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

NCT ID: NCT03096132

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2023-02-03

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Family Based Behavioral Treatment

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Guided Self-Help Fam. Based Bx Treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FBT; gshFBT

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Kerri Boutelle

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerri Boutelle, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25181608 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23545372 (View on PubMed)

Other Identifiers

R01DK108686

Identifier Type: NIH

Identifier Source: secondary_id

View Link

160289

Identifier Type: -

Identifier Source: org_study_id