CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment

Background: Socioeconomically-disadvantaged households have a high prevalence of pediatric overweight/obesity, and also face barriers to accessing weight loss treatment in healthcare settings. Delivering family-based pediatric weight loss treatment in the home setting may enhance its efficacy by facilitating treatment attendance, enabling more tailored treatment recommendations informed by observations of the home environment, and increasing accountability. This paper describes the design of the Creating Health Environments for Chicago Kids (CHECK) Trial, which evaluates the efficacy, cost-effectiveness, and mechanisms of home visitation in family-based pediatric weight loss treatment for children in low-income households. Design: CHECK is a two-arm, parallel group, randomized controlled trial that is enrolling N = 266 children, ages 6–12 y, who have overweight/obesity (BMI percentile ≥85) and live in a low-income household. Participants are randomized in a 1:1 ratio to either standard of care family-based weight loss treatment delivered in the home, or the identical intervention delivered in an academic medical center. The primary outcome is change in child BMI z-score from baseline to 12 months. Program delivery costs are rigorously documented to enable cost-effectiveness analyses from the societal and payer perspectives. Objectively-documented changes to the home environment and aspects of intervention delivery (e.g., hours of in-person contact received, quantity of behavioral goals set per session) will be tested as hypothesized treatment mechanisms. Implications: Findings will inform the design of future interventions, and treatment dissemination decisions by public health agencies and third-party payers. Trial Registration:ClinicalTrials.gov identifier: NCT03195790