Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study.

Family-based behavioral treatment (FBT) is an evidence-based treatment for pediatric obesity. FBT has primarily been implemented in specialty clinics, with highly trained interventionists. The goal of this study is to assess effectiveness of FBT implemented in pediatric primary care settings using newly trained interventionists who might implement FBT in pediatric practices. The goal is to randomize 528 families with a child with overweight/obesity (≥85th BMI percentile) and parent with overweight/obesity (BMI ≥ 25) across four sites (Buffalo and Rochester, New York; Columbus, Ohio; St. Louis, Missouri) to FBT or usual care and obtain assessments at 6-month intervals over 24 months of treatment. FBT is implemented using a mastery model, which provides quantity of treatment tailored to family progress and following the United States Preventive Services Task Force recommendations for effective dose and duration of treatment. The primary outcome of the trial is change in relative weight for children, and secondarily, for parents and siblings who are overweight/obese. Between group differences in the tendency to prefer small immediate rewards over larger, delayed rewards (delay discounting) and how this is related to treatment outcome is also evaluated. Challenges in translation of group-based interventions to individualized treatments in primary care settings, and in study implementation that arose due to the COVID-19 pandemic are discussed. It is hypothesized that the FBT intervention will be associated with better changes in relative weight for children, parents, and siblings than usual care. The results of this study can inform future dissemination and implementation of FBT into primary care settings.