Design of the FRESH study: A randomized controlled trial of a parent-only and parent-child family-based treatment for childhood obesity.

Approximately 1 out of 3 children in the United States is overweight or obese. Family-based treatment (FBT) is considered the gold-standard treatment for childhood obesity, but FBT is both staff and cost intensive. Therefore, we developed the FRESH (Family, Responsibility, Education, Support, & Health) study to evaluate the effectiveness of intervening with parents, without child involvement, to facilitate and improve the child's weight status. Targeting parents directly in the treatment of childhood obesity could be a promising approach that is developmentally appropriate for grade-school age children, highly scalable, and may be more cost effective to administer. The current paper describes the FRESH study which was designed to compare the effectiveness of parent-based therapy for pediatric obesity (PBT) to a parent and child (FBT) program for childhood obesity. We assessed weight, diet, physical activity, and parenting, as well as cost-effectiveness, at baseline, post-treatment, and at 6- and 18-month follow-ups. Currently, all participants have been recruited and completed assessment visits, and the initial stages of data analysis are underway. Ultimately, by evaluating a PBT model, we hope to optimize available child obesity treatments and improve their translation into clinical settings.