Abstract
Background: This proof-of-concept trial examined a 6-month Prevention Plus (PP) intervention implemented in a federally qualified health center on child standardized BMI (ZBMI), using a planned clinical effect threshold of -0.16 ZBMI. The relationship between food security status and PP delivered with caregiver goals (PP+) and without caregiver goals (PP-) on energy balance behaviors (i.e., fruits and vegetables, physical activity) and child ZBMI was explored. Methods: Seventy-three, underserved children, 4-10 years of age with a BMI ≥85th percentile, were randomized to one of two interventions, PP+ and PP-, both providing 2.5 hours of contact time, implemented in five clinics by behavioral health consultants (BHCs). Outcomes were child anthropometrics (included 9-month follow-up), implementation data collected from electronic health records, and caregiver and BHC evaluations. Results: Children were 57.5% female and 78.1% Hispanic, with 32.9% from food-insecure households and 58.9% from households with an annual income of less than $20,000. Child ZBMI significantly (p < 0.05) decreased at 6 and 9 months (-0.08 ± 0.24 and -0.12 ± 0.43), with only PP+ reaching the clinical threshold at 9 months (PP+: -0.20 ± 0.42 vs. PP-: -0.05 ± 0.42). Sixty-four percent of families attended ≥50% of the sessions, and BHCs delivered 78.5% ± 23.5% of components at attended sessions. Caregivers were satisfied with the intervention and BHCs found the intervention helpful/useful. No relationship with food insecurity status and outcomes was found. Conclusions: PP+ when delivered by a primary care provider to underserved families showed promise for producing a clinically meaningful effect. Families and providers felt the intervention was a viable treatment option.