION BETWEEN PTSD SYMPTOMS AND 24-HOUR ABP. DR. LEE HAS ASSEMBLED AN EXPERT MENTORSHIP TEAM OF LEADING SCIENTISTS IN THE FIELDS OF CLINICAL PSYCHOLOGY, EXPERIMENTAL MEDICINE, BEHAVIORAL CARDIOLOGY, PREVENTIVE CARDIOLOGY, CARDIOVASCULAR EPIDEMIOLOGY, AND INTENSIVE LONGITUDINAL MODELING. THE MIRIAM HOSPITAL AND ALPERT MEDICAL SCHOOL OF BROWN UNIVERSITY ARE IDEALLY RESOURCED ENVIRONMENTS FOR DR. LEE TO SUCCESSFULLY CARRY OUT THE PROPOSED TRAINING AND STUDY. DR. LEE’S K23 TRAINING PLAN AND PROJECT ALIGN WITH THE NHLBI RESEARCH PRIORITY REGARDING MECHANISMS WHEREBY PSYCHOSOCIAL STRESS CONTRIBUTES TO ISCHEMIC HEART DISEASE PROGRESSION. TO THIS END, DR. LEE WILL EMERGE FROM THIS FIVE-YEAR MENTORED AWARD AS AN INDEPENDENT INVESTIGATOR WHO WILL CONTRIBUTE TO OUR KNOWLEDGE ABOUT STRESS REACTIVITY AS A MODIFIABLE MECHANISM FOR DISRUPTING THE RELATIONSHIP BETWEEN PTSD SYMPTOMS AND POOR CARDIOVASCULAR HEALTH IN MI PATIENTS. | $374.1K | FY2024 | Feb 2024 – Jan 2029 |
| Department of Health and Human Services | FECAL BACTERIOTHERAPY FOR RELAPSING CLOSTRIDIUM DIFFICILE INFECTION | $368.8K | FY2012 | Aug 2012 – Jul 2014 |
| Department of Health and Human Services | EXAMINING A TEXT MESSAGE INTERVENTION FOR SMOKING CESSATION | $361.1K | FY2009 | Aug 2009 – Jul 2011 |
| National Science Foundation | STRESS RESPONSE & THE ADOLESCENT TRANSITION | $354.8K | FY2007 | Sep 2007 – Aug 2010 |
| Department of Health and Human Services | PRISONER OVERDOSE TRAINING AND NALOXONE UPON RELEASE | $354.1K | FY2011 | Apr 2011 – Mar 2013 |
| Department of Health and Human Services | PILOT STUDY TO MONITOR HIV CLUSTER DYNAMICS AND ACTIVE HIV SUB-EPIDEMICS IN REAL TIME | $321.5K | FY2018 | Jul 2018 – Jun 2022 |
| Department of Health and Human Services | SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE | $317.8K | FY2004 | Sep 2004 – Aug 2010 |
| Department of Health and Human Services | IMPACT OF ALCOHOL USE AND HIV INFECTION ON BRAIN CONNECTIVITY ABNORMALITIES | $309.9K | FY2011 | Mar 2011 – Feb 2013 |
| Department of Health and Human Services | ADDRESSING EMOTIONAL AND COGNITIVE FACTORS IN BEHAVIORAL WEIGHT LOSS TREATMENT | $306K | FY2006 | Feb 2006 – Aug 2009 |
| Department of Health and Human Services | ANTIVIRAL THERAPY AND HIV IN THE GENITAL TRACT OF WOMEN | $300.9K | FY2005 | Aug 2005 – Jun 2010 |
| National Science Foundation | COLLABORATIVE RESEARCH: SCH: AI-DRIVEN RFID SENSING FOR SMART HEALTH APPLICATIONS -MANY EXISTING HEALTH MONITORING SYSTEMS ARE EXPENSIVE, UNCOMFORTABLE TO WEAR, OR CAN ONLY BE ADMINISTERED IN A HOSPITAL ENVIRONMENT. WITH ADVANCES IN THE INTERNET OF THINGS (IOT) AND MACHINE LEARNING (ML)/ARTIFICIAL INTELLIGENCE (AI), IT IS HIGHLY DESIRABLE TO DEVELOP AI-DRIVEN RADIO FREQUENCY SENSING TECHNIQUES TO MAKE SMART HEALTH MONITORING CHEAPER, MORE COMFORTABLE TO USE, AND MORE ACCESSIBLE TO THE BROAD POPULATION, WHILE SUPPORTING EXCELLENT MONITORING PERFORMANCE. THE MAIN CHALLENGES TO ACHIEVING SUCH GOALS ARE THE NOISY RF DATA AND STRONG INTERFERENCE COMING FROM THE DYNAMIC ENVIRONMENT. A MULTI-DISCIPLINARY TEAM OF SIX INVESTIGATORS WITH COMPLEMENTARY EXPERTISE WILL WORK CLOSELY TOGETHER TO SIGNIFICANTLY IMPROVE THE STATE-OF-THE-ART OF RADIO FREQUENCY SENSING BASED SMART HEALTHCARE PROVISIONING AND MAKE A SIGNIFICANT STEP FORWARD TO FULLY HARVEST THE POTENTIAL OF THE IOT AND ML/AI. THE TEAM OF INVESTIGATORS WILL ALSO JOINTLY DEVELOP A NEW GRADUATE-LEVEL COURSE ON DEEP LEARNING EMPOWERED RF HEALTH SENSING AND ENHANCE THEIR UNDERGRADUATE AND GRADUATE LEVEL COURSES. THE PROJECT WILL ALSO ENGAGE STUDENTS BY PROVIDING HANDS-ON EXPERIENCE WITH CUTTING-EDGE TECHNOLOGIES THAT ARE AT THE VERY FRONTIER OF WIRELESS SENSING, DEEP LEARNING, AND SMART HEALTH. OUTCOMES FROM THIS PROJECT WILL BE DISSEMINATED THROUGH TECHNICAL PUBLICATIONS, CONFERENCE KEYNOTES, DISTINGUISHED LECTURES AND TUTORIALS, A PROJECT WEBSITE, AND OPEN-SOURCE REPOSITORIES. THE INVESTIGATORS ARE COMMITTED TO BROADENING PARTICIPATION FROM UNDERREPRESENTED GROUPS, THROUGH THEIR INSTITUTIONAL OUTREACH PROGRAMS AND THE NSF RESEARCH EXPERIENCES FOR UNDERGRADUATES AND RESEARCH EXPERIENCES FOR TEACHERS PROGRAMS. THIS PROJECT DEVELOPS RADIO FREQUENCY IDENTIFICATION (RFID) BASED SENSING SYSTEMS FOR SMART HEALTH MONITORING. SPECIFICALLY, SEVERAL FUNDAMENTAL PROBLEMS WILL BE INVESTIGATED, AND NOVEL ML/AI TECHNIQUES WILL BE DEVELOPED FOR RFID SENSING BASED SMART HEALTH APPLICATIONS. THIS PROJECT LEVERAGES PASSIVE RFID TAGS AS WEARABLE SENSORS FOR MONITORING HUMAN HEALTH CONDITIONS TO HELP DIAGNOSE DISEASES SUCH AS PARKINSON?S AND INTERSTITIAL LUNG DISEASE. ML/AI-DRIVEN METHODS, SUCH AS TENSOR DECOMPOSITION, TRANSFER LEARNING (VIA DOMAIN ADAPTATION AND META-LEARNING), DEEP GAUSSIAN PROCESSES, AND FEDERATED LEARNING WILL BE INCORPORATED TO DEVELOP EFFECTIVE SOLUTIONS TO THESE CHALLENGING PROBLEMS. THE RESEARCH AGENDA CONSISTS OF FOUR WELL INTEGRATED THRUSTS: (I) TO INVESTIGATE THE CHALLENGES AND FUNDAMENTAL PERFORMANCE LIMITS OF THE SENSORS; (II) TO DEVELOP RFID-BASED RESPIRATION RATE, PULMONARY FUNCTION TEST, AND HEARTBEAT SIGNAL MONITORING SCHEMES; (III) TO DEVELOP RFID-BASED POSE MONITORING, ACTIVITY RECOGNITION, AND PD DETECTION SYSTEMS; AND (IV) TO DEVELOP ROBUST AND FAIR FEDERATED LEARNING MODELS FOR HANDLING HEALTH DATA. THE PROJECT?S ALGORITHMS WILL BE IMPLEMENTED AND VALIDATED WITH EXTENSIVE EXPERIMENTS IN EMULATED AND REAL CLINICAL ENVIRONMENTS, WITH A FOCUS ON TWO IMPORTANT SMART HEALTH APPLICATIONS, PARKINSON?S DISEASE DETECTION AND BREATHING-BASED INTERSTITIAL LUNG DISEASE DETECTION. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA. | $299.7K | FY2023 | Aug 2023 – Jul 2027 |
| Department of Health and Human Services | PREVENTING ALCOHOL MISUSE AND CONSEQUENCES IN VULNERABLE WOMEN | $266.6K | FY2020 | Sep 2020 – Aug 2022 |
| Department of Health and Human Services | MACHINE LEARNING METHODS TO ASSESS RISK FOR PRENATAL AND NEONATAL IRON DEFICIENCY ANEMIA FROM MATERNAL STRESS EXPOSURE - PROJECT SUMMARY THIS K99 APPLICATION AIMS TO DETERMINE BIOLOGICAL AND BEHAVIORAL PATHWAYS BY WHICH MATERNAL PSYCHOSOCIAL STRESS IN PREGNANCY IMPACTS RISK FOR MATERNAL AND INFANT IRON DEFICIENCY ANEMIA (IDA). IDA IS ONE OF THE MOST COMMON CAUSES OF ANEMIA WORLDWIDE, AND AROUND 20% OF WOMEN IN THE US EXPERIENCE A STRESSFUL LIFE EVENT THROUGHOUT THEIR PREGNANCY. DUE TO THE INCREASED IRON DEMANDS OF PREGNANCY, PREGNANCY ITSELF POSES A SIGNIFICANT RISK OF IDA, ESPECIALLY FOR LOW-INCOME AND RACIALLY- AND ETHNICALLY-MINORITIZED WOMEN. IDA INCREASES THE RISK OF ADVERSE PREGNANCY OUTCOMES AND CAN NEGATIVELY IMPACT THE IRON STATUS OF THE NEONATE THAT MAY CAUSE IRREVERSIBLE HARM TO NEURODEVELOPMENT. THERE IS GROWING CONCERN THAT ORAL VITAMIN SUPPLEMENTATION MIGHT NOT BE ENOUGH TO COUNTERACT THE RISKS OF IDA IN THE CONTEXT OF SYSTEMIC INFLAMMATION, INCLUDING INFLAMMATION PRODUCED BY CHRONIC PSYCHOSOCIAL STRESS AND SUBSEQUENT NEUROENDOCRINE DYSREGULATION. MATERNAL PSYCHOSOCIAL STRESS HAS BEEN ASSOCIATED WITH INFANT IRON STATUS PREVIOUSLY, BUT THE POTENTIAL BIOLOGICAL MECHANISMS ARE NOT YET CHARACTERIZED DESPITE THE | $253.8K | FY2022 | Sep 2022 – Aug 2024 |
| Department of Health and Human Services | TRIAL OF ORAL DOXYCYCLINE FOR THE TREATMENT OF CHILDHOOD LYME MENINGITIS | $238.6K | FY2018 | Jun 2018 – May 2020 |
| Department of Health and Human Services | IMAGING THE DEVELOPING FETAL BRAIN: NOVEL MARKERS OF RISK FOR MATERNAL SMOKING | $228.4K | FY2014 | Mar 2014 – Feb 2017 |
| Department of Health and Human Services | HUMAN-CENTERED DESIGN OF A BEHAVIORAL INTERVENTION TO REVERSE SMALL WEIGHT REGAINS DURING WEIGHT LOSS MAINTENANCE - PROJECT SUMMARY/ABSTRACT WEIGHT LOSS MAINTENANCE (WLM) IS THE MOST PRESSING ISSUE IN CURRENT OBESITY TREATMENTS. WLM PROGRAMS MITIGATE, BUT DO NOT PREVENT, WEIGHT REGAIN AND INDIVIDUALS WHO LOSE WEIGHT HAVE TROUBLE RE-INSTATING WEIGHT LOSS EFFORTS DESPITE HAVING USED THEM EFFECTIVELY DURING WEIGHT LOSS. ACTIVE INTERVENTION TO RETURN TO WEIGHT LOSS BEHAVIORS IMMEDIATELY FOLLOWING A SMALL REGAIN MAY PREVENT FURTHER REGAIN AND AID IN LONG-TERM WLM, BUT HAS NOT BEEN SYSTEMATICALLY TESTED. THE MAINTAIN STUDY EXAMINED WHETHER A BRIEF TELEPHONE-BASED COACHING INTERVENTION COULD HELP REVERSE SMALL WEIGHT REGAINS FOLLOWING PARTICIPATION IN A BEHAVIORAL WEIGHT LOSS INTERVENTION (BWLI) COMPARED TO NO INTERVENTION CONTROL. THE COACHING GROUP SHOWED STATISTICALLY-SIGNIFICANT IMPROVEMENTS IN WEIGHT COMPARED TO THE CONTROL GROUP FROM PRE- TO POST-COACHING, BUT WEIGHTS WERE NOT SIGNIFICANTLY DIFFERENT AT THE 12-MONTH STUDY END POINT. THUS, ADDITIONAL RESEARCH IS WARRANTED TO INFORM INTERVENTION MODIFICATIONS TO MAXIMIZE THE LONG-TERM EFFECTIVENESS OF PROVIDING COACHING AT THE POINT OF INITIAL REGAIN. THIS R03 SMALL GRANT PROGRAM FOR NIDDK K RECIPIENTS PROPOSAL SEEKS TO OPTIMIZE AND REFINE THE MAINTAIN PHONE COACHING INTERVENTION TO PROMOTE RECOVERY FROM SMALL WEIGHT REGAIN DURING WLM. SPECIFICALLY, THE DOUBLE DIAMOND MODEL, A 4-PHASE HUMAN-CENTERED DESIGN (HCD) PROCESS, WILL BE USED TO GUIDE INTERVENTION REFINEMENT TO SUPPORT RECOVERY FROM REGAINS IN THE SHORT AND LONG-TERM. HCD FOCUSES ON ENHANCING THE USABILITY OF A PRODUCT TO IMPROVE EFFECTIVENESS, EFFICIENCY, AND SATISFACTION AND CAN BE UTILIZED TO OPTIMIZE BEHAVIORAL INTERVENTIONS. AS PART OF THIS PROCESS, FOR AIM 1 THE RESEARCH TEAM WILL EXAMINE THE PSYCHOLOGICAL AND BEHAVIORAL MECHANISMS OF COACHING AND HOW LONG COACHING EFFECTS PERSIST FOLLOWING INTERVENTION IN THE MAINTAIN STUDY. THEY WILL ALSO ENGAGE IN QUALITATIVE INTERVIEWS WITH INDIVIDUALS WITH LIVED EXPERIENCE REGAINING WEIGHT AND RECOVERING FROM WEIGHT REGAIN. NEXT FOR AIM 2, THE MAINTAIN INTERVENTION WILL BE REFINED USING DATA-DRIVEN DESIGN CHOICES AND HCD PRINCIPLES. THE PRODUCT OF THIS PROJECT WILL BE A REVISED MAINTAIN INTERVENTION PROTOCOL AND MATERIALS FOR EFFICACY TESTING IN A FUTURE FULLY POWERED RANDOMIZED-CONTROLLED TRIAL. THE RESEARCH ACTIVITIES PROPOSED IN THIS R03 AWARD WILL PROVIDE THE OPPORTUNITY TO FINE-TUNE SKILLS DR. HAYES HAS DEVELOPED THROUGH THE K23, INCLUDING SKILLS RELATED TO LONGITUDINAL DATA ANALYSIS AND INTERVENTION DEVELOPMENT, AND FACILITATE THEIR APPLICATION TO WLM. THIS AWARD WILL BE INTEGRAL TO COMPLETING HER TRANSITION TO INDEPENDENCE BY OPENING UP A NEW, BUT RELATED, PROGRAM OF RESEARCH THAT WILL DIRECTLY LEAD TO AN R01 SUBMISSION AND A POTENTIALLY UNIQUE AND PROMISING MODEL FOR THE MANAGEMENT OF OBESITY AS A CHRONIC DISEASE. | $223.5K | FY2025 | Jun 2025 – May 2027 |
| Department of Health and Human Services | OPTIMIZING A WEIGHT NEUTRAL INTERVENTION TO IMPROVE HEALTH AMONG ADULTS OF HIGHER BODY WEIGHT: A MOST PREPARATION PHASE STUDY - PROJECT SUMMARY OBESITY REMAINS A MAJOR PUBLIC HEALTH CONCERN AND IS A LEADING CONTRIBUTOR TO CARDIOMETABOLIC DISEASE. FRONTLINE TREATMENTS AIM TO DIRECTLY FACILITATE WEIGHT LOSS, BUT OUTCOMES ARE VARIABLE AND DIFFICULT TO SUSTAIN. WEIGHT NEUTRAL APPROACHES ARE GAINING SCIENTIFIC, CLINICAL, AND PUBLIC ATTENTION AS AN ALTERNATIVE PATHWAY TO REDUCING CARDIOMETABOLIC RISK FOR INDIVIDUALS OF HIGHER BODY WEIGHT. THESE PROGRAMS SUPPORT IMPROVED QUALITY OF DIETARY INTAKE AND ENGAGEMENT WITH PHYSICAL ACTIVITY WITHOUT ENCOURAGING WEIGHT LOSS, AND TARGET NOVEL ‘WEIGHT NEUTRAL’ MECHANISMS TO SUPPORT ADHERENCE OVER TIME (E.G., EATING IN RESPONSE TO HUNGER/SATIETY CUES, DISENGAGING FROM RIGID RULES ABOUT FOOD, INCREASED BODY APPRECIATION, COMBATING WEIGHT-RELATED STIGMA, AND PROMOTING PHYSICAL ACTIVITY FOR ENJOYMENT.) DESPITE GROWING INTEREST, EFFICACY FOR WEIGHT NEUTRAL INTERVENTIONS ON CARDIOMETABOLIC HEALTH, ALONG WITH THE GENERALIZABILITY, SCALABILITY, AND SUSTAINABILITY OF TREATMENT EFFECTS IS NOT ESTABLISHED. ADDITIONALLY, THERE IS SIGNIFICANT VARIABILITY IN HOW THE WEIGHT NEUTRAL PROGRAMS ARE DESIGNED (I.E., WHICH WEIGHT NEUTRAL MECHANISMS ARE TARGETED AND HOW), LEAVING IT UNCLEAR WHICH WEIGHT NEUTRAL MECHANISMS MEANINGFULLY CONTRIBUTE TO TREATMENT EFFECTS. THE GOAL OF THIS R03 IS TO USE THE MULTIPHASE OPTIMIZATION STRATEGY (MOST) TO BUILD A CLEARLY DEFINED WEIGHT NEUTRAL INTERVENTION THAT EFFECTIVELY TARGETS THE WEIGHT NEUTRAL MECHANISMS THAT ARE CENTRAL TO THIS THERAPEUTIC APPROACH. CANDIDATE WEIGHT NEUTRAL COMPONENTS WILL INCLUDE THE FOLLOWING EXISTING, EVIDENCE-BASED INTERVENTIONS WITH DEMONSTRATED EFFECTS ON WEIGHT NEUTRAL MECHANISMS; (1) MINDFULNESS-BASED EATING AWARENESS TRAINING (MECHANISMS: TO INCREASE EATING IN RESPONSE TO HUNGER/SATIETY CUES AND REDUCE RIGID DIETARY RESTRAINT), (2) BODY ACCEPTANCE PROGRAM (MECHANISMS: TO IMPROVE BODY APPRECIATION AND REDUCE INTERNALIZED WEIGHT-RELATED BIAS), AND (3) A TAILORED INTERVENTION TO PROMOTE ENJOYMENT OF PHYSICAL ACTIVITY (MECHANISM: ENJOYMENT OF PHYSICAL ACTIVITY). WEIGHT NEUTRAL COMPONENTS WILL COMPLEMENT A CORE INTERVENTION OF STANDARDIZED EDUCATION ON HEALTHY DIET (EMPHASIZING THE MEDITERRANEAN DIET) AND PHYSICAL ACTIVITY GUIDELINES FOR AMERICANS (I.E., AEROBIC ACTIVITY, MUSCLE STRENGTHENING AND SEDENTARY BEHAVIOR). BEFORE EVERY POTENTIAL COMBINATION OF CORE + CANDIDATE WEIGHT NEUTRAL COMPONENTS CAN BE TESTED IN A FULLY POWERED FACTORIAL EXPERIMENT, WE WILL CONDUCT NECESSARY PILOT TESTING IN THIS PREPARATION PHASE STUDY TO ENSURE WE CAN RECRUIT OUR TARGET SAMPLE AND DELIVER THE NOVEL COMBINATIONS OF WEIGHT NEUTRAL COMPONENTS AS INTENDED. TO MAKE STRATEGIC USE OF RESOURCES, A FRACTIONAL FACTORIAL DESIGN WILL BE DEPLOYED. THE CORE INTERVENTION AND CONDITIONS WITH 2+ WEIGHT NEUTRAL CANDIDATE COMPONENTS WILL BE PILOT TESTED. SMALL GROUPS OF RACIALLY/ETHNICALLY DIVERSE ADULTS WITH BMI 25-40KG/M2 (N=50) WILL BE RECRUITED AND RANDOMLY ASSIGNED TO ONE OF THE FIVE TREATMENT COMBINATIONS. THIS PROJECT WILL LEVERAGE THE EXPERTISE THE PI HAS DEVELOPED THROUGH COMPLETION OF HER NIDDK-FUNDED K23 AND ENHANCE HER CAPACITY TO TRANSITION TO INDEPENDENCE BY LAUNCHING A RELATED BUT DISTINCT LINE OF RESEARCH INVESTIGATING THE HEALTH BENEFITS OF WEIGHT NEUTRAL LIFESTYLE INTERVENTIONS FOR INDIVIDUALS OF HIGHER BODY WEIGHT. | $223.5K | FY2025 | Jun 2025 – May 2027 |
| Department of Health and Human Services | EXAMINATION OF THE FEASIBILITY AND PRELIMINARY EFFICACY OF YOGA AS AN INTERVENTION APPROACH TO IMPROVING LONG-TERM WEIGHT LOSS | $219K | FY2018 | Sep 2018 – Feb 2021 |
| Department of Health and Human Services | AN AI-BASED CHATBOT FOR DOXYCYCLINE AS POST-EXPOSURE PROPHYLAXIS AMONG MEN WHO HAVE SEX WITH MEN - BACTERIAL SEXUALLY TRANSMITTED INFECTIONS (STIS)—INCLUDING SYPHILIS, GONORRHEA, AND CHLAMYDIA—ARE INCREASING IN THE UNITED STATES, WITH DISPROPORTIONATELY HIGH RATES AMONG MEN WHO HAVE SEX WITH MEN (MSM). THESE INFECTIONS CAN LEAD TO SERIOUS HEALTH COMPLICATIONS SUCH AS NEUROLOGICAL AND CARDIOVASCULAR SYPHILIS, INFERTILITY, PELVIC INFLAMMATORY DISEASE, AND INCREASED HIV TRANSMISSION. DOXYCYCLINE, A WIDELY AVAILABLE AND SAFE ANTIBIOTIC, HAS SHOWN PROMISE AS POST-EXPOSURE PROPHYLAXIS (DOXY-PEP) TO PREVENT BACTERIAL STIS. MOTIVATIONAL INTERVIEWING (MI) IS EFFECTIVE IN PROMOTING HIV PREVENTION BEHAVIORS, ESPECIALLY WHEN PAIRED WITH THE TRANSTHEORETICAL MODEL (TTM) TO ASSESS READINESS FOR CHANGE AND TAILOR MESSAGING. HOWEVER, TRADITIONAL MI REQUIRES MULTIPLE SESSIONS AND IS RESOURCE-INTENSIVE. THIS PILOT STUDY AIMS TO OVERCOME THOSE LIMITATIONS BY DEVELOPING AND TESTING SAI (STI PREVENTION AI-CHATBOT), AN AI-BASED CHATBOT POWERED BY THE LATEST CHATGPT MODEL. IN SPECIFIC AIM 1, SAI WILL BE TAILORED TO ASSESS STI RISK AND TTM STAGE, DELIVER STAGE-APPROPRIATE EDUCATION, AND USE MI-BASED COUNSELING TO PROMOTE DOXY-PEP UPTAKE AMONG MSM. IN SPECIFIC AIM 2, WE WILL CONDUCT AN OPEN PILOT TRIAL WITH 25 ADULT MSM RECRUITED VIA SOCIAL MEDIA TO EVALUATE SAI’S ACCURACY, USABILITY, APPROPRIATENESS, AND USER SATISFACTION, FOLLOWED BY ITERATIVE REFINEMENT. IF SUCCESSFUL, THIS STUDY WILL DEMONSTRATE THE FEASIBILITY OF USING AI TO SCALE BEHAVIORAL INTERVENTIONS FOR STI PREVENTION AND SUPPORT BROADER IMPLEMENTATION OF DOXY-PEP STRATEGIES AMONG HIGH-RISK POPULATIONS. MODIFIED PROJECT TITLE AN AI-BASED CHATBOT FOR DOXYCYCLINE AS POST-EXPOSURE PROPHYLAXIS AMONG MEN WHO HAVE SEX WITH MEN | $200.8K | FY2025 | Sep 2025 – Aug 2027 |
| Department of Health and Human Services | INTEGRATED SMOKING CESSATION AND MOOD MANAGEMENT FOR ACS PATIENTS | $199.3K | FY2016 | Sep 2016 – Mar 2017 |
| Department of Health and Human Services | HIV PREVENTION AND SUBSTANCE USE TREATMENT FOR PEOPLE WITH DRUG USE-ASSOCIATED WOUNDS - PROJECT ABSTRACT THIS TIMELY K01 AWARD FOCUSES ON IDENTIFYING OPTIMAL TREATMENT APPROACHES IN AN EVOLVING DRUG USE LANDSCAPE, WHILE PROVIDING THE PI WITH THE NECESSARY TRAINING TO ADVANCE HER LONG-TERM GOAL OF LEADING IMPACTFUL RESEARCH AT THE INTERSECTION OF SUBSTANCE USE AND INFECTIOUS DISEASES. ALONGSIDE AN UNPRECEDENTED OVERDOSE CRISIS, PEOPLE WHO USE DRUGS ARE FACING AN INCREASE IN INFECTIOUS DISEASE COMPLICATIONS, INCLUDING BACTERIAL INFECTIONS AND WOUNDS COMPLICATED BY DRUG SUPPLY ADDITIVES LIKE XYLAZINE. WHEN PEOPLE RECEIVE HEALTHCARE FOR THESE INFECTIONS, THIS INTERACTION SERVES AS AN IMPORTANT OPPORTUNITY TO PROVIDE OTHER KEY PREVENTION AND TREATMENT SERVICES THAT MIGHT OTHERWISE BE MISSED, LIKE PRE-EXPOSURE PROPHYLAXIS (PREP) AND MEDICATIONS FOR OPIOID USE DISORDER (MOUD). HOWEVER, SEVERAL CHALLENGES PREVENT MANY FROM SEEKING CARE IN TRADITIONAL SETTINGS LIKE CLINICS AND HOSPITALS. IN CONTRAST, NEW MODELS OF CARE PROVIDED THROUGH MOBILE CLINICS SHOW PROMISE IN IMPROVING CARE QUALITY AND EFFECTIVENESS. THE RESEARCH OBJECTIVE OF THIS K01 IS TO COMPREHENSIVELY EVALUATE AND IDENTIFY OPTIMAL SETTINGS TO IMPROVE MOUD, PREP, AND WOUND CARE OUTCOMES FOR PEOPLE WHO USE DRUGS WITHIN THE CHANGING CONTEXT OF THE DRUG SUPPLY. OUR CENTRAL HYPOTHESIS IS THAT WOUND CARE OFFERED THROUGH MOBILE CLINICS IS ASSOCIATED WITH IMPROVED PATIENT-PROVIDER RELATIONSHIPS AND LOGISTICAL ACCESS, THUS LEADING TO IMPROVED UPTAKE OF PREVENTION AND TREATMENT SERVICES. TO STUDY THIS, WE WILL QUALITATIVELY EXPLORE HOW INTERPERSONAL INTERACTIONS DURING WOUND CARE INFLUENCE CARE EXPERIENCES AND PREFERENCES AMONG PEOPLE WHO USE DRUGS AND THEIR PROVIDERS. NEXT, WE WILL QUANTITATIVELY EXAMINE THE INFLUENCE OF INDIVIDUAL AND INTERPERSONAL FACTORS ON PREFERENCES IN INTEGRATED WOUND CARE, PREP, AND MOUD BY LEVERAGING AN EXISTING COHORT STUDY OF PEOPLE WHO USE DRUGS. FINALLY, WE WILL CONDUCT A MIXED METHODS ANALYSIS TO ASSESS INDIVIDUAL AND ORGANIZATIONAL DETERMINANTS OF MOUD AND PREP UTILIZATION WITHIN DIFFERENT MODELS OF WOUND CARE (MOBILE SETTINGS VERSUS BRICK-AND-MORTAR SITES) THROUGH AN EXISTING NETWORK OF INNOVATIVE SUBSTANCE USE SERVICES. THROUGH THIS K01 AWARD, THE PI WILL EXPAND UPON HER BACKGROUND IN EPIDEMIOLOGY AND APPLIED RESEARCH BY GAINING COMPLEMENTARY TRAINING IN QUALITATIVE AND MIXED METHODS RESEARCH, MEASUREMENT OF INTERPERSONAL DYNAMICS INFLUENCING TREATMENT DELIVERY, AND IMPLEMENTATION SCIENCE RESEARCH. TRAINING WILL BE GUIDED BY AN EXCEPTIONAL TEAM OF LEADING EXPERTS IN SUBSTANCE USE TREATMENT AND INFECTIOUS DISEASE CARE WHO HAVE OUTSTANDING TRACK RECORDS OF MENTORSHIP AND IMPACTFUL RESEARCH. THROUGH THESE RESEARCH AIMS, THE PI WILL OBTAIN PRELIMINARY DATA TO INFORM SUBSEQUENT STUDIES FOCUSED ON COMPREHENSIVELY EVALUATING NOVEL MODELS OF CARE AMONG PEOPLE WHO USE DRUGS. ULTIMATELY, THIS K01 AWARD WILL SUPPORT THE PI AS SHE PROGRESSES INTO AN INDEPENDENT RESEARCH CAREER FOCUSED ON IDENTIFYING AND ASSESSING NEW APPROACHES IN SUBSTANCE USE AND INFECTIOUS DISEASE CARE AS IT ADAPTS TO THE CHANGING DRUG USE ENVIRONMENT. | $186.9K | FY2026 | May 2026 – Apr 2031 |
| Department of Health and Human Services | GAPCARE: THE GERIATRIC ACUTE & POST-ACUTE CARE COORDINATION PROGRAM FOR FALL PREVENTION IN THE EMERGENCY DEPARTMENT | $186.1K | FY2017 | Jul 2017 – May 2020 |
| Department of Health and Human Services | EVALUATION OF MANAGEMENT STRATEGIES FOR MAXIMIZING SUPPORTIVE CARE FOR PATIENTS WITH EBOLA VIRUS DISEASE | $169.4K | FY2017 | Jun 2017 – May 2020 |
| Department of Health and Human Services | PARENTAL INVOLVEMENT AS A STRATEGY TO ENHANCE ADOLESCENT WEIGHT CONTROL | $159.6K | FY2009 | Aug 2009 – Jul 2011 |
| Department of Health and Human Services | WEB-BASED PHYSICAL ACTIVITY INTERVENTION FOR YOUNG ADULT CANCER SURVIVORS | $158.4K | FY2008 | Sep 2008 – Aug 2010 |
| Department of Health and Human Services | STATISTICAL METHODS FOR ASSESSING PATTERNS OF CHANGE IN CANCER-CONTROL BEHAVIOR | $157.4K | FY2010 | Jul 2010 – Jun 2012 |
| Department of Health and Human Services | POSTPARTUM EXERCISE INTERVENTION FOR PREVIOUSLY SMOKING MOTHERS | $155.5K | FY2012 | Apr 2012 – Mar 2015 |
| Department of Health and Human Services | RESISTANCE TRAINING AS AN AID TO STANDARD SMOKING CESSATION TREATMENT | $153.6K | FY2008 | Aug 2008 – Jul 2010 |
| Department of Health and Human Services | A NOVEL BEHAVIORAL APPROACH FOR THE ADOPTION AND MAINTENANCE OF HABITUAL PHYSICAL ACTIVITY | $145.6K | FY2017 | Sep 2017 – Feb 2020 |
| Department of Health and Human Services | PROMOTION AND PREVENTION IN THE TREATMENT OF OBESITY | $144.9K | FY2016 | Jul 2016 – Nov 2018 |
Department of Health and Human Services
$37.1M
LIFESPAN/TUFTS/BROWN CENTER FOR AIDS RESEARCH (CFAR)
Department of Health and Human Services
$10.2M
LOOK AHEAD: ACTION FOR HEALTH IN DIABETES
Department of Health and Human Services
$10.1M
COBRE FOR STRESS, TRAUMA AND RESILIENCE (STAR) - PROJECT SUMMARY / ABSTRACT THERE IS INCREASING EVIDENCE FOR A PROFOUND AND PERSISTENT IMPACT OF CHILDHOOD STRESS AND TRAUMA ON PSYCHO- LOGICAL AND PHYSICAL HEALTH OUTCOMES OVER THE LIFESPAN. THE STRENGTH AND CONSISTENCY OF THESE ASSOCIATIONS HAS LED TO A PARADIGM SHIFT IN APPROACHING ADULT DISEASE IN WHICH ADDRESSING THE EARLY CHILDHOOD ORIGINS OF HEALTH AND DISEASE IS CONSIDERED TO BE EQUAL TO IF NOT MORE CRITICAL THAN INTERVENTION EFFORTS WITH ADULTS. HOWEVER, DE- SPITE THE MAGNITUDE OF RISK ASSOCIATED WITH ADVERSE CHILDHOOD EXPERIENCES, THERE IS LIMITED UNDERSTANDING OF THE PRECISE MECHANISMS BY WHICH EARLY ADVERSITY IMPACTS HEALTH. WE PROPOSE TO ESTABLISH A PHASE I CENTER OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE) FOR STRESS, TRAUMA, AND RESILIENCE (STAR) AT THE MIRIAM HOSPITAL TO ADDRESS THIS CRITICAL GAP. THE STAR COBRE IS UNIFIED BY A CONCEPTUAL FRAMEWORK FOCUSED ON (A) ISOLATING/DISENTANGLING SPECIFIC STRESS EXPOSURES AND TRAUMAS, AND (B) IDENTIFYING PROXIMAL MECHANISMS OF RISK AND RESILIENCE WITH IN-VIVO ECOLOGICAL SAMPLING THAT WILL LEAD RAPIDLY TO NOVEL AND ACTIONABLE INTER- VENTION TARGETS TO IMPROVE HEALTH. THE COBRE INCORPORATES A LIFE COURSE APPROACH, WITH AN EMPHASIS ON SENSITIVE PERIODS OF DEVELOPMENT—PREGNANCY, CHILDHOOD, AND YOUNG ADULTHOOD. THREE PROMISING, EARLY CA- REER PROJECT LEADERS, A JUNIOR FACULTY RECRUIT WITH EXPERTISE IN STAR FROM AN UNDER-REPRESENTED MINORITY GROUP, AND A DIVERSITY-FOCUSED PILOT PROJECT PROGRAM FUNDED BY THE MIRIAM HOSPITAL FORM THE NEXUS OF THE STAR CO- BRE. CO-MENTORSHIP BY TWO LEADING NIH-FUNDED SCIENTISTS WITH COMPLEMENTARY EXPERTISE WILL CATALYZE THE TRAN- SITION OF THE PROJECT LEADERS TO INDEPENDENT FUNDING. DR. BUBLITZ WILL UTILIZE CUTTING-EDGE ECOLOGICAL METHODS TO UNDERSTAND LINKS BETWEEN MATERNAL HISTORY OF CHILDHOOD SEXUAL ABUSE AND HYPERTENSIVE DISORDERS OF PREG- NANCY. DR. EVANS WILL CONDUCT A NATURALISTIC EXPERIMENT IN CHILDREN TO ELUCIDATE THE SPECIFIC IMPACT OF FOOD IN- SECURITY FROM OTHER POVERTY-RELATED STRESSORS ON DIET, INFLAMMATORY AND METABOLIC BIOMARKERS AND SUMMER WEIGHT GAIN; DR. VERGARA-LOPEZ WILL UTILIZE A NOVEL DIMENSIONAL APPROACH TO CHILDHOOD MALTREATMENT TO CONTRAST THE IMPACT OF DEPRIVATION (NEGLECT) VS. THREAT (ABUSE) ON YOUNG ADULT EMOTION REGULATION STRATEGIES AND MENTAL HEALTH SYMPTOMS. TO SUPPORT PROJECT LEADERS AND THE STAR COBRE, WE WILL ESTABLISH AN ADMINISTRATIVE CORE, INCLUDING A COMMUNITY ADVISORY BOARD AND A STATE-OF-THE ART MENTORING AND EDUCATION PROGRAM, AND TWO RESEARCH CORES: THE TECHNOLOGY, ASSESSMENT, DATA, AND ANALYSIS (TADA) CORE WILL SUPPORT METHODS HAR- NESSING CUTTING-EDGE TECHNOLOGY, DATA MANAGEMENT AND STATISTICS; THE HUMAN SUBJECTS AND VULNERABLE POP- ULATIONS (VP) CORE WILL SUPPORT RECRUITMENT/RETENTION OF VULNERABLE AND DIVERSE POPULATIONS AND COMMUNITY PARTNERSHIPS. THE STAR COBRE WILL SERVE AS THE ONLY RESEARCH CENTER IN RHODE ISLAND FOCUSED ON STRESS, TRAUMA, AND RESILIENCE. OUR LONG-TERM GOAL IS TO DEVELOP AND SUSTAIN A CRITICAL MASS OF INVESTIGATORS TO ESTABLISH THE MIRIAM HOSPITAL AS A VIBRANT REGIONAL AND NATIONAL HUB FOR TRANSFORMATIVE RESEARCH INTO MECHA- NISMS OF RISK AND RESILIENCE FOLLOWING CHILDHOOD EXPOSURE TO STRESS, TRAUMA, AND ADVERSITY.
