Key result
This protocol describes a 6-month Sequential Multi-Assignment, Randomized Trial comparing location-based versus standard remote messaging to improve physical activity in African American women.
Why the study?
Physical activity reduces cardiovascular disease risk, but interventions focused on African American women living in resource-limited communities with scarce physical activity infrastructure are needed.
Does location-based remote messaging improve physical activity levels compared to standard remote messaging in African American women in resource-limited communities?
RCT
Sequential Multi-Assignment, Randomized Trial (SMART)
Does location-based remote messaging improve physical activity levels compared to standard remote messaging in African American women in resource-limited communities?
This protocol describes a SMART design to evaluate an adaptive mHealth intervention using location-based messaging to increase physical activity in African American women.
Supports mHealth PA protocol testing in AA women; leaves open effects on PA levels or CVD outcomes.
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.
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Tamura et al. (2020) conducted an RCT in Physical inactivity. Location-based remote messaging ('tailored-to-place') vs. Standard remote messaging was evaluated on Physical activity level. This protocol describes a 6-month Sequential Multi-Assignment, Randomized Trial comparing location-based versus standard remote messaging to improve physical activity in African American women.
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