Community-Based, Cluster-Randomized Pilot Trial of a Cardiovascular Mobile Health Intervention: Preliminary Findings of the FAITH! Trial

Abstract

Background: African Americans continue to have suboptimal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7), 7 health-promoting behaviors and biological risk factors (eg, physical activity, blood pressure). Innovative, community-level interventions in partnership with trusted institutions such as African American churches are potential means to improve CVH in this population.

Methods: Using a community-based participatory research approach, the FAITH! Trial (Fostering African American Improvement in Total Health) rigorously assessed the feasibility and preliminary efficacy of a refined, community-informed, mobile health intervention (FAITH! App) for promoting CVH among African Americans in faith communities using a cluster randomized controlled trial. Participants from 16 churches in Rochester and Minneapolis-St Paul, MN, were randomized to receive the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. The 10-week intervention core features included culturally relevant and LS7-focused education modules, diet/physical activity self-monitoring, and a group sharing board. Data were collected via electronic surveys and health assessments. Primary outcomes were average change in mean LS7 score (continuous measure of CVH ranging from poor to ideal [0-14 points]) from baseline to 6 months post-intervention (using generalized estimating equations) and app engagement/usability (by the Health Information Technology Usability Evaluation Scale; range, 0-5).

Results: Of 85 enrolled participants (randomized to immediate [N=41] and delayed [control] intervention [N=44] groups), 76 and 68 completed surveys/health assessments at baseline and 6 months post-intervention, respectively (80% retention rate with assessments at both baseline and 6-month time points); immediate intervention [N=30] and control [N=38] groups). At baseline, the majority of participants (mean age [SD], 54.2 [12.3] years, 71% female) had <4-year college education level (39/66, 59%) and poor CVH (44% in poor category; mean LS7 score [SD], 6.8 [1.9]). The mean LS7 score of the intervention group increased by 1.9 (SD 1.9) points compared with 0.7 (SD 1.7) point in the control group (both P<0.0001) at 6 months. The estimated difference of this increase between the groups was 1.1 (95% CI, 0.6-1.7; P<0.0001). App engagement/usability was overall high (100% connection to app; >75% completed weekly diet/physical activity tracking; Health Information Technology Usability Evaluation Scale, mean [SD], 4.2 [0.7]).

Conclusions: On the basis of preliminary findings, the refined FAITH! App appears to be an efficacious mobile health tool to promote ideal CVH among African Americans.

Registration: URL: https://www.

Clinicaltrials: gov; Unique identifier: NCT03777709.

Keywords: African Americans; cardiovascular diseases; clinical trial; community-based participatory research; health equity; mobile health; risk factors.

Figures

Figure 1.

Randomization scheme: cluster randomized controlled trial with delayed intervention. Group 1 (immediate intervention) is represented by the blue arrows and text. Group 2 (delayed intervention, control group) is represented by the orange arrows and text. Dates correspond with trial time points and phases (intervention, maintenance). LS7 indicates Life’s Simple 7; and T, time.

Figure 2.

Modified CONSORT flow diagram: screening, enrollment, and follow-up of church participants. FAITH! indicates Fostering African-American Improvement in Total Health!; F/V, fruit/vegetable; and PA, physical activity. *Among the 18 churches with participants assessed for eligibility, 2 churches were excluded because all individuals within them either declined participation or were deemed ineligible.

Figure 3.

Primary outcome measure: change in Life’s Simple 7 score, baseline to 6 months post-intervention. A, Mean change in LS7 score. P<0.0001 between and within-group differences. B, Comparison of LS7 score categories. LS7 categories: Poor (0–6), Intermediate (7–8), Ideal (9–14). Difference in proportion of intervention group participants in the Ideal category from baseline to 6 months post-intervention, P=0.004. LS7 indicates Life’s Simple 7.

Figure 4.

Change in Life’s Simple 7 individual components, baseline to 6 months post-intervention. Proportion of participants in Intermediate/Ideal level of Life’s Simple 7 metric at baseline and 6 months post-intervention. Statistical significance achieved for diet (P=0.003) and physical activity (P=0.03). 6M indicates 6 months; BL, baseline; BMI, body mass index; BP, blood pressure; and PA, physical activity.