Reinforced Enhanced - Families Responsibility Education Support and Health

NCT02976636 | Completed DMC

• 2 other identifiers: 1R01DK106157R01DK106157
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this application is to evaluate whether a pediatric weight control program that incorporates comprehensive parenting training with behavioral therapy can increase weight loss in children compared to traditional family-based behavioral therapy programs. Since certain parenting styles are associated with greater weight loss during interventions and appear to enhance the impact of key behavioral strategies, adding parenting training to these interventions may increase the overall effectiveness of these programs and increase our ability to help children obtain a healthy weight. This project could result in identifying an improved method of pediatric obesity treatment that provides additional benefits to the growth and development of children via improved self-regulatory behaviors.

Conditions

Pediatric Obesity

Keywords

Obesity treatment; Parenting training; Parenting style; Family-based behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change in BMI percentile

  Change in BMI percentile at the end of treatment and follow-up period

  6 months and 18 months

Secondary Outcomes (5)

• Percent of families who Drop-out of study

  6 months

• Child Report of Parent Behavior Inventory

  6 months and 18 months

• Percentage of sessions attended between groups

  6 months

• Percent of families who adhered to treatment goals

  6 months

• Child feeding questionnaire

  6 months and 18 months

Study Arms (2)

Family-based behavioral therapy (FBT)

ACTIVE COMPARATOR

Family-based behavioral therapy for pediatric weight loss

Behavioral: Family-based behavioral therapy

Parenting training and FBT

EXPERIMENTAL

Family-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes

Behavioral: Family-based behavioral therapy; Behavioral: Parenting training

Interventions

Family-based behavioral therapy BEHAVIORAL

Traditional family-based, group-based behavioral therapy for weight loss. Parent and child groups will be held separately. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.

Also known as: FBT, FRESH

Family-based behavioral therapy (FBT); Parenting training and FBT

Parenting training BEHAVIORAL

Parenting skills training for parents. Parent and child groups will be held separately and only parents will receive this training. Children will not receive any additional materials. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.

Also known as: Re-FRESH, FBT + PT

Parenting training and FBT

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 7 and 12 years old;
• BMI ≥85th percentile but \<100% overweight, so as to