Colorado PROFILES, The Colorado Clinical and Translational Sciences Institute (CCTSI)
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Iterative development and pilot testing of a mobile health intervention to increase postpartum weight loss in women at increased risk for cardiometabolic disease


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PROJECT SUMMARY/ABSTRACT BACKGROUND: Certain pregnancy complications sound an early warning for future cardiometabolic disease, often before traditional risk factors manifest. Since about 30% of US women will have at least one of these pregnancy complications, nearly one-third of postpartum women have a risk factor demonstrating elevated risk for cardiovascular disease or diabetes. Postpartum women at elevated cardiometabolic risk are difficult to reach by traditional means, yet preventive interventions can have wide-reaching impact. Mobile health (mHealth) provides an unprecedented opportunity to reach postpartum women, collect detailed behavioral data, allow for tracking of behavior, and intervene in ecologic moments, when real-life decisions are being made. The use of technology in postpartum women at elevated cardiometabolic risk is a novel, scalable approach to a difficult problem. There are currently no evidence-based programs clinically available for this population. CANDIDATE: The candidate is an Assistant Professor in the Division of General Internal Medicine at the University of Colorado School of Medicine and a K12 Building Interdisciplinary Research Careers in Women's Health Research (BIRCWH) Scholar. She received her MD from Harvard Medical School, completed her residency in Internal Medicine at Brigham and Women's Hospital, completed her MPH at the Harvard School of Public Health, and completed a T32 clinical research fellowship at Harvard Medical School. During Dr. Nicklas' BIRCWH K12 award, she has been developing a novel mHealth intervention program called Fit After Baby. She now requires additional training and mentoring in order to iteratively improve, and then pilot test her intervention in order to transition to research independence. Her immediate goals are to acquire critical training in: 1) the analysis of qualitative and quantitative user data, 2) formal training in behavioral theory and user- centered design, 3) mentored training in the conduct of mHealth clinical trials, and 4) training in dissemination and implementation science. Her long term goal career goal is to become a national leader in women's cardiometabolic health and the application of technological interventions for the prevention and treatment of obesity, diabetes, and cardiovascular disease in women. ENVIRONMENT: The environment for this project is outstanding, and draws on the research mentors' expertise in: 1) cardiometabolic disease among women of childbearing age (Dr. Linda Barbour); 2) mHealth research and health promotion clinical trials (Dr. Sheana Bull); 3) cardiovascular risk factors in women and technology based RCTs (Dr. Ellen Seely); and 4) pragmatic trials and implementation science (Dr. Allison Kempe). The candidate has also assembled an interdisciplinary team of consultants to aid in critical areas of research and career development, including an expert in: 1) biostatistics, and design and analysis of clinical trials (Dr. John Kittleson); 2) health behavioral theory (Dr. Jennifer Leiferman), and 3) bioinformatics and user- centered design (Dr. Lisa Schilling). A key consultant on this project is the candidate's technology partner, Digifit. The Center for Research in Implementation Science and Prevention located at the University of Colorado and run by mentor Dr. Allison Kempe is also a major strength of the proposed training program. RESEARCH: During her K12 award the applicant has been developing Fit After Baby, an mHealth program designed for postpartum women whose pregnancy complications revealed elevated risk for cardiometabolic disease. Fit After Baby is an interactive program delivered by a mobile app and a lifestyle coach, designed to increase postpartum weight loss and prevent the development of obesity, diabetes, and cardiovascular disease. The overarching goal of this K23 is to iteratively improve and then pilot test the Fit After Baby program. The proposed research program will advance scientific knowledge by: 1) Rapidly and inexpensively developing and testing an innovative, practical, and scalable mHealth intervention program grounded in behavioral theory tailored for postpartum women at elevated risk for cardiometabolic disease; 2) Developing and refining a model to improve engagement and satisfaction for mHealth intervention programs using an iterative process; and 3) Collecting preliminary efficacy data from a pilot RCT to inform the design of a pragmatic trial for a future R01 application.
Collapse sponsor award id
K23HL133604

Collapse Time 
Collapse start date
2016-09-01
Collapse end date
2021-06-30

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