Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, Overeating, Body Mass Index, Treatment, Intervention, Family Based Therapy, Weight, Children
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.
Interventions
BEHAVIORALFamily Based Behavioral Treatment
Treatment includes 20 90 minute visits over 6 months which include 60 min parent and child separate groups and 30 min behavioral coaching. FBT includes information regarding nutrition and physical activity, as well as behavior therapy skills, including parenting skills, self-monitoring, problem solving skills, motivation systems, emotional regulation, stress management, stimulus control, and relapse prevention.
BEHAVIORALGuided Self-Help Fam. Based Bx Treatment
Treatment includes 14 20 minute visits over 6 months. gshFBT is delivered to parent/child dyads and includes the same content in the FBT groups but it is provided in a manual. The 20-minute visits focus on clarifying information in the manuals, collecting weight and self-monitoring logs, and problem solving any barriers to implementation.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. 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) 2. The parent willing to participate can read English at a minimum of a 5th grade level 3. Parent and Child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm 4. Child or parent is free from psychiatric illness than may affect participation; 5. Child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment 6. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child weight loss | Change from baseline to month 6, 12 and 18 | BMI; BMIz |
| Cost-effectiveness | 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
| Measure | Time frame | Description |
|---|---|---|
| Parent Physical Activity - minutes of moderate-vigorous activity | Change from baseline to month 6, 12 and 18 | Measured by accelerometer, minutes in Moderate to Vigorous physical activity |
| Parent BMI | Change from baseline to month 6, 12 and 18 | BMI |
| Parent Nutrition-measured as servings of fruit and vegetables per day | Change from baseline to month 6, 12 and 18 | Self-reported number of servings of fruits and vegetables consumed each day |
| Child Nutrition-measured as servings of fruit and vegetables per day | Change from baseline to month 6, 12 and 18 | Self-reported number of servings of fruits and vegetables consumed each day |
| Child Physical Activity - minutes of moderate-vigorous activity | Change from baseline to month 6, 12 and 18 | Measured by accelerometer, minutes in Moderate to Vigorous physical activity |
Countries
United States
Outcome results
None listed