Department of Health and Human Services
$9.3M
COBRE CENTER FOR ANTIMICROBIAL RESISTANCE AND THERAPEUTIC DISCOVERY
Department of Health and Human Services
$8.5M
OP EARLY INTERVENTION SVCS W/RESPECT TO HIV DISEASE
Department of Health and Human Services
$7.1M
HIV AND OTHER INFECTIOUS CONSEQUENCES OF SUBSTANCE ABUSE
Department of Health and Human Services
$6.4M
THUMB CMC BIOMECHANICS AND EARLY OA PROGRESSION
Department of Health and Human Services
$6.4M
RYAN WHITE PART C OUTPATIENT EIS PROGRAM
Department of Health and Human Services
$6.3M
COBRE CENTER FOR CANCER RESEARCH DEVELOPMENT
Department of Health and Human Services
$5.8M
BIOLOGICALLY ENHANCED HEALING OF AUTOGRAFT ACL RECONSTRUCTION.
Department of Health and Human Services
$4.9M
CARE CORRECTIONS: TECHNOLOGY FOR JAIL HIV/HCV TESTING LINKAGE AND CARE (TLC)
Department of Health and Human Services
$4.8M
TRAINING IN BEHAVIORAL & PREVENTIVE MEDICINE
Department of Health and Human Services
$4.6M
PREVENTION OF WEIGHT GAIN IN YOUNG ADULTS
Department of Health and Human Services
$4.4M
INCREASING SLEEP DURATION: A NOVEL APPROACH TO WEIGHT CONTROL
Department of Health and Human Services
$4M
IMPROVING LINKAGE TO HIV CARE FOLLOWING RELEASE FROM INCARCERATION
Department of Health and Human Services
$3.9M
ADDRESSING HIV DRUG RESISTANCE RESEARCH GAPS IN A COHORT OF PERINATALLY INFECTED KENYAN CHILDREN AND ADOLESCENTS
Department of Health and Human Services
$3.5M
FACILITATING HIV/AIDS AND HIV TESTING LITERACY FOR EMERGENCY DEPARTMENT PATIENTS
Department of Health and Human Services
$3.5M
PRENATAL MARIJUANA: IMPACT ON INFANT NEUROBEHAVIOR, STRESS, & EPIGENETIC MECHANISMS
Department of Health and Human Services
$3.5M
THE LIFESPAN/BROWN CRIMINAL JUSTICE RESEARCH PROGRAM ON SUBSTANCE USE AND HIV
Department of Health and Human Services
$3.4M
REAL TIME PHYLOGENY AND CONTACT TRACING TO DISRUPT HIV TRANSMISSION
Department of Health and Human Services
$3.4M
TARGETING COGNITIVE FUNCTION AND INTEROCEPTIVE AWARENESS TO IMPROVE SELF-MANAGEMENT IN PATIENTS WITH CO-MORBID HEART FAILURE AND COGNITIVE IMPAIRMENT. - PROJECT SUMMARY/ABSTRACT DUE TO POPULATION AGEING, HEART FAILURE (HF) IS REACHING PANDEMIC PROPORTIONS AND IS NOW THE MOST COMMON HOSPITAL DISCHARGE DIAGNOSIS AMONG OLDER ADULTS IN THE UNITED STATES. HF CARRIES AN UNFAVORABLE PROGNOSIS, WITH BOTH 6-MONTH HOSPITAL READMISSIONS AND 5-YEAR MORTALITY RATES REACHING 50%. TO IMPROVE CLINICAL OUTCOMES, IT IS CRITICAL THAT PATIENTS IMPLEMENT ADEQUATE SELF-CARE, I.E., THEY ADHERE TO PHARMACOLOGICAL AND LIFESTYLE RECOMMENDATIONS AND MONITOR THEIR SYMPTOMS TO ENSURE THEY RECEIVE MEDICAL ATTENTION IN A TIMELY FASHION. MILD COGNITIVE IMPAIRMENT (MCI) AFFECTS UP TO TWO-THIRDS OF PATIENTS WITH HF AND IS A KEY BARRIER TO THEIR ABILITY TO EFFECTIVELY IMPLEMENT SELF-CARE. DESPITE ITS NEGATIVE IMPACT ON SELF-CARE AND ON CLINICAL OUTCOMES, ONLY A SMALL NUMBER OF SELF-CARE INTERVENTION STUDIES SPECIFICALLY ADDRESS MCI AND INTERVENTIONS TARGETING THIS IMPORTANT COMORBIDITY ARE SORELY NEEDED. THERE IS PRELIMINARY EVIDENCE THAT MINDFULNESS TRAINING (MT) CAN IMPROVE COGNITIVE FUNCTION IN INDIVIDUALS WITH MCI. MT HAS ALSO BEEN SHOWN TO IMPROVE INTEROCEPTIVE AWARENESS, A SKILL WHICH COULD INCREASE THE PATIENT’S ABILITY TO RECOGNIZE WORSENING OF HF SYMPTOMS IN A TIMELY FASHION, RECEIVE TREATMENT SOONER, AND POTENTIALLY PREVENT RE-ADMISSIONS. FINALLY, BY ELICITING THE RELAXATION RESPONSE, MT ENHANCES VAGAL CONTROL, WHICH HAS BEEN ASSOCIATED WITH BETTER COGNITIVE FUNCTION. THIS APPLICATION, DESIGNED IN RESPONSE TO PAR-20-180 “IDENTIFYING INNOVATIVE MECHANISMS OR INTERVENTIONS THAT TARGET MULTIMORBIDITY AND ITS CONSEQUENCES” AND IN LINE WITH NIA INTERESTS, WILL LEVERAGE OUR EXPERTISE WITH REMOTE MT FOR PATIENTS WITH CHRONIC CONDITIONS TO CONDUCT A PHASE II MECHANISTIC RCT WITH THE FOLLOWING OBJECTIVES: A) TO STUDY THE EFFECTS OF MT ON COGNITIVE FUNCTION AND INTEROCEPTIVE AWARENESS IN PATIENTS WITH CO- MORBID MCI AND HF, B) TO ASSESS WHETHER IMPROVEMENTS IN THESE PROXIMAL FACTORS COULD POSITIVELY IMPACT SELF- CARE AND C) TO STUDY THE UNDERLYING PHYSIOLOGICAL MECHANISMS BY WHICH MT COULD IMPROVE COGNITION IN THIS POPULATION. STABLE OUTPATIENTS (N=176) WITH HF AND MCI WILL BE RANDOMLY ASSIGNED TO PHONE-DELIVERED MT (A WEEKLY, 30-MINUTE SESSION FOR 8 WEEKS INTEGRATED WITH A 20-MIN GUIDED DAILY INDIVIDUAL PRACTICE VIA DIGITAL RECORDINGS) PLUS ENHANCED USUAL CARE (EUC) OR TO EUC ALONE. CONSISTENT WITH CURRENT RECOMMENDATIONS, USUAL CARE WILL BE ENHANCED IN BOTH GROUPS WITH SELF-CARE EDUCATION MATERIALS. AT BASELINE, 3 MONTHS (END OF TREATMENT), AND 9 MONTHS SINCE BASELINE PARTICIPANTS WILL UNDERGO COMPREHENSIVE ASSESSMENTS OF COGNITIVE FUNCTION, INTEROCEPTIVE AWARENESS, HF SELF-CARE AND OTHER PSYCHO-BEHAVIORAL FACTORS, CARDIAC VAGAL CONTROL, AND HF BIOMARKERS. THIS IS THE FIRST RIGOROUS INVESTIGATION OF THE EFFECTS OF MT ON COGNITIVE FUNCTION, INTEROCEPTIVE AWARENESS, AND SELF-CARE IN PATIENTS WITH CO-MORBID MCI AND HF. DEMONSTRATING THAT, BY IMPROVING COGNITIVE PERFORMANCE AND INTEROCEPTIVE AWARENESS, MT PROMOTES SELF-CARE IN PATIENTS WITH CO-MORBID HF AND MCI WILL PAVE THE WAY TO THE INTEGRATION OF MT INTO REHABILITATION PROGRAMS AND SELF-CARE INTERVENTIONS TO IMPROVE CLINICAL OUTCOMES IN THIS VULNERABLE POPULATION.
Department of Health and Human Services
$3.3M
ETHANOL INSULIN/IGF SIGNALING AND NEURONAL MIGRATION
Department of Health and Human Services
$3.3M
FETAL BEHAVIOR, BRAIN & STRESS RESPONSE: ULTRASOUND MARKERS OF MATERNAL SMOKING
Department of Health and Human Services
$3.3M
CHARACTERIZING THE HIV PRE-EXPOSURE PROPHYLAXIS CARE CONTINUUM FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN
Department of Health and Human Services
$3.3M
ELECTRONIC CIGARETTES DURING PREGNANCY: IMPACT ON FETAL DEVELOPMENT
Department of Health and Human Services
$3M
ENHANCING EMOTION REGULATION TO SUPPORT WEIGHT CONTROL EFFORTS IN ADOLESCENTS WITH OVERWEIGHT AND OBESITY
Department of Health and Human Services
$2.9M
HIV PREVENTION FOR STD CLINIC PATIENTS
Department of Health and Human Services
$2.9M
STUDY OF NOVEL APPROACHES TO WEIGHT GAIN PREVENTION - EXTENSION (SNAP-E)
Department of Health and Human Services
$2.9M
EFFICACY OF YOGA AS AN ALTERNATIVE THERAPY FOR SMOKING CESSATION
Department of Health and Human Services
$2.9M
PACKAGING AND DISSEMINATING THE JOIN FOR ME PROGRAM IN LOW-INCOME SETTINGS
Department of Health and Human Services
$2.9M
HETEROGENEITY AND PREDICTORS OF STRESS REACTIVITY IN TAKOTSUBO SYNDROME
Department of Health and Human Services
$2.8M
MOTIVATING SMOKERS WITH MOBILITY IMPAIRMENTS TO QUIT SMOKING
Department of Health and Human Services
$2.8M
MATERNAL SMOKING: HPA AND EPIGENETIC PATHWAYS TO INFANT NEUROBEHAVIORAL DEFICITS
Department of Defense
$2.8M
SEXUAL ASSAULT PREVENTION FOR MEN IN THE MILITARY
Department of Health and Human Services
$2.8M
MECHANISMS OF MINDFULNESS TRAINING TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY - ABSTRACT HYPERTENSIVE DISORDERS OF PREGNANCY ARE THE MOST COMMON MEDICAL CONDITION AFFECTING PREGNANCY AND A LEADING CAUSE OF MATERNAL MORBIDITY AND MORTALITY IN THE UNITES STATES. HYPERTENSIVE DISORDERS OF PREGNANCY INCREASE LIFETIME CARDIAC DISEASE RISK IN WOMEN AND INFANTS EXPOSED DURING PREGNANCY AND ARE CONSIDERED AN INDEPENDENT, GENDER-SPECIFIC CARDIOVASCULAR RISK FACTOR BY THE AMERICAN HEART ASSOCIATION. CURRENT INTERVENTIONS TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY ARE EXTREMELY LIMITED AND MINIMALLY EFFECTIVE. MINDFULNESS-BASED INTERVENTIONS HOLD SIGNIFICANT PROMISE AS A NON-PHARMACOLOGICAL INTERVENTION TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY; MINDFULNESS-BASED INTERVENTIONS SIGNIFICANTLY REDUCE BLOOD PRESSURE IN ADULTS WITH HYPERTENSION AND PREHYPERTENSION. HOWEVER, PRENATAL CLINICAL TRIALS OF MINDFULNESS-BASED INTERVENTIONS HAVE EXCLUDED WOMEN AT RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY FROM PARTICIPATING, AND HAVE NOT EXAMINED EFFECTS OF MINDFULNESS ON MATERNAL CARDIOVASCULAR PARAMETERS. OUR PILOT RCT OF PRENATAL MINDFULNESS TRAINING FOR WOMEN AT RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY DEMONSTRATED MEDIUM TO LARGE EFFECTS ON MATERNAL CARDIOVASCULAR PARAMETERS OF RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY, INCLUDING LOWER AMBULATORY BLOOD PRESSURE AND ACCELERATED FETAL GROWTH VELOCITY. HOWEVER, THE MECHANISMS EXPLAINING EFFECTS OF PRENATAL MINDFULNESS TRAINING ON INDICATORS OF RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY ARE UNKNOWN. BUILDING UPON THESE PROMISING PRELIMINARY FINDINGS, THE PROPOSED RCT WILL HARNESS SUBJECTIVE AND OBJECTIVE ECOLOGICAL MOMENTARY ASSESSMENT (EMA) METHODOLOGIES (IN VIVO REPEATED ASSESSMENTS) IN COMBINATION WITH WEARABLE BIOSENSOR TECHNOLOGY TO CAPTURE RICH EPOCHS OF ECOLOGICALLY-VALID PSYCHOLOGICAL (AIM 1), PHYSIOLOGICAL (AIM 2), AND INTERPERSONAL (AIM 3) PROCESSES THROUGH WHICH MINDFULNESS TRAINING MAY LEAD TO IMPROVED MATERNAL CARDIOVASCULAR PARAMETERS AND REDUCED RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY. N=150 PREGNANT WOMEN AT RISK FOR HDP WILL BE RANDOMIZED TO AN 8-WEEK PHONE-DELIVERED MINDFULNESS INTERVENTION OR USUAL CARE. FOR EVERY PARTICIPANT, WE WILL MEASURE MATERNAL CARDIOVASCULAR PARAMETERS (24-HOUR BLOOD PRESSURE AND UTERINE ARTERY RESISTANCE VALUES BY ULTRASOUND DOPPLER) BEFORE AND AFTER THE RCT. ALL PARTICIPANTS WILL COMPLETE EMA FOR 2 WEEKS ‘BURSTS’ BEFORE AND AFTER THE RCT TO EVALUATE MECHANISMS OF MINDFULNESS TRAINING ON MATERNAL CARDIOVASCULAR PARAMETERS. EMA WILL INCLUDE SMARTPHONE-APP BASED EXPERIENCE SAMPLING OF PSYCHOLOGICAL PROCESSES; SMARTPHONE-APP BASED AMBIENT AUDIO SAMPLING (I.E. THE ELECTRONICALLY ACTIVATED RECORDER [EAR] METHOD) AND WEARABLE WRIST-WORN BIOSENSOR MONITORING (HEART RATE AND HEART RATE VARIABILITY) OF PHYSIOLOGICAL RESPONSES TO EVERYDAY EXPERIENCES. RESULTS WILL PROVIDE NEW INSIGHTS INTO 1) EFFECTS OF MINDFULNESS TRAINING ON CARDIOVASCULAR PARAMETERS IN PREGNANCY, 2) PATHOPHYSIOLOGICAL MECHANISMS OF HYPERTENSIVE DISORDERS OF PREGNANCY, AND 3) NEW TARGETS FOR PREVENTION STRATEGIES.
Department of Health and Human Services
$2.7M
HPA & NEURAL RESPONSE TO PEER REJECTION: BIOMARKERS OF ADOLESCENT DEPRESSION RISK
Department of Health and Human Services
$2.7M
PLACENTAL ROLE IN MEDIATING ADVERSE OUTCOMES IN OBSTRUCTIVE SLEEP APNEA
Department of Health and Human Services
$2.6M
A NOVEL CYCLIC PEPTIDE-BASED TREATMENT FOR TBI
Department of Health and Human Services
$2.6M
PLACENTAL GENOMICS IN THE DEVELOPMENTAL CONSEQUENCES OF MARIJUANA USE IN PREGNANCY - PROJECT SUMMARY/ABSTRACT THIS APPLICATION IS RESPONSIVE TO NOT-DA-20-039: EFFECTS OF CANNABIS USE AND CANNABINOIDS ON THE DEVEL- OPING BRAIN. PRENATAL CANNABIS USE IS COMMON AND INCREASING, WITH RATES AS HIGH AS 1 IN 4 IN POOR, YOUNG, UNDERSERVED WOMEN. EXPANDING LEGALIZATION OF CANNABIS HAS LED TO INCREASING AVAILABILITY, USE, PERCEPTIONS OF SAFETY AS WELL AS INCREASED POTENCY. HOWEVER, DATA IS LACKING REGARDING THE IMPACT OF PRENATAL USE OF INCREASE- ED-POTENCY CANNABIS ON OFFSPRING NEURODEVELOPMENT. OUR GROUP IS CURRENTLY CONDUCTING AN INTENSIVE, PROSPECTIVE INVESTIGATION OF THE IMPACT OF MATERNAL PRENATAL CANNABIS USE ON INFANT NEURODEVELOPMENT (R01DA044504). OUR ONGOING STUDY HAS YIELDED PRELIMINARY EVIDENCE FOR AN IMPACT OF PRENATAL CANNABIS ON OFFSPRING GROWTH AND NEURODEVELOPMENT, BUT DOES NOT INVOLVE A COMPREHENSIVE INTERROGATION OF GENOMIC PATHWAYS UNDERLYING THESE ASSOCIATIONS. PINPOINTING GENOMIC PATHWAYS WILL ALLOW US TO IDENTIFY BIOMARKERS OF FETAL HARM AND DEVELOP NOVEL SCREENING TOOLS AND INTERVENTION TARGETS TO PROTECT AND TREAT EXPOSED OFFSPRING. THE PLACENTA IS A UNIQUE ORGAN THAT REGULATES THE INTRAUTERINE ENVIRONMENT, MATERNAL-FETAL COMMUNICATION--INCLUDING PASSAGE OF CANNABINOIDS--AND PLAYS A CRITICAL ROLE IN SUPPORTING FETAL GROWTH AND NEURODEVELOPMENT. SEMINAL WORK BY OUR GROUP HAS REVEALED THAT THE PRENATAL ENVIRONMENT IMPACTS PLACENTA FUNCTION, THAT ALTERATIONS IN PLACENTA FUNCTION CAN BE INFORMED BY GENOMIC PROFILING OF THE PLACENTA, AND THAT ALTERATIONS IN PLACENTA GENOMIC PROFILES ARE LINKED TO NEWBORN GROWTH AND NEUROBEHAVIOR. MICRORNAS (MIRNAS) ARE AN UNDERSTUDIED ASPECT OF PLACENTA EPIGENETIC REGULATION; MIRNAS ARE SHORT NON-CODING RNAS THAT REGULATE GENE EXPRESSION POST-TRANSCRIPTIONALLY AND ARE CRIT- ICAL REGULATORS OF PLACENTAL- AND NEURO-DEVELOPMENT. A RECENT INITIAL STUDY SUPPORTS THE HYPOTHESIS THAT MATERNAL CANNABIS MAY IMPACT PLACENTA IMMUNE GENE NETWORKS, AND OFFSPRING ANXIETY, BUT WAS NOT DESIGNED TO INVESTIGATE PRENATAL CANNABIS, ONLY INCLUDED A SMALL NUMBER OF CANNABIS USERS, AND DID NOT INCLUDE MIRNA. WE PROPOSE A COMPREHENSIVE PLACENTA MIRNA AND MRNA PROFILING STUDY TO DEFINE THE IMPACT OF PRENATAL CANNABIS EXPOSURE ON PLACENTA GENOMIC ACTIVITY AND INFANT NEURODEVELOPMENT. WE TEST THE CENTRAL HYPOTHESIS THAT PRENATAL CANNABIS EXPOSURE LEADS TO UNIQUE ALTERATIONS IN PLACENTA ENDOCANNABINOID, NEURONAL DEVELOPMENT, IMMUNE, AND STRESS SIGNALING PATHWAYS, AND THAT THESE FUNCTIONAL GENOMIC FEATURES WILL ALSO IMPACT INFANT DE- VELOPMENT. WE LEVERAGE OUR ONGOING COHORT (N=100 CANNABIS USERS, N=100 NON-USERS) DESIGNED TO ASSESS THE IMPACT OF PRENATAL CANNABIS ON INFANT NEURODEVELOPMENT AND INCLUDING PLACENTA COLLECTION FOR CANDIDATE METHYL- ATION ASSAYS. OUR PROPOSED GENOMIC MECHANISMS STUDY INVOLVES THE ADDITION OF STATE-OF-THE-ART WHOLE TRANSCRIP- TOME RNA-SEQUENCING (MRNA AND MIRNA) TO DELINEATE THE FUNCTIONAL IMPACTS OF PRENATAL CANNABIS EXPOSURE AND LINKS TO INFANT DEVELOPMENT. DETERMINING GENOMIC PROFILES UNDERLYING THE IMPACT OF PRENATAL CANNABIS ON INFANT DEVELOPMENT IS TIMELY AND OFFERS POTENTIAL TO IDENTIFY BIOMARKERS OF EXPOSURE AND OFFSPRING RISK AS WELL AS MOLECULAR TARGETS FOR FUTURE INTERVENTION EFFORTS.
