Effect of Treatment Dose on Childhood Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Child weight loss
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •An overweight child age 7-12, whose BMI is ≥ 85th percentile but does not meet criteria for severe obesity (i.e., BMI ≥120% of the 95th percentile or an absolute BMI ≥ 35 kg/m2 , whichever is lower for age and gender)
- •The parent willing to participate can read English at a minimum of a 5th grade level
- •Parent and Child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm
- •Child or parent is free from psychiatric illness than may affect participation;
- •Child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment
- •Child is not taking medications that may impact their weight (unless medication dosage is stable and not for the purpose of impacting weight and appetite)
Exclusion Criteria
- Not provided
Arms & Interventions
Family Based Behavioral Treatment
The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a weekly group setting.
Intervention: Family Based Behavioral Treatment (Behavioral)
Guided Self-Help Fam. Based Bx Treatment
The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a guided self-help manual.
Intervention: Guided Self-Help Fam. Based Bx Treatment (Behavioral)
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)
Investigators
Kerri Boutelle
Professor
University of California, San Diego