Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity
Sophie E Claudel,
Joniqua N Ceasar,
Marcus R Andrews,
Valerie M Mitchell,
Kosuke Tamura,
Gwenyth R Wallen,
Nithya P Vijayakumar,
James F Troendle,
Kaveri Curlin,
Sam J Neally,
Billy S Collins,
Yvonne Baumer,
Cristhian A Gutierrez-Huerta,
Rafique Islam,
Briana S Turner,
Kathryn G Tippey,
Shayne Giuliano,
Regina McCoy,
Jessica Zahurak,
Sharon Lambert,
Philip J Moore,
Mary Douglas-Brown,
Tonya Dodge,
Tiffany M Powell-Wiley
Affiliations
Sophie E Claudel
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Joniqua N Ceasar
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Marcus R Andrews
Cardiovascular Branch, NHLBI, Bethesda, Maryland, USA
Valerie M Mitchell
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, NHLBI, Bethesda, Maryland, USA
Kosuke Tamura
Cardiovascular Branch, NHLBI, Bethesda, Maryland, USA
Gwenyth R Wallen
Translational Biobehavioral and Health Disparities Branch, National Institutes of Health Clinical Center, Bethesda, Maryland, USA
Nithya P Vijayakumar
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
James F Troendle
Office of Biostatistics Research, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Kaveri Curlin
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Sam J Neally
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Billy S Collins
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Yvonne Baumer
The Social Determinants of Obesity and Cardiovascular Risk Laboratory, National Heart Lung and Blood Institute, Bethesda, Maryland, USA
Cristhian A Gutierrez-Huerta
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Rafique Islam
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Briana S Turner
Social Determinants of Obesity and Cardiovascular Risk Laboratory, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
Kathryn G Tippey
University of North Carolina, Nutrition Obesity Research Center, Lineberger Comprehensive Cancer Center, Connected Health Applications and Interventions (CHAI) Core, Chapel Hill, North Carolina, USA
Shayne Giuliano
University of North Carolina, Nutrition Obesity Research Center, Lineberger Comprehensive Cancer Center, Connected Health Applications and Interventions (CHAI) Core, Chapel Hill, North Carolina, USA
Regina McCoy
University of North Carolina, Nutrition Obesity Research Center, Lineberger Comprehensive Cancer Center, Connected Health Applications and Interventions (CHAI) Core, Chapel Hill, North Carolina, USA
Jessica Zahurak
University of North Carolina, Nutrition Obesity Research Center, Lineberger Comprehensive Cancer Center, Connected Health Applications and Interventions (CHAI) Core, Chapel Hill, North Carolina, USA
Sharon Lambert
Department of Psychological and Brain Sciences, George Washington University, Washington, District of Columbia, USA
Philip J Moore
Department of Psychological and Brain Sciences, George Washington University, Washington, District of Columbia, USA
Mary Douglas-Brown
Health Ministry, Pilgrim Rest Baptist Church, Washington, DC, USA
Tonya Dodge
Department of Psychological and Brain Sciences, George Washington University, Washington, District of Columbia, USA
Tiffany M Powell-Wiley
The Social Determinants of Obesity and Cardiovascular Risk Laboratory, National Heart Lung and Blood Institute, Bethesda, Maryland, USA
Introduction Although physical activity (PA) reduces cardiovascular disease (CVD) risk, physical inactivity remains a pressing public health concern, especially among African American (AA) women in the USA. PA interventions focused on AA women living in resource-limited communities with scarce PA infrastructure are needed. Mobile health (mHealth) technology can increase access to PA interventions. We describe the development of a clinical protocol for a multilevel, community-based, mHealth PA intervention for AA women.Methods and analysis An mHealth intervention targeting AA women living in resource-limited Washington, DC communities was developed based on the socioecological framework for PA. Over 6 months, we will use a Sequential Multi-Assignment, Randomized Trial approach to compare the effects on PA of location-based remote messaging (named ‘tailored-to-place’) to standard remote messaging in an mHealth intervention. Participants will be randomised to a remote messaging intervention for 3 months, at which point the intervention strategy will adapt based on individuals’ PA levels. Those who do not meet the PA goal will be rerandomised to more intensive treatment. Participants will be followed for another 3 months to determine the contribution of each mHealth intervention to PA level. This protocol will use novel statistical approaches to account for the adaptive strategy. Finally, effects of PA changes on CVD risk biomarkers will be characterised.Ethics and dissemination This protocol has been developed in partnership with a Washington, DC-area community advisory board to ensure feasibility and acceptability to community members. The National Institutes of Health Intramural IRB approved this research and the National Heart, Lung, and Blood Institute provided funding. Once published, results of this work will be disseminated to community members through presentations at community advisory board meetings and our quarterly newsletter.Trial registration number NCT03288207.
