FRESH-DOSE: Families Responsibility Education Support Health-Dual Options for Sustained Effectiveness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Treatment Dose on Childhood Obesity

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Family Based Behavioral Treatment
* Behavioral: Guided Self-Help Fam. Based Bx Treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Family Based Behavioral Treatment<br>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. | Behavioral: Family Based Behavioral Treatment<br>* 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.<br>* Other names: FBT;|
| Experimental: Guided Self-Help Fam. Based Bx Treatment<br>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. | Behavioral: Guided Self-Help Fam. Based Bx Treatment<br>* 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.<br>* Other names: gshFBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child weight loss | BMI; BMIz | 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. | Baseline to month 6, 12 and 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent BMI | BMI | 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 | 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 | 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 | 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 | Change from baseline to month 6, 12 and 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Overeating, Body Mass Index, Treatment, Intervention, Family Based Therapy, Weight, Children