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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Guided Self-Help Fam. Based Bx Treatment; Behavioral: Family Based Behavioral Treatment

• Registration Number: NCT03096132
• Lead Sponsor: University of California, San Diego

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 Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-30
• Study Start: 2017-04-18
• Primary Completion: 2023-01-05
• Study Completion: 2023-02-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Self-Help Fam. Based Bx Treatment	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.
Family Based Behavioral Treatment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Parent BMI	Change from baseline to month 6, 12 and 18	BMI
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
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
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

Trial Locations

Locations (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR); 🇺🇸 La Jolla, California, United States