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Community-based, cluster-randomized pilot trial of a cardiovascular mHealth intervention: Rationale, design, and baseline findings of the FAITH! Trial - 05/04/22

Doi : 10.1016/j.ahj.2022.01.009 
LaPrincess C. Brewer, MD, MPH a, b, ⁎ , Sarah Jenkins, MS c, Sharonne N. Hayes, MD d, Ashok Kumbamu, PhD d, Clarence Jones, Med e, Lora E. Burke, PhD, MPH f, Lisa A. Cooper, MD, MPH g, Christi A. Patten, PhD h
a Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, MN 
b Center for Health Equity and Community Engagement Research, Mayo Clinic, Rochester, MN 
c Division of Clinical Trials and Biostatistics, Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN 
d Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN 
e Hue-Man Partnership, Minneapolis, MN 
f School of Nursing, Department of Health and Community Systems, University of Pittsburgh, Pittsburgh, PA 
g Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 
h Department of Psychiatry and Psychology, Mayo Clinic College of Medicine, Rochester, MN 

⁎Reprint request: LaPrincess C. Brewer, MD, MPH, Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, 200 First St. SW, Rochester, MN 55905.Department of Cardiovascular MedicineMayo Clinic College of Medicine200 First St. SWRochesterMN55905.

Riassunto

Background

Compared to whites, African-Americans have lower prevalence of ideal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7). These CVH inequities have worsened during the COVID-19 pandemic. Ideal LS7 health-promoting behaviors and biological risk factors (eg, diet, blood pressure) are associated with improved CVH outcomes. The FAITH! (Fostering African-American Improvement in Total Health) App, a community-informed, mobile health (mHealth) intervention, previously demonstrated significant improvements in LS7 components among African-Americans, suggesting that mHealth interventions may be effective in improving CVH. This paper presents the FAITH! Trial design, baseline findings, and pandemic-related lessons learned.

Methods

Utilizing a community-based participatory research approach, this study assessed the feasibility/preliminary efficacy of a refined FAITH! App for promoting LS7 among African-Americans in faith communities using a cluster, randomized controlled trial. Participants received the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. Baseline data were collected via electronic surveys and health assessments. Primary outcomes are change in LS7 score from baseline to 6-months post-intervention and app engagement/usability.

Results

Of 85 enrolled individuals, 76 completed baseline surveys/health assessments, for a participation rate of 89% (N = 34 randomized to the immediate intervention, N = 42 to delayed intervention). At baseline, participants were predominantly female (54/76, 71%), employed (56/76, 78%) and of high cardiometabolic risk (72/76, 95% with hypertension and/or overweight/obesity) with mean LS7 scores in the poor range (6.8, SD = 1.9).

Conclusions

The FAITH! Trial recruitment was feasible, and its results may inform the use of mHealth tools to increase ideal CVH among African-Americans.

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© 2022  Pubblicato da Elsevier Masson SAS.
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