IntroductionAlthough 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 analysisAn 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 disseminationThis 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 numberNCT03288207.
Background
Innovative analyses of cardiovascular (CV) risk markers and health behaviors linked to neighborhood stressors are essential to further elucidate the mechanisms by which adverse neighborhood social conditions lead to poor CV outcomes. We propose to objectively measure physical activity (PA), sedentary behavior, and neighborhood stress using accelerometers, GPS, and real-time perceived ecological momentary assessment via smartphone apps and to link these to biological measures in a sample of White and African American women in Washington, DC, neighborhoods.
Objective
The primary aim of this study is to test the hypothesis that living in adverse neighborhood social conditions is associated with higher stress-related neural activity among 60 healthy women living in high or low socioeconomic status neighborhoods in Washington, DC. Sub-aim 1 of this study is to test the hypothesis that the association is moderated by objectively measured PA using an accelerometer. A secondary objective is to test the hypothesis that residing in adverse neighborhood social environment conditions is related to differences in vascular function. Sub-aim 2 of this study is to test the hypothesis that the association is moderated by objectively measured PA. The third aim of this study is to test the hypothesis that adverse neighborhood social environment conditions are related to differences in immune system activation.
Methods
The proposed study will be cross-sectional, with a sample of at least 60 women (30 healthy White women and 30 healthy Black women) from Wards 3 and 5 in Washington, DC. A sample of the women (n=30) will be recruited from high-income areas in Ward 3 from census tracts within a 15% of Ward 3’s range for median household income. The other participants (n=30) will be recruited from low-income areas in Wards 5 from census tracts within a 15% of Ward 5’s range for median household income. Finally, participants from Wards 3 and 5 will be matched based on age, race, and BMI. Participants will wear a GPS unit and accelerometer and report their stress and mood in real time using a smartphone. We will then examine the associations between GPS-derived neighborhood variables, stress-related neural activity measures, and adverse biological markers.
Results
The National Institutes of Health Institutional Review Board has approved this study. Recruitment will begin in the summer of 2021.
Conclusions
Findings from this research could inform the development of multilevel behavioral interventions and policies to better manage environmental factors that promote immune system activation or psychosocial stress while concurrently working to increase PA, thereby influencing CV health.
International Registered Report Identifier (IRRID)
PRR1-10.2196/29191
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