Different Lifestyle Interventions in Adults from Underserved Communities: The FAMILIA Trial

Abstract Background The current trends of unhealthy lifestyle behaviors in underserved communities are disturbing. Thus, effective health promotion strategies constitute an unmet need. Objective To assess the impact of two different lifestyle interventions on parents/caregivers of children attending preschools in a socioeconomically disadvantaged community. Methods The FAMILIA study is a cluster-randomized trial involving 15 Head Start preschools in Harlem, New York. Schools, and their children’s parents/caregivers, were randomized to receive either an “individual-focused” or “peer-to-peer based” lifestyle intervention program for 12 months or control. The primary outcome was the change from baseline to 12 months in a composite health score related to Blood pressure, Exercise, Weight, Alimentation and Tobacco (Fuster-BEWAT Score, FBS), ranging from 0 to 15 (ideal health=15). To assess the sustainability of the intervention, we evaluated the change of FBS at 24 months. Main pre-specified secondary outcomes included changes in FBS subcomponents and the impact of the knowledge of presence of atherosclerosis as assessed by bilateral carotid/femoral vascular ultrasound. Mixed-effects models were used to test for intervention effects. Results We enrolled 635 parents/caregivers with a mean age of 38±11 years, 83% female, 57% Hispanic/Latino and 31% African American, and a baseline FBS of 9.3±2.4 points. The mean within-group change in FBS from baseline to 12 months was ∼0.20 points in all groups, with no overall between-group differences. However, high-adherence participants to the intervention exhibited a greater change in FBS than their low-adherence counterparts: 0.30 points (95% CI: 0.03 to 0.57; p-value = 0.025) vs. 0.00 points (95% CI: -0.43 to 0.43; p-value = 1.0), respectively. Furthermore, the knowledge by the participant of the presence of atherosclerosis significantly boosted the intervention effects. Similar results were sustained at 24 months. Conclusions Although we did not observe overall significant differences between intervention and control groups, the FAMILIA trial highlights that high adherence rates to lifestyle interventions may improve health outcomes. It also suggests a potential contributory role of the presentation of atherosclerosis pictures, providing helpful information to improve future lifestyle interventions in adults.