The Healthy Children, Strong Families 2 (HCSF2) Randomized Controlled Trial Improved Healthy Behaviors in American Indian Families with Young Children

American Indian (AI) families experience a disproportionate risk of obesity due to a number of complex reasons, including poverty, historic trauma, rural isolation or urban loss of community connections, lack of access to healthy foods and physical activity opportunities, and high stress. Home-based obesity prevention interventions are lacking for these families. Healthy Children, Strong Families 2 (HCSF2) was a randomized controlled trial of a healthy lifestyle promotion/obesity prevention intervention for AI families. Four hundred and fifty dyads consisting of an adult primary caregiver and a child ages 2 to 5 y from 5 AI communities were randomly assigned to a monthly mailed healthy lifestyle intervention toolkit (Wellness Journey) with social support or to a child safety control toolkit (Safety Journey) for 1 y. The Wellness Journey toolkit targeted increased fruit/vegetable (F/V) intake and physical activity, improved sleep, decreased added sugar intake and screen time, and improved stress management (adults only). Anthropometrics were collected, and health behaviors were assessed via survey at baseline and at the end of Year 1. Adults completed surveys for themselves and the participating child. Repeated measures analysis of variance was used to assess change over the intervention period. Significant improvements to adult and child healthy diet patterns, adult F/V intake, adult moderate-to-vigorous physical activity, home nutrition environment, and adult self-efficacy for health behavior change were observed in Wellness Journey compared with Safety Journey families. No changes were observed in adult body mass index (BMI), child BMI z-score, adult stress measures, adult/child sleep and screen time, or child physical activity. Qualitative feedback suggests the intervention was extremely well-received by both the families and our community partners across the 5 participating sites. This multi-site community-engaged intervention addressed key gaps regarding family home-based approaches for early obesity prevention in AI communities and showed several significant improvements in health behaviors. Multiple communities are working to sustain intervention efforts. This trial was registered at clinicaltrials.gov as NCT01776255.