Effect of Treatment Dose on Childhood Obesity
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- University of California, San Diego
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Child weight loss
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of the study is to evaluate whether a less intensive intervention, Guided Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness of both treatments will also be compared.
Detailed Description
The primary aim of this project is to determine whether gshFBT is non-inferior to FBT for childhood obesity on child weight loss. Four assessments will be conducted; baseline (month 0), month 6 (post-treatment), and at month 12 and month 18. Assessments will include the following for child and parent: anthropometry, physical activity, nutrition, and cost-effectiveness. Cost-effectiveness will be calculated from a societal perspective and a third party payor perspective. This program of research has the potential to advance the standard of practice for children who are overweight or obese by providing a less intensive but more cost-effective intervention.
Investigators
Kerri Boutelle
Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Child weight loss
Time Frame: Change from baseline to month 6, 12 and 18
BMI; BMIz
Cost-effectiveness
Time Frame: Baseline to month 6, 12 and 18
Cost per .1 BMIz change in child weight including health care costs, participant costs and treatment costs.
Secondary Outcomes
- Parent Nutrition-measured as servings of fruit and vegetables per day(Change from baseline to month 6, 12 and 18)
- Parent BMI(Change from baseline to month 6, 12 and 18)
- Child Physical Activity - minutes of moderate-vigorous activity(Change from baseline to month 6, 12 and 18)
- Child Nutrition-measured as servings of fruit and vegetables per day(Change from baseline to month 6, 12 and 18)
- Parent Physical Activity - minutes of moderate-vigorous activity(Change from baseline to month 6, 12 and 18)