Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity

Kosuke Tamura, Nithya P Vijayakumar, James F Troendle, Kaveri Curlin, Sam J Neally, Valerie M Mitchell, Billy S Collins, Yvonne Baumer, Cristhian A Gutierrez-Huerta, Rafique Islam, Briana S Turner, Marcus R Andrews, Joniqua N Ceasar, Sophie E Claudel, Kathryn G Tippey, Shayne Giuliano, Regina McCoy, Jessica Zahurak, Sharon Lambert, Philip J Moore, Mary Douglas-Brown, Gwenyth R Wallen, Tonya Dodge, Tiffany M Powell-Wiley, Kosuke Tamura, Nithya P Vijayakumar, James F Troendle, Kaveri Curlin, Sam J Neally, Valerie M Mitchell, Billy S Collins, Yvonne Baumer, Cristhian A Gutierrez-Huerta, Rafique Islam, Briana S Turner, Marcus R Andrews, Joniqua N Ceasar, Sophie E Claudel, Kathryn G Tippey, Shayne Giuliano, Regina McCoy, Jessica Zahurak, Sharon Lambert, Philip J Moore, Mary Douglas-Brown, Gwenyth R Wallen, Tonya Dodge, Tiffany M Powell-Wiley

Abstract

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.

Keywords: cardiology; health informatics; protocols & guidelines; public health; social medicine; statistics & research methods.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Adapted socioecological model that accounts for various factors affecting an individual’s decision to engage in physical activity. Tailored-to-place messaging will focus on the neighbourhood environment and work/home/church levels of the socioecological model, while standard-remote messaging focuses on the person-level.
Figure 2
Figure 2
Step It Up: A Sequential, Multiple-Assignment Randomised Trial targeting physical activity (PA) with standard and tailored remote messaging. Four intervention types are as follows: (1) TPM followed by TPM+face-to-face coaching, (2) TPM followed by TPM with increased messaging frequency, (3) SRM followed by SRM+face-to-face coaching, (4) SRM followed by TPM. Patients initially randomised to standard remote messaging (SRM) who do not reach goal of 10 000 steps/day by the end of 3 months will be rerandomised to receive tailored-to-place messaging (TPM) or SRM coupled with face-to-face coaching. Similarly, patients initially randomised to TPM who do not reach goal of 10 000 steps/day will be rerandomised to TPM supplemented with face-to-face coaching or increased messaging frequency. BMI, body mass index.
Figure 3
Figure 3
Components of Step It Up app with (A) a dashboard featuring educational modules, daily motivational messages and awards, (B) a goal-setting page and (C, D) graphs to self-monitor physical activity (PA) and health metrics measured by Bluetooth-enabled PA monitor, scale, blood pressure cuff and glucometer. The app also includes a social forum, not pictured.
Figure 4
Figure 4
Examples of standard remote messages, which are goal-based and time-based, in comparison to location-based tailored-to-place messages.

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