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

May 12, 2023 updated by: Kerri Boutelle, University of California, San Diego

Effect of Treatment Dose on Childhood Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Center for Healthy Eating and Activity Research (CHEAR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Family 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.
Other Names:
  • FBT
Experimental: 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.
Behavioral: Guided 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.
Other Names:
  • gshFBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child weight loss
Time Frame: Change from baseline to month 6, 12 and 18
BMI; BMIz
Change from baseline to month 6, 12 and 18
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.
Baseline to month 6, 12 and 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent BMI
Time Frame: Change from baseline to month 6, 12 and 18
BMI
Change from baseline to month 6, 12 and 18
Child Physical Activity - minutes of moderate-vigorous activity
Time Frame: Change from baseline to month 6, 12 and 18
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
Time Frame: Change from baseline to month 6, 12 and 18
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
Time Frame: Change from baseline to month 6, 12 and 18
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
Time Frame: Change from baseline to month 6, 12 and 18
Self-reported number of servings of fruits and vegetables consumed each day
Change from baseline to month 6, 12 and 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Kerri Boutelle, PhD, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2017

Primary Completion (Actual)

January 5, 2023

Study Completion (Actual)

February 3, 2023

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160289
  • R01DK108686 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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