Department of Health and Human Services
$2.6M
OPTIMIZING JUST-IN-TIME ADAPTIVE INTERVENTION TO IMPROVE DIETARY ADHERENCE IN BEHAVIORAL OBESITY TREATMENT: A MICRO-RANDOMIZED TRIAL
Department of Health and Human Services
$2.6M
COMMUNITY- AND CLINIC-BASED SUBSTANCE USE TREATMENT AND HIV PREVENTION FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN
Department of Health and Human Services
$2.6M
PREDICTORS OF DE NOVO DEVELOPMENT OF OBSTRUCTIVE SLEEP APNEA IN PREGNANCY
Department of Health and Human Services
$2.6M
MATERNAL DEPRESSION PLACENTAL HPA REGULATION & FETAL-NEONATAL STRESS RESPONSE
Department of Health and Human Services
$2.6M
PRAGMATIC TRIAL OF TECHNOLOGY-SUPPORTED BEHAVIORAL OBESITY TREATMENT IN THE PRIMARY CARE SETTING: A MULTIPHASE EFFECTIVENESS AND IMPLEMENTATION HYBRID DESIGN
Department of Health and Human Services
$2.5M
A RANDOMIZED TRIAL OF CONTINUED METHADONE MAINTENANCE VS. DETOXIFICATION IN JAIL
Department of Health and Human Services
$2.5M
EFFICACY OF EXERCISE VIDEOGAMES FOR PHYSICAL ACTIVITY ADOPTION AND MAINTENANCE
Department of Health and Human Services
$2.5M
USING MULTIMODAL REAL-TIME ASSESSMENT TO PHENOTYPE DIETARY NON-ADHERENCE BEHAVIORS THAT CONTRIBUTE TO POOR OUTCOMES IN BEHAVIORAL OBESITY TREATMENT - PROJECT SUMMARY/ABSTRACT BEHAVIORAL OBESITY TREATMENT (BOT) PRODUCES CLINICALLY SIGNIFICANT WEIGHT LOSS AND REDUCED DISEASE RISK/SEVERITY FOR MANY INDIVIDUALS WITH OVERWEIGHT/OBESITY. YET, MANY PATIENTS FALL SHORT OF EXPECTED OUTCOMES, WHICH CAN BE LARGELY ATTRIBUTED TO LAPSES FROM THE RECOMMENDED DIET. OUR WORK HAS SHOWN THAT DIETARY LAPSES (SPECIFIC INSTANCES OF NONADHERENCE TO THE PRESCRIBED CALORIE TARGET(S) IN BOT) ARE FREQUENT DURING WEIGHT LOSS ATTEMPTS, AND ARE ASSOCIATED WITH POORER WEIGHT LOSSES AND HIGHER DAILY ENERGY INTAKE. DESPITE THE POTENTIAL FOR LAPSES TO INFLUENCE BOT OUTCOMES AND HEALTH, POORLY UNDERSTOOD VARIABILITY IN TYPES OF LAPSE BEHAVIORS AND THEIR MECHANISMS INTERFERES WITH OUR ABILITY TO INTERVENE ON THEM. IN OUR RESEARCH, PARTICIPANTS HAVE IDENTIFIED DISTINCT BEHAVIORS ASSOCIATED WITH LAPSE (E.G., EATING AN OFF-PLAN FOOD, EATING TOO LARGE A PORTION OF FOOD). ACROSS SEVERAL STUDIES, WE HAVE ESTABLISHED THE CONCEPT OF “DIETARY LAPSE TYPES” (I.E., SPECIFIC EATING BEHAVIOR(S) AND CONTEXTUAL FACTORS UNDERLYING A DIETARY LAPSE). WE HAVE SHOWN THAT BEHAVIORAL, PSYCHOSOCIAL, AND CONTEXTUAL MECHANISMS MAY DIFFER ACROSS DIETARY LAPSE TYPES, AND THAT SOME LAPSE TYPES APPEAR TO BE MORE DETRIMENTAL THAN OTHERS FOR WEIGHT CONTROL. ELUCIDATING CLEAR DIETARY LAPSE TYPES THEREFORE HAS MAJOR POTENTIAL FOR UNDERSTANDING AND IMPROVING ADHERENCE IN BOT, BUT WE HAVE BEEN UNABLE TO DO SO BECAUSE OUR WORK IS LIMITED TO SECONDARY ANALYSES OF DATA FROM LARGER TRIALS THAT HAVE INCOMPLETE MEASURES OF LAPSE TYPES, POTENTIAL MECHANISMS, AND CLINICAL OUTCOMES. WE PROPOSE TO EXTEND OUR RESEARCH BY USING BEHAVIORAL PHENOTYPING (I.E., DATA-DRIVEN IDENTIFICATION OF UNDERLYING BEHAVIORAL, PSYCHOLOGICAL, AND CONTEXTUAL FACTORS OF A HEALTH BEHAVIOR) TO ESTABLISH LAPSE PHENOTYPES, AND UNDERSTAND THEIR IMPACT ON CLINICAL OUTCOMES. WHILE TYPICAL PHENOTYPING STUDIES CLUSTER INDIVIDUALS VIA UNIQUE CHARACTERISTICS, WE AIM TO UNDERSTAND PHENOTYPES OF LAPSES AS A SPECIFIC BEHAVIOR WITHIN INDIVIDUALS. WE WILL USE MULTIMODAL REAL-TIME ASSESSMENT TOOLS WITHIN A MULTI-LEVEL FACTOR ANALYSIS FRAMEWORK TO UNCOVER PHENOTYPES WHILE ACCOUNTING FOR BEHAVIORS OCCURRING WITHIN INDIVIDUALS AND WITHIN DAYS. ADULTS WITH OVERWEIGHT/OBESITY (N=150) WILL PARTICIPATE IN A WELL-ESTABLISHED 12-MO. ONLINE BOT AND 6-MO. WEIGHT LOSS MAINTENANCE PERIOD. PARTICIPANTS WILL COMPLETE A 14-DAY LAPSE PHENOTYPING ASSESSMENT BATTERY AT BASELINE, 4, 8, 12 AND 18 MONTHS. EMA AND PASSIVE SENSING TOOLS (I.E., WRIST DEVICES, GEOLOCATION) WILL ASSESS DIETARY LAPSES AND RELEVANT PHENOTYPING CHARACTERISTICS IDENTIFIED FROM OUR PRIOR WORK. PARTICIPANT ENERGY INTAKE WILL BE ASSESSED WITH 24-HOUR DIETARY RECALLS AND WEIGHT WILL BE MEASURED PRE- AND POST- ASSESSMENT. RESULTS WILL YIELD A SET OF LAPSE PHENOTYPES AND KNOWLEDGE OF THEIR UNDERLYING MECHANISMS, WHICH WILL CAN INFORM NOVEL INTERVENTIONS TO IMPROVE DIETARY ADHERENCE IN BOT (AND IN OTHER TREATMENTS FOR WHICH DIETARY ADHERENCE IS CRITICAL). THIS INNOVATIVE APPROACH WILL ADVANCE THE SCIENCE OF ADHERENCE MORE BROADLY BY SUPPORTING THE DEVELOPMENT OF SOPHISTICATED THEORETICAL MODELS OF ADHERENCE BEHAVIOR AND GIVE RISE TO NOVEL PHENOTYPING METHODS THAT CAN BE LEVERAGED TO BETTER UNDERSTAND AND TREAT NON-ADHERENCE TO OTHER HEALTH BEHAVIORS (E.G., MEDICATIONS, ACTIVITY).
Department of Health and Human Services
$2.5M
SYSTEM-BASED TRACKING AND TREATMENT FOR EMERGENCY PATIENTS WHO SMOKE: STTEPS
Department of Health and Human Services
$2.4M
EFFICACY OF RESISTANCE TRAINING AS AN AID TO SMOKING CESSATION TREATMENT
Department of Health and Human Services
$2.4M
RAPID EVALUATION OF INNOVATIVE INTERVENTION COMPONENTS TO MAXIMIZE THE HEALTH BENEFITS OF BEHAVIORAL OBESITY TREATMENT DELIVERED ONLINE: AN APPLICATION OF MULTIPHASE OPTIMIZATION STRATEGY
Department of Health and Human Services
$2.4M
CARDIAC UBIQUITIN LIGASES: REGULATION AND ROLE IN MODULATING CARDIAC EXCITATION.
Department of Health and Human Services
$2.3M
TEACHING NOVEL VALUES-BASED SKILLS TO IMPROVE LONG-TERM WEIGHT LOSS: A RANDOMIZED TRIAL EXAMINING THE EFFICACY OF A WEIGHT LOSS MAINTENANCE INTERVENTION BASED ON ACCEPTANCE AND COMMITMENT THERAPY
Department of Health and Human Services
$2.3M
ADAPTING EPISODIC FUTURE THINKING FOR BEHAVIORAL WEIGHT LOSS: COMPARING STRATEGIES AND CHARACTERIZING TREATMENT RESPONSE - PROJECT SUMMARY/ABSTRACT OBESITY IS ONE OF THE MOST IMPORTANT PUBLIC HEALTH ISSUES TODAY, CONTRIBUTING TO MANY OF THE LEADING CAUSES OF MORBIDITY AND MORTALITY IN THE UNITED STATES. DESPITE STRONG DESIRES TO ACHIEVE LONG-TERM WEIGHT LOSS GOALS, INDIVIDUALS WITH OBESITY TEND TO OVERVALUE IMMEDIATE REWARDS AND DISCOUNT THE FUTURE. EPISODIC FUTURE THINKING (EFT), A COGNITIVE STRATEGY IN WHICH INDIVIDUALS ENVISION THEMSELVES IN THE FUTURE AND SIMULATE POTENTIAL EXPERIENCES, HAS BEEN SHOWN TO HELP SHIFT ATTENTION TO THE FUTURE, IMPROVE FOOD CHOICES, AND REDUCE INTAKE. MOST PREVIOUS STUDIES HAVE USED PROMOTION-FOCUSED EFT, IN WHICH PARTICIPANTS ENVISION THEMSELVES EXPERIENCING POSITIVE FUTURE OUTCOMES. HOWEVER, THEORIES SUGGEST IT IS POSSIBLE EFT-BASED STRATEGIES MAY BE ALTERNATIVELY FOCUSED ON PREVENTION, GUIDING PARTICIPANTS TO CONSIDER FUTURE CONSEQUENCES OF UNHEALTHY CHOICES. OUR RECENT PILOT (R03 DK106405) RANDOMIZED CONTROLLED TRIAL IMPLEMENTED THESE APPROACHES IN A 3-MONTH INTERNET-DELIVERED BEHAVIORAL WEIGHT LOSS PROGRAM (IBWL). PARTICIPANTS (N=95) WERE RANDOMIZED TO EITHER: (1) STANDARD IBWL (NO EFT-BASED STRATEGIES), (2) PREVENT (IBWL + EFT-BASED STRATEGIES FOCUSED ON PREVENTING LONG-TERM NEGATIVE CONSEQUENCES OF UNHEALTHY CHOICES), OR (3) PROMOTE (IBWL + EFT-BASED STRATEGIES FOCUSED ON PROMOTING LONG-TERM BENEFITS OF HEALTHY CHOICES). PREVENT WAS SUPERIOR TO STANDARD IBWL PRODUCING THE GREATEST OVERALL WEIGHT LOSS, WHICH WAS COUPLED WITH REDUCED FOOD REWARD DRIVE AND INCREASED SELF-CONTROL. THIS IS CONSISTENT WITH OUR PREVIOUS WORK IN WHICH USE OF THE PREVENT STRATEGY WAS ASSOCIATED WITH REDUCED CRAVING AND INCREASED INHIBITORY CONTROL NEURAL ACTIVITY. ALTHOUGH PREVENT PRODUCED THE GREATEST WEIGHT LOSS, VARIABILITY SUGGESTS INDIVIDUAL DIFFERENCES MAY MODERATE SUCCESS IN EACH TREATMENT. FOR INSTANCE, INDIVIDUALS HIGH IN PROMOTION-FOCUS WERE MORE LIKELY TO HAVE GREATER WEIGHT LOSS IN PROMOTE. WE NOW PROPOSE A FULLY POWERED RANDOMIZED CONTROLLED TRIAL (RCT) TO TEST IF EITHER OF THESE NOVEL APPROACHES MAY PROVIDE BENEFIT OVER STANDARD TREATMENT. FURTHER, THE PROPOSED STUDY WILL SEEK TO IDENTIFY MODERATORS THAT PREDICT SUCCESS, DETERMINING FOR WHOM EACH STRATEGY IS BEST. INDIVIDUALS WITH OVERWEIGHT/OBESITY (N=360) WILL BE RANDOMIZED TO 12 MONTHS OF EITHER (1) STANDARD IBWL, (2) PREVENT, OR (3) PROMOTE. ALL PARTICIPANTS WILL HAVE AN INTRODUCTORY TRAINING SESSION, DURING WHICH PREVENT AND PROMOTE GROUPS WILL RECEIVE TRAINING IN THEIR SPECIFIC EFT-BASED STRATEGY. IBWL LESSONS WILL THEN BE WEEKLY FOR 3 MONTHS FOLLOWED BY A ‘REFRESHER’ TRAINING SESSION FOR ALL GROUPS, AND MONTHLY IBWL FOR THE REMAINING 9 MONTHS. IN PREVENT AND PROMOTE IBWL LESSONS AND FEEDBACK MESSAGES WILL CONTINUOUSLY FEATURE EXERCISES AND REMINDERS TO UTILIZE THE ASSIGNED EFT-BASED STRATEGIES. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, DURING TREATMENT AT 3 AND 6 MONTHS, AT THE END OF TREATMENT (12 MONTHS), AND 6 MONTHS POST-TREATMENT (18 MONTHS). THE PRIMARY OUTCOME IS WEIGHT CHANGE. THIS RCT WILL PROVIDE CRITICAL INSIGHT INTO NOVEL TREATMENT STRATEGIES FOR IMPROVING WEIGHT LOSS AND MAY LEAD TO FUTURE OPTIMIZATION OF WEIGHT LOSS VIA INDIVIDUALLY TAILORED TREATMENT.
Department of Health and Human Services
$2.3M
PHONE COACHING AS A RESCUE STRATEGY FOR EARLY NON-RESPONDERS ENROLLED IN AN INTERNET-DELIVERED WEIGHT LOSS PROGRAM
Department of Health and Human Services
$2.2M
NON-TRIBOLOGIC BIOACTIVITY OF LUBRICIN
Department of Health and Human Services
$2.2M
LIVE SMART: SMARTPHONE INTERVENTION FOR WEIGHT CONTROL
Department of Health and Human Services
$2.1M
ESTABLISHING MULTI-SITE FEASIBILITY AND FIDELITYOF YOGA TO IMPROVE MANAGEMENT OF TYPE-2 DIABETES - PROJECT ABSTRACT/SUMMARY EFFECTIVE INTERVENTIONS ARE URGENTLY NEEDED TO HELP ADULTS WITH TYPE 2 DIABETES (T2DM) ACHIEVE AND MAINTAIN A HEALTHY LIFESTYLE. A SIGNIFICANT AND GROWING PROPORTION OF AMERICANS, NEARLY 1 IN 10, HAVE T2DM.[1] UNCONTROLLED DIABETES CAUSES SERIOUS DAMAGE TO KIDNEYS, EYES AND NERVES, AND INCREASES RISK OF HEART DISEASE AND STROKE.[2,3] CONTROLLING BLOOD GLUCOSE IS CRUCIAL TO AVOID THESE COMPLICATIONS. ACHIEVING GLYCEMIC CONTROL REQUIRES ATTENTION TO MULTIPLE LIFESTYLE BEHAVIORS INCLUDING HEALTHY EATING AND REGULAR PHYSICAL ACTIVITY.[4-7] HOWEVER, ONLY 39% OF ADULTS WITH DIABETES ARE PHYSICALLY ACTIVE.[8] TRADITIONAL (WESTERN) EXERCISE (E.G., WALKING, CYCLING) IMPROVES BLOOD GLUCOSE LEVELS IN ADULTS WITH T2DM.[9,10] LONG-TERM ADHERENCE IS ESSENTIAL TO MAINTAIN HEALTH BENEFITS. HOWEVER, INDIVIDUALS WITH T2DM FACE GREATER BARRIERS TO SUSTAINING PHYSICAL ACTIVITY COMPARED TO THEIR HEALTHY PEERS DUE TO THE PREVALENCE OF OVERWEIGHT AND OBESITY AMONG THOSE WITH T2DM AND THE CO- MORBIDITIES OF DIABETES (E.G., POOR CIRCULATION, FOOT CARE ISSUES) THAT CREATE MORE DISCOMFORT DURING EXERCISE. YOGA IS SIMILAR TO TRADITIONAL EXERCISE IN ITS ABILITY TO IMPROVE PHYSICAL FITNESS BUT CAN BE HIGHLY ACCOMMODATING TO THOSE WITH PHYSICAL LIMITATIONS.[11] MOREOVER, AS A MINDFULNESS PRACTICE, WITH EMPHASIS ON RELAXATION, MEDITATION, AND DEEP BREATHING, YOGA’S EFFECTS ON STRESS REDUCTION MAY HAVE SPECIAL RELEVANCE TO PEOPLE WITH T2DM.[12-14] INCREASED MINDFULNESS LEADS TO IMPROVED SELF-CARE BEHAVIORS INCLUDING PHYSICAL ACTIVITY. RECENT META-ANALYSES SUGGEST A BENEFICIAL EFFECT OF YOGA ON GLYCEMIC OUTCOMES.[15,16] HOWEVER, EXISTING STUDIES HAVE GENERALLY BEEN OF LOW QUALITY AND CONDUCTED WITH NON-US POPULATIONS. THIS U01 APPLICATION IS THE NEXT LOGICAL STEP FOLLOWING SUCCESSFUL CONCLUSION OF OUR PILOT YOGA INTERVENTION FOR ADULTS WITH T2DM (R21AT008830). FEASIBILITY AND ACCEPTABILITY WERE HIGH AS MEASURED BY PROGRAM ATTENDANCE (>80% OF SESSIONS), STUDY COMPLETION (92% OF PARTICIPANTS) AND PARTICIPANT SATISFACTION (M=4.6 ±0.57, 1-5 SCALE; SECTION 4.1.2). YOGA ALSO IMPROVED DIABETES SELF-CARE, QUALITY OF LIFE AND LED TO REDUCTIONS IN EMOTIONAL DISTRESS AND HBA1C.[17,18] THE PROPOSED STUDY WILL BUILD ON THESE EFFORTS BY RANDOMIZING A DIVERSE SAMPLE OF 90 ADULTS WITH T2DM FROM THREE DIFFERENT STATES (RI, MA, AND AL) TO A 12-WEEK PROGRAM OF EITHER (1) YOGA OR (2) STANDARD EXERCISE (SE) WITH FOLLOW UP AT 3 AND 6-MONTHS POST-TREATMENT. RESULTS OF THIS STUDY WILL DETERMINE OUR ABILITY TO DELIVER THESE INTERVENTIONS WITH STRONG RIGOR AND FIDELITY ACROSS MULTIPLE SITES AND WILL ESTABLISH THE FEASIBILITY AND ACCEPTABILITY OF THIS INTERVENTION ACROSS RACIALLY AND ETHNICALLY DIVERSE POPULATIONS. WE WILL ALSO EXAMINE FACTORS (E.G., OUTCOME EXPECTATIONS, BARRIERS TO HOME PRACTICE) THAT PROMOTE LONG-TERM ADHERENCE TO YOGA/PHYSICAL ACTIVITY. SUCCESSFUL CONCLUSION OF THIS U01 WILL STRENGTHEN FUTURE APPLICATIONS FOR A MULTI-SITE RCT TO RIGOROUSLY TEST THE EFFICACY OF YOGA FOR IMPROVING HBA1C AND DIABETES MANAGEMENT. IF SUPPORTED, YOGA COULD OFFER AN ATTRACTIVE, SUSTAINABLE FORM OF PHYSICAL ACTIVITY FOR FUTURE DIABETES MANAGEMENT PROGRAMS.
Department of Health and Human Services
$2.1M
USE OF BIOMIMICRY TO DETERMINE THE EFFECT OF SEPSIS ON NEUTROPHIL TRACTION
Department of Health and Human Services
$2.1M
BEHAVIORAL WEIGHT LOSS AS A TREATMENT FOR MIGRAINE IN OBESE WOMEN
Department of Health and Human Services
$2M
PSYCHOSOCIAL, IMMUNOLOGICAL AND BIOBEHAVIORAL BENEFITS OF STRESS MANAGEMENT INTERVENTIONS FOR CHRONIC DISEASES: COMPREHENSIVE SYSTEMATIC REVIEW AND M
Department of Defense
$1.9M
INTRA-ARTICULAR INJECTION OF ALPHA-2 MACROGLOBULIN PREVENTS POST-TRAUMATIC OSTEOARTHRITIS
Department of Health and Human Services
$1.9M
ACCEPTANCE BASED BEHAVIORAL INTERVENTION FOR WEIGHT LOSS: A RANDOMIZED TRIAL
Department of Health and Human Services
$1.9M
CONTROL SYSTEMS ENGINEERING TO ADDRESS THE PROBLEM OF WEIGHT LOSS MAINTENANCE: A SYSTEM IDENTIFICATION EXPERIMENT TO MODEL BEHAVIORAL & PSYCHOSOCIAL FACTORS MEASURED BY ECOLOGICAL MOMENTARY ASSESSMENT - PROJECT SUMMARY/ABSTRACT THE MOST MAJOR AND CRITICAL BARRIER TO THE TREATMENT OF OBESITY AND COMORBID CONDITIONS IS WEIGHT LOSS MAINTENANCE. A RANGE OF ESTABLISHED TREATMENTS RELIABLY PRODUCE CLINICALLY SIGNIFICANT INITIAL WEIGHT LOSSES OF 3- 30% OF BODY WEIGHT, WHICH SUBSTANTIALLY REDUCE RISK AND SEVERITY OF DISEASE, EVEN WHEN THE WEIGHT LOSS IS MODEST. HOWEVER, WEIGHT LOSS MAINTENANCE IS UNIFORMLY POOR, WITH MOST PATIENTS REGAINING AT LEAST SOME WEIGHT AND BEHAVIORALLY TREATED PATIENTS RETURNING TO BASELINE WEIGHT WITHIN 5 YEARS, THEREBY RENEWING RISK FOR WEIGHT-RELATED ILLNESS. WHILE REGAIN IS COMMON, IT IS DIFFICULT TO PREDICT WHEN OR WHY AN INDIVIDUAL WILL BEGIN TO REGAIN LOST WEIGHT. WE THEREFORE PROPOSE AN EXPERIMENT THAT WILL ENABLE A FUTURE JUST-IN-TIME ADAPTIVE INTERVENTION (JITAI) THAT PASSIVELY MONITORS TRIGGERS FOR LAPSE, IDENTIFIES WHICH TRIGGERS ARE MOST LIKELY TO CONTRIBUTE TO LAPSE FOR EACH PATIENT, ACCURATELY PREDICTS WHEN A PATIENT IS ENTERING A PERIOD OF HEIGHTENED RISK FOR LAPSE, DETERMINES THE TYPE(S) OF INTERVENTION(S) THAT ARE LIKELY TO PREVENT THE LAPSE, ADMINISTERS INTERVENTION FOR AS LONG AS NEEDED TO REESTABLISH HEALTHY BEHAVIORAL PATTERNS FOR WEIGHT MAINTENANCE, AND THEN RETURNS TO PASSIVE MONITORING. THIS AUTOMATED INTERVENTION IS NEARLY WITHIN REACH VIA A COMBINATION OF MOBILE TECHNOLOGIES, ANALYTICS, AND BEHAVIORAL INTERVENTION TECHNIQUES THAT OUR TEAM HAS ALREADY ESTABLISHED, INCLUDING: (A) AN ECOLOGICAL MOMENTARY ASSESSMENT PLATFORM TO MEASURE DAILY WEIGHT AND RELATED BEHAVIORAL AND PSYCHOSOCIAL INFLUENCES; (B) AN ANALYTIC FRAMEWORK, CONTROL SYSTEMS ENGINEERING, CAPABLE OF MODELING COMPLEX PATTERNS OF BEHAVIORAL AND PSYCHOSOCIAL INFLUENCES ON WEIGHT, AND DETERMINING HOW BEST TO INTERVENE ON THIS “SYSTEM” TO FACILITATE WEIGHT LOSS MAINTENANCE; AND (C) A TOOLBOX OF EMPIRICALLY VALIDATED BEHAVIORAL INTERVENTION STRATEGIES KNOWN TO BE EFFECTIVE FOR ADDRESSING COMMON CAUSES OF WEIGHT REGAIN. THIS PROPOSAL AIMS TO SUPPORT OUR MULTIDISCIPLINARY TEAM IN COMBINING OUR AREAS OF EXPERTISE AND PRIOR WORK TO ENABLE A “SYSTEM IDENTIFICATION (ID) EXPERIMENT” WITH N=120 PARTICIPANTS WHO HAVE RECENTLY LOST =3% OF INITIAL BODY WEIGHT IN A 6-MONTH BEHAVIORAL OBESITY TREATMENT (N=180 WILL UNDERGO BEHAVIORAL OBESITY TREATMENT TO PRODUCE THIS SAMPLE), WHO WILL BE STUDIED OVER A 12-MONTH MAINTENANCE PERIOD. THE DATA WILL BE USED TO VALIDATE AND REFINE A THEORETICAL MODEL OF WEIGHT LOSS MAINTENANCE. DURING THE STUDY, 4 INTERVENTIONS FROM THE BEHAVIORAL TOOLBOX WILL BE ADMINISTERED RANDOMLY, THUS PROVIDING NECESSARY DATA ON: (A) HOW LAPSE TRIGGERS ARE RELATED TO EACH OTHER AND WEIGHT, AND (B) WHICH INTERVENTIONS ARE EFFECTIVE FOR ADDRESSING WHICH TRIGGERS, FOR WHOM, AND UNDER WHAT CIRCUMSTANCES. THE END RESULT OF THIS PROJECT WILL BE A CONTROL SYSTEMS ALGORITHM THAT CAN PREDICT WHEN, FOR WHOM, AND HOW TO INTERVENE TO PREVENT WEIGHT REGAIN, AND A MOBILE PLATFORM THAT CAN BE USED TO DELIVER JITAI IN THE NEXT PHASE OF RESEARCH. THIS HIGHLY INNOVATIVE APPROACH TO WEIGHT LOSS MAINTENANCE COULD ULTIMATELY PREVENT REGAIN IN LARGE NUMBERS OF INDIVIDUALS AT LOW COST USING SMARTPHONE TECHNOLOGY THAT IS ALREADY UBIQUITOUS.
Department of Health and Human Services
$1.8M
OPTIMIZING ANTIMICROBIAL USE IN MAINTENANCE DIALYSIS UNITS (OPTIMUS)
Department of Health and Human Services
$1.8M
A REMOTE-BASED YOGA INTERVENTION FOR IMPROVING LONG-TERM WEIGHT LOSS - PROJECT SUMMARY EFFECTIVE INTERVENTIONS WITH STRONG DISSEMINATION POTENTIAL ARE CRITICAL FOR ADDRESSING THE OBESITY EPIDEMIC. INTERNET-DELIVERED WEIGHT LOSS (IDWL) PROGRAMS OVERCOME MANY OF THE BARRIERS COMMON TO FACE-TO-FACE INTERVENTIONS (E.G., GEOGRAPHICAL CONSTRAINTS, LACK OF CHILDCARE, HIGH COST), BUT WEIGHT LOSSES ARE APPROXIMATELY HALF OF THAT OBSERVED WITHIN IN-PERSON TREATMENT. NOVEL APPROACHES FOR IMPROVING LONG-TERM WEIGHT LOSS (WL) WITHIN IDWL PROGRAMS ARE NEEDED. YOGA HAS BEEN FOUND TO BE AN EFFECTIVE STRATEGY FOR TREATING A VARIETY OF HEALTH CONDITIONS (E.G., CVD RISK FACTORS, DEPRESSION, PAIN SYNDROMES), BUT HAS BEEN LARGELY OVERLOOKED WITHIN THE CONTEXT OF OBESITY MANAGEMENT. YOGA HAS ALSO BEEN SHOWN TO STRENGTHEN SELF-REGULATORY SKILLS (E.G., EMOTION REGULATION, COGNITIVE REGULATION, AND SELF-RELATED PROCESSES) WHICH ARE IMPORTANT FOR KEEPING WL OFF LONG-TERM. NONETHELESS, ONLY TWO RANDOMIZED TRIALS TO DATE HAVE COMBINED YOGA AND BEHAVIORAL WL TREATMENT. WHILE FINDINGS ARE INITIALLY PROMISING, SIGNIFICANT LIMITATIONS INCLUDE A LACK OF A CONTROL GROUP AND SMALL SAMPLE SIZE IN ONE STUDY AND A SHORT FOLLOW-UP (12 WEEKS) IN THE OTHER. ALSO, MECHANISMS THROUGH WHICH YOGA IMPACTS WL WITHIN A WEIGHT MANAGEMENT PROGRAM HAVE NOT BEEN EXPLORED. IN OUR PILOT STUDY, WE FOUND THAT PROVIDING YOGA FOLLOWING THREE MONTHS OF BEHAVIORAL WL TREATMENT LED TO FAVORABLE EFFECTS ON DIETARY LAPSES (I.E., DISCRETE EPISODES OF DIETARY NON-ADHERENCE WHICH THREATEN WL), IMPROVED AFFECT, AND INCREASED ABILITY TO RESIST DIETARY TEMPTATIONS COMPARED TO A CONTACT-MATCHED CONTROL. FURTHER, YOGA HAD A SIGNIFICANT EFFECT ON WL AND MEASURES OF SELF-REGULATION (DISTRESS TOLERANCE, MINDFULNESS, AND SELF-COMPASSION) AMONG INDIVIDUALS WHO LOST MORE WEIGHT WITHIN THE FIRST THREE MONTHS OF TREATMENT. ADHERENCE TO THE YOGA INTERVENTION, RETENTION, AND PROGRAM SATISFACTION RATINGS WERE HIGH. THE PROPOSED TRIAL EXPANDS UPON THESE PROMISING PRELIMINARY FINDINGS BY INCREASING THE LENGTH OF YOGA TREATMENT (3 TO 9 MONTHS), ASSESSING PARTICIPANTS OVER A LONGER, 18-MONTH PERIOD, BROADENING PARTICIPANT CHARACTERISTICS (INCLUDING MEN AND INCREASING RACIAL/ETHNIC DIVERSITY), AND INCREASING THE SAMPLE SIZE, SO THAT IT IS SUFFICIENTLY POWERED TO EXAMINE PRIMARY (WL) AND SECONDARY OUTCOMES (DIETARY LAPSES AND OTHER UNCOMFORTABLE EXPERIENCES WHICH COULD TRIGGER A DIETARY LAPSE) AT 12 MONTHS. FURTHER, IT SEEKS TO FILL AN IMPORTANT GAP IN THE LITERATURE BY FORMALLY ASSESSING THE MECHANISMS THROUGH WHICH YOGA IMPACTS WL. ALL INDIVIDUALS WILL RECEIVE A 12-MONTH INTERNET-DELIVERED WL PROGRAM AND WILL BE RANDOMIZED AT THE END OF MONTH 3 TO A 9-MONTH YOGA PROGRAM (DELIVERED VIA VIDEOCONFERENCE) OR 9-MONTH HEALTH AND WELLNESS PROGRAM (CONTACT-MATCHED CONTROL). PARTICIPANTS WILL BE FOLLOWED FOR 6 MONTHS BEYOND THE END OF TREATMENT (FINAL ASSESSMENT AT 18 MONTHS). THIS FULLY REMOTE TRIAL HAS GREAT POTENTIAL TO IMPACT BOTH THE YOGA AND WEIGHT CONTROL FIELDS AND IS PARTICULARLY RELEVANT GIVEN EMERGING RESEARCH INDICATING THAT MANY INDIVIDUALS NOW PREFER ONLINE HEALTHCARE PROGRAMS VS. IN-PERSON PROGRAMS.
