Bump Inc

CLINICAL TESTING AND REFINEMENT OF BUMPTUP®: A MOBILE HEALTH APP TO INCREASE PHYSICAL ACTIVITY AND IMPROVE OBSTETRIC OUTCOMES AMONG PREGNANT AND POSTPARTUM WOMEN - PROJECT SUMMARY U.S. MATERNAL MORTALITY RATES HAVE RISEN BY 63.7% SINCE 2019, MAKING THE U.S. THE MOST DANGEROUS DEVELOPED NATION TO GIVE BIRTH IN. A MAJOR CONTRIBUTOR IS THAT MANY WOMEN ARE BECOMING PREGNANT WITH CHRONIC HEALTH CONDITIONS LIKE OBESITY, HYPERTENSION, AND DIABETES. UNDERSERVED AND MINORITY WOMEN ARE PARTICULARLY VULNERABLE TO CHRONIC HEALTH CONDITIONS (E.G. BLACK WOMEN ARE 2.3 TIMES MORE LIKELY TO BE OVERWEIGHT COMPARED TO WHITE WOMEN) AND POOR PREGNANCY OUTCOMES (E.G. BLACK WOMEN ARE 2.6 TIMES MORE LIKELY TO SUFFER A PREGNANCY-RELATED DEATH THAN WHITE WOMEN). THESE POPULATIONS ALSO HAVE LIMITED ACCESS TO PRENATAL CARE (6.9 MILLION WOMEN OF CHILDBEARING AGE HAVE LITTLE OR NO ACCESS TO MATERNAL HEALTH CARE). FORTUNATELY, PHYSICAL ACTIVITY DURING AND AFTER PREGNANCY IMPROVES MATERNAL AND INFANT OUTCOMES. PROFESSIONALS RECOMMEND ALL PREGNANT WOMEN EXERCISE FOR 150 MINUTES PER WEEK. HOWEVER, LESS THAN 15% OF PREGNANT WOMEN MEET THESE GUIDELINES BECAUSE THEY LACK TIME AND RESOURCES, FEAR THEY WILL HARM THE UNBORN BABY, OR HAVE PREGNANCY- RELATED SYMPTOMS (E.G. FATIGUE, NAUSEA, DISCOMFORT). THERE REMAINS A SIGNIFICANT, UNMET NEED TO DEVELOP EFFECTIVE INTERVENTION STRATEGIES TO REDUCE OBESITY RATES AND INCREASE PHYSICAL ACTIVITY IN PREGNANT AND POSTPARTUM WOMEN. TO ADDRESS THIS NEED, BUMPTUP LABS, INC. CREATED BUMPTUP®, THE FIRST MOBILE HEALTH APP TO PROVIDE PREGNANT AND POSTPARTUM WOMEN WITH CAREFUL SCREENING AND EVIDENCE-BASED, SAFE EXERCISE PROGRAMMING. STRONG PRELIMINARY DATA SUPPORT THE APP’S POTENTIAL FOR IMPACT, BUT MORE WORK IS NEEDED TO TEST THE APP’S EFFICACY FOR IMPROVING KEY HEALTH OUTCOMES. THE OBJECTIVE OF THIS PROJECT IS TO CONDUCT A CLINICAL TRIAL TO DEMONSTRATE BUMPTUP®’S EFFICACY, WHILE ALSO UTILIZING REAL-TIME CUSTOMER FEEDBACK TO ENHANCE THE APP’S EXPERIENCE AND FEATURES. BUMPTUP® SEEKS TO ENTER THE MARKET OF MHEALTH APPS THROUGH BUSINESS-TO- CONSUMER AND BUSINESS-TO-BUSINESS SALES. DURING PHASE I, THE FOLLOWING AIMS WILL BE COMPLETED: AIM 1— CONDUCT A RANDOMIZED CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFICACY OF BUMTPUP® FOR INCREASING PHYSICAL ACTIVITY LEVELS DURING PREGNANCY (13-15, 23-25, AND 35-37 WEEKS GESTATION) AND POSTPARTUM (6 AND 12 WEEKS). AIM 2—PERFORM DESIGN CHANGES TO BUMPTUP® IN RESPONSE TO RESULTS FROM THE COMPLETED CLINICAL TRIAL TO IMPROVE USABILITY AND ALGORITHM PERFORMANCE. THESE GOALS SUPPORT THE NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT’S MISSION TO IMPROVE REPRODUCTIVE HEALTH. AT THE END OF PHASE I, BUMPTUP LABS WILL HAVE CLINICAL TRIAL DATA TO DEMONSTRATE ITS EFFICACY AND A REFINED APP THAT IS PREPPED FOR SUCCESS IN COMMERCIAL MARKET SPACES. DURING PHASE II, A NEW APP FEATURE—A MOBILE MATERNAL AND FETAL HEART RATE MONITOR—WILL BE ENGINEERED AND SYNCED WITH THE APP TO PROVIDE ADDITIONAL REASSURANCE TO MOTHERS DURING EXERCISE. WE WILL ALSO MAKE ADDITIONAL APP ADAPTATIONS TO MEET THE SPECIFIC NEEDS OF UNDERSERVED SUBGROUPS (BLACK, LOW SOCIOECONOMIC STATUS, RURAL). OVERALL, THE DEVELOPMENT OF BUMPTUP® IS EXPECTED TO IMPROVE MATERNAL HEALTH OUTCOMES WHILE LOWERING HEALTHCARE COSTS FOR CONSUMERS AND INSURANCE COMPANIES.

THIS GRANT SUPPORTS THE COSTS INCURRED TO IMPLEMENT MEASURES TO RESPOND TO THE NOVEL CORONAVIRUS 2019 (COVID-19), WHICH MAY INCLUDE WORKPLACE SAFETY, MARKET PIVOTS, RETROFITTING FACILITIES, TRANSPORTATION, WORKER HOUSING, AND MEDICAL EXPENSES. IT PROVIDES NEEDED RELIEF TO THE FOOD PROCESSORS, DISTRIBUTORS, FARMERS MARKETS, AND PRODUCERS FOR THEIR COSTS INCURRED BETWEEN JANUARY 27, 2020, THE DATE UPON WHICH THE PUBLIC HEALTH EMERGENCY WAS DECLARED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICE (HHS) UNDER SECTION 319 OF THE PUBLIC HEALTH SERVICE ACT, AND DECEMBER 31, 2021. BENEFICIARIES INCLUDE THE EMPLOYEES OF THE FOOD PROCESSORS, DISTRIBUTORS, FARMERS MARKETS, AND PRODUCERS.