A comparative effectiveness trial of two family-based childhood obesity treatment programs in a medically underserved region: Rationale, design & methods.

While there is a large body of literature documenting the efficacy of family-based childhood obesity (FBCO) treatment interventions, there is little evidence that these interventions have been systematically translated into regular practice - particularly in health disparate regions. To address this research-practice gap, this project was guided by a community advisory board (CAB) and the RE-AIM planning and evaluation framework within a systems-based and community-based participatory research approach. Families with overweight or obese children between 5 and 12 years old, in the medically-underserved Dan River Region, were randomly assigned to one of two FBCO treatment programs (iChoose vs. Family Connections) delivered by local Parks & Recreation staff. Both programs have previously demonstrated clinically meaningful child BMI z-score reductions, but vary in intensity, structure, and implementation demands. Two clinical CAB partners embedded recruitment methods into their regional healthcare organization, using procedures representative to what could be used if either program was taken to scale. The primary effectiveness outcome is child BMI z-scores at 6-months, with additional assessments at 3-months and at 12-months. Secondary goals are to determine: (1) reach into the intended audience; (2) effectiveness on secondary child and parent outcomes; (3) intervention adoption by organizations and staff; (4) fidelity, cost, and capacity for intervention implementation; and (5) maintenance of individual-level changes and organizational-level sustainability. This research addresses literature gaps related to the features within clinical and community settings that could improve both child weight status and the translation of FBCO interventions into typical practice in medically-underserved communities. IDENTIFIERS: Clincialtrials.gov: NCT03245775.