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Randomized Controlled Trial
. 2022 May:247:1-14.
doi: 10.1016/j.ahj.2022.01.009. Epub 2022 Jan 20.

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

LaPrincess C Brewer  1 , Sarah Jenkins  2 , Sharonne N Hayes  3 , Ashok Kumbamu  3 , Clarence Jones  4 , Lora E Burke  5 , Lisa A Cooper  6 , Christi A Patten  7
Affiliations
Randomized Controlled Trial

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

LaPrincess C Brewer et al. Am Heart J. 2022 May.

Abstract

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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Conflict of interest statement

Declarations of interest

None

Figures

Figure 1.
Figure 1.
Study design by modified community-based participatory research conceptual logic model Adapted from Wallerstein et al, 2008 and Wallerstein and Duran, 2010
Figure 2.
Figure 2.
Randomization scheme: Cluster randomized controlled trial with delayed intervention
Figure 3.
Figure 3.
Modified CONSORT flow diagram F/V indicates fruit/vegetable; PA, physical activity
See this image and copyright information in PMC

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