Familial Overweight: Comparing Use of Strategies — FOCUS  

Overweight and Obesity Clinical Trial

Official title: Behavioral Skill Adherence in Pediatric Obesity Treatment

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the efficacy of two different approaches (prescribed & self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.

Clinical Trial Description

Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population. The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU). In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability. Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity. Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested. This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment. Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months. Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment. BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator. Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined. This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

• NCT number: NCT00746629
• Study type: Interventional
• Source: Seattle Children's Hospital
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Completion date: December 2012