Child Health Promotion in Underserved Communities: Primary Results From the Cluster Randomized FAMILIA Trial

Abstract

Introduction: Preschool-based interventions offer promise to instill healthy behaviors in children. However, its efficacy in underserved communities is not well established.

Objective: To assess the impact of a preschool-based health promotion education intervention in an underserved community.

Methods: We performed the cluster-randomized controlled “Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health” (FAMILIA) trial involving 15 Head Start preschools in Harlem, New York. Schools and their children were 3:2 randomized to either receive the usual curriculum (control); or a 4-month educational intervention for a total of 50 hours to instill healthy behaviors in relation to diet, physical activity, understanding how the human body and heart work, and emotion management. The primary outcome was the change from baseline in the overall knowledge, attitudes, and habits (KAH) score of the child. As secondary outcomes, we evaluated the changes in KAH subcomponents and in the test of emotion comprehension. Linear mixed-effects models were used to test for intervention effects.

Results: We enrolled 562 children 3 to 5 years old, 51% female, 54% Hispanic/Latino and 37% African-American. The mean % relative change from baseline in the overall KAH score was 5.5% and 11.8% in control and intervention groups, respectively. The average between-group absolute difference in overall KAH was 2.89 points (95% CI: 0.61 to 5.17; p = 0.013; Figure). Physical activity and understanding of the human body and heart components, and knowledge and attitudes domains, were the main drivers of the effect. Changes in emotion comprehension trended to favor intervened children as compared to controls.

Conclusions: The FAMILIA trial demonstrates that a multidimensional school-based education intervention is an effective strategy for instilling healthy behaviors among preschoolers from a diverse and socially/economically disadvantaged community. As part of our long-term vision, we are conducting a long-term follow-up of the children to assess the sustainability of the intervention effects.