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

Obesity Clinical Trial

Official title:

Effect of Treatment Dose on Childhood Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096132
• Other study ID #: 160289
• Secondary ID: R01DK108686
• Status: Completed
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: February 3, 2023

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: February 3, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSD Center for Healthy Eating and Activity Research (CHEAR)	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child weight loss	BMI; BMIz	Change from baseline to month 6, 12 and 18
Primary	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	Parent BMI	BMI	Change from baseline to month 6, 12 and 18
Secondary	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
Secondary	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
Secondary	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
Secondary	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