A Physical Activity and Diet Just-in-Time Adaptive Intervention to Reduce Blood Pressure: The MyBPmyLife Study Rationale and Design

Overview

Journal J Am Heart Assoc

Specialty Cardiology & Vascular Diseases

Date 2024 Jan 16

PMID 38226507

Authors

Jessica R Golbus

V Swetha E Jeganathan

Rachel Stevens

Weena Ekechukwu

Zahera Farhan

Rocio Contreras

Nikhila Rao

Brad Trumpower

Tanima Basu

Evan Luff

Lesli E Skolarus

Mark W Newman

Brahmajee K Nallamothu

Michael P Dorsch

Affiliations

Soon will be listed here.

Abstract

Background: Smartphone applications and wearable devices are promising mobile health interventions for hypertension self-management. However, most mobile health interventions fail to use contextual data, potentially diminishing their impact. The myBPmyLife Study is a just-in-time adaptive intervention designed to promote personalized self-management for patients with hypertension.

Methods And Results: The study is a 6-month prospective, randomized-controlled, remotely administered trial. Participants were recruited from the University of Michigan Health in Ann Arbor, Michigan or the Hamilton Community Health Network, a federally qualified health center network in Flint, Michigan. Participants were randomized to a mobile application with a just-in-time adaptive intervention promoting physical activity and lower-sodium food choices as well as weekly goal setting or usual care. The mobile study application encourages goal attainment through a central visualization displaying participants' progress toward their goals for physical activity and lower-sodium food choices. Participants in both groups are followed for up for 6 months with a primary end point of change in systolic blood pressure. Exploratory analyses will examine the impact of notifications on step count and self-reported lower-sodium food choices. The study launched on December 9, 2021, with 484 participants enrolled as of March 31, 2023. Enrollment of participants was completed on July 3, 2023. After 6 months of follow-up, it is expected that results will be available in the spring of 2024.

Conclusions: The myBPmyLife study is an innovative mobile health trial designed to evaluate the effects of a just-in-time adaptive intervention focused on improving physical activity and dietary sodium intake on blood pressure in diverse patients with hypertension.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05154929.

References

Chandrasekaran R, Katthula V, Moustakas E . Patterns of Use and Key Predictors for the Use of Wearable Health Care Devices by US Adults: Insights from a National Survey. J Med Internet Res. 2020; 22(10):e22443. PMC: 7600024. DOI: 10.2196/22443. View

Brewer L, Jenkins S, Hayes S, Kumbamu A, Jones C, Burke L . Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial. Am Heart J. 2022; 247:1-14. PMC: 9037298. DOI: 10.1016/j.ahj.2022.01.009. View

Krebs P, Duncan D . Health App Use Among US Mobile Phone Owners: A National Survey. JMIR Mhealth Uhealth. 2015; 3(4):e101. PMC: 4704953. DOI: 10.2196/mhealth.4924. View

Spruijt-Metz D, Marlin B, Pavel M, Rivera D, Hekler E, De La Torre S . Advancing Behavioral Intervention and Theory Development for Mobile Health: The HeartSteps II Protocol. Int J Environ Res Public Health. 2022; 19(4). PMC: 8872509. DOI: 10.3390/ijerph19042267. View

Iwane M, Arita M, Tomimoto S, Satani O, Matsumoto M, Miyashita K . Walking 10,000 steps/day or more reduces blood pressure and sympathetic nerve activity in mild essential hypertension. Hypertens Res. 2000; 23(6):573-80. DOI: 10.1291/hypres.23.573. View

Tangney C, Rasmussen H, Richards C, Li M, Appelhans B . Evaluation of a Brief Sodium Screener in Two Samples. Nutrients. 2019; 11(1). PMC: 6356775. DOI: 10.3390/nu11010166. View

Muller-Nordhorn J, Roll S, Willich S . Comparison of the short form (SF)-12 health status instrument with the SF-36 in patients with coronary heart disease. Heart. 2004; 90(5):523-7. PMC: 1768233. DOI: 10.1136/hrt.2003.013995. View

Jeganathan V, Golbus J, Gupta K, Luff E, Dempsey W, Boyden T . Virtual AppLication-supported Environment To INcrease Exercise (VALENTINE) during cardiac rehabilitation study: Rationale and design. Am Heart J. 2022; 248:53-62. DOI: 10.1016/j.ahj.2022.02.012. View

Klasnja P, Hekler E, Shiffman S, Boruvka A, Almirall D, Tewari A . Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015; 34S:1220-8. PMC: 4732571. DOI: 10.1037/hea0000305. View

10.

Arnett D, Blumenthal R, Albert M, Buroker A, Goldberger Z, Hahn E . 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019; 140(11):e596-e646. PMC: 7734661. DOI: 10.1161/CIR.0000000000000678. View

11.

Igarashi Y, Akazawa N, Maeda S . The required step count for a reduction in blood pressure: a systematic review and meta-analysis. J Hum Hypertens. 2018; 32(12):814-824. DOI: 10.1038/s41371-018-0100-z. View

12.

Klasnja P, Smith S, Seewald N, Lee A, Hall K, Luers B . Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps. Ann Behav Med. 2018; 53(6):573-582. PMC: 6401341. DOI: 10.1093/abm/kay067. View

13.

Skolarus L, Cowdery J, Dome M, Bailey S, Baek J, Byrd J . Reach Out Churches: A Community-Based Participatory Research Pilot Trial to Assess the Feasibility of a Mobile Health Technology Intervention to Reduce Blood Pressure Among African Americans. Health Promot Pract. 2017; 19(4):495-505. PMC: 6813820. DOI: 10.1177/1524839917710893. View

14.

Neal D, Engelsma T, Tan J, Craven M, Marcilly R, Peute L . Limitations of the new ISO standard for health and wellness apps. Lancet Digit Health. 2022; 4(2):e80-e82. DOI: 10.1016/S2589-7500(21)00273-9. View

15.

Hellem A, Casetti A, Bowie K, Golbus J, Merid B, Nallamothu B . A Community Participatory Approach to Creating Contextually Tailored mHealth Notifications: myBPmyLife Project. Health Promot Pract. 2023; 25(3):417-427. PMC: 11154014. DOI: 10.1177/15248399221141687. View

16.

Sohn A, Hasnain M, Sinacore J . Impact of exercise (walking) on blood pressure levels in African American adults with newly diagnosed hypertension. Ethn Dis. 2007; 17(3):503-7. View

17.

Springer M, Skolarus L . Community-Based Participatory Research. Stroke. 2019; 50(3):e48-e50. PMC: 6594378. DOI: 10.1161/STROKEAHA.118.024241. View

18.

Joffres M, Falaschetti E, Gillespie C, Robitaille C, Loustalot F, Poulter N . Hypertension prevalence, awareness, treatment and control in national surveys from England, the USA and Canada, and correlation with stroke and ischaemic heart disease mortality: a cross-sectional study. BMJ Open. 2013; 3(8):e003423. PMC: 3758966. DOI: 10.1136/bmjopen-2013-003423. View

19.

Segura Anaya L, Alsadoon A, Costadopoulos N, Prasad P . Ethical Implications of User Perceptions of Wearable Devices. Sci Eng Ethics. 2017; 24(1):1-28. DOI: 10.1007/s11948-017-9872-8. View

20.

Wang C, Yuan Y, Zheng M, Pan A, Wang M, Zhao M . Association of Age of Onset of Hypertension With Cardiovascular Diseases and Mortality. J Am Coll Cardiol. 2020; 75(23):2921-2930. DOI: 10.1016/j.jacc.2020.04.038. View