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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
151
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.
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.
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States
Child weight loss
BMI; BMIz
Time frame: Change from baseline to month 6, 12 and 18
Cost-effectiveness
Cost per .1 BMIz change in child weight including health care costs, participant costs and treatment costs.
Time frame: Baseline to month 6, 12 and 18
Parent BMI
BMI
Time frame: Change from baseline to month 6, 12 and 18
Child Physical Activity - minutes of moderate-vigorous activity
Measured by accelerometer, minutes in Moderate to Vigorous physical activity
Time frame: Change from baseline to month 6, 12 and 18
Parent Physical Activity - minutes of moderate-vigorous activity
Measured by accelerometer, minutes in Moderate to Vigorous physical activity
Time frame: Change from baseline to month 6, 12 and 18
Child Nutrition-measured as servings of fruit and vegetables per day
Self-reported number of servings of fruits and vegetables consumed each day
Time frame: Change from baseline to month 6, 12 and 18
Parent Nutrition-measured as servings of fruit and vegetables per day
Self-reported number of servings of fruits and vegetables consumed each day
Time frame: Change from baseline to month 6, 12 and 18
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