Department of Health and Human Services
$1.8M
HEPATITIS B VIRUS VACCINE ESCAPE MUTANTS
Department of Health and Human Services
$1.8M
A STATE-WIDE INITIATIVE TO SPREAD EFFECTIVE BEHAVIORAL WEIGHT LOSS STRATEGIES
Department of Health and Human Services
$1.8M
A RANDOMIZED TRIAL TESTING LAY HEALTH COACHES FOR OBESITY TREATMENT
Department of Health and Human Services
$1.7M
PREVENTING SEXUAL AGGRESSION AMONG HIGH SCHOOL BOYS
Department of Health and Human Services
$1.7M
MIDCAREER INVESTIGATOR AWARD IN PATIENT ORIENTED RESEARCH
Department of Health and Human Services
$1.7M
RESEARCH TRAINING IN CHILDHOOD STRESS, TRAUMA, AND RESILIENCE
Department of Health and Human Services
$1.6M
DIFFERENTIAL THROMBOGENESIS EFFECTS OF EPA AND DHA MEDIATED BY HDL - PROJECT SUMMARY EPIDEMIOLOGICAL STUDIES SUGGEST THAT THE CONSUMPTION OF OMEGA-3 POLYUNSATURATED FATTY ACIDS (N-3 PUFAS) DERIVED FROM FISH OIL, MAINLY CONSISTING OF EICOSAPENTAENOIC ACID (EPA; 20:5 N-3) AND DOCOSAHEXAENOIC ACID (DHA; 22:6 N-3), IS ASSOCIATED WITH LOWER CARDIOVASCULAR RISK. HOWEVER, INTERVENTIONAL CLINICAL TRIALS AIMED AT REDUCING CARDIOVASCULAR INCIDENTS BY SUPPLEMENTATION WITH N-3 PUFAS HAVE YIELDED INCONSISTENT RESULTS. THE MECHANISMS RESPONSIBLE FOR THE BENEFIT OF N-3 PUFAS ON CARDIOVASCULAR RISK ARE STILL NOT COMPLETELY UNDERSTOOD. MOUNTING EVIDENCE SUGGESTS THAT IN ADDITION TO LOWERING TRIGLYCERIDES, THE TRIGLYCERIDE-INDEPENDENT EFFECTS OF N-3 PUFAS ALSO CONTRIBUTE TO THEIR CARDIOVASCULAR BENEFITS. IT IS LIKELY THAT DIFFERENTIAL EFFECTS OF EPA AND DHA ALSO CONTRIBUTE TO THE INCONSISTENT CLINICAL RESULTS. A HEAD-TO-HEAD COMPARISON OF THE BIOLOGICAL EFFECTS OF EPA AND DHA IN A RELEVANT POPULATION IS URGENTLY REQUIRED. BASED ON OUR PRELIMINARY DATA, WE HYPOTHESIZE THAT EPA AND DHA HAVE DIFFERENTIAL EFFECTS ON THROMBOGENESIS IN PATIENTS WITH ATHEROGENIC DYSLIPIDEMIA THAT ARE MEDIATED BY THE MODIFICATION OF HDL PARTICLE FUNCTION. WE PROPOSE A PROOF-OF-CONCEPT CLINICAL STUDY COMPARING THE BIOLOGICAL EFFECTS, PARTICULARLY THE THROMBOGENESIS AND ANTIPLATELET EFFECTS, OF AN ADEQUATE DOSE OF EPA AND DHA HEAD-TO- HEAD IN ATHEROGENIC DYSLIPIDEMIA SUBJECTS. WE WILL ALSO EXAMINE THE MECHANISM OF HOW HDL PARTICLES MEDIATE THESE ANTITHROMBOTIC EFFECTS. SPECIFIC AIM1: TO TEST THE HYPOTHESIS THAT EPA AND DHA DIFFERENTIALLY AFFECT PLATELET ACTIVATION AND THROMBOSIS IN VIVO IN SUBJECTS WITH ATHEROGENIC DYSLIPIDEMIA. HUMAN SUBJECTS WITH ATHEROGENIC DYSLIPIDEMIA WILL BE RANDOMIZED TO DIETARY SUPPLEMENTATION WITH FOUR GRAMS OF EITHER EPA OR DHA N-3 PUFAS IN A SINGLE-BLINDED FASHION FOR EIGHT WEEKS. AT BASELINE AND AFTER THE SUPPLEMENTATION, VARIOUS MARKERS OF THROMBOGENESIS WILL BE ASSESSED. SPECIFIC AIM 2: TO TEST THE HYPOTHESIS THAT THE EFFECTS OF N-3 PUFAS ON PLATELETS ARE MEDIATED BY THE MODULATION OF HDL PARTICLE FUNCTION. AT BASELINE AND POST N-3 PUFA SUPPLEMENTATION, HDL PARTICLE COMPOSITION AND HDL FUNCTIONS WILL BE ANALYZED, RESPECTIVELY. WE WILL FURTHER TEST OUR HYPOTHESIS MECHANISTICALLY IN AN HDL-DEFICIENT MOUSE MODEL. HDL-DEPENDENT BIOACTIVE LIPID PRODUCTION WILL BE CHARACTERIZED IN BOTH HUMAN AND MOUSE STUDIES. THESE STUDIES WILL PROVIDE INSIGHT INTO A NEW PARADIGM OF UNDERSTANDING THE PUZZLING CLINICAL EVIDENCE OF N-3 PUFAS AND MAY ULTIMATELY LEAD TO THE DEVELOPMENT OF NOVEL THERAPIES TO COMBAT CARDIOMETABOLIC RISK.
Department of Health and Human Services
$1.6M
MICRORANDOMIZED TRIAL TO OPTIMIZE USE OF BURDEN-REDUCING SELF-MONITORING APPROACHES IN BEHAVIORAL OBESITY TREATMENT - PROJECT SUMMARY ABSTRACT SELF-MONITORING (SM) IS AN ESSENTIAL COMPONENT GOLD-STANDARD BEHAVIORAL TREATMENT OF OBESITY (BOT) – THE MOST PREVALENT CAUSE OF MORBIDITY AND MORTALITY IN THE US. ADHERENCE TO DIETARY SELF-MONITORING IS ONE OF THE STRONGEST CONSISTENT PREDICTORS OF TREATMENT OUTCOMES. HOWEVER, ADHERENCE TO DIETARY SM IS GENERALLY POOR DUE TO THE BURDEN OF THE GOLD-STANDARD SM APPROACH (I.E., DETAILED TRACKING OF ALL FOOD & DRINK CONSUMED). DISCONTINUATION OF DIETARY SM IS DIRECTLY CORRELATED WITH AN END TO WEIGHT LOSS, AND IT INCREASES RISK OF WEIGHT REGAIN. IMPROVING ADHERENCE TO DIETARY SM IS THUS ONE OF THE MOST CRITICAL STRATEGIES FOR TREATING OBESITY. ALTERNATIVE SM APPROACHES HAVE BEEN DEVELOPED TO REDUCE BURDEN OF DIETARY SM AND THEREBY IMPROVE ADHERENCE. PRIOR WORK SHOWS THAT THESE SM ALTERNATIVES HAVE THE POTENTIAL TO SUSTAIN SM ADHERENCE AND IMPROVE WEIGHT LOSS IN BOT. HOWEVER, THERE IS NO SCIENTIFIC CONSENSUS IN HOW OR WHEN TO APPLY SM ALTERNATIVES FOR MAXIMUM BENEFIT. TO ADDRESS THIS CRITICAL GAP, WE WILL CONDUCT A MICRO-RANDOMIZED TRIAL (MRT) TO DETERMINE WHICH SM STRATEGY TO APPLY FOR WHOM, AND AT WHAT POINT DURING BOT, TO MAXIMIZE SM ADHERENCE AND WEIGHT LOSS. MRT INVOLVES REPEATED RANDOMIZATIONS AT SPECIFIC DECISION POINTS, WHICH ENABLES DATA-DRIVEN OPTIMIZATION OF THE COMPOSITION, TAILORING, AND TIMING OF BEHAVIORAL INTERVENTIONS. BY USING MRT TO COMPARE SM STRATEGIES OVER TIME WITHIN INDIVIDUALS AND EVALUATING FACTORS THAT INFLUENCE THEIR EFFICACY, WE CAN ENABLE BROADLY-APPLICABLE SM RECOMMENDATIONS TO IMPROVE BOT. WE CAN THEN USE THESE DATA TO DEVELOP ALGORITHMS THAT CAN REPEATEDLY AND AUTOMATICALLY ADAPT SM RECOMMENDATIONS BASED ON EACH INDIVIDUAL’S PERFORMANCE AND NEEDS. OUR MRT WILL TEST THE EFFECTS OF GOLD- STANDARD DIETARY SM AND 4 SM ALTERNATIVES ON SM ADHERENCE AND WEIGHT LOSS DURING A 24-WEEK BOT. A DIVERSE SAMPLE OF ADULTS WITH OVERWEIGHT/OBESITY WILL RECEIVE OUR ESTABLISHED, ONLINE BOT FOR 24 WEEKS. AT PROGRAM START, AND EVERY 2 WEEKS THEREAFTER, PARTICIPANTS WILL BE RANDOMIZED TO ONE OF FIVE SM APPROACHES, FOR A TOTAL OF 12 INDEPENDENT RANDOMIZATIONS PER PERSON. THE SM APPROACHES TO BE TESTED ARE: GOLD-STANDARD FULL DIETARY SM OF ALL FOODS/DRINKS AND THEIR KCALS; REDUCED-FREQUENCY FULL DIETARY SM (3 D/WK); SM OF DIETARY LAPSES ONLY; SMARTWATCH-BASED MONITORING OF ENERGY INTAKE; AND SM OF BODY WEIGHT ONLY VIA SMART SCALE. DATA FROM THIS MRT WILL HAVE TREMENDOUS SCIENTIFIC AND PRACTICAL IMPACTS; WE WILL EVALUATE THE EFFICACY OF ALTERNATIVE SM APPROACHES ON SM ADHERENCE AND WEIGHT LOSS AS WELL AS HOW EACH STRATEGY WORKS ACROSS INDIVIDUAL DIFFERENCES (E.G., SEX), SOCIAL DETERMINANTS OF HEALTH (E.G., FINANCIAL RESOURCE STRAIN), AND TIME-VARYING TREATMENT (E.G., WEEK OF TREATMENT) FACTORS. WE WILL USE REINFORCEMENT LEARNING, A MACHINE LEARNING APPROACH, TO CREATE AN ADAPTIVE SM-SELECTION ALGORITHM THAT AUTOMATICALLY DETERMINES THE SM APPROACH MOST LIKELY TO MAXIMIZE OUTCOMES FOR A GIVEN INDIVIDUAL THROUGHOUT TREATMENT. THIS PROPOSAL WILL ACHIEVE BOTH SCIENTIFIC AND PRACTICAL PUBLIC HEALTH BENEFIT BY USING A SOPHISTICATED DATA-DRIVEN APPROACH TO UNDERSTAND THE FACTORS THAT INFLUENCE SM ADHERENCE DURING BEHAVIORAL OBESITY TREATMENT, AND PROVIDE AN ALGORITHM TO OPTIMIZE SM IN FUTURE CLINICAL AND RESEARCH APPLICATIONS.
Department of Health and Human Services
$1.6M
SNRK(SUCROSE NON-FERMENTING RELATED KINASE)AND ADIPOSE ENERGY HOMEOSTASIS
Department of Health and Human Services
$1.6M
SUB-CELLULAR TARGETING OF ENDOTHELIAL ROS IN MYOCARDIAL ISCHEMIA
Department of Health and Human Services
$1.6M
COMMUNITY-LEVEL PRIMARY PREVENTION OF DATING AND SEXUAL VIOLENCE IN MIDDLE SCHOOLS
Department of Health and Human Services
$1.6M
IMPACT OF FLAVORS AND DESIGN FEATURES ON PATTERNS OF WATERPIPE USE AND TOXICITY IN PREGNANT MOTHERS
Department of Health and Human Services
$1.5M
METABOLIC REGULATION OF SKCA/IKCA CHANNELS AND ENDOTHELIAL FUNCTION
Department of Health and Human Services
$1.5M
EFFECTS OF ENDOGENOUS AND EXOGENOUS OVARIAN HORMONES ON ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) USE - ABSTRACT IN 2018 THE U.S. SURGEON GENERAL DECLARED ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) USE A YOUTH EPIDEMIC. ENDS USE CONTINUES TO SOAR, ESPECIALLY AMONG YOUNG ADULTS (AGES 18-24) WHO USE MORE THAN ANY OTHER COHORT. ENDS USE IS ASSOCIATED WITH NEGATIVE CARDIOVASCULAR, IMMUNOLOGIC, AND NEURODEVELOPMENTAL ILLNESS. YOUNG WOMEN ARE DISPROPORTIONATELY IMPACTED BY ENDS USE, DUE TO MORE NICOTINE WITHDRAWAL SYMPTOMS, GREATER CUE INDUCED CRAVINGS, AND POORER TREATMENT RESPONSE. YET, LITTLE IS KNOWN ABOUT FACTORS THAT CAN INFORM SEX-SPECIFIC ENDS TREATMENTS. VARIATION IN EXPOSURE TO OVARIAN HORMONES EITHER ENDOGENOUSLY VIA THE MENSTRUAL CYCLE OR EXOGENOUSLY VIA ORAL CONTRACEPTIVES MAY BE CRITICAL SEX-SPECIFIC FACTORS IMPACTING ENDS USE. THERE IS A DEARTH OF STUDIES FOCUSED ON ENDS; HOWEVER, BURGEONING ANIMAL AND HUMAN RESEARCH ON COMBUSTIBLE CIGARETTES SUGGESTS THAT THERE MAY BE THREE PATHWAYS LINKING OVARIAN HORMONES TO NICOTINE USE. ENDOGENOUS ESTRADIOL AND PROGESTERONE ARE OVARIAN HORMONES THAT FLUCTUATE ACROSS THE MENSTRUAL CYCLE. BASED ON THE POSITIVE REINFORCEMENT PATHWAY NATURALLY OCCURRING INCREASES IN ESTRADIOL PAIRED WITH DECREASES IN PROGESTERONE DURING THE FOLLICULAR PHASE ENHANCE THE REWARDING EFFECTS OF NICOTINE LEADING TO USE. BASED ON THE NEGATIVE REINFORCEMENT PATHWAY WE EXPECT THAT INDIVIDUALS WHO EXPERIENCE AFFECTIVE REACTIVITY IN RESPONSE TO NATURALLY OCCURRING DROPS IN ESTRADIOL AND PROGESTERONE DURING THE LUTEAL PHASE USE NICOTINE TO COPE WITH DISTRESS. LASTLY, ETHINYL ESTRADIOL (A SYNTHETIC FORM OF ESTROGEN COMMON IN ORAL CONTRACEPTIVES) INCREASES NICOTINE METABOLISM (I.E., QUICKER ELIMINATION OF NICOTINE) RESULTING IN MORE USE TO “REPLENISH” NICOTINE CONCENTRATIONS. DESPITE PROMISING STUDIES SUPPORTING THESE THREE PATHWAYS, META-ANALYTIC FINDINGS SHOW THAT SEVERAL STUDIES SHOW NO EFFECTS. THIS MAY BE BECAUSE MOST STUDIES DO NOT DIRECTLY MEASURE OVARIAN HORMONES OR INCLUDE BIOMARKERS OF NICOTINE METABOLISM, RELY ON CROSS-SECTIONAL BETWEEN-SUBJECT DESIGNS, AND INFER A DICHOTOMIZED MENSTRUAL CYCLE PHASE, RATHER THAN CAPTURE HORMONAL VARIATION. THIS PROJECT WILL UTILIZE A 35-DAY EXPERIENCE-SAMPLING METHODS PROTOCOL THAT PROSPECTIVELY TRACKS MENSTRUAL CYCLE DAY, ORAL CONTRACEPTIVE USE, ENDS USE, PERCEIVED NICOTINE REWARD, AND AFFECT. OVARIAN HORMONES AND A RATIO OF TRANS 3'-HYDROXYCOTININE TO COTININE (AN ESTABLISHED BIOMARKER OF NICOTINE METABOLISM) WILL BE ASSESSED FROM DRIED BLOOD SPOTS. WE WILL RECRUIT ENDS USERS WITH NATURALLY OCCURRING MENSTRUAL CYCLES (N=100) AND THOSE ON COMBINED-TYPE ORAL CONTRACEPTIVES (N=100). THIS PROJECT EXPANDS RESEARCH ON BIOLOGICAL SEX-SPECIFIC MECHANISMS AND WILL GENERATE DATA THAT CAN GUIDE TAILORED INTERVENTIONS.
Department of Health and Human Services
$1.5M
SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE
Department of Health and Human Services
$1.5M
COMMUNITY VOLUNTEERS PROMOTING PHYSICAL ACTIVITY AMONG CANCER SURVIVORS
Department of Health and Human Services
$1.5M
ALCOHOL CONSUMPTION AND HIV BEHAVIOR: EVALUATING THE EVIDENCE
Department of Health and Human Services
$1.5M
REAL TIME PHYLOGENY AND CONTACT TRACING TO DISRUPT HIV TRANSMISSION - REAL TIME PHYLOGENY AND CONTACT TRACING TO DISRUPT HIV TRANSMISSION KANTOR, RAMI MD SUMMARY HIV TRANSMISSION REMAINS A GLOBAL CHALLENGE, AND INNOVATIVE APPROACHES WITHIN CONSTRAINED PUBLIC HEALTH SYSTEMS ARE NEEDED FOR ITS DISRUPTION. THOUGH ACTUAL TRANSMISSION NETWORKS ARE UNKNOWN, CHARACTERIZING SOCIAL AND PHYLOGENETIC NETWORKS CAN GUIDE PUBLIC HEALTH INTERVENTIONS TOWARDS PREVENTING HIV TRANSMISSION. CONTACT TRACING IS THE CURRENT PUBLIC HEALTH TOOL TO DERIVE AND CHARACTERIZE SOCIAL NETWORKS AND IDENTIFY, NOTIFY, TEST AND LINK TO CARE PARTNERS OF THOSE NEWLY DIAGNOSED. ANALYSIS OF MOLECULAR HIV CLUSTERS BY GENETIC DISTANCE-BASED METHODS IS NOW RECOMMENDED IN THE US TO DETECT OUTBREAKS AS PART OF ENDING THE HIV EPIDEMIC. HOWEVER, THE ADDED VALUE OF PHYLOGENETIC (BEYOND DISTANCE-BASED) CLUSTER ANALYSES AND HOW THEY MAY FOCUS AND BENEFIT ROUTINE (BEYOND OUTBREAKS) PUBLIC HEALTH ACTIVITIES TO REDUCE TRANSMISSION IS AN EXISTING KNOWLEDGE GAP. IN THE PRIOR CYCLE WE STARTED TO ADDRESS THIS GAP, ESTABLISHED A STRONG ACADEMIC-GOVERNMENTAL PARTNERSHIP IN RHODE ISLAND, DEVELOPED A BIOINFORMATICS PIPELINE TO SHARE AND ANALYZE STATEWIDE DATA, AND FOR THE FIRST-TIME ROUTINELY AND IN NEAR-REAL-TIME CONDUCTED CLUSTER ANALYSES, IDENTIFIED RECENT HIV DIAGNOSES WHO WERE PART OF MOLECULAR CLUSTERS, AND ATTEMPTED TO RE-INTERVIEW ALL OF THEM, TO INCREASE THEIR MOTIVATION AND ENHANCE CONTACT TRACING. THE IMPORTANT FINDING THAT DESPITE BETTER CLUSTER DETECTION A RE-INTERVIEW WAS NOT BENEFICIAL, TOGETHER WITH OUR ACHIEVEMENTS IN THE PRIOR CYCLE, INFORMED AND REFOCUSED THIS RENEWAL, GUIDING ITS RESTRUCTURED SCOPE. IN THIS RENEWAL, LEVERAGING THE PARTNERSHIP WE ESTABLISHED AND OUR GAINED EXPERIENCE, WE PROPOSE TO REDESIGN OUR BIOINFORMATICS PIPELINE TO ROUTINELY AND IN NEAR-REAL-TIME CONDUCT CLUSTER ANALYSES AND INTEGRATE MOLECULAR DATA WITH TYPICALLY SILOED CLINICAL AND PUBLIC HEALTH DATA, USE THEM TO PRIORITIZE ALL INDIVIDUALS AND CLUSTERS WITH NEW SEQUENCES, USE THIS PRIORITIZATION TO INFORM TAILORED AND INTENSIVE PUBLIC HEALTH INTERVENTIONS, AND EVALUATE THE IMPACT OF THESE PROCESSES, WHILE IMPROVING REPRESENTATION AND PHYLOGENETIC INFERENCE OF THE LOCAL AND REGIONAL EPIDEMIC. WE HYPOTHESIZE THAT THESE INNOVATIVE APPROACHES WILL FOCUS RESTRICTED PUBLIC HEALTH EFFORTS AND MORE EFFICIENTLY IDENTIFY AND LINK TO CARE PERSONS UNAWARE OF THEIR HIV STATUS, PERSONS AWARE BUT NOT LINKED TO CARE, OR PERSONS AT HIGH RISK OF GETTING INFECTED. THE SPECIFIC AIMS TO ADDRESS THIS HYPOTHESIS ARE TO: (1) REDESIGN THE PIPELINE AND CONDUCT NEAR-REAL-TIME CLUSTER ANALYSES IN AND BEYOND RHODE ISLAND; (2) LEVERAGE THE REDESIGNED PIPELINE TO EVALUATE THE ADDED VALUE OF ROUTINE, NEAR-REAL-TIME INTEGRATION OF CLUSTER ANALYSES PRIORITIZING PUBLIC HEALTH INTERVENTIONS; AND (3) AUGMENT PHYLOGENETIC INFERENCE BY INCREASED SEQUENCE AVAILABILITY AND MORE COMPREHENSIVE ANALYSES. OUR APPROACH IS STRENGTHENED BY A MULTIDISCIPLINARY EXPERIENCED TEAM OF PUBLIC HEALTH OFFICIALS, ETHICISTS, CLINICIANS, STATISTICIANS, BIOINFORMATICIANS, BEHAVIORAL SCIENTISTS, EVOLUTIONARY AND MOLECULAR BIOLOGISTS, WITH INFRASTRUCTURE AND EXPERTISE DEVELOPED IN THE PRIOR CYCLE. THIS RENEWAL, BUILT ON A STRONG ETHICS PLATFORM, WILL HAVE HIGH IMPACT ON THE CARE CONTINUUM; BRING RHODE ISLAND CLOSER TO ZERO NEW HIV INFECTIONS; AND SERVE AS A MODEL FOR LARGER JURISDICTIONS, AS WE AIM TO END THE HIV EPIDEMIC IN RHODE ISLAND AND BEYOND.
Department of Health and Human Services
$1.4M
AN APPLICATION OF SMART METHODOLOGY TO OPTIMIZE AN INTERVENTION TO MAINTAIN IMPROVEMENTS IN HEALTH BEHAVIORS IN UNDER-RESOURCED PATIENTS AFTER PHASE II CARDIAC REHABILITATION - PROJECT SUMMARY/ABSTRACT CARDIOVASCULAR DISEASE (CVD) IS THE LEADING CAUSE OF DEATH IN THE UNITED STATES. CARDIAC REHABILITATION (CR) IS AN EVIDENCE-BASED, COST-EFFECTIVE, AND WIDELY AVAILABLE MULTIDISCIPLINARY PROGRAM THAT COMBINES SUPERVISED EXERCISE WITH PSYCHOEDUCATION ON HEALTH BEHAVIOR CHANGE AIMED AT IMPROVING OVERALL HEALTH AND REDUCING CARDIOVASCULAR RISK IN INDIVIDUALS WITH ESTABLISHED CVD. HOWEVER, UNDER-RESOURCED AND UNDERSERVED CVD PATIENTS (E.G., WOMEN, RACIAL AND ETHNIC MINORITIES, LOW SOCIOECONOMIC STATUS, DISABLED) ARE LESS LIKELY TO MAINTAIN THEIR ADHERENCE TO KEY CARDIOPROTECTIVE BEHAVIORS (WEIGHT MANAGEMENT, PHYSICAL ACTIVITY [PA], AND MEDICATION ADHERENCE) AFTER CR AND ARE UNDER-REPRESENTED IN POST-CR RESEARCH; THESE FACTORS COMBINED INCREASE THE HEALTH DISPARITIES IN CVD CARE THAT THESE SUB-POPULATIONS EXPERIENCE, ESPECIALLY SINCE MANY CANNOT COMPLETE SELF-PAY PHASE III MAINTENANCE PROGRAMS. IN THE PI’S PREVIOUS WORK, UNDER-RESOURCED AND UNDER-REPRESENTED PATIENTS INDICATED THAT THEY WANT TECHNOLOGY-BASED MAINTENANCE SUPPORT INTERVENTIONS THAT UTILIZE TECHNOLOGY THEY ALREADY OWN, ARE MINIMAL BURDEN, OFFER A FLEXIBLE SCHEDULE, OFFER MORE SUPPORT FOR PATIENT NEEDS WITHOUT OVERWHELMING THEM WITH PROGRAM REQUIREMENTS BEFORE DEMONSTRATING THAT A LOWER LEVEL OF SUPPORT WAS INSUFFICIENT, AND PRODUCE DESIRED RESULTS. PATIENTS FELT RESISTANT TO INITIATING A DEMANDING, TIME- INTENSIVE, OR IN-PERSON MAINTENANCE INTERVENTION IMMEDIATELY FOLLOWING CR. THE PRESENT APPLICATION UTILIZES A SEQUENTIAL, MULTIPLE ASSIGNMENT, RANDOMIZED TRIAL (SMART) DESIGN TO CREATE A STEPPED CARE MODEL THAT ADAPTS TO PATIENT NEEDS AND MINIMIZES PATIENT BURDEN. PARTICIPANTS (N=400) WILL BE RANDOMIZED TO RECEIVE EITHER A LOW-INTENSITY TEXT MESSAGING INTERVENTION OR AN AUTOMATED ONLINE PROGRAM FOR 2 MONTHS AND DETERMINE WHICH PRODUCES SUPERIOR ADHERENCE (AIM 1). FOLLOWING CLASSIFICATION AS INTERVENTION RESPONDERS OR NON- RESPONDERS, RESPONDERS WILL CONTINUE RECEIVING THEIR INITIAL LOW-INTENSITY INTERVENTION. WE WILL THEN DETERMINE WHETHER LOW- OR HIGH-INTENSITY HOME-BASED CR (WITH OR WITHOUT CASE MANAGEMENT) FOR 3 MONTHS PRODUCES BETTER BEHAVIORAL ADHERENCE FOLLOWING FAILURE OF A LOW-INTENSITY INTERVENTION FAILURE (AIM 2). WE WILL THEN FINALIZE THE IDEAL ADAPTIVE INTERVENTION BASED ON AIMS 1 AND 2 RESULTS AND MODERATOR ANALYSES (AIM 3). PATIENTS WILL COMPLETE POST-INTERVENTION ASSESSMENTS AT 6 MONTHS AND EXPLORATORY OUTCOMES ASSESSMENT (DEATH, REHOSPITALIZATION, QUALITY OF LIFE). THIS RESEARCH WILL RESULT IN A STEPPED CARE MODEL FOR UNDER-RESOURCED PATIENTS’ BEHAVIORAL ADHERENCE MAINTENANCE FOLLOWING CR. THIS PROJECT ADVANCES THE SCIENCE OF CVD TREATMENT AND POST-CR CARE, AND IT WILL DIRECTLY IMPACT CVD PATIENT OUTCOMES BY EXTENDING THE BENEFITS OF EVIDENCE-BASED, EFFECTIVE CARE AS WELL AS TARGET HEALTH DISPARITIES AMONG LESS-RESOURCED CVD PATIENTS.
Department of Health and Human Services
$1.4M
LINKING BIOPHYSICAL FUNCTIONS OF MICROBICIDES TO USER PERCEPTION & ACCEPTABILITY
Department of Health and Human Services
$1.3M
HIV DRUG RESISTANCE IN THE NEW ANTIRETROVIRAL THERAPY ERA IN KENYA - HIV DRUG RESISTANCE IN THE NEW ART ERA IN KENYA RAMI KANTOR, MD SUMMARY SINCE THE EMERGENCE OF RESISTANCE TO ZIDOVUDINE IN THE LATE 1980’S, WE HAVE BEEN IN A RACE: AN HIV DRUG IS DEVELOPED AND USED, FOLLOWED BY THE INEVITABLE EMERGENCE OF VIRAL RESISTANCE TO IT, ANOTHER DRUG IS DEVELOPED AND USED, AND SO ON. THIS LARGELY RESISTANCE-DRIVEN PROCESS HAS INFORMED ANTIRETROVIRAL DRUG DEVELOPMENT SINCE ITS INCEPTION. HOWEVER, TREATMENT MONITORING, INCLUDING DRUG RESISTANCE TESTING AND AT TIMES VIRAL LOAD TESTING, ARE LIMITED IN RESOURCE LIMITED SETTINGS, WHERE HIV BURDEN IS GREATEST, CREATING THE GLOBAL PARADOX: WE TEST FOR AND KNOW LESS ABOUT HIV DRUG RESISTANCE IN LOCATIONS WHERE OUR UNDERSTANDING OF IT IS MOST CRUCIAL. SUCH SETTINGS MAY BE MORE PRONE FOR RESISTANCE DUE TO RESTRICTED MONITORING IN CLINICAL CARE, HIGHER TREATMENT FAILURE THRESHOLDS, LIMITED AVAILABILITY OF ADVANCED MEDICATIONS AND FORMULATIONS, CIRCULATING DIVERSE HIV-1 SUBTYPES, AND SPECIAL CIRCUMSTANCES LIKE HIV-TB COINFECTION. SUCH SITUATIONS MIGHT FURTHER ENHANCE THE RISK TO DEVELOP RESISTANCE AND EXACERBATE THE COMPLEXITY OF ADDRESSING IT. THIS PARADOX IS EVEN GREATER NOW THAT WE ARE IN THE NEW GLOBAL ANTIRETROVIRAL THERAPY (ART) ERA. REMARKABLE PROGRESS IN ANTIRETROVIRALS LIKE DOLUTEGRAVIR (DTG), WITH ENHANCED EFFICACY, REDUCED TOXICITY, HIGH BARRIER TO RESISTANCE, AND IMPORTANTLY, GLOBAL ACCESSIBILITY, ALL INSTILL A PROFOUND CONFIDENCE, SUGGESTING THAT WE MAY HAVE ACHIEVED A PIVOTAL MILESTONE IN THE ONGOING RACE AGAINST HIV. HOWEVER, THE WIDESPREAD UTILIZATION OF DTG IN ALL LINES OF ART, ESPECIALLY IN SETTINGS WITH IMPERFECT MONITORING AND LIMITED MEDICATION AVAILABILITY, RAISES CONCERNS ABOUT CONTINUING THE DRUG RESISTANCE RACE. EMERGING DATA CONFIRM THESE CONCERNS AND HIGHLIGHT RESEARCH GAPS RELATED TO RESISTANCE DEVELOPMENT TO CURRENT ERA DRUGS AND THEIR MAGNITUDE AND CONSEQUENCES. THIS PROPOSAL IS DESIGNED TO ADDRESS THESE GAPS. LEVERAGING OUR LONG-STANDING NORTH- SOUTH COLLABORATION, WE PROPOSE TO COMPREHENSIVELY AND PROSPECTIVELY INVESTIGATE THE EXTENT AND IMPACT OF TRANSMITTED AND ACQUIRED RESISTANCE IN A LARGE HIV CARE PROGRAM IN KENYA, ONE OF THE EARLIER COUNTRIES TO ENTER THE NEW ART ERA IN 2017. WE HYPOTHESIZE THAT THE SCALE-UP OF DTG-BASED REGIMENS ACROSS ALL LINES OF TREATMENT IN RESOURCE LIMITED SETTINGS IS LEADING TO A GRADUAL ESCALATION OF DRUG RESISTANCE OVER TIME, IMPACTING CARE. TO ADDRESS THIS HYPOTHESIS, WE WILL ENROLL AND PROSPECTIVELY FOLLOW 1,840 KENYAN PERSONS WITH HIV ACROSS THE HIV, ART AND RESISTANCE TIMELINES. WE WILL CHARACTERIZE TRANSMITTED RESISTANCE (AIM 1) AND INVESTIGATE ACQUIRED RESISTANCE (AIM 2) OF 1ST-LINE DTG-BASED ART (AIM 2A), 2ND-LINE ART (AIM 2B), BEYOND 2ND-LINE ART (AIM 2C), AND SPECIAL POPULATIONS (AIM 3). OUR UNDERSTANDING OF RESISTANCE DEVELOPMENT IN THE NEW ART ERA IS LIMITED, YET CRUCIAL TO ENSURE ITS SUSTAINABLE SUCCESS. THIS TIMELY PROPOSAL WILL GENERATE HYPOTHESIS-DRIVEN DATA TO ADDRESS EXISTING GAPS AND INFORM PATIENT CARE TOWARDS ENDING THE HIV EPIDEMIC. WE EXPECT TO HAVE A HIGH AND DIRECT IMPACT ON GUIDING FUTURE ART STRATEGIES TO MINIMIZE RESISTANCE. THE NEW ART ERA HAS BEEN ROLLED OUT FOR ~5 YEARS, PROVIDING A UNIQUE OPPORTUNITY TO CONDUCT THIS RESEARCH. THE RIGHT TIME TO COMPREHENSIVELY INVESTIGATE RESISTANCE IN THE NEW ART ERA IS NOW, TO ENSURE THAT WE DON’T LOSE THE RACE, IN KENYA AND BEYOND.
