Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the JOIN for ME Family-Based Childhood...

Background: Overweight and obesity in children is a public health crisis in the United States. Although evidence-based interventions have been developed, such programs are difficult to access. Dissemination of evidence-based pediatric weight management interventions (PWMIs) to families from diverse low-income communities is the primary objective of the CDC Childhood Obesity Research Demonstration (CORD) projects. Methods: The goal of the Rhode Island CORD 3.0 project is to adapt the evidence-based PWMI, JOIN for ME, for delivery among diverse families from low-income backgrounds and to test it in a hybrid effectiveness-implementation trial design in which the aims are to examine implementation and patient-centered outcomes. Children between the ages of 6 and 12 years with BMI ≥85th percentile and a caregiver will be recruited through two settings, a federally qualified health center, which serves as a patient-centered medical home, or low-income housing. Dyads will receive a remotely delivered group-based intervention that is 10 months in duration and includes 16 weekly sessions, followed by 4 biweekly and 4 monthly meetings. Assessments of child and caregiver weight status and child health-related quality of life will be conducted at baseline, and at 4 and 10 months after the start of intervention. Implementation outcomes assessing intervention acceptability, adoption, feasibility, fidelity, and penetration/reach will be collected to inform subsequent dissemination. Conclusions: If the adapted version of the JOIN for ME intervention can be successfully implemented and is shown to be effective, this project will provide a model for a scalable PWMI for families from low-income backgrounds. ClinicalTrials.gov no. NCT04647760.