Implementation and Effectiveness of the Healthy Weight Clinic Type III Hybrid Trial: Massachusetts CORD 3.0

<b><i>Background:</i></b> There is a pressing need to provide evidence-based treatment for obesity to millions of children. We sought to implement and evaluate the packaged Healthy Weight Clinic (HWC), a primary care-based Family Healthy Weight Program (FHWP) delivering Intensive Health Behavior and Lifestyle Treatment.<b><i>Methods:</i></b> We conducted a Type III hybrid effectiveness-implementation study in four health care organizations affiliated with eight primary care clinics. Sites received provider training, technical assistance, and participated in a virtual learning community with quality improvement. Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) implementation frameworks were used to evaluate implementation via quantitative and qualitative methods. Children with a BMI ≥85th percentile were eligible to participate in the effectiveness trial. A group of 5990 children with a BMI ≥ 95th percentile receiving care at the eight health centers but not participating in the HWC served as the comparison group.<b><i>Results:</i></b> The packaged HWC reached 191 children. The HWC was effective in reducing BMI -0.26 (95% confidence interval [CI]: -0.47, -0.04), percentage of the median -1.87 (95% CI: -3.09, -0.64), and %BMIp95 -1.05 (95% CI: -1.97, -0.13) compared with comparisons. Seven of the eight sites were able to adopt all the components of the program except the texting campaign and sustain the program 18 months after training. Qualitative themes contextualized implementation findings, highlighting barriers and facilitators.<b><i>Conclusions:</i></b> The HWC is a promising FHWP that can improve health for children with overweight and obesity. The implementation package can facilitate the adoption across diverse primary care settings in the United States.