Department of Health and Human Services
$1.3M
HIV DRUG RESISTANCE, MONITORING AND TRANSMISSION
Department of Health and Human Services
$1.3M
ECOLOGICAL MOMENTARY ASSESSMENT OF BEHAVIORAL AND PSYCHOSOCIAL PREDICTORS OF WEIGHT LOSS FOLLOWING BARIATRIC SURGERY
Department of Health and Human Services
$1.2M
SUSTAINING CESSATION IN SMOKERS WITH KIDS WITH ASTHMA
Department of Health and Human Services
$1.2M
THE ROLE OF NPR-C IN MODULATION OF ACUTE LUNG INJURY
Department of Health and Human Services
$1.2M
MECHANISMS OF MINDFULNESS TRAINING TO REDUCE MATERNAL AND INFANT CARDIOVASCULAR DISEASE RISK - ABSTRACT HYPERTENSIVE DISORDERS OF PREGNANCY ARE THE MOST COMMON MEDICAL CONDITION AFFECTING PREGNANCY AND A LEADING CAUSE OF MATERNAL MORBIDITY AND MORTALITY IN THE UNITES STATES. FIFTY PERCENT OF WOMEN WITH PRENATAL HYPERTENSIVE DISORDERS WILL CONTINUE TO EXPERIENCE HYPERTENSION IN THE POSTPARTUM PERIOD. MORE THAN HALF OF ALL PREGNANCY-RELATED DEATHS OCCUR IN THE POSTPARTUM PERIOD, AND OVER 30% OF MATERNAL DEATHS ARE COMPLICATED BY HYPERTENSIVE DISORDERS. CONSEQUENCES OF HYPERTENSIVE DISORDERS EXTEND WELL PAST THE PERINATAL PERIOD; WOMEN WITH PRENATAL HYPERTENSIVE DISORDERS ARE TWICE AS LIKELY TO DEVELOP HEART DISEASE IN THEIR LIFETIME, AND OFFSPRING EXPOSED TO HYPERTENSIVE DISORDERS IN UTERO FACE SIGNIFICANT LIFETIME CARDIOVASCULAR DISEASE RISK. THEREFORE, PREVENTION OF PRENATAL HYPERTENSIVE DISORDERS IS CRITICAL TO REDUCING RISK FOR POSTPARTUM OBSTETRIC COMPLICATIONS AND LIFELONG CARDIOVASCULAR DISEASE. MINDFULNESS-BASED INTERVENTIONS HOLD SIGNIFICANT PROMISE AS A NON- PHARMACOLOGICAL INTERVENTION TO PREVENT THESE DISORDERS AS MINDFULNESS-BASED INTERVENTIONS REDUCE BLOOD PRESSURE IN ADULTS WITH HYPERTENSION AND PREHYPERTENSION, AND RESULTS FROM OUR PILOT RCT INDICATING THAT PRENATAL MINDFULNESS TRAINING WAS ASSOCIATED WITH REDUCED BLOOD PRESSURE AND RISK FOR HYPERTENSIVE DISORDERS IN AT-RISK WOMEN. NOW, OUR TEAM IS CONDUCTING A 5-YEAR RCT INVESTIGATING THE DAILY MECHANISMS OF PRENATAL MINDFULNESS TRAINING ON PRENATAL MARKERS OF CARDIOVASCULAR RISK (R01HL157288). TO DATE, WE HAVE RECRUITED A RACIALLY AND ETHNICALLY DIVERSE SAMPLE OF WOMEN AT RISK FOR HYPERTENSIVE DISORDERS OF PREGNANCY, WITH >90% PARTICIPANT RETENTION, AND 89% OF PARTICIPANTS WHO COMPLETED THE PARENT STUDY REPORTED INTEREST IN PARTICIPATING IN THE PROPOSED ANCILLARY STUDY. HOWEVER, THE MOST SEVERE AND FATAL CARDIOVASCULAR COMPLICATIONS OCCUR IN THE POSTPARTUM PERIOD, AND IT IS NOT YET KNOWN WHETHER THE CARDIOVASCULAR BENEFITS OF PRENATAL MINDFULNESS TRAINING EXTEND INTO THE POSTPARTUM PERIOD. THUS, IN RESPONSE TO THE NOTICE OF SPECIAL INTEREST (NOSI): “HEART, LUNG, BLOOD AND SLEEP FOCUSED ANCILLARY STUDIES TO ONGOING CLINICAL STUDIES,” WE PROPOSE TO TEST THE LONG-TERM EFFECTS OF PRENATAL MINDFULNESS TRAINING ON POSTPARTUM MECHANISMS OF RISK FOR MATERNAL AND INFANT CARDIOVASCULAR DISEASE. THE PROPOSED ANCILLARY STUDY WILL FOLLOW N=130 PARTICIPANTS AND INFANTS THAT ARE ENROLLED IN THE PARENT RCT ACROSS THE FIRST POSTPARTUM YEAR. AT 4-, 6-, AND 12-MONTHS POSTPARTUM, WE WILL MEASURE EFFECTS OF PRENATAL MINDFULNESS TRAINING ON: 1) POSTPARTUM MATERNAL CARDIOVASCULAR DISEASE BIOMARKERS, 2) POSTPARTUM PHYSIOLOGICAL AND PSYCHOLOGICAL RESPONSES TO ECOLOGICALLY VALID DAILY EXPERIENCES, AND 3) INFANT GROWTH TRAJECTORIES THAT CONFER RISK FOR LIFETIME CVD. RESULTS WILL HAVE A SIGNIFICANT IMPACT ON THE FIELD BY IDENTIFYING MODIFIABLE MECHANISMS IN THE PRE AND POSTNATAL PERIODS TO REDUCE RATES OF HYPERTENSIVE DISORDERS AND DECREASE LIFELONG BURDEN OF CVD IN WOMEN AND THEIR OFFSPRING. CONSISTENT WITH NHLBI’S OBJECTIVES, RESULTS FROM THIS STUDY WILL HELP TO DEVELOP AND OPTIMIZE NOVEL THERAPEUTIC STRATEGIES TO PREVENT HEART, LUNG, AND BLOOD DISEASES IN WOMEN AND INFANTS.
Department of Health and Human Services
$1.2M
COMPARISON OF BEHAVIORALLY-BASED REMOTE APPROACHES TO OPTIMIZE WEIGHT LOSS AND IDENTIFICATION OF FACTORS WHICH CHARACTERIZE TREATMENT RESPONSE - PROJECT SUMMARY IN-PERSON BEHAVIORAL WEIGHT LOSS (WL) PROGRAMS ARE THE GOLD STANDARD OF OBESITY TREATMENT, BUT REMOTE-BASED INTERVENTIONS ARE BECOMING INCREASINGLY UTILIZED AS THEY OVERCOME BARRIERS COMMON TO IN-PERSON PROGRAMS (E.G., GEOGRAPHICAL, TIME, AND TRAVEL CONSTRAINTS) AND REPRESENT A MORE TRANSLATABLE INTERVENTION MODEL. YET, REMOTE WL INTERVENTIONS CAN VARY SUBSTANTIALLY, AND QUESTIONS REMAIN REGARDING WHICH TYPE IS MOST EFFECTIVE AND WHETHER THERE ARE CERTAIN GROUPS OF INDIVIDUALS WHO RESPOND BEST TO ONE TYPE OVER ANOTHER. FOR EXAMPLE, OUR FULLY AUTOMATED, ONLINE PROGRAM PRODUCES A 4.5% WL ON AVERAGE AND ABOUT HALF OF PARTICIPANTS ACHIEVE A WL ≥5%. WHILE THIS LOW-TOUCH INTERVENTION IS EFFECTIVE FOR MANY, OTHERS HAVE LIMITED SUCCESS AND MAY BENEFIT FROM A DIFFERENT TYPE OF REMOTE INTERVENTION (E.G., GROUP-BASED VIDEOCONFERENCE PROGRAM, RESEMBLING IN-PERSON TREATMENT) OR MORE INDIVIDUAL SUPPORT (E.G., VIA COACHING). THIS TRIAL UTILIZES A 2X2 FACTORIAL DESIGN TO COMPARE TWO REMOTE-DELIVERY FORMATS (AUTOMATED ONLINE PROGRAM VS. GROUP-BASED VIDEOCONFERENCE PROGRAM) AND THE ADDED EFFECT OF COACHING (VS. NO COACHING) ON 12-MONTH WL. DIRECT COMPARISONS OF THESE APPROACHES HAVE BEEN LIMITED. FROM A PERSONALIZED MEDICINE PERSPECTIVE, IT IS ALSO IMPORTANT TO UNDERSTAND FOR WHOM EACH REMOTE APPROACH SHOULD BE RECOMMENDED. THUS, AN ADDITIONAL AIM IS TO DEVELOP TWO ALGORITHMS WHICH COULD BE USED TO REFER PATIENTS INTO REMOTE WL PROGRAMS. THE ‘WIDELY-APPLICABLE’ ALGORITHM WILL USE METRICS COMMON TO ELECTRONIC MEDICAL RECORDS (SEX, BMI, AGE, RACE, ETHNICITY), AND THE ‘MORE COMPREHENSIVE’ ALGORITHM WILL FURTHER INCLUDE ADDITIONAL BASELINE CHARACTERISTICS (E.G., EDUCATION, HOUSEHOLD INCOME, HEALTH LITERACY, GROUP PREFERENCE, ETC). PARTICIPANTS WILL BE RANDOMIZED AT BASELINE (OUT OF 4 POSSIBLE COMBINATIONS) AND RECEIVE A 12- MONTH, REMOTE-BASED BEHAVIORAL WL PROGRAM. ALL PROGRAMS INCLUDE DAILY SELF-MONITORING OF DIET, EXERCISE, AND WEIGHT AND THE PROVISION OF AUTOMATED FEEDBACK. THOSE RECEIVING THE ONLINE PROGRAM WILL ALSO BE INSTRUCTED TO VIEW VIDEO LESSONS (24 IN TOTAL, 10-15 MIN EACH) WHICH FOCUS ON BEHAVIORAL STRATEGIES FOR CHANGING DIET AND EXERCISE. INDIVIDUALS RANDOMIZED TO THE VIDEOCONFERENCE PROGRAM WILL PARTICIPATE IN 24 GROUP SESSIONS (1 HOUR EACH) DESIGNED TO MIMIC IN-PERSON TREATMENT AND ALLOW FOR PARTICIPANT INTERACTION VIA LARGE AND SMALL GROUP DISCUSSIONS. COACHING CALLS (10-15 MIN EACH) WILL BE MONTHLY AND FOCUS ON INDIVIDUAL BARRIERS, PROBLEM SOLVING, GOAL SETTING, AND FOSTERING SUPPORT AND ACCOUNTABILITY. ASSESSMENTS WILL OCCUR AT BASELINE, 6 (MID-TREATMENT), 12 (POST-TREATMENT), AND 18 MONTHS (FOLLOWING 6 MONTHS OF NO INTERVENTION). SECONDARY AIMS WILL EXAMINE THE EFFECTS OF DELIVERY FORMAT AND COACHING ON INTERVENTION ENGAGEMENT (E.G., FREQUENCY OF SELF-MONITORING), PSYCHOSOCIAL OUTCOMES (E.G., PERCEIVED SUPPORT, SELF-EFFICACY, AND MOTIVATION), 18-MONTH WL, AND THE COST PER KILOGRAM OF WL (TO EXAMINE WHETHER THE ADDITION OF HUMAN SUPPORT IS COST-EFFECTIVE). STUDY FINDINGS HAVE THE POTENTIAL TO INFORM PATIENT REFERRALS AND INSURANCE COVERAGE DECISIONS FOR REMOTE WL TREATMENT.
Department of Health and Human Services
$1.2M
TRANSDISCIPLINARY CANCER CONTROL RESEARCH TRAINING GRANT
Department of Health and Human Services
$1.2M
A MULTIDISCIPLINARY APPROACH TO INTEGRATE HIV PREVENTION SERVICES INTO CLINICAL CARE SETTINGS FOR PEOPLE WITH OPIOID USE DISORDER - PROJECT SUMMARY OPIOID USE CONTINUES TO BE A PUBLIC HEALTH CRISIS IN THE UNITED STATES (US). AN ESTIMATED 2.7 MILLION PEOPLE HAD OPIOID USE DISORDER (OUD) WITH OVER 107,000 OVERDOSE DEATHS IN 2022 IN THE US. OUD IS ALSO A MAJOR RISK FACTOR FOR HIV INFECTION DUE TO INJECTION AND HIGH-RISK SEXUAL BEHAVIORS. DESPITE THE HIGHER RISK OF HIV, OUD PATIENTS HAVE HAD VERY LIMITED ENGAGEMENT WITH HIV PREVENTION SERVICES, INCLUDING HIV SCREENING, HIV PRE- EXPOSURE PROPHYLAXIS (PREP), AND MEDICATION FOR OUD (MOUD) SERVICES, WHICH ARE HIGHLY EFFECTIVE IN PREVENTING HIV INFECTION. NOVEL APPROACHES ARE NEEDED TO EXPLORE HOW TO ENGAGE PEOPLE WITH OUD IN HIV PREVENTION SERVICES WITH THE LONG-TERM GOAL OF REDUCING HIV INCIDENCE. THE INTEGRATION OF HIV PREVENTION SERVICES INTO CARE SETTING (E.G. EMERGENCY DEPARTMENTS, PRIMARY CARE, MENTAL HEALTH CLINICS, AND SUBSTANCE TREATMENT CENTERS) WHERE PEOPLE WITH OUD ALREADY SEEK CARE IS PROMISING. AS THE INTEGRATION OF HIV PREVENTION SERVICES INTO CARE SETTINGS IS COMPLICATED DUE TO THE INDIVIDUAL-, SOCIAL- AND STRUCTURAL-LEVEL BARRIERS, WE WILL USE INNOVATION AND MULTIDISCIPLINARY APPROACHES TO ACHIEVE THIS GOAL. IN THIS PROPOSAL, WE WILL CONDUCT A SYSTEMATIC ASSESSMENT OF HEALTHCARE UTILIZATION IN GENERAL, HIV PREVENTION SERVICES, AND MOUD USING THE ALL PAYERS CLAIMS DATABASE (APCD) AND STATE EMERGENCY DEPARTMENT DATABASE (SEDD) (SPECIFIC AIM (SA) 1), USE THE EVIDENCE-BASED QUALITY IMPROVEMENT (EBQI) - A COLLABORATIVE STAKEHOLDER-GUIDED INTERVENTION/STRATEGY DEVELOPMENT PROCESS TO DETERMINE THE OPTIMAL CARE SETTING AND IDENTIFY IMPLEMENTATION STRATEGIES OF INTEGRATING HIV PREVENTION SERVICES AND MOUD (SA 2), AND THEN TEST THEIR EFFECTS ON REDUCING HIV INCIDENCE AT THE POPULATION LEVEL USING AGENT-BASED MODELING (SA3). THIS INNOVATIVE STUDY WILL IDENTIFY CARE SETTINGS TO MAXIMUM HIV PREVENTION EFFORTS, TEST MULTIPLE PROMISING IMPLEMENTATION STRATEGIES, AND IDENTIFY THE MOST EFFECTIVE IMPLEMENTATION STRATEGY, WHICH IS READY FOR REAL-WORLD IMPLEMENTATION.
Department of Health and Human Services
$1.2M
USING A YMCA EXERCISE PROGRAM TO ENHANCE NICOTINE DEPENDENCE TREATMENT FOR WOMEN
Department of Health and Human Services
$1.2M
PREVENTION OF WEIGHT GAIN IN YOUNG ADULTS
Department of Health and Human Services
$1.1M
PRENATAL SMOKING, FETAL BEHAVIOR, AND INFANT WITHDRAWAL
Department of Defense
$1.1M
ENGINEERED NEUTROPHILS FOR INTRATUMORAL DELIVERY AND TARGETING
Department of Health and Human Services
$1M
ADDRESSING BODY IMAGE IN WEIGHT MANAGEMENT: AN OVERLOOKED RISK FACTOR FOR POOR TREATMENT OUTCOME AMONG WOMEN
Department of Health and Human Services
$999.5K
DEVELOPMENT OF A VALUES-AFFIRMATION INTERVENTION TARGETING MEDICATION ADHERENCE IN OLDER ADULTS WITH HEART FAILURE COMPLETING CARDIAC REHABILITATION
Department of Health and Human Services
$998K
COMMUNITY-BASED SUBSTANCE USE TREATMENT AND HIV PREVENTION FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN - THE PURPOSE OF OUR PROPOSED PROJECT, "COMMUNITY-AND CLINIC-BASED SUBSTANCE USE TREATMENT AND HIV PREVENTION FOR AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN" IS TO INCREASE STATUS NEUTRAL ACCESS TO AND ENGAGEMENT IN CARE FOR RACIAL AND ETHNIC MEDICALLY UNDERSERVED INDIVIDUALS AT RISK FOR OR LIVING WITH SYNDEMIC CONDITIONS INCLUDING SUBSTANCE USE, MENTAL ILLNESS, HIV, VIRAL HEPATITIS, AND MINORITY STRESS. WITH NEARLY 1.1 MILLION RESIDENTS, RHODE ISLAND HAS ONE OF THE HIGHEST PERCENTAGES OF LGBTQ+ RESIDENTS OF ANY STATE IN THE COUNTRY AND THE MAJORITY RESIDE IN PROVIDENCE, THE CAPITAL CITY. PROVIDENCE IS THE EPICENTER OF SUBSTANCE USE IN RHODE ISLAND AND HAS AMONG THE HIGHEST RATES OF ILLICIT DRUG USE IN THE UNITED STATES. DISPARITIES EXIST BETWEEN THE GENERAL POPULATION AND THE LGBTQ+ COMMUNITY WITH HIGHER RATES AND SEVERITY OF SUBSTANCE USE DISORDERS (SUDS) AND CO-OCCURRING MENTAL HEALTH DISORDERS (CODS) AND LOWER RATES OF ACCESS TO- AND ENGAGEMENT IN- SUBSTANCE USE TREATMENT AMONG RACIAL AND ETHNIC MINORITIES WITH INTERSECTIONAL LGBTQ+ IDENTITIES.DESPITE THE LARGE PERCENTAGE OF UNDERSERVED INDIVIDUALS AND THE KNOWLEDGE OF THESE DISPARITIES, RHODE ISLAND DOES NOT HAVE A DEDICATED TREATMENT PROGRAM THAT ADDRESSES THE IMPORTANT AND UNIQUE NEEDS OF RACIAL AND ETHNIC MEDICALLY UNDERSERVED INDIVIDUALS WITH INTERSECTIONAL LGBTQ+ IDENTITIES WHO SUFFER DISPROPORTIONATE RATES OF SYNDEMIC SUBSTANCE USE, CO-OCCURRING MENTAL HEALTH, MEDICAL, AND SOCIAL CONCERNS. . OUR PROPOSED COMMUNITY- AND CLINIC-BASED PROJECT WILL AIM TO ADDRESS THESE UNMET NEEDS BY PROVIDING AFFIRMING, EVIDENCE-BASED, STATUS NEUTRAL, AND INCLUSIVE OUTREACH AND TREATMENT FOR SUD AND CODS FOR 225 INDIVIDUALS FROM THIS UNDERSERVED COMMUNITY IN RHODE ISLAND. ALIGNED WITH OUR PURPOSE, THE GOALS FOR OUR PROJECT INCLUDE: 1) INCREASING ACCESS TO AND ENGAGEMENT IN CULTURALLY CONGRUENT SUD CARE, 2) DECREASING SUBSTANCE USE AND MENTAL HEALTH SYMPTOMS AMONG CLIENTS WHO ENGAGE IN AND COMPLETE OUR PROJECT SERVICES, 3) INCREASING KNOWLEDGE OF MEDICAL STATUSES OF HIV, VIRAL HEPATITIS, AND STDS, 4) DECREASING HIV INFECTIONS, AND 5) PROMOTING PERSONAL AND ORGANIZATIONAL HEALTH LITERACY TO PREVENT THE PERPETUATION OF MINORITY STRESS, STIGMA, AND DISCRIMINATION WHICH CONTRIBUTE TO SUDS AND CODS. OUR PROGRAM GOALS AND DESIGN ARE DERIVED FROM OUR PROCESS OF CENTERING THE VOICES OF THOSE WITH LIVED EXPERIENCES. WE PLAN TO USE A STATUS NEUTRAL APPROACH BY BRAIDING TOGETHER EXISTING RESOURCES WITH THE NEW PROGRAM SERVICES ACROSS SITES TO DECREASE DISPARITIES IN HEALTH AND ATTEND TO "WHOLE PERSON" HEALTH CARE. TO MEET THE NEEDS OF OUR COMMUNITY AND ACCOMPLISH OUR GOALS, THE OBJECTIVES OF OUR PROJECT INCLUDE:) SCREENING AT LEAST 800 RACIAL AND ETHNIC MEDICALLY UNDERSERVED INDIVIDUALS WITH INTERSECTIONAL LGBTQ+ IDENTITIES IN COMMUNITY AND CLINIC SETTINGS; 2) PROVIDING COLLABORATIVE, CULTURALLY CONGRUENT, STATUS NEUTRAL MULTIDISCIPLINARY CARE TO 225 INDIVIDUALS TO ADDRESS THE SYNDEMIC OF SUD, CODS, MEDICAL CONCERNS, AND SOCIAL DETERMINANTS OF HEALTH NEEDS, 3) TESTING FOR HIV, VIRAL HEPATITIS, AND STDS IN THE COMMUNITY AND CLINICS, 4) PROVIDING EDUCATION ABOUT UNDETECTABLE = UNTRANSMISSIBLE AND SUPPORT FOR ADHERENCE AND PREP CARE, AND 5) COLLABORATIVELY CREATING AND ENGAGING IN A DYNAMIC EDUCATIONAL CURRICULUM TO SUPPORT DIVERSITY, EQUITY, INCLUSION, BELONGING, AND ANTI-RACISM ACROSS THE THREE PROGRAM SITES.IN SUMMARY, THE PROJECT WILL PROVIDE CRITICAL SERVICES FOR THE SCREENING AND TREATMENT OF SUBSTANCE USE AND OTHER CO-OCCURRING DISORDERS AMONG RACIAL AND ETHNIC UNDERSERVED INDIVIDUALS WITH INTERSECTIONAL LGBTQ+ IDENTITIES IN THE STATE OF RHODE ISLAND WHICH HAS AMONG THE HIGHEST RATES OF ILLICIT DRUG USE IN THE COUNTRY.
Department of Health and Human Services
$993.7K
DEVELOPING A BEHAVIORAL WEIGHT LOSS INTERVENTION FOR EMERGING ADULTS IMPLEMENTED WITHIN COLLEGE HEALTH SERVICE CENTERS - PROJECT SUMMARY/ABSTRACT FORTY PERCENT OF EMERGING ADULTS (AGE 18-25) HAVE OVERWEIGHT OR OBESITY, WHICH IS UNLIKELY TO REMIT AND HAS SIGNIFICANT HEALTH CONSEQUENCES. HOWEVER, EMERGING ADULTS ARE UNDERREPRESENTED IN TRADITIONAL WEIGHT LOSS PROGRAMS, DROP-OUT AT HIGH RATES, AND HAVE BLUNTED WEIGHT LOSS OUTCOMES. ONE POTENTIAL WAY TO IMPROVE PARTICIPATION IS TO OFFER BWLIS IN COLLEGE HEALTH SERVICE CENTERS TO REDUCE BARRIERS TO PARTICIPATION. APPROXIMATELY 40% OF EMERGING ADULTS ARE ENROLLED IN A POSTSECONDARY INSTITUTION AND COLLEGE HEALTH CENTERS ARE USED WIDELY BY STUDENTS. MOREOVER, DELIVERING AN INTERVENTION WITH DESIGN FEATURES THAT ARE RESPONSIVE TO EMERGING ADULT PREFERENCES AND LIFESTYLES MAY ALSO IMPROVE INTERVENTION EFFECTIVENESS AND ATTRACTIVENESS. THE “SMALL CHANGE” (SC) APPROACH TO WEIGHT LOSS ADDRESSES EMERGING ADULT BARRIERS TO ENGAGEMENT BY FOCUSING ON REDUCING CALORIES THROUGH A FEW SELF-SELECTED, SPECIFIC CHANGES TO CURRENT OBESOGENIC BEHAVIORS, REQUIRING LESS TIME AND EFFORT THAN TRADITIONAL BEHAVIORAL WEIGHT LOSS INTERVENTIONS (BWLI) AND PROMOTING AUTONOMY AND SELF- EFFICACY. THE SC APPROACH HAS BEEN USED EFFECTIVELY FOR WEIGHT LOSS IN OTHER POPULATIONS. THE GOAL OF THIS K23 IS TO DEVELOP AND REFINE A NOVEL AND EFFECTIVE BWLI BASED ON A SC APPROACH THAT IS DESIGNED FOR EMERGING ADULTS AND FOR IMPLEMENTATION IN COLLEGE HEALTH CENTERS, AN ACCESSIBLE CARE SETTING. TO ACHIEVE THIS RESEARCH GOAL, I WILL DEVELOP A PROTOTYPE BWLI FOR EMERGING ADULT COLLEGE STUDENTS (BWLI-COLLEGE) THAT WILL INTEGRATE 1) RESULTS FROM QUALITATIVE INTERVIEWS WITH COLLEGE STAKEHOLDER GROUPS REGARDING PERCEIVED BARRIERS AND FACILITATORS OF IMPLEMENTATION IN HEALTH CENTERS AND 2) PREVIOUS FINDINGS REGARDING EMERGING ADULT PREFERENCES FOR WEIGHT LOSS INTERVENTIONS (AIM 1A & 1B). NEXT, I WILL ITERATIVELY ADAPT THE BWLI-COLLEGE PROTOTYPE THROUGH 2-3 UNCONTROLLED PILOT TRIALS WITH FEEDBACK FROM EMERGING ADULT STUDENTS WITH OVERWEIGHT/OBESITY (N=10/TRIAL) TO MAXIMIZE FEASIBILITY, ACCEPTABILITY, AND WEIGHT LOSS (AIM 2). FINALLY, I WILL TEST BWLI-COLLEGE AGAINST A ONE-SESSION PSYCHOEDUCATIONAL CONTROL GROUP IN A SMALL RANDOMIZED-CONTROLLED PILOT TRIAL (N=60; AIM 3). THIS PROJECT WILL FILL A CRITICAL NEED FOR AN EVIDENCE-BASED WEIGHT MANAGEMENT INTERVENTION FOR EMERGING ADULTS THAT CAN BE DELIVERED VIA COLLEGE CAMPUSES. TO COMPLETE THIS K23 RESEARCH STUDY, I PROPOSE TO RECEIVE TRAINING IN 1) DESIGNING AND TESTING OBESITY INTERVENTIONS, 2) THE UNIQUE FEATURES OF EMERGING ADULT POPULATIONS, 3) IMPLEMENTATION PRINCIPLES AND METHODS FOR THE TRANSLATION OF OBESITY INTERVENTIONS TO REAL- WORLD SETTINGS AND 4) ADVANCED STATISTICAL METHODS FOR LONGITUDINAL DATA FROM EFFICACY AND EFFECTIVENESS TRIALS. WITH THIS TRAINING AND RESEARCH PLAN, THE COMPREHENSIVE TEAM OF MENTORS I HAVE ASSEMBLED TO FACILITATE MY PROGRESS, AND THE RIGOROUS ACADEMIC AND TRAINING ENVIRONMENT OF BROWN UNIVERSITY AND THE MIRIAM HOSPITAL, I WILL BE WELL-POSITIONED TO LAUNCH MY CAREER AS AN INDEPENDENT INVESTIGATOR DEDICATED TO DEVELOPING, TESTING, AND IMPLEMENTING NOVEL OBESITY INTERVENTIONS TO PROVIDE EARLY TREATMENT OF OBESITY AND PREVENT THE ASSOCIATED DOWNSTREAM HEALTH CONSEQUENCES IN LATER ADULTHOOD.
