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A cluster randomized trial of a community-based intervention among African-American adults: effects on dietary and physical activity outcomes
Frerichs L, Bess K, Young TL, Hoover SM, Calancie L, Wynn M, McFarlin S, Cene CW, Dave G, Corbie-Smith G
Prevention Science 2020 Apr;21(3):344-354
clinical trial
3/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Evidence of the effectiveness of community-based lifestyle behavior change interventions among African-American adults is mixed. We implemented a behavioral lifestyle change intervention, Heart Matters, in two rural counties in North Carolina with African-American adults. Our aim was to evaluate the effect of Heart Matters on dietary and physical activity behaviors, self-efficacy, and social support. We used a cluster randomized controlled trial to compare Heart Matters to a delayed intervention control group after 6 months. A total of 143 African-American participants were recruited and 108 completed 6-month follow-up assessments (75.5%). We used mixed regression models to evaluate changes in outcomes from baseline to 6-month follow-up. The intervention had a significant positive effect on self-reported scores of encouragement of healthy eating, resulting in an increase in social support from family of 6.11 units (95% CI (1.99 to 10.22)) (p < 0.01). However, intervention participants also had an increase in discouragement of healthy eating compared to controls of 5.59 units (95% CI (1.46 to 9.73)) among family (p < 0.01). There were no significant differences in changes in dietary behaviors. Intervention participants had increased odds (OR 2.86, 95% CI (1.18 to 6.93)) of increased frequency of vigorous activity for at least 20 min per week compared to control participants (p < 0.05). Individual and group lifestyle behavior counseling can have a role in promoting physical activity levels among rural African-American adults, but more research is needed to identify the best strategies to bolster effectiveness and influence dietary change. TRIAL REGISTRATION: ClinicalTrials.gov NCT02707432. Registered 13 March 2016.

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