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

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Family Based Behavioral Treatment

Guided Self-Help Fam. Based Bx Treatment

About this trial

This is an interventional treatment trial for Overweight focused on measuring Obesity, Overweight, Overeating, Body Mass Index, Treatment, Intervention, Family Based Therapy, Weight, Children

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

UCSD Center for Healthy Eating and Activity Research (CHEAR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Family Based Behavioral Treatment

Guided Self-Help Fam. Based Bx Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child weight loss

BMI; BMIz

Cost-effectiveness

Cost per .1 BMIz change in child weight including health care costs, participant costs and treatment costs.

Secondary Outcome Measures

Parent BMI

BMI

Child Physical Activity - minutes of moderate-vigorous activity

Measured by accelerometer, minutes in Moderate to Vigorous physical activity

Parent Physical Activity - minutes of moderate-vigorous activity

Measured by accelerometer, minutes in Moderate to Vigorous physical activity

Child Nutrition-measured as servings of fruit and vegetables per day

Self-reported number of servings of fruits and vegetables consumed each day

Parent Nutrition-measured as servings of fruit and vegetables per day

Self-reported number of servings of fruits and vegetables consumed each day

Full Information

NCT ID

NCT03096132

First Posted

March 9, 2017

Last Updated

May 12, 2023

Sponsor

University of California, San Diego

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03096132

Brief Title

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

Official Title

Effect of Treatment Dose on Childhood Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 18, 2017 (Actual)

Primary Completion Date

January 5, 2023 (Actual)

Study Completion Date

February 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

Obesity, Overweight, Overeating, Body Mass Index, Treatment, Intervention, Family Based Therapy, Weight, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

151 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Family Based Behavioral Treatment

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Guided Self-Help Fam. Based Bx Treatment

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Family Based Behavioral Treatment

Other Intervention Name(s)

FBT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Guided Self-Help Fam. Based Bx Treatment

Other Intervention Name(s)

gshFBT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Child weight loss

Description

BMI; BMIz

Time Frame

Change from baseline to month 6, 12 and 18

Title

Cost-effectiveness

Description

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

Secondary Outcome Measure Information:

Title

Parent BMI

Description

BMI

Time Frame

Change from baseline to month 6, 12 and 18

Title

Child Physical Activity - minutes of moderate-vigorous activity

Description

Measured by accelerometer, minutes in Moderate to Vigorous physical activity

Time Frame

Change from baseline to month 6, 12 and 18

Title

Parent Physical Activity - minutes of moderate-vigorous activity

Description

Measured by accelerometer, minutes in Moderate to Vigorous physical activity

Time Frame

Change from baseline to month 6, 12 and 18

Title

Child Nutrition-measured as servings of fruit and vegetables per day

Description

Self-reported number of servings of fruits and vegetables consumed each day

Time Frame

Change from baseline to month 6, 12 and 18

Title

Parent Nutrition-measured as servings of fruit and vegetables per day

Description

Self-reported number of servings of fruits and vegetables consumed each day

Time Frame

Change from baseline to month 6, 12 and 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerri Boutelle, PhD

Organizational Affiliation

UCSD

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Center for Healthy Eating and Activity Research (CHEAR)

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25181608

Citation

Accurso EC, Norman GJ, Crow SJ, Rock CL, Boutelle KN. The role of motivation in family-based guided self-help treatment for pediatric obesity. Child Obes. 2014 Oct;10(5):392-9. doi: 10.1089/chi.2014.0023. Epub 2014 Sep 2.

Results Reference

background

PubMed Identifier

23545372

Citation

Boutelle KN, Norman GJ, Rock CL, Rhee KE, Crow SJ. Guided self-help for the treatment of pediatric obesity. Pediatrics. 2013 May;131(5):e1435-42. doi: 10.1542/peds.2012-2204. Epub 2013 Apr 1.

Results Reference

background

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

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