Department of Health and Human Services
$992.1K
AGE EFFECTS ON HIV-ASSOCIATED BRAIN DYSFUNCTION
Department of Health and Human Services
$930.9K
THE EFFECT OF ANTENATAL MATERNAL CANNABIS USE ON PARENTING BEHAVIOR - PROJECT SUMMARY AS UNITED STATES CANNABIS POLICY SHIFTS TOWARD LIBERALIZATION, NORMS AND BEHAVIORS AROUND ADULT USE HAVE SHIFTED IN KIND. THIS INCLUDES PARENT USE, WHICH IS INCREASING IN FREQUENCY AND PREVALENCE. WHILE CERTAIN DEFICITS HAVE BEEN FOUND IN CHILDREN OF PARENTS WHO USE CANNABIS, THESE ASSOCIATIONS ARE INHERENTLY SUBJECT TO CONFOUNDING BY PARENTS AND CHILDREN’S SOCIAL ENVIRONMENTS, AND POTENTIAL FOR CAUSAL INFERENCE HAS BEEN LIMITED. PARENTS REPORT USING FOR STRESS-COPING, BUT THE RELATIONSHIP BETWEEN CANNABIS AND STRESS IS COMPLEX AND HIGHLY DEPENDENT ON SOCIAL CONTEXT. PATTERNS OF CANNABIS USE AMONG PARENTS MIRROR EXISTING HEALTH INEQUITIES. THEORETICAL SOCIAL EPIDEMIOLOGIC MODELS SUGGEST THAT DRUG USE AS A STRESS-COPING MECHANISM IS BOTH A REFLECTION OF HEALTH INEQUITIES AND CAUSE OF HEALTH DISPARITIES, WHICH MAY BE FURTHER EXACERBATED IN THE CONTEXT OF INTERGENERATIONAL EFFECTS. THEORETICAL MODELS AND EMPIRICAL EVIDENCE FROM DEVELOPMENTAL PSYCHOLOGY UNDERLINE THE IMPORTANT AND INTERACTING ROLES OF SUBSTANCE USE, STRESS AND THE SOCIAL ENVIRONMENT ON PARENTING. THIS MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) WILL SUPPORT THE CANDIDATE’S CAREER DEVELOPMENT AS AN INDEPENDENT INTERDISCIPLINARY RESEARCHER IN MODIFIABLE FACTORS THAT PRODUCE DISPARITIES AND INEQUITIES IN SUBSTANCE USE, TREATMENT AND CONSEQUENCES ACROSS THE LIFE COURSE. THE AWARD WILL SUPPORT THE CANDIDATE’S SHORT-TERM GOAL OF UNDERSTANDING THE INTERGENERATIONAL TRANSMISSION OF CANNABIS-RELATED HARM. THIS APPLICATION AIMS TO CONTRIBUTE A CLEARER UNDERSTANDING OF THE COMPLEX RELATIONSHIPS BETWEEN DIVERSE FAMILIES’ SOCIAL ENVIRONMENTS, MATERNAL CANNABIS USE, PARENTING BEHAVIORS, AND THE MATERNAL-INFANT RELATIONSHIP IN THE SIX MONTHS POSTPARTUM. SPECIFIC AIMS ARE TO 1) UNDERSTAND THE IMPACT OF MATERNAL CANNABIS USE IN THE FIRST SIX MONTHS POSTPARTUM ON PARENTING BEHAVIORS AND MATERNAL-INFANT INTERACTION; 2) UNDERSTAND THE INFLUENCE OF DISCRIMINATION IN THE RELATIONSHIP BETWEEN STRESS, CANNABIS USE AND PARENTING; AND 3) CHARACTERIZE MOTIVATIONS FOR MATERNAL CANNABIS USE THROUGH QUALITATIVE INTERVIEWS. RESEARCH AIMS WILL BE EXPLORED IN A PROSPECTIVE LONGITUDINAL COHORT OF PREGNANT WOMEN WHO USE CANNABIS, FOLLOWING MOTHERS AND INFANTS UNTIL ONE YEAR POSTPARTUM. OUTCOMES WILL BE ASSESSED USING QUALITATIVE AND QUANTITATIVE TECHNIQUES, INCLUDING INTERVIEWS, SURVEYS, BEHAVIORAL OBSERVATION, AND BIOMARKER MEASUREMENT. BY FOCUSING ON MULTIPLE LEVELS OF MODIFIABLE INFLUENCE ON MATERNAL CANNABIS USE, PARENTING AND THE MATERNAL-INFANT RELATIONSHIP, INCLUDING BEHAVIORAL AND BIOLOGICAL PATHWAYS, RESULTS FROM THIS RESEARCH HAVE THE POTENTIAL TO PROVIDE UNIQUE OPPORTUNITIES TO ADDRESS MATERNAL AND CHILD HEALTH IN THE CONTEXT OF SHIFTING SOCIAL AND LEGAL NORMS SURROUNDING ADULT CANNABIS USE. THIS RESEARCH IS DESIGNED TO ADDRESS THE OBJECTIVE 4.1 OF NIDA’S STRATEGIC PLAN TO DETERMINE THE IMPACT OF DRUG USE AND ADDICTION ON INDIVIDUALS, FAMILIES, PEERS AND SOCIETY. THE TRAINING PLAN IS DESIGNED TO PREPARE THE CANDIDATE FOR A CAREER AS AN INTERDISCIPLINARY RESEARCHER IN SUBSTANCE USE BY SUPPLEMENTING HER BACKGROUND IN SOCIAL EPIDEMIOLOGY AND SECONDARY DATA ANALYSIS WITH TRAINING IN STRESS RESEARCH AND PRIMARY DATA COLLECTION.
Department of Health and Human Services
$930.3K
INNOVATIVE TECHNOLOGY TO IMPROVE PATIENT ADHERENCE TO WEIGHT LOSS RECOMMENDATIONS
Department of Health and Human Services
$930K
OPTIMIZATION AND EVALUATION OF A TAILORED BEHAVIORAL EHEALTH/MHEALTH WEIGHT LOSS INTERVENTION FOR CARDIAC REHABILITATION PATIENTS USING THE MULTIPHASE OPTIMIZATION STRATEGY
Department of Health and Human Services
$885.4K
MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH
Department of Health and Human Services
$882.4K
BUPRENORPHINE AS A BRIDGE TO HCV TREATMENT FOR HIV/HCV COINFECTED OPIOID USERS
Department of Health and Human Services
$865.2K
BASIC ASPECTS OF HEMATOPOIETIC STEM CELLS AND AGING
Department of Health and Human Services
$863.1K
USING NOVEL BEHAVIORAL APPROACHES TO IMPROVE LONG-TERM WEIGHT LOSS OUTCOMES
Department of Health and Human Services
$860.9K
ACHIEVING PHYSICAL ACTIVITY GUIDELINES THROUGH AN ENHANCED PRINT INTERVENTION
Department of Health and Human Services
$860.8K
STRESS RESPONSE, COGNITIVE CONTROL & "REAL TIME" RUMINATION: SHARED MECHANISMS UNDERLYING SUBSTANCE USE AND DEPRESSION
Department of Health and Human Services
$827.2K
ADDRESSING WEIGHT BIAS INTERNALIZATION TO IMPROVE ADOLESCENT WEIGHT MANAGEMENT OUTCOMES - PROJECT SUMMARY/ABSTRACT WEIGHT BIAS INTERNALIZATION (WBI), OR SELF-DIRECTED WEIGHT-BASED STIGMA, HAS BEEN ASSOCIATED WITH A NUMBER OF NEGATIVE PHYSICAL AND MENTAL HEALTH CONSEQUENCES FOR ADOLESCENTS WITH OBESITY, INCLUDING NEGATIVE WEIGHT- RELATED OUTCOMES (E.G., INCREASED CALORIE CONSUMPTION, POORER WEIGHT LOSS OUTCOMES). THE PREVALENCE AND SALIENCE OF WBI AS A STRESSOR IMPACTING WEIGHT-RELATED OUTCOMES IN ADOLESCENTS PAIRED WITH THE HETEROGENEOUS RESPONSE TO INTERVENTIONS FOR ADOLESCENTS WITH OBESITY HIGHLIGHTS THE POTENTIAL UTILITY OF COMBINED INTERVENTION FOR WBI AND OBESITY IN YOUTH TO PROMOTE IMPROVED WEIGHT MANAGEMENT OUTCOMES DURING THIS CRITICAL DEVELOPMENTAL PERIOD. THIS K23 AWARD IS DESIGNED TO FILL GAPS IN MY TRAINING AND SUPPORT A RESEARCH STUDY THAT WILL PROVIDE NEXT STEPS IN IMPROVING THE HEALTH OF ADOLESCENTS WITH OBESITY. THE FIRST PHASE OF THE RESEARCH PROJECT WILL EMPLOY FOCUS GROUPS AND AN OPEN PILOT TRIAL TO DEVELOP AND TEST FEASIBILITY OF AN INTEGRATED INTERVENTION THAT COMBINES TREATMENT FOR WBI WITH AN EVIDENCE-BASED ADOLESCENT BEHAVIORAL WEIGHT CONTROL (BWC). I WILL THEN CONDUCT A SMALL RCT TO TEST THE EFFECTS OF THE NEWLY DESIGNED WBI+BWC INTERVENTION ON WBI AND MECHANISMS OF WEIGHT- STIGMA STRESS INDUCED WEIGHT GAIN, SPECIFICALLY PHYSIOLOGICAL MARKERS OF STRESS (DIURNAL CORTISOL) AND INFLAMMATION (C-REACTIVE PROTEIN, INTERLEUKIN-6), AND DYSREGULATED EATING BEHAVIORS (EMOTIONAL EATING, LOSS OF CONTROL, UNHEALTHY WEIGHT CONTROL BEHAVIORS). I HYPOTHESIZE THAT BWC COMBINED WITH INTERVENTION FOR WBI, WILL LEAD TO IMPROVEMENTS IN MECHANISMS OF WEIGHT-STIGMA STRESS INDUCED WEIGHT GAIN, IN TURN PROMOTING IMPROVED WEIGHT LOSS OUTCOMES. THIS RESEARCH PROJECT HAS SIGNIFICANT CLINICAL IMPLICATIONS FOR THE IMPROVEMENT OF ADOLESCENT BWC AND REDUCTION OF THE NEGATIVE EFFECTS OF WEIGHT-BASED STIGMA IN ADOLESCENTS. TO CONDUCT THIS RESEARCH AND FILL CRITICAL GAPS IN MY TRAINING THAT WILL FACILITATE BECOMING AN INDEPENDENT INVESTIGATOR FOCUSED ON BEHAVIORAL TREATMENT OF OBESITY IN ADOLESCENTS, I WILL COMPLETE A RIGOROUS, TARGETED TRAINING PROGRAM. THE PROPOSED TRAINING PLAN INCLUDES DEVELOPING EXPERTISE IN 1) CONDUCTING RCTS TO DEVELOP AND TEST BWC INTERVENTIONS FOR ADOLESCENTS; 2) THEORETICAL AND CONCEPTUAL MODELS OF WEIGHT-BASED STIGMA AND WBI; 3) INTEGRATION OF MECHANISMS IN CLINICAL TRIALS FOCUSED ON BIOLOGICAL MARKERS AND DYSREGULATED EATING BEHAVIORS; AND 4) PROFESSIONAL DEVELOPMENT. THIS TRAINING WILL BE CONDUCTED UNDER THE PRIMARY MENTORSHIP OF DR. ELISSA JELALIAN, WITH CO-MENTORS DRS. REBECCA PUHL, STEPHANIE PARADE, ANDREA GOLDSCHMIDT, AND CONTRIBUTOR DR. DAVID BARKER. THE SKILLS I WILL ACQUIRE MAP DIRECTLY ONTO THE PROPOSED RESEARCH PROJECT AND PROVIDE THE KNOWLEDGE AND EXPERTISE NECESSARY TO PREPARE A SUCCESSFUL R01 APPLICATION BY THE END OF THE AWARD PERIOD. THE MENTORSHIP TEAM, IN COMBINATION WITH THE RIGOROUS ACADEMIC AND TRAINING ENVIRONMENT PROVIDED BY THE WEIGHT CONTROL AND DIABETES RESEARCH CENTER AT THE MIRIAM HOSPITAL AND BROWN UNIVERSITY, REPRESENT AN IDEAL ENVIRONMENT TO ACCOMPLISH THESE TRAINING AND RESEARCH GOALS. THROUGH THIS CAREER DEVELOPMENT AWARD, I WILL ESTABLISH MYSELF AS AN INDEPENDENT INVESTIGATOR DEDICATED TO THE DEVELOPMENT OF NOVEL INTERVENTIONS TO IMPROVE HEALTH OUTCOMES FOR ADOLESCENTS WITH OBESITY.
Department of Health and Human Services
$826.5K
USING THE MULTIPHASE OPTIMIZATION STRATEGY TO OPTIMIZE A CULTURALLY TAILORED ONLINE BEHAVIORAL WEIGHT LOSS INTERVENTION FOR SEXUAL MINORITY WOMEN
Department of Health and Human Services
$775.9K
DEVELOPMENT OF A TAI CHI PROGRAM TO OVERCOME BARRIERS TO CARDIAC REHABILITATION
Department of Health and Human Services
$753.5K
OPIATE REPLACEMENT THERAPY AT RELEASE FROM INCARCERATION
Department of Health and Human Services
$752.7K
LINKAGE TO COMMUNITY-BASED HIV PRE-EXPOSURE PROPHYLAXSIS CARE AMONG AT RISK WOMEN UPON RELEASE FROM INCARCERATION
Department of Defense
$750K
STIMULATING MENISCUS FIBROCARTILAGE HEALING BY BIOLOGIC CELL THERAPY
Department of Health and Human Services
$749.9K
ADAPTING AN ADOLESCENT WEIGHT MANAGEMENT PROGRAM FOR A TYPE 1 DIABETES POPULATION - PROJECT ABSTRACT COMORBID OVERWEIGHT/OBESITY (BMI>85TH PERCENTILE FOR SEX AND AGE) WAS RARE IN YOUTH WITH TYPE 1 DIABETES MELLITUS (T1DM) PRIOR TO THE 1990S, BUT THE PREVALENCE NOW EXCEEDS THAT OF YOUTH IN THE GENERAL POPULATION. BEHAVIORAL WEIGHT MANAGEMENT INTERVENTIONS ARE EVIDENCE-BASED, FIRST-LINE TREATMENTS FOR PEDIATRIC OBESITY. YET, THERE ARE UNIQUE CHALLENGES OF T1DM THAT REQUIRE THOUGHTFUL ADAPTATIONS TO THESE INTERVENTIONS. EXAMPLES INCLUDE REDUCED EXERCISE AND EXCESS CALORIE CONSUMPTION DUE TO HYPOGLYCEMIA. ADOLESCENTS WITH T1DM AND COMORBID OVERWEIGHT/OBESITY ARE ALSO AT HIGH RISK OF DEVELOPING DISORDERED EATING BEHAVIORS. THERE IS A CRITICAL NEED FOR BEHAVIORAL WEIGHT MANAGEMENT INTERVENTIONS THAT ADDRESS BARRIERS SPECIFIC TO T1DM AND INCORPORATE ATTENTION TO EATING DISORDER PREVENTION IN THIS AT-RISK POPULATION. THE OBJECTIVE OF THIS K23 PROJECT IS TO ADAPT THE PRIMARY MENTOR’S (DR. ELISSA JELALIAN) ESTABLISHED 16-WEEK ADOLESCENT WEIGHT MANAGEMENT INTERVENTION FOR A T1DM POPULATION. USING THE OBESITY-RELATED BEHAVIORAL INTERVENTION TRIALS (ORBIT) MODEL, A FRAMEWORK FOR INTERVENTION DEVELOPMENT, THIS PROJECT WILL DESIGN, REFINE, AND TEST AN ADAPTED BEHAVIORAL WEIGHT MANAGEMENT INTERVENTION FOR ADOLESCENTS WITH COMORBID T1DM AND OVERWEIGHT/OBESITY USING TWO RELATED YET DISTINCT STUDIES. STUDY 1 WILL ENSURE FEASIBILITY (I.E., PARTICIPANT ATTENDANCE) AND ACCEPTABILITY OF INTERVENTION MATERIALS BY ADOLESCENTS WITH COMORBID T1DM AND OVERWEIGHT/OBESITY USING AN OPEN-TRIAL DESIGN WITH 2-3 SMALL GROUPS (N=5 ADOLESCENTS/GROUP). PARTICIPANTS WILL COMPLETE VALIDATED MEASURES OF ACCEPTABILITY AFTER EACH WEEKLY SESSION AND AN EXIT SURVEY POST-INTERVENTION. THE CANDIDATE WILL ITERATIVELY REFINE THE INTERVENTION BASED UPON STUDY 1 RESULTS. STUDY 2 WILL COMPARE THE ADAPTED WEIGHT MANAGEMENT INTERVENTION TO A USUAL CARE CONTROL GROUP USING A PILOT RANDOMIZED CONTROLLED TRIAL DESIGN (N=50 TOTAL ADOLESCENTS) TO VERIFY THAT THE ADAPTED INTERVENTION REDUCES PARTICIPANT BMI AND INCREASES THE PERCENT TIME SPENT IN THE TARGET BLOOD GLUCOSE RANGE (70-180MG/DL; PRIMARY OUTCOMES). PARTICIPANTS IN STUDY 2 WILL COMPLETE ECOLOGICAL MOMENTARY ASSESSMENTS (EMA) AT BASELINE AND 16-WEEKS TO DETERMINE EVENTS OF MALADAPTIVE EATING AND WEIGHT CONTROL BEHAVIORS OVER TIME (SECONDARY OUTCOMES). EXPLORATORY ANALYSES WILL EVALUATE CORRELATES OF THESE MALADAPTIVE EATING AND WEIGHT CONTROL BEHAVIORS IN REAL-WORLD SETTINGS. THIS K23 PROJECT BUILDS UPON THE CANDIDATE’S PRIOR WORK IN PEDIATRIC OBESITY AND T1DM. THE HIGHLY QUALIFIED AND EXPERT MENTORSHIP TEAM WILL PROVIDE SUPPORT AND OVERSIGHT, ALLOWING THE CANDIDATE TO ACQUIRE THE NECESSARY SKILLS TO LAUNCH AN INDEPENDENT RESEARCH CAREER AIMED AT IMPROVING WEIGHT MANAGEMENT FOR ADOLESCENTS WITH COMORBID T1DM AND OVERWEIGHT/OBESITY. RESULTS WILL PROVIDE DATA FOR A SUBSEQUENT APPLICATION TO CONDUCT A FULLY POWERED RANDOMIZED CONTROLLED TRIAL TO TEST THE EFFICACY OF THE ADAPTED WEIGHT MANAGEMENT INTERVENTION. THE PROPOSED PROJECT ALIGNS WITH THE NIDDK’S MISSION TO MITIGATE DIABETES-RELATED CARDIOVASCULAR EVENTS AND HAS THE POTENTIAL TO BE AN IMPORTANT PUBLIC HEALTH INTERVENTION TO IMPROVE THE HEALTH OF ADOLESCENTS WITH T1DM AND OVERWEIGHT/OBESITY.
Department of Health and Human Services
$746.8K
CHILDHOOD ADVERSITY AND SUBSTANCE USE: INTEGRATING LABORATORY AND ECOLOGICAL APPROACHES TO UNDERSTAND THE ROLE OF AFFECT - PROJECT SUMMARY/ABSTRACT BY 12TH GRADE, OVER 50% OF ADOLESCENTS IN THE UNITED STATES ENDORSE LIFETIME SUBSTANCE USE. CHILDHOOD ADVERSITY IS A PREVALENT AND ROBUST RISK FACTOR FOR ADOLESCENT SUBSTANCE USE. APPROXIMATELY 54% OF ADOLESCENTS REPORT ADVERSE CHILDHOOD EXPERIENCES (ACES), MAKING THEM OVER 1.5 TIMES MORE LIKELY TO USE SUBSTANCES. YET, MANY ADOLESCENTS WITH ACES DENY SUBSTANCE USE ENGAGEMENT, IMPLYING THE EXISTENCE OF MODIFIABLE RISK FACTORS. USING AN INTEGRATIVE MODEL OF ECOLOGICAL AND LABORATORY APPROACHES, THE PROPOSED STUDY EXAMINES THE ROLE OF AFFECT IN THE LINK BETWEEN ACES AND ADOLESCENT SUBSTANCE USE. CANDIDATE: THE CANDIDATE IS A CLINICAL CHILD PSYCHOLOGIST WITH A LONG-STANDING COMMITMENT TO STUDYING RISK AND RESILIENCE ASSOCIATED WITH EARLY LIFE STRESS. HER PRIOR RESEARCH HAS FOCUSED ON ELUCIDATING MECHANISMS THAT CONTRIBUTE TO SUBSTANCE USE IN EMERGING ADULTS WITH ACES. SHE IS APPLYING FOR A FIVE-YEAR K08 CAREER DEVELOPMENT AWARD TO EXPAND HER EXPERTISE AND SUPPORT HER TRAINING, MENTORSHIP, AND RESEARCH IN ADOLESCENT SUBSTANCE USE. TRAINING: THE PROPOSED TRAINING PLAN INCLUDES FORMAL WORKSHOPS, SEMINARS, CONFERENCES, DIRECTED READINGS, AND MENTORED EXPERIENCES THAT WILL ADVANCE HER TRAJECTORY TOWARD RESEARCH INDEPENDENCE BY FOSTERING NEW EXPERTISE IN: (1) HIGHLY RIGOROUS AND CUTTING EDGE LABORATORY-BASED PHYSIOLOGICAL TECHNIQUES, INCLUDING EYE TRACKING, PUPIL DILATION, GALVANIC SKIN RESPONSE, AND HEART RATE MEASUREMENT, (2) THE COLLECTION, MANAGEMENT, AND ANALYSIS OF ECOLOGICAL MOMENTARY ASSESSMENT (EMA) DATA, (3) ADVANCED ANALYTICAL APPROACHES TO INTEGRATE MULTIMETHOD RESEARCH DESIGNS, (4) THE DESIGN AND IMPLEMENTATION OF ADOLESCENT SUBSTANCE USE RESEARCH, AND (5) ENHANCED PROFESSIONAL DEVELOPMENT. THE CANDIDATE IS INSTITUTIONALLY SUPPORTED BY THE MIRIAM HOSPITAL AND THE WARREN ALPERT MEDICAL SCHOOL OF BROWN UNIVERSITY. MENTORING: FIVE WELL-ESTABLISHED RESEARCHERS SERVE AS MENTORS ON THIS PROPOSAL. EACH MENTOR OFFERS COMPLEMENTARY EXPERTISE CONSISTENT WITH THE STUDY’S AIMS AND TRAINING OBJECTIVES, INCLUDING ADVANCED DATA ANALYTIC TECHNIQUES, EMA, CHILDHOOD TRAUMATIC STRESS, LABORATORY-BASED BIO-BEHAVIORAL ASSESSMENT, AND ADOLESCENT SUBSTANCE USE RESEARCH. RESEARCH: THE PROPOSED STUDY WILL RECRUIT ADOLESCENT PARTICIPANTS (N=100, AGES 13-18) FROM AN ACTIVE LONGITUDINAL STUDY (R01HD104187). USING EMA, EYE TRACKING, BEHAVIORAL TASK PERFORMANCE, AND TRADITIONAL SELF-REPORT DATA, THE AIMS OF THE PROPOSAL ARE TO: EXAMINE THE INDIRECT EFFECTS OF ACES ON SUBSTANCE USE VIA AFFECT BALANCE (AIM 1), TOLERANCE OF AFFECTIVE DISTRESS (AIM 2), AND ATTENTION/REACTIVITY TO AFFECTIVE STIMULI (AIM 3).
Department of Health and Human Services
$732.3K
DEVELOPMENT OF A NOVEL HIV RISK REDUCTION INTERVENTION FOR ABUSED WOMEN
Department of Health and Human Services
$728.1K
EXERCISE AS A BUFFER AGAINST STRESSED-INDUCED EATING
Department of Health and Human Services
$726.8K
LIFESTYLE INTERVENTION TO TREAT ERECTILE DYSFUNCTION (LITE)
Department of Health and Human Services
$725.1K
IMPLEMENTING A BRIEF SUICIDE INTERVENTION FOR HIGH RISK YOUTH WITH FRONT-LINE JUVENILE JUSTICE STAFF
Department of Health and Human Services
$717.3K
LONG-ACTING INJECTABLE ANTIRETROVIRAL TREATMENT TO IMPROVE HIV TREATMENT AMONG JUSTICE-INVOLVED PERSONS BEING RELEASED TO THE COMMUNITY - PERSONS WHO EXPERIENCE INCARCERATION IN THE UNITED STATES ARE DISPROPORTIONATELY IMPACTED BY HIV INFECTION AND SUBSTANCE USE DISORDERS (SUD) AND ARE AT INCREASED RISK OF HAVING POOR HEALTH OUTCOMES. THE TIME OF RELEASE FROM CARCERAL SETTINGS, KNOWN AS COMMUNITY RE-ENTRY, IS A PERIOD OF PARTICULARLY HIGH RISK FOR PERSONS WITH HIV (PWH). NEW AND CREATIVE APPROACHES TO SUSTAINING HIV TREATMENT AND VIRAL SUPPRESSION DURING COMMUNITY RE- ENTRY ARE URGENTLY NEEDED. ANTIRETROVIRAL TREATMENT (ART) IS HIGHLY EFFECTIVE IN CONTROLLING HIV AND CAN SIGNIFICANTLY REDUCE HIV TRANSMISSION. HOWEVER, JUSTICE INVOLVED PWH OFTEN STRUGGLE WITH DAILY ART ADHERENCE DURING COMMUNITY RE-ENTRY AND CONSEQUENTLY EXPERIENCE DISEASE PROGRESSION AND CONTRIBUTE TO HIV TRANSMISSION. LONG- ACTING INJECTABLE (LAI) ART IS A NEW ALTERNATIVE TO HELP OVERCOME THE CHALLENGES OF ADHERING TO DAILY PILLS. THE FIRST FDA-APPROVED LAI ART REGIMEN, CABOTEGRAVIR (CAB) AND RILPIVIRINE (RPV), IS ADMINISTERED BY INTRAMUSCULAR INJECTION EVERY FOUR WEEKS. THERE IS AN IMMEDIATE OPPORTUNITY TO INVESTIGATE WHETHER USING LAI ART, AS OPPOSED TO DAILY ORAL ART, HAS A UNIQUE AND IMPORTANT ROLE WHEN INITIATED IN CARCERAL SETTINGS AND CONTINUED DURING COMMUNITY RE-ENTRY WITH THE GOAL OF IMPROVING TREATMENT OUTCOMES. WE PROPOSE A MIXED METHODS STUDY THAT WILL DEVELOP AND PILOT TEST AN LAI ART PROTOCOL DESIGNED SPECIFICALLY FOR COMMUNITY RE-ENTRY. THIS STUDY WILL BE CONDUCTED IN COLLABORATION WITH THE MARYLAND DEPARTMENT OF PUBLIC SAFETY AND CORRECTIONAL SERVICES, CORIZON HEALTH (STATE PRISON MEDICAL CONTRACTOR), AND TOTAL HEALTH CARE, A FEDERALLY QUALIFIED HEALTH CENTER IN THE BALTIMORE METROPOLITAN AREA, AN ENDING THE HIV EPIDEMIC GEOGRAPHIC HOTSPOT. FRAMED BY THE BEHAVIORAL MODEL FOR VULNERABLE POPULATIONS, OUR AIMS INCLUDE: 1) CONDUCT INTERVIEWS WITH JUSTICE AND TREATMENT EXPERIENCED PWH (N=20), AND CARCERAL AND COMMUNITY KEY STAKEHOLDERS (N=20), TO OBTAIN GUIDANCE ON THE DEVELOPMENT AND IMPLEMENTATION OF A PROTOCOL TO TRANSITION PWH ON ORAL ART TO LAI ART IN PRISON WITH CONTINUATION DURING COMMUNITY RE-ENTRY. 2) DEVELOP AN INITIAL LAI ART COMMUNITY RE-ENTRY PROTOCOL AND CONDUCT AN OPEN LABEL PILOT STUDY THAT WILL FOLLOW 10 INCARCERATED PWH ELIGIBLE FOR LAI ART WHO ARE NEAR RELEASE FROM PRISON FOR THREE MONTHS IN ORDER TO OPTIMIZE PROTOCOL PROCEDURES AND TO PILOT STUDY RETENTION METHODS AND ASSESSMENTS. 3) FOLLOWING OPTIMIZATION OF PROTOCOL, CONDUCT A PILOT RANDOMIZED CONTROLLED TRIAL AMONG 50 INCARCERATED PWH ELIGIBLE FOR LAI ART AND SCHEDULED TO BE RELEASED FROM PRISON; PARTICIPANTS WILL BE RANDOMIZED 1:1 TO TRANSITION ART TO INJECTABLE CAB/RPV OR CONTINUE DAILY ORAL ART REGIMEN THROUGH A SIX-MONTH FOLLOW-UP PERIOD AFTER RELEASE. DURING THE FOLLOW-UP PERIOD, WE WILL ASSESS THE PRIMARY OUTCOME OF HIV VIRAL SUPPRESSION AND SECONDARY OUTCOMES INCLUDING CONTINUANCE OF THE ASSIGNED LAI OR ORAL ART REGIMEN, ART ADHERENCE, AND SUBSTANCE USE. THIS STUDY WILL PROVIDE PRELIMINARY DATA TO INFORM THE DESIGN OF A FUTURE MULTI-SITE FULLY POWERED CLINICAL TRIAL THAT WILL COMPARE LAI ART TO DAILY ORAL ART DURING COMMUNITY RE-ENTRY ON SUSTAINING HIV VIRAL SUPPRESSION AFTER RELEASE FROM PRISON.
Department of Health and Human Services
$716.6K
A SLEEP HYGIENE INTERVENTION TO IMPROVE SLEEP QUALITY IN URBAN, LATINO MIDDLE SCHOOL CHILDREN
Department of Health and Human Services
$706.4K
PREVENTION OF POSTPARTUM WEIGHT RETENTION
Department of Health and Human Services
$705.3K
AN AI-BASED BEHAVIORAL INTERVENTION TO IMPROVE PRE-EXPOSURE PROPHYLAXIS FOR HIV PREVENTION - HIV CONTINUES TO DISPROPORTIONATELY AFFECT MEN WHO HAVE SEX WITH MEN (MSM), PARTICULARLY THOSE LIVING IN THE ENDING THE HIV EPIDEMIC (EHE) JURISDICTIONS. DESPITE THE PROVEN EFFECTIVENESS OF HIV PRE-EXPOSURE PROPHYLAXIS (PREP) IN PREVENTING HIV INFECTIONS, ITS UPTAKE AMONG MSM IS NOTABLY INADEQUATE, PARTICULARLY AMONG THOSE LIVING IN EHE JURISDICTIONS. MOTIVATIONAL INTERVIEWING (MI) HAS SHOWN EFFECTIVENESS IN ENCOURAGING AT-RISK MSM TO ADOPT PREP; INTEGRATING THE TRANSTHEORETICAL MODEL (TTM) INTO MI ENABLES THE ASSESSMENT OF AN INDIVIDUAL'S READINESS FOR CHANGE AND THE DELIVERY OF TAILORED MI SESSIONS. HOWEVER, ITS LABOR-INTENSIVE NATURE, REQUIRING MULTIPLE SESSIONS, POSES A SIGNIFICANT CHALLENGE. THE POTENTIAL SOLUTION LIES IN HARNESSING GENERATIVE ARTIFICIAL INTELLIGENCE (AI) TO STREAMLINE AND MAKE MI MORE ACCESSIBLE. THIS PILOT STUDY AIMS TO LEVERAGE AI TECHNOLOGY TO OVERCOME THE LABOR-INTENSIVE ASPECTS OF MI, POTENTIALLY REACHING A BROADER AUDIENCE SIMULTANEOUSLY. IN THE STUDY, WE AIM TO TAILOR, REFINE, AND TEST AN AI-BASED CHATBOT CALLED CHIA (CHATBOT FOR HIV PREVENTION AND ACTION) WITH MI TECHNIQUES TO PROMOTE HIV PREP AMONG MSM LIVING IN THE EHE JURISDICTIONS. THE CHIA WILL BE TAILORED AND FINE-TUNED BASED ON THE LATEST CHAT GENERATIVE PRE-TRAINED TRANSFORMER (CHATGPT) MODEL TO EMPLOY MI TECHNIQUES TO ASSESS HIV RISK AND TTM STAGE, PROVIDE STAGE APPROPRIATE EDUCATION, AND MOTIVATE INDIVIDUALS TO INITIATE PREP (SPECIFIC AIM [SA] 1). IN AN OPEN PILOT TRIAL INVOLVING 15 PARTICIPANTS AGED 18 YEARS OR OLDER RECRUITED VIA VARIOUS SOCIAL MEDIA PLATFORMS, WE WILL RIGOROUSLY EVALUATE THE CHIA'S ACCURACY, PARTICIPANT SATISFACTION, AND RESPONSIVENESS TO INDIVIDUALS’ NEEDS WITH REFINEMENT MADE AS INDICATED IN SA2. THE REFINED CHIA WILL SUBSEQUENTLY UNDERGO EVALUATION IN A PILOT RANDOMIZED CONTROLLED TRIAL (SA3) TO ASSESS ITS ACCEPTABILITY, FEASIBILITY, AND PRELIMINARY EFFICACY IN PROMOTING PREP UPTAKE. WE WILL RANDOMLY ASSIGN PARTICIPANTS TO THE INTERVENTION (AT LEAST 60 MINUTES OF ENGAGEMENT WITH CHIA IN TWO OR MORE SESSIONS WITHIN TWO WEEKS OF ENROLLMENT, N=50) OR THE CONTROL ARMS (STANDARD OF CARE BY RESEARCH STAFF: RISK ASSESSMENT, PREP EDUCATION, RISK REDUCTION COUNSELING, AND PREP REFERRAL IF INTERESTED, N=50) WITH A 1:1 RATIO. PRIMARY OUTCOMES INCLUDE PRESCRIPTION RECEIPT, PHARMACY FILLING, AND DRUG CONCENTRATION LEVELS, PROVIDING DEFINITIVE MARKERS OF PREP UPTAKE. THE PROPOSED PILOT STUDY HAS THE POTENTIAL TO LEVERAGE THE POWER OF EMERGING AI TECHNOLOGIES TO INCORPORATE MI INTO HIV PREVENTION AND PREP PROMOTION. IF SUCCESSFUL, THE PROPOSED PILOT STUDY WILL HELP FACILITATE AI IN THE FIELD OF HIV PREVENTION AS WELL AS REDUCE HIV INCIDENCE AMONG MSM.
Department of Health and Human Services
$702.1K
MYSTYLE: ONLINE FAMILY-BASED HIV PREVENTION FOR NON-HETEROSEXUAL BLACK ADOLESCENT MALES IN THE SOUTH
Department of Health and Human Services
$691.8K
A BRIEF MOTIVATIONAL INTERVIEWING-BASED INTERVENTION TO IMPROVE HIV PRE-EXPOSURE PROPHYLAXIS UPTAKE AMONG MEN WHO HAVE SEX WITH MEN
Department of Health and Human Services
$691.2K
INTEGRATED SMOKING CESSATION AND MOOD MANAGEMENT FOR CARDIAC PATIENTS
Department of Health and Human Services
$689.3K
ADVANCING REPRODUCTIVE HEALTH: QUALITATIVE METHODS & INTERDISCIPLINARY MENTORSHIP
Department of Health and Human Services
$681.5K
MULTISITE FEASIBILITY OF BA-HD: AN INTEGRATED DEPRESSION AND BEHAVIORAL RISK FACTOR REDUCTION COACHING PROGRAM FOLLOWING ACUTE CORONARY SYNDROME - PROJECT ABSTRACT ACUTE CORONARY SYNDROME (ACS) IS AN URGENT PUBLIC HEALTH ISSUE WHICH CONTRIBUTES TO OVER ONE MILLION HOSPITALIZATIONS ANNUALLY. DEPRESSION UNDERMINES OPTIMAL RECOVERY FOLLOWING ACS, OFTEN AT LEAST PARTIALLY THROUGH INTERFERENCE WITH HEALTH BEHAVIORS. POST-ACS PATIENTS WITH DEPRESSION SMOKE MORE, ADHERE TO MEDICATIONS LESS OFTEN, ARE LESS PHYSICALLY ACTIVE, AND HAVE POORER DIET THAN POST-ACS PATIENTS WITHOUT DEPRESSION. THIS REDUCED ADHERENCE TO RECOMMENDED HEALTH BEHAVIORS, IN TURN, WORSENS CARDIOVASCULAR HEALTH AND INCREASES RISK OF ADDITIONAL MORBIDITY AND MORTALITY. OUR TEAM DEVELOPED BEHAVIORAL ACTIVATION FOR HEALTH AND DEPRESSION (BA-HD) WHICH IS A BEHAVIORAL ACTIVATION-BASED INTERVENTION THAT INTEGRATES TREATMENT FOR DEPRESSION AND MULTIPLE HEALTH BEHAVIOR CHANGE POST-ACS. THE OVERARCHING GOAL OF THIS R34 APPLICATION IS TO PILOT BA-HD ACROSS THREE DISTINCT REGIONS (NORTHEAST, MIDWEST, AND SOUTHEAST) IN PREPARATION FOR A SUBSEQUENT FULLY POWERED MULTISITE RANDOMIZED CONTROLLED EFFICACY TRIAL. SPECIFICALLY, THE RESEARCH TEAM WILL CONDUCT A MULTISITE PILOT RANDOMIZED CONTROLLED FEASIBILITY TRIAL OF BA-HD COMPARING THE INTERVENTION TO AN ENHANCED USUAL CARE (EUC) CONTROL GROUP. THIS TRIAL WILL ACCOMPLISH TWO AIMS: FIRST, WE WILL EXAMINE STUDY FEASIBILITY (E.G., RECRUITMENT, TREATMENT ENGAGEMENT, RETENTION) AND ACCEPTABILITY OF BOTH STUDY PROCEDURES AND THE BA-HD TREATMENT. SECOND, WE WILL EXAMINE THE PRELIMINARY EFFICACY OF BA-HD TO IMPROVE (1) DEPRESSED MOOD AND (2) CARDIOVASCULAR HEALTH ASSESSED VIA THE AMERICAN HEART ASSOCIATION’S LIFE’S SIMPLE 7 TOTAL SCORE. FINDINGS FROM THE PROPOSED RESEARCH ARE NECESSARY TO FINALIZE STUDY DESIGN IN PREPARATION FOR A SUBSEQUENT FULLY POWERED TRIAL TO EVALUATE THE EFFICACY OF BA-HD TO IMPROVE CARDIOVASCULAR HEALTH AND DEPRESSION
Department of Health and Human Services
$676.4K
A MOBILE INTERVENTION TO IMPROVE UPTAKE OF PREP FOR SOUTHERN BLACK MSM
Department of Health and Human Services
$672.6K
NEURODEVELOPMENTAL SUBSTRATES OF EMOTION REGULATION IN OBESE, BINGE EATING YOUTH
Department of Health and Human Services
$668.4K
THE NEURAL CORRELATES OF FOOD CHOICE DECISION-MAKING IN OBESITY AND WEIGHT LOSS
Department of Health and Human Services
$665K
PEER-DRIVEN INTERVENTION PROMOTING PRE-EXPOSURE PROPHYLAXIS UPTAKE AMONG AFRICAN AMERICAN AND HISPANIC/LATINO MEN WHO HAVE SEX WITH MEN
Department of Health and Human Services
$664.7K
THE IMPACT OF MATERNAL S. JAPONICUM INFECTION ON FETAL METABOLISM AND GROWTH
Department of Health and Human Services
$661.5K
REDUCING ALCOHOL-RELATED HIV/STI RISK FOR WOMEN IN REPRODUCTIVE HEALTH CLINICS
Department of Health and Human Services
$656.8K
MINDFULNESS TRAINING TO IMPROVE ART ADHERENCE AND REDUCE RISK BEHAVIOR AMONG PERSONS LIVING WITH HIV
Department of Health and Human Services
$655.1K
UNDERNUTRITION-HELMINTH-ALCOHOL INTERACTIONS, PLACENTAL MECHANISMS, AND FASD RISK
Department of Health and Human Services
$653.5K
INCREASING PHYSICAL ACTIVITY AMONG INACTIVE BARIATRIC SURGERY PATIENTS
Department of Health and Human Services
$650K
MOLECULAR EPIDEMIOLOGY OF HIV TRANSMISSION NETWORKS
Department of Health and Human Services
$645.1K
EVALUATING THE IMPLEMENTATION AND IMPACT OF A NOVEL MEDICATION ASSISTED TREATMENT PROGRAM IN A UNIFIED JAIL AND PRISON SYSTEM
Department of Health and Human Services
$644.9K
IMPROVING ADHERENCE AND COGNITION IN SUBSTANCE-USING HIV PATIENTS
Department of Health and Human Services
$644.4K
TRAUMA-INFORMED OBSTETRIC CARE: DEVELOPMENT AND IMPLEMENTATION OF A STAKEHOLDER-INFORMED TOOLKIT FOR OBSTETRIC PROVIDERS AND PATIENTS - PROJECT SUMMARY/ABSTRACT MANY PREGNANT WOMEN HAVE EXPERIENCED TRAUMA, WHICH CAN MAKE PERINATAL CARE STRESSFUL AND INCREASE THE RISK OF PREGNANCY-RELATED HEALTH CONDITIONS. HOWEVER, OBSTETRIC PROVIDERS CAN MODIFY PROCEDURES TO REDUCE DISTRESS AND ENHANCE PATIENTS’ SENSE OF CONTROL AND SAFETY. ALTHOUGH OBSTETRIC PROVIDERS FREQUENTLY CARE FOR TRAUMA SURVIVORS, MOST ARE NOT TRAINED IN TRAUMA-INFORMED CARE (TIC). ADDITIONALLY, THERE ARE NO DATA ON FEASIBILITY, APPROPRIATENESS, OR ACCEPTABILITY OF TIC TOOLS AND INTERVENTIONS IN THE CONTEXT OF OBSTETRICS. THE GOAL OF THE PROPOSED K23 PROJECT IS TO DEVELOP THE FIRST, STAKEHOLDER-INFORMED OBSTETRIC TIC TOOLKIT COMPOSED OF TREATMENT PROTOCOLS, CLINICIAN TRAINING, TRAUMA AND VIOLENCE SCREENING TOOLS, AND OTHER RESOURCES TO HELP OBSTETRIC PROVIDERS APPLY TIC PRACTICES TO ALL CLINICAL INTERACTIONS IN ADDITION TO IDENTIFYING AND PROVIDING SUPPORT FOR TRAUMA SURVIVORS. THE OBSTETRIC TIC INTERVENTION TOOLKIT (OB-TIC) WILL BE DEVELOPED IN COLLABORATION WITH KEY STAKEHOLDERS (PREGNANT AND POSTPARTUM PATIENTS, NURSES, PHYSICIANS, AND ADMINISTRATORS) TO ENSURE THAT IT IS FEASIBLE, ACCEPTABLE, APPROPRIATE, COST-EFFECTIVE, AND CLINICALLY USEFUL. CURRENT PRACTICES AND PREFERENCES WILL BE CHARACTERIZED IN QUALITATIVE INTERVIEWS WITH STAKEHOLDERS WHICH WILL INFORM THE DEVELOPMENT OF OB-TIC IN COLLABORATION WITH A COMMUNITY WORKING GROUP OF STAKEHOLDERS. A PILOT IMPLEMENTATION TRIAL OF OB-TIC WILL BE CONDUCTED IN TWO OUTPATIENT OBSTETRICS CLINICS TO GATHER REAL-WORLD DATA THAT WILL INFORM THE FINAL INTERVENTION TOOLKIT, WHICH WILL BE TESTED ON A LARGER SCALE IN FUTURE (R01) STUDIES. THE K23 AWARD WILL FACILITATE THE CANDIDATE’S TRANSITION TOWARDS AN INDEPENDENT RESEARCH CAREER FOCUSED ON IMPROVING THE WELL-BEING OF WOMEN THROUGH TRAUMA-INFORMED PERINATAL HEALTHCARE AND IMPLEMENTATION SCIENCE, WHICH IS DIRECTLY IN LINE WITH THE NICHD PREGNANCY AND PERINATOLOGY PRIORITY OF “IMPROVING THE HEALTH OF WOMEN BEFORE, DURING, AND AFTER PREGNANCY.” TO DATE, THE CANDIDATE’S TRAINING HAS FOCUSED ON DEVELOPING CLINICAL EXPERTISE IN PERINATAL BEHAVIORAL MEDICINE, AND RESEARCH EXPERIENCE IN OBSTETRICS, PERINATAL STRESS, AND BEHAVIORAL INTERVENTIONS FOR STRESS AND DISCRIMINATION. THE K23 AWARD WILL PROVIDE PROTECTED TIME FOR TRAINING IN 1) IMPLEMENTATION SCIENCE METHODOLOGY FOCUSED ON THE DEVELOPMENT OF STAKEHOLDER INFORMED INTERVENTIONS AND SCALE-UP AND SPREAD OF EVIDENCE-BASED INTERVENTIONS; 2) QUALITATIVE RESEARCH METHODOLOGY, A FOUNDATIONAL COMPONENT OF IMPLEMENTATION SCIENCE AND STAKEHOLDER-BASED INTERVENTION DEVELOPMENT; 3) AND TRAUMA-INFORMED CARE IN OBSTETRICS, WHICH WILL PROVIDE A KNOWLEDGE BASE FOR OB-TIC. EXPERTS IN EACH OF THE KEY TRAINING DOMAINS WILL PROVIDE INDIVIDUAL MENTORSHIP IN ADDITION TO SPECIALIZED WORKSHOPS AND DIDACTICS. DURING THE PROPOSED K23 AWARD, THE CANDIDATE WILL BE A RESEARCH SCIENTIST AT THE MIRIAM HOSPITAL AND AN ASSISTANT PROFESSOR AT BROWN UNIVERSITY. THIS ENVIRONMENT IS RICH WITH INNOVATION AND COLLABORATION AND WILL ENHANCE THE CANDIDATE’S TRAINING AND FACILITATE THEIR RESEARCH GOALS. THE MENTORSHIP AND SKILLS GAINED AS PART OF THIS K23 AWARD, WILL PREPARE THE CANDIDATE TO PURSUE FUNDING FOR AN R01 FOCUSED ON A RANDOMIZED CONTROLLED TRIAL OF OB-TIC.
Department of Health and Human Services
$635K
IMPACT OF DYSFUNCTIONAL HDL ON PLATELET FUNCTION AND IN VIVO THROMBOSIS
Department of Health and Human Services
$629.3K
COMPREHENSIVE HIV TESTING STRATEGIES FOR JAILS
Department of Health and Human Services
$625.7K
DETERMINING THE ROLE OF RETROTRANSPOSON LINE-1 IN ALZHEIMERS DISEASE
Department of Defense
$573K
COLLAGEN VARIANTS SENSITIZE STOMACH TUMORS TO THERAPEUTICS
Department of Health and Human Services
$564.6K
ADAPTING ONLINE OBESITY TREATMENT FOR PRIMARY CARE PATIENTS IN POVERTY - PROJECT SUMMARY POVERTY AFFECTS OVER 37 MILLION INDIVIDUALS IN THE U.S., SUBJECTING THEM TO SYNDEMICS – CLUSTERED, MUTUALLY ENHANCING EPIDEMICS SUCH AS OBESITY, DIABETES, AND DEPRESSION THAT ARISE FROM AND PERPETUATE SOCIOECONOMIC INEQUALITY. SYNDEMIC THEORY UNDERSCORES A PATHWAY TO MITIGATE SYNDEMICS BY INTERVENING ON A SINGLE TARGET WITHIN THE CLUSTER. OBESITY’S HIGH PREVALENCE IN POVERTY; ROLE IN INCREASING LEADING CAUSES OF DEATH (E.G., CARDIOVASCULAR DISEASE, CANCER, DEMENTIA); AND ADVERSE PSYCHOSOCIAL EFFECTS (E.G., INCREASED DEPRESSION) MAKE IT A CRUCIAL, HIGH PRIORITY TARGET. WHILE STRUCTURAL AND SOCIAL FACTORS CONTRIBUTE TO OBESITY IN POVERTY, RESEARCH SHOWS THE EFFECTIVENESS OF INDIVIDUAL-LEVEL INTERVENTIONS IN IMPROVING HEALTH BEHAVIORS AND WEIGHT WHEN HIGHLY RESPONSIVE TO OVERBURDENED POPULATIONS’ NEEDS. AT THE SAME TIME, EVIDENCE GUIDING REFINEMENT OF INTERVENTIONS IS SPARSE AS PARTICIPANTS WITH SOCIOECONOMIC DISADVANTAGE ARE UNDERREPRESENTED IN OBESITY TREATMENT RESEARCH. REFLECTING THIS PHENOMENON, RX WEIGHT LOSS, A FULLY AUTOMATED ONLINE OBESITY TREATMENT, HAS SEEN LIMITED USE AMONG PATIENTS WITH LOW INCOME DESPITE PAST WORK SHOWING IT CAN BE DELIVERED EFFECTIVELY THROUGH PRIMARY CARE AT LOW COST. SINCE 72.8% OF ADULTS IN POVERTY HAVE A USUAL PRIMARY CARE PROVIDER, AND 83% HAVE INTERNET ACCESS, THIS GAP IN ADOPTION REPRESENTS A SIGNIFICANT OPPORTUNITY FOR PUBLIC HEALTH IMPACT THROUGH ADAPTATION OF RXWL THAT INCREASES RELEVANCE FOR TRADITIONALLY UNDERSERVED POPULATIONS. FURTHER, THIS RESEARCH IS POISED TO FILL A CRITICAL GAP IN OBESITY TREATMENT LITERATURE. THUS, THIS APPLICATION AIMS TO REVISE RXWL CONTENT AND THE PROCESS BY WHICH PRIMARY CARE PROVIDERS REFER PATIENTS TO THE PROGRAM (REFERENCED COLLECTIVELY AS THE “RXWL PACKAGE”) TO MAXIMIZE RESPONSIVENESS, REACH, AND EFFECTIVENESS FOR THOSE IN POVERTY. USING MIXED METHODS DATA COLLECTION, THIS PROJECT STRUCTURES RESEARCH ACTIVITIES USING THE SOCIAL MARKETING ASSESSMENT AND RESPONSE TOOL (SMART) AND EXAMINES IMPLEMENTATION OUTCOMES IDENTIFIED BY THE CONSOLIDATED FRAMEWORK FOR IMPLEMENTATION RESEARCH (CFIR). PRIMARY CARE PROVIDER (N = 23) AND PATIENT (N = 16) STAKEHOLDERS WILL PROVIDE FEEDBACK ON THE EXISTING RXWL PACKAGE (AIM 1); INSIGHTS AND SCIENTIFIC KNOWLEDGE WILL BE INTEGRATED TO PRODUCE A LOW-COST RXWL PACKAGE PROTOTYPE (I.E., A PDF WITH EMBEDDED LINKS APPROXIMATING THE INTENDED PROGRAM) FOR USABILITY TESTING (N = 8 PROVIDERS, 10 PATIENTS; AIM 2); AND DATA WILL DRIVE DEVELOPMENT OF A FINALIZED RXWL PACKAGE TO DISSEMINATE THROUGH PRIMARY CARE AND EVALUATE IN AN OPEN TRIAL (N = 12 PROVIDERS, 32 PATIENTS; AIM 3). AIM 3 WILL EXAMINE BOTH IMPLEMENTATION AND PRELIMINARY CLINICAL OUTCOMES, INCLUDING EFFECTS ON WEIGHT LOSS AND SYNDEMIC SEQUELAE; OBTAIN INSIGHTS FOR FURTHER REFINEMENT; AND INDICATE READINESS FOR A LARGER R- FUNDED CLINICAL TRIAL. REVISING RXWL HOLDS HIGH POTENTIAL TO REDUCE HEALTH DISPARITIES FOR THOSE FROM SOCIOECONOMICALLY DISADVANTAGED BACKGROUNDS. MOREOVER, FINDINGS WILL MAKE SIGNIFICANT CONTRIBUTIONS TO THE LITERATURE ON RECRUITMENT AND RETENTION OF PATIENTS IN POVERTY IN OBESITY TREATMENT RESEARCH; ADAPTATION OF OBESITY TREATMENT TO FIT THE UNIQUE NEEDS OF TRADITIONALLY UNDERSERVED POPULATIONS; AND IMPACT OF SOCIAL DETERMINANTS OF HEALTH ON THE COURSE OF OBESITY TREATMENT.
Department of Health and Human Services
$560.5K
EVALUATION AND ENHANCEMENT OF THE SUMMER FOOD SERVICE PROGRAM IN YOUTH FROM AN URBAN, LOW-RESOURCE COMMUNITY
Department of Health and Human Services
$531.6K
GENETIC AND BEHAVIORAL EFFECTS ON HIGH-DENSITY LIPOPROTEIN: THE LOOK AHEAD STUDY
Department of Health and Human Services
$529.7K
YOGA FOR WOMEN ATTEMPTING SMOKING CESSATION: AN INITIAL INVESTIGATION
Department of Health and Human Services
$507.7K
PEDIATRIC ASTHMA DISPARITIES: THE ROLE OF SLEEP AND IMMUNE BALANCE
Department of Health and Human Services
$487.8K
PHARMACOGENETICS AND DRUG-DRUG INTERACTIONS DURING HIV/TB THERAPY
Department of Health and Human Services
$467.5K
AN EMOTION REGULATION INTERVENTION FOR EARLY ADOLESCENT RISK BEHAVIOR PREVENTION
Department of Health and Human Services
$451.8K
PREDICTING THE IMPACT OF COST ON HIV PRE-EXPOSURE PROPHYLAXIS UPTAKE AND RACIAL/ETHNIC DISPARITIES AMONG MSM
Department of Health and Human Services
$450.1K
1/5 THE CUMULATIVE RISK OF SUBSTANCE EXPOSURE AND EARLY LIFE ADVERSITY ON CHILD HEALTH DEVELOPMENT AND OUTCOMES
Department of Health and Human Services
$436.2K
TEEN JOIN: A SCALABLE WEIGHT CONTROL INTERVENTION FOR ADOLESCENTS
Department of Health and Human Services
$432.5K
TRANSLATING A DEMENTIA CAREGIVER INTERVENTION INTO A MOBILE APPLICATION
Department of Health and Human Services
$429.1K
ENTRY AND POST ENTRY EFFECT OF NTCP RECEPTOR ON HBV LIFE CYCLE
Department of Health and Human Services
$425.6K
EXPLORING THE ROLE OF MINDFULNESS TRAINING IN THE PROMOTION OF MEDICATION ADHERENCE IN HEART FAILURE OUTPATIENTS
Department of Health and Human Services
$425.4K
EVALUATING HIV PRE-EXPOSURE PROPHYLAXIS IMPLEMENTATION USING AN ALL PAYERS CLAIMS DATABASE
Department of Health and Human Services
$417.3K
HIV DRUG RESISTANCE MONITORING IN CHENNAI, INDIA
Department of Health and Human Services
$415.2K
YOGA AS A COMPLEMENTARY THERAPY FOR TYPE 2 DIABETES: AN INITIAL INVESTIGATION
Department of Health and Human Services
$402.6K
ROLE OF M6A RNA METHYLATION IN REGULATION OF TRANSLATION IN HUMAN GLIOBLASTOMA
Department of Health and Human Services
$390.9K
CARDIAC AUTONOMIC REGULATION ENHANCEMENT THROUGH EXERCISE (CARE-E) TRIAL
Department of Health and Human Services
$380.9K
CONCURRENT HAART AND TUBERCULOSIS TREATMENT: DRUG TO DRUG INTERACTIONS
Department of Health and Human Services
$377.4K
TEXT MESSAGING AS A NOVEL ALCOHOL INTERVENTION FOR COMMUNITY COLLEGE STUDENTS
Department of Health and Human Services
$374.1K
POSTTRAUMATIC STRESS AND STRESS REACTIVITY AFTER MYOCARDIAL INFARCTION - PROJECT SUMMARY/ABSTRACT IN THE US, AN ADULT SUFFERS A MYOCARDIAL INFARCTION (MI) EVERY 40 SECONDS. OVER 35% OF MI PATIENTS DEVELOP POSTTRAUMATIC STRESS DISORDER (PTSD) SYMPTOMS WITHIN 1 MONTH, INCREASING RISK OF 1-YEAR REHOSPITALIZATION AND MORTALITY IN A DOSE-RESPONSE MANNER. HOWEVER, BIOBEHAVIORAL PATHWAYS WHEREBY PTSD SYMPTOMS LEAD TO REHOSPITALIZATION AND MORTALITY HAVE YET TO BE IDENTIFIED. GIVEN PTSD SYMPTOMS POTENTIATE STRESS REACTIVITY AND PATIENTS SHOW GREATER STRESS REACTIVITY AFTER A MI, STRESS REACTIVITY IS A PROMISING MECHANISM TO STUDY IN THE ASSOCIATION BETWEEN PTSD SYMPTOMS AND PROXIMAL CARDIOVASCULAR HEALTH OUTCOMES SUCH AS AMBULATORY BLOOD PRESSURE (ABP). THE OBJECTIVE OF THIS MENTORED PATIENT-ORIENTED RESEARCH CAREER DEVELOPMENT AWARD (K23) IS TO PROVIDE DR. SHARON LEE, THE CANDIDATE, WITH NECESSARY TRAINING TO BECOME AN INDEPENDENT CLINICAL SCIENTIST WITH EXPERTISE IN THE BIOBEHAVIORAL MECHANISMS LINKING PTSD SYMPTOMS AND CARDIOVASCULAR DISEASE RISK. TO PREPARE DR. LEE TO BECOME AN INDEPENDENT INVESTIGATOR BY THE COMPLETION OF THIS AWARD, MENTORED TRAINING WILL ADDRESS FOUR DOMAINS: (1) PSYCHOPHYSIOLOGY OF CARDIOVASCULAR STRESS REACTIVITY, (2) METHODOLOGIES IN ECOLOGICAL MOMENTARY ASSESSMENT AND ABP MONITORING, (3) EPIDEMIOLOGY OF MI AND POST-MI CLINICAL OUTCOMES, AND (4) PROFESSIONAL DEVELOPMENT INTO AN INDEPENDENT CLINICAL SCIENTIST IN CARDIOVASCULAR BEHAVIORAL MEDICINE. THE PROPOSED INTENSIVE LONGITUDINAL STUDY FOCUSES ON THE POTENTIAL MECHANISTIC ROLE OF PSYCHOLOGICAL AND PHYSIOLOGICAL STRESS REACTIVITY IN THE ASSOCIATION BETWEEN PTSD SYMPTOMS AND 24-HOUR ABP IN MI PATIENTS. DR. LEE WILL LEVERAGE ECOLOGICAL MOMENTARY ASSESSMENT INCLUDING ABP MONITORING TO EXAMINE THE ASSOCIATION BETWEEN PTSD SYMPTOMS AND STRESS REACTIVITY (MOMENTARY PERCEIVED STRESS AND ABP REACTIVITY) AS IT UNFOLDS DURING THE 6-MONTH POST-MI ADJUSTMENT PERIOD. DATA COLLECTION WILL OCCUR AT THREE TIME POINTS, EACH CONSISTING OF A GOLD-STANDARD CLINICAL ASSESSMENT OF PTSD SYMPTOMS FOLLOWED BY A 7-DAY ECOLOGICAL MOMENTARY ASSESSMENT WITH A 24-HOUR PERIOD OF ABP MONITORING. THE FOLLOWING SPECIFIC AIMS WILL BE ACHIEVED: (1) TEST THE INTRAINDIVIDUAL ASSOCIATION BETWEEN PTSD SYMPTOMS AND STRESS REACTIVITY AND (2) TEST THE ROLE OF STRESS REACTIVITY IN THE INTRAINDIVIDUAL ASSOCIATION BETWEEN PTSD SYMPTOMS AND 24-HOUR ABP. DR. LEE HAS ASSEMBLED AN EXPERT MENTORSHIP TEAM OF LEADING SCIENTISTS IN THE FIELDS OF CLINICAL PSYCHOLOGY, EXPERIMENTAL MEDICINE, BEHAVIORAL CARDIOLOGY, PREVENTIVE CARDIOLOGY, CARDIOVASCULAR EPIDEMIOLOGY, AND INTENSIVE LONGITUDINAL MODELING. THE MIRIAM HOSPITAL AND ALPERT MEDICAL SCHOOL OF BROWN UNIVERSITY ARE IDEALLY RESOURCED ENVIRONMENTS FOR DR. LEE TO SUCCESSFULLY CARRY OUT THE PROPOSED TRAINING AND STUDY. DR. LEE’S K23 TRAINING PLAN AND PROJECT ALIGN WITH THE NHLBI RESEARCH PRIORITY REGARDING MECHANISMS WHEREBY PSYCHOSOCIAL STRESS CONTRIBUTES TO ISCHEMIC HEART DISEASE PROGRESSION. TO THIS END, DR. LEE WILL EMERGE FROM THIS FIVE-YEAR MENTORED AWARD AS AN INDEPENDENT INVESTIGATOR WHO WILL CONTRIBUTE TO OUR KNOWLEDGE ABOUT STRESS REACTIVITY AS A MODIFIABLE MECHANISM FOR DISRUPTING THE RELATIONSHIP BETWEEN PTSD SYMPTOMS AND POOR CARDIOVASCULAR HEALTH IN MI PATIENTS.
Department of Health and Human Services
$368.8K
FECAL BACTERIOTHERAPY FOR RELAPSING CLOSTRIDIUM DIFFICILE INFECTION
Department of Health and Human Services
$361.1K
EXAMINING A TEXT MESSAGE INTERVENTION FOR SMOKING CESSATION
National Science Foundation
$354.8K
STRESS RESPONSE & THE ADOLESCENT TRANSITION
Department of Health and Human Services
$354.1K
PRISONER OVERDOSE TRAINING AND NALOXONE UPON RELEASE
Department of Health and Human Services
$321.5K
PILOT STUDY TO MONITOR HIV CLUSTER DYNAMICS AND ACTIVE HIV SUB-EPIDEMICS IN REAL TIME
Department of Health and Human Services
$317.8K
SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE
Department of Health and Human Services
$309.9K
IMPACT OF ALCOHOL USE AND HIV INFECTION ON BRAIN CONNECTIVITY ABNORMALITIES
Department of Health and Human Services
$306K
ADDRESSING EMOTIONAL AND COGNITIVE FACTORS IN BEHAVIORAL WEIGHT LOSS TREATMENT
Department of Health and Human Services
$300.9K
ANTIVIRAL THERAPY AND HIV IN THE GENITAL TRACT OF WOMEN
National Science Foundation
$299.7K
COLLABORATIVE RESEARCH: SCH: AI-DRIVEN RFID SENSING FOR SMART HEALTH APPLICATIONS -MANY EXISTING HEALTH MONITORING SYSTEMS ARE EXPENSIVE, UNCOMFORTABLE TO WEAR, OR CAN ONLY BE ADMINISTERED IN A HOSPITAL ENVIRONMENT. WITH ADVANCES IN THE INTERNET OF THINGS (IOT) AND MACHINE LEARNING (ML)/ARTIFICIAL INTELLIGENCE (AI), IT IS HIGHLY DESIRABLE TO DEVELOP AI-DRIVEN RADIO FREQUENCY SENSING TECHNIQUES TO MAKE SMART HEALTH MONITORING CHEAPER, MORE COMFORTABLE TO USE, AND MORE ACCESSIBLE TO THE BROAD POPULATION, WHILE SUPPORTING EXCELLENT MONITORING PERFORMANCE. THE MAIN CHALLENGES TO ACHIEVING SUCH GOALS ARE THE NOISY RF DATA AND STRONG INTERFERENCE COMING FROM THE DYNAMIC ENVIRONMENT. A MULTI-DISCIPLINARY TEAM OF SIX INVESTIGATORS WITH COMPLEMENTARY EXPERTISE WILL WORK CLOSELY TOGETHER TO SIGNIFICANTLY IMPROVE THE STATE-OF-THE-ART OF RADIO FREQUENCY SENSING BASED SMART HEALTHCARE PROVISIONING AND MAKE A SIGNIFICANT STEP FORWARD TO FULLY HARVEST THE POTENTIAL OF THE IOT AND ML/AI. THE TEAM OF INVESTIGATORS WILL ALSO JOINTLY DEVELOP A NEW GRADUATE-LEVEL COURSE ON DEEP LEARNING EMPOWERED RF HEALTH SENSING AND ENHANCE THEIR UNDERGRADUATE AND GRADUATE LEVEL COURSES. THE PROJECT WILL ALSO ENGAGE STUDENTS BY PROVIDING HANDS-ON EXPERIENCE WITH CUTTING-EDGE TECHNOLOGIES THAT ARE AT THE VERY FRONTIER OF WIRELESS SENSING, DEEP LEARNING, AND SMART HEALTH. OUTCOMES FROM THIS PROJECT WILL BE DISSEMINATED THROUGH TECHNICAL PUBLICATIONS, CONFERENCE KEYNOTES, DISTINGUISHED LECTURES AND TUTORIALS, A PROJECT WEBSITE, AND OPEN-SOURCE REPOSITORIES. THE INVESTIGATORS ARE COMMITTED TO BROADENING PARTICIPATION FROM UNDERREPRESENTED GROUPS, THROUGH THEIR INSTITUTIONAL OUTREACH PROGRAMS AND THE NSF RESEARCH EXPERIENCES FOR UNDERGRADUATES AND RESEARCH EXPERIENCES FOR TEACHERS PROGRAMS. THIS PROJECT DEVELOPS RADIO FREQUENCY IDENTIFICATION (RFID) BASED SENSING SYSTEMS FOR SMART HEALTH MONITORING. SPECIFICALLY, SEVERAL FUNDAMENTAL PROBLEMS WILL BE INVESTIGATED, AND NOVEL ML/AI TECHNIQUES WILL BE DEVELOPED FOR RFID SENSING BASED SMART HEALTH APPLICATIONS. THIS PROJECT LEVERAGES PASSIVE RFID TAGS AS WEARABLE SENSORS FOR MONITORING HUMAN HEALTH CONDITIONS TO HELP DIAGNOSE DISEASES SUCH AS PARKINSON?S AND INTERSTITIAL LUNG DISEASE. ML/AI-DRIVEN METHODS, SUCH AS TENSOR DECOMPOSITION, TRANSFER LEARNING (VIA DOMAIN ADAPTATION AND META-LEARNING), DEEP GAUSSIAN PROCESSES, AND FEDERATED LEARNING WILL BE INCORPORATED TO DEVELOP EFFECTIVE SOLUTIONS TO THESE CHALLENGING PROBLEMS. THE RESEARCH AGENDA CONSISTS OF FOUR WELL INTEGRATED THRUSTS: (I) TO INVESTIGATE THE CHALLENGES AND FUNDAMENTAL PERFORMANCE LIMITS OF THE SENSORS; (II) TO DEVELOP RFID-BASED RESPIRATION RATE, PULMONARY FUNCTION TEST, AND HEARTBEAT SIGNAL MONITORING SCHEMES; (III) TO DEVELOP RFID-BASED POSE MONITORING, ACTIVITY RECOGNITION, AND PD DETECTION SYSTEMS; AND (IV) TO DEVELOP ROBUST AND FAIR FEDERATED LEARNING MODELS FOR HANDLING HEALTH DATA. THE PROJECT?S ALGORITHMS WILL BE IMPLEMENTED AND VALIDATED WITH EXTENSIVE EXPERIMENTS IN EMULATED AND REAL CLINICAL ENVIRONMENTS, WITH A FOCUS ON TWO IMPORTANT SMART HEALTH APPLICATIONS, PARKINSON?S DISEASE DETECTION AND BREATHING-BASED INTERSTITIAL LUNG DISEASE DETECTION. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.
Department of Health and Human Services
$266.6K
PREVENTING ALCOHOL MISUSE AND CONSEQUENCES IN VULNERABLE WOMEN
Department of Health and Human Services
$253.8K
MACHINE LEARNING METHODS TO ASSESS RISK FOR PRENATAL AND NEONATAL IRON DEFICIENCY ANEMIA FROM MATERNAL STRESS EXPOSURE - PROJECT SUMMARY THIS K99 APPLICATION AIMS TO DETERMINE BIOLOGICAL AND BEHAVIORAL PATHWAYS BY WHICH MATERNAL PSYCHOSOCIAL STRESS IN PREGNANCY IMPACTS RISK FOR MATERNAL AND INFANT IRON DEFICIENCY ANEMIA (IDA). IDA IS ONE OF THE MOST COMMON CAUSES OF ANEMIA WORLDWIDE, AND AROUND 20% OF WOMEN IN THE US EXPERIENCE A STRESSFUL LIFE EVENT THROUGHOUT THEIR PREGNANCY. DUE TO THE INCREASED IRON DEMANDS OF PREGNANCY, PREGNANCY ITSELF POSES A SIGNIFICANT RISK OF IDA, ESPECIALLY FOR LOW-INCOME AND RACIALLY- AND ETHNICALLY-MINORITIZED WOMEN. IDA INCREASES THE RISK OF ADVERSE PREGNANCY OUTCOMES AND CAN NEGATIVELY IMPACT THE IRON STATUS OF THE NEONATE THAT MAY CAUSE IRREVERSIBLE HARM TO NEURODEVELOPMENT. THERE IS GROWING CONCERN THAT ORAL VITAMIN SUPPLEMENTATION MIGHT NOT BE ENOUGH TO COUNTERACT THE RISKS OF IDA IN THE CONTEXT OF SYSTEMIC INFLAMMATION, INCLUDING INFLAMMATION PRODUCED BY CHRONIC PSYCHOSOCIAL STRESS AND SUBSEQUENT NEUROENDOCRINE DYSREGULATION. MATERNAL PSYCHOSOCIAL STRESS HAS BEEN ASSOCIATED WITH INFANT IRON STATUS PREVIOUSLY, BUT THE POTENTIAL BIOLOGICAL MECHANISMS ARE NOT YET CHARACTERIZED DESPITE THE
Department of Health and Human Services
$238.6K
TRIAL OF ORAL DOXYCYCLINE FOR THE TREATMENT OF CHILDHOOD LYME MENINGITIS
Department of Health and Human Services
$228.4K
IMAGING THE DEVELOPING FETAL BRAIN: NOVEL MARKERS OF RISK FOR MATERNAL SMOKING
Department of Health and Human Services
$223.5K
HUMAN-CENTERED DESIGN OF A BEHAVIORAL INTERVENTION TO REVERSE SMALL WEIGHT REGAINS DURING WEIGHT LOSS MAINTENANCE - PROJECT SUMMARY/ABSTRACT WEIGHT LOSS MAINTENANCE (WLM) IS THE MOST PRESSING ISSUE IN CURRENT OBESITY TREATMENTS. WLM PROGRAMS MITIGATE, BUT DO NOT PREVENT, WEIGHT REGAIN AND INDIVIDUALS WHO LOSE WEIGHT HAVE TROUBLE RE-INSTATING WEIGHT LOSS EFFORTS DESPITE HAVING USED THEM EFFECTIVELY DURING WEIGHT LOSS. ACTIVE INTERVENTION TO RETURN TO WEIGHT LOSS BEHAVIORS IMMEDIATELY FOLLOWING A SMALL REGAIN MAY PREVENT FURTHER REGAIN AND AID IN LONG-TERM WLM, BUT HAS NOT BEEN SYSTEMATICALLY TESTED. THE MAINTAIN STUDY EXAMINED WHETHER A BRIEF TELEPHONE-BASED COACHING INTERVENTION COULD HELP REVERSE SMALL WEIGHT REGAINS FOLLOWING PARTICIPATION IN A BEHAVIORAL WEIGHT LOSS INTERVENTION (BWLI) COMPARED TO NO INTERVENTION CONTROL. THE COACHING GROUP SHOWED STATISTICALLY-SIGNIFICANT IMPROVEMENTS IN WEIGHT COMPARED TO THE CONTROL GROUP FROM PRE- TO POST-COACHING, BUT WEIGHTS WERE NOT SIGNIFICANTLY DIFFERENT AT THE 12-MONTH STUDY END POINT. THUS, ADDITIONAL RESEARCH IS WARRANTED TO INFORM INTERVENTION MODIFICATIONS TO MAXIMIZE THE LONG-TERM EFFECTIVENESS OF PROVIDING COACHING AT THE POINT OF INITIAL REGAIN. THIS R03 SMALL GRANT PROGRAM FOR NIDDK K RECIPIENTS PROPOSAL SEEKS TO OPTIMIZE AND REFINE THE MAINTAIN PHONE COACHING INTERVENTION TO PROMOTE RECOVERY FROM SMALL WEIGHT REGAIN DURING WLM. SPECIFICALLY, THE DOUBLE DIAMOND MODEL, A 4-PHASE HUMAN-CENTERED DESIGN (HCD) PROCESS, WILL BE USED TO GUIDE INTERVENTION REFINEMENT TO SUPPORT RECOVERY FROM REGAINS IN THE SHORT AND LONG-TERM. HCD FOCUSES ON ENHANCING THE USABILITY OF A PRODUCT TO IMPROVE EFFECTIVENESS, EFFICIENCY, AND SATISFACTION AND CAN BE UTILIZED TO OPTIMIZE BEHAVIORAL INTERVENTIONS. AS PART OF THIS PROCESS, FOR AIM 1 THE RESEARCH TEAM WILL EXAMINE THE PSYCHOLOGICAL AND BEHAVIORAL MECHANISMS OF COACHING AND HOW LONG COACHING EFFECTS PERSIST FOLLOWING INTERVENTION IN THE MAINTAIN STUDY. THEY WILL ALSO ENGAGE IN QUALITATIVE INTERVIEWS WITH INDIVIDUALS WITH LIVED EXPERIENCE REGAINING WEIGHT AND RECOVERING FROM WEIGHT REGAIN. NEXT FOR AIM 2, THE MAINTAIN INTERVENTION WILL BE REFINED USING DATA-DRIVEN DESIGN CHOICES AND HCD PRINCIPLES. THE PRODUCT OF THIS PROJECT WILL BE A REVISED MAINTAIN INTERVENTION PROTOCOL AND MATERIALS FOR EFFICACY TESTING IN A FUTURE FULLY POWERED RANDOMIZED-CONTROLLED TRIAL. THE RESEARCH ACTIVITIES PROPOSED IN THIS R03 AWARD WILL PROVIDE THE OPPORTUNITY TO FINE-TUNE SKILLS DR. HAYES HAS DEVELOPED THROUGH THE K23, INCLUDING SKILLS RELATED TO LONGITUDINAL DATA ANALYSIS AND INTERVENTION DEVELOPMENT, AND FACILITATE THEIR APPLICATION TO WLM. THIS AWARD WILL BE INTEGRAL TO COMPLETING HER TRANSITION TO INDEPENDENCE BY OPENING UP A NEW, BUT RELATED, PROGRAM OF RESEARCH THAT WILL DIRECTLY LEAD TO AN R01 SUBMISSION AND A POTENTIALLY UNIQUE AND PROMISING MODEL FOR THE MANAGEMENT OF OBESITY AS A CHRONIC DISEASE.
Department of Health and Human Services
$223.5K
OPTIMIZING A WEIGHT NEUTRAL INTERVENTION TO IMPROVE HEALTH AMONG ADULTS OF HIGHER BODY WEIGHT: A MOST PREPARATION PHASE STUDY - PROJECT SUMMARY OBESITY REMAINS A MAJOR PUBLIC HEALTH CONCERN AND IS A LEADING CONTRIBUTOR TO CARDIOMETABOLIC DISEASE. FRONTLINE TREATMENTS AIM TO DIRECTLY FACILITATE WEIGHT LOSS, BUT OUTCOMES ARE VARIABLE AND DIFFICULT TO SUSTAIN. WEIGHT NEUTRAL APPROACHES ARE GAINING SCIENTIFIC, CLINICAL, AND PUBLIC ATTENTION AS AN ALTERNATIVE PATHWAY TO REDUCING CARDIOMETABOLIC RISK FOR INDIVIDUALS OF HIGHER BODY WEIGHT. THESE PROGRAMS SUPPORT IMPROVED QUALITY OF DIETARY INTAKE AND ENGAGEMENT WITH PHYSICAL ACTIVITY WITHOUT ENCOURAGING WEIGHT LOSS, AND TARGET NOVEL ‘WEIGHT NEUTRAL’ MECHANISMS TO SUPPORT ADHERENCE OVER TIME (E.G., EATING IN RESPONSE TO HUNGER/SATIETY CUES, DISENGAGING FROM RIGID RULES ABOUT FOOD, INCREASED BODY APPRECIATION, COMBATING WEIGHT-RELATED STIGMA, AND PROMOTING PHYSICAL ACTIVITY FOR ENJOYMENT.) DESPITE GROWING INTEREST, EFFICACY FOR WEIGHT NEUTRAL INTERVENTIONS ON CARDIOMETABOLIC HEALTH, ALONG WITH THE GENERALIZABILITY, SCALABILITY, AND SUSTAINABILITY OF TREATMENT EFFECTS IS NOT ESTABLISHED. ADDITIONALLY, THERE IS SIGNIFICANT VARIABILITY IN HOW THE WEIGHT NEUTRAL PROGRAMS ARE DESIGNED (I.E., WHICH WEIGHT NEUTRAL MECHANISMS ARE TARGETED AND HOW), LEAVING IT UNCLEAR WHICH WEIGHT NEUTRAL MECHANISMS MEANINGFULLY CONTRIBUTE TO TREATMENT EFFECTS. THE GOAL OF THIS R03 IS TO USE THE MULTIPHASE OPTIMIZATION STRATEGY (MOST) TO BUILD A CLEARLY DEFINED WEIGHT NEUTRAL INTERVENTION THAT EFFECTIVELY TARGETS THE WEIGHT NEUTRAL MECHANISMS THAT ARE CENTRAL TO THIS THERAPEUTIC APPROACH. CANDIDATE WEIGHT NEUTRAL COMPONENTS WILL INCLUDE THE FOLLOWING EXISTING, EVIDENCE-BASED INTERVENTIONS WITH DEMONSTRATED EFFECTS ON WEIGHT NEUTRAL MECHANISMS; (1) MINDFULNESS-BASED EATING AWARENESS TRAINING (MECHANISMS: TO INCREASE EATING IN RESPONSE TO HUNGER/SATIETY CUES AND REDUCE RIGID DIETARY RESTRAINT), (2) BODY ACCEPTANCE PROGRAM (MECHANISMS: TO IMPROVE BODY APPRECIATION AND REDUCE INTERNALIZED WEIGHT-RELATED BIAS), AND (3) A TAILORED INTERVENTION TO PROMOTE ENJOYMENT OF PHYSICAL ACTIVITY (MECHANISM: ENJOYMENT OF PHYSICAL ACTIVITY). WEIGHT NEUTRAL COMPONENTS WILL COMPLEMENT A CORE INTERVENTION OF STANDARDIZED EDUCATION ON HEALTHY DIET (EMPHASIZING THE MEDITERRANEAN DIET) AND PHYSICAL ACTIVITY GUIDELINES FOR AMERICANS (I.E., AEROBIC ACTIVITY, MUSCLE STRENGTHENING AND SEDENTARY BEHAVIOR). BEFORE EVERY POTENTIAL COMBINATION OF CORE + CANDIDATE WEIGHT NEUTRAL COMPONENTS CAN BE TESTED IN A FULLY POWERED FACTORIAL EXPERIMENT, WE WILL CONDUCT NECESSARY PILOT TESTING IN THIS PREPARATION PHASE STUDY TO ENSURE WE CAN RECRUIT OUR TARGET SAMPLE AND DELIVER THE NOVEL COMBINATIONS OF WEIGHT NEUTRAL COMPONENTS AS INTENDED. TO MAKE STRATEGIC USE OF RESOURCES, A FRACTIONAL FACTORIAL DESIGN WILL BE DEPLOYED. THE CORE INTERVENTION AND CONDITIONS WITH 2+ WEIGHT NEUTRAL CANDIDATE COMPONENTS WILL BE PILOT TESTED. SMALL GROUPS OF RACIALLY/ETHNICALLY DIVERSE ADULTS WITH BMI 25-40KG/M2 (N=50) WILL BE RECRUITED AND RANDOMLY ASSIGNED TO ONE OF THE FIVE TREATMENT COMBINATIONS. THIS PROJECT WILL LEVERAGE THE EXPERTISE THE PI HAS DEVELOPED THROUGH COMPLETION OF HER NIDDK-FUNDED K23 AND ENHANCE HER CAPACITY TO TRANSITION TO INDEPENDENCE BY LAUNCHING A RELATED BUT DISTINCT LINE OF RESEARCH INVESTIGATING THE HEALTH BENEFITS OF WEIGHT NEUTRAL LIFESTYLE INTERVENTIONS FOR INDIVIDUALS OF HIGHER BODY WEIGHT.
Department of Health and Human Services
$219K
EXAMINATION OF THE FEASIBILITY AND PRELIMINARY EFFICACY OF YOGA AS AN INTERVENTION APPROACH TO IMPROVING LONG-TERM WEIGHT LOSS
Department of Health and Human Services
$200.8K
AN AI-BASED CHATBOT FOR DOXYCYCLINE AS POST-EXPOSURE PROPHYLAXIS AMONG MEN WHO HAVE SEX WITH MEN - BACTERIAL SEXUALLY TRANSMITTED INFECTIONS (STIS)—INCLUDING SYPHILIS, GONORRHEA, AND CHLAMYDIA—ARE INCREASING IN THE UNITED STATES, WITH DISPROPORTIONATELY HIGH RATES AMONG MEN WHO HAVE SEX WITH MEN (MSM). THESE INFECTIONS CAN LEAD TO SERIOUS HEALTH COMPLICATIONS SUCH AS NEUROLOGICAL AND CARDIOVASCULAR SYPHILIS, INFERTILITY, PELVIC INFLAMMATORY DISEASE, AND INCREASED HIV TRANSMISSION. DOXYCYCLINE, A WIDELY AVAILABLE AND SAFE ANTIBIOTIC, HAS SHOWN PROMISE AS POST-EXPOSURE PROPHYLAXIS (DOXY-PEP) TO PREVENT BACTERIAL STIS. MOTIVATIONAL INTERVIEWING (MI) IS EFFECTIVE IN PROMOTING HIV PREVENTION BEHAVIORS, ESPECIALLY WHEN PAIRED WITH THE TRANSTHEORETICAL MODEL (TTM) TO ASSESS READINESS FOR CHANGE AND TAILOR MESSAGING. HOWEVER, TRADITIONAL MI REQUIRES MULTIPLE SESSIONS AND IS RESOURCE-INTENSIVE. THIS PILOT STUDY AIMS TO OVERCOME THOSE LIMITATIONS BY DEVELOPING AND TESTING SAI (STI PREVENTION AI-CHATBOT), AN AI-BASED CHATBOT POWERED BY THE LATEST CHATGPT MODEL. IN SPECIFIC AIM 1, SAI WILL BE TAILORED TO ASSESS STI RISK AND TTM STAGE, DELIVER STAGE-APPROPRIATE EDUCATION, AND USE MI-BASED COUNSELING TO PROMOTE DOXY-PEP UPTAKE AMONG MSM. IN SPECIFIC AIM 2, WE WILL CONDUCT AN OPEN PILOT TRIAL WITH 25 ADULT MSM RECRUITED VIA SOCIAL MEDIA TO EVALUATE SAI’S ACCURACY, USABILITY, APPROPRIATENESS, AND USER SATISFACTION, FOLLOWED BY ITERATIVE REFINEMENT. IF SUCCESSFUL, THIS STUDY WILL DEMONSTRATE THE FEASIBILITY OF USING AI TO SCALE BEHAVIORAL INTERVENTIONS FOR STI PREVENTION AND SUPPORT BROADER IMPLEMENTATION OF DOXY-PEP STRATEGIES AMONG HIGH-RISK POPULATIONS. MODIFIED PROJECT TITLE AN AI-BASED CHATBOT FOR DOXYCYCLINE AS POST-EXPOSURE PROPHYLAXIS AMONG MEN WHO HAVE SEX WITH MEN
Department of Health and Human Services
$199.3K
INTEGRATED SMOKING CESSATION AND MOOD MANAGEMENT FOR ACS PATIENTS
Department of Health and Human Services
$186.9K
HIV PREVENTION AND SUBSTANCE USE TREATMENT FOR PEOPLE WITH DRUG USE-ASSOCIATED WOUNDS - PROJECT ABSTRACT THIS TIMELY K01 AWARD FOCUSES ON IDENTIFYING OPTIMAL TREATMENT APPROACHES IN AN EVOLVING DRUG USE LANDSCAPE, WHILE PROVIDING THE PI WITH THE NECESSARY TRAINING TO ADVANCE HER LONG-TERM GOAL OF LEADING IMPACTFUL RESEARCH AT THE INTERSECTION OF SUBSTANCE USE AND INFECTIOUS DISEASES. ALONGSIDE AN UNPRECEDENTED OVERDOSE CRISIS, PEOPLE WHO USE DRUGS ARE FACING AN INCREASE IN INFECTIOUS DISEASE COMPLICATIONS, INCLUDING BACTERIAL INFECTIONS AND WOUNDS COMPLICATED BY DRUG SUPPLY ADDITIVES LIKE XYLAZINE. WHEN PEOPLE RECEIVE HEALTHCARE FOR THESE INFECTIONS, THIS INTERACTION SERVES AS AN IMPORTANT OPPORTUNITY TO PROVIDE OTHER KEY PREVENTION AND TREATMENT SERVICES THAT MIGHT OTHERWISE BE MISSED, LIKE PRE-EXPOSURE PROPHYLAXIS (PREP) AND MEDICATIONS FOR OPIOID USE DISORDER (MOUD). HOWEVER, SEVERAL CHALLENGES PREVENT MANY FROM SEEKING CARE IN TRADITIONAL SETTINGS LIKE CLINICS AND HOSPITALS. IN CONTRAST, NEW MODELS OF CARE PROVIDED THROUGH MOBILE CLINICS SHOW PROMISE IN IMPROVING CARE QUALITY AND EFFECTIVENESS. THE RESEARCH OBJECTIVE OF THIS K01 IS TO COMPREHENSIVELY EVALUATE AND IDENTIFY OPTIMAL SETTINGS TO IMPROVE MOUD, PREP, AND WOUND CARE OUTCOMES FOR PEOPLE WHO USE DRUGS WITHIN THE CHANGING CONTEXT OF THE DRUG SUPPLY. OUR CENTRAL HYPOTHESIS IS THAT WOUND CARE OFFERED THROUGH MOBILE CLINICS IS ASSOCIATED WITH IMPROVED PATIENT-PROVIDER RELATIONSHIPS AND LOGISTICAL ACCESS, THUS LEADING TO IMPROVED UPTAKE OF PREVENTION AND TREATMENT SERVICES. TO STUDY THIS, WE WILL QUALITATIVELY EXPLORE HOW INTERPERSONAL INTERACTIONS DURING WOUND CARE INFLUENCE CARE EXPERIENCES AND PREFERENCES AMONG PEOPLE WHO USE DRUGS AND THEIR PROVIDERS. NEXT, WE WILL QUANTITATIVELY EXAMINE THE INFLUENCE OF INDIVIDUAL AND INTERPERSONAL FACTORS ON PREFERENCES IN INTEGRATED WOUND CARE, PREP, AND MOUD BY LEVERAGING AN EXISTING COHORT STUDY OF PEOPLE WHO USE DRUGS. FINALLY, WE WILL CONDUCT A MIXED METHODS ANALYSIS TO ASSESS INDIVIDUAL AND ORGANIZATIONAL DETERMINANTS OF MOUD AND PREP UTILIZATION WITHIN DIFFERENT MODELS OF WOUND CARE (MOBILE SETTINGS VERSUS BRICK-AND-MORTAR SITES) THROUGH AN EXISTING NETWORK OF INNOVATIVE SUBSTANCE USE SERVICES. THROUGH THIS K01 AWARD, THE PI WILL EXPAND UPON HER BACKGROUND IN EPIDEMIOLOGY AND APPLIED RESEARCH BY GAINING COMPLEMENTARY TRAINING IN QUALITATIVE AND MIXED METHODS RESEARCH, MEASUREMENT OF INTERPERSONAL DYNAMICS INFLUENCING TREATMENT DELIVERY, AND IMPLEMENTATION SCIENCE RESEARCH. TRAINING WILL BE GUIDED BY AN EXCEPTIONAL TEAM OF LEADING EXPERTS IN SUBSTANCE USE TREATMENT AND INFECTIOUS DISEASE CARE WHO HAVE OUTSTANDING TRACK RECORDS OF MENTORSHIP AND IMPACTFUL RESEARCH. THROUGH THESE RESEARCH AIMS, THE PI WILL OBTAIN PRELIMINARY DATA TO INFORM SUBSEQUENT STUDIES FOCUSED ON COMPREHENSIVELY EVALUATING NOVEL MODELS OF CARE AMONG PEOPLE WHO USE DRUGS. ULTIMATELY, THIS K01 AWARD WILL SUPPORT THE PI AS SHE PROGRESSES INTO AN INDEPENDENT RESEARCH CAREER FOCUSED ON IDENTIFYING AND ASSESSING NEW APPROACHES IN SUBSTANCE USE AND INFECTIOUS DISEASE CARE AS IT ADAPTS TO THE CHANGING DRUG USE ENVIRONMENT.
Department of Health and Human Services
$186.1K
GAPCARE: THE GERIATRIC ACUTE & POST-ACUTE CARE COORDINATION PROGRAM FOR FALL PREVENTION IN THE EMERGENCY DEPARTMENT
Department of Health and Human Services
$169.4K
EVALUATION OF MANAGEMENT STRATEGIES FOR MAXIMIZING SUPPORTIVE CARE FOR PATIENTS WITH EBOLA VIRUS DISEASE
Department of Health and Human Services
$159.6K
PARENTAL INVOLVEMENT AS A STRATEGY TO ENHANCE ADOLESCENT WEIGHT CONTROL
Department of Health and Human Services
$158.4K
WEB-BASED PHYSICAL ACTIVITY INTERVENTION FOR YOUNG ADULT CANCER SURVIVORS
Department of Health and Human Services
$157.4K
STATISTICAL METHODS FOR ASSESSING PATTERNS OF CHANGE IN CANCER-CONTROL BEHAVIOR
Department of Health and Human Services
$155.5K
POSTPARTUM EXERCISE INTERVENTION FOR PREVIOUSLY SMOKING MOTHERS
Department of Health and Human Services
$153.6K
RESISTANCE TRAINING AS AN AID TO STANDARD SMOKING CESSATION TREATMENT
Department of Health and Human Services
$145.6K
A NOVEL BEHAVIORAL APPROACH FOR THE ADOPTION AND MAINTENANCE OF HABITUAL PHYSICAL ACTIVITY
Department of Health and Human Services
$144.9K
PROMOTION AND PREVENTION IN THE TREATMENT OF OBESITY
Source: Federal Audit Clearinghouse (fac.gov)
No federal single audit records found for this organization.
Single audits are required for entities expending $750,000+ in federal awards annually.
Tax Year 2024 · Source: IRS e-Filed Form 990
Individuals serving as officers, directors, or trustees of the organization.
| Name | Title | Hrs/Wk | Compensation | Related Orgs | Other |
|---|
Source: IRS Publication 78, Auto-Revocation List & e-Postcard Data
Tax-deductible contributions: Yes
Deductibility code: PC
WarningTax-exempt status was revoked on May 15, 2018
Status has NOT been reinstated
Exemption type: 03
Sources: IRS e-Filed Form 990 (XML) & ProPublica Nonprofit Explorer
Scroll →
| Year | Revenue | Contributions | Expenses | Assets | Net Assets |
|---|---|---|---|---|---|
| 2024IRS e-File | $199.1K | $106.6K | $199.4K | $350.7K | $86.9K |
| 2023 | $255.6K | $166.3K | $190.7K | $360.7K | $87.1K |
| 2022 | $174.4K | $79.9K | $189.5K | $22.5K | $22.2K |
| 2021 | $249.7K | $84.8K |
Sources: ProPublica Nonprofit Explorer & IRS e-File Index
| Tax Year | Form Type | Source | Documents |
|---|---|---|---|
| 2024 | 990 | IRS e-File | PDF not yet published by IRSView Filing → |
| 2023 | 990 | DataIRS e-File | |
| 2022 | 990 | DataIRS e-File |
Financial data: IRS e-Filed Form 990 (Tax Year 2024)
Leadership & compensation: IRS e-Filed Form 990, Part VII (Tax Year 2024)
Federal grants: USAspending.gov (live)
Organization info: IRS Business Master File
Tax-deductibility: IRS Publication 78
Revocation status: IRS Auto-Revocation List
| Total |
|---|
| Tami Thomas | Executive Di | — | $0 | $0 | $0 | $0 |
| Bryan Lassiter | President | — | $0 | $0 | $0 | $0 |
| Jim Willard | Vice Preside | — | $0 | $0 | $0 | $0 |
| Cathryn Double | Treasurer | — | $0 | $0 | $0 | $0 |
| Melanie Batchelor | Secretary | — | $0 | $0 | $0 | $0 |
| Vicky Pohoresky | Treasurer | — | $0 | $0 | $0 | $0 |
Tami Thomas
Executive Di
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Bryan Lassiter
President
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Jim Willard
Vice Preside
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Cathryn Double
Treasurer
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Melanie Batchelor
Secretary
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Vicky Pohoresky
Treasurer
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Members of the governing board. Board members often serve without compensation.
| Name | Title | Hrs/Wk | Compensation | Related Orgs | Other | Total |
|---|---|---|---|---|---|---|
| Alyn Lasko | Board Member | — | $0 | $0 | $0 | $0 |
| Betsy Decampo | Board Member | — | $0 | $0 | $0 | $0 |
| Bob Oliver | Board Member | — | $0 | $0 | $0 | $0 |
| Deena Edwards | Board Member | — | $0 | $0 | $0 | $0 |
| Renee Griffin | Board Member | — | $0 | $0 | $0 | $0 |
Alyn Lasko
Board Member
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Betsy Decampo
Board Member
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Bob Oliver
Board Member
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
| $221.6K |
| $39.9K |
| $37.4K |
| 2020 | $179.8K | $83.9K | $210.1K | $12.7K | $9,225 |
| 2019 | $227.5K | $158K | $196.2K | $43.1K | $39.6K |
| 2018 | $105.2K | — | $103.1K | $8,632 | — |
| 2017 | $64.1K | — | $78.9K | $7,744 | — |
| 2021 | 990 | Data |
| 2020 | 990 | Data | PDF not yet published by IRS |
| 2019 | 990 | Data |
| 2018 | 990-EZ | Data | PDF not yet published by IRS |
| 2017 | 990-EZ | Data |
Deena Edwards
Board Member
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0
Renee Griffin
Board Member
$0
Hrs/Wk
—
Compensation
$0
Related Orgs
$0
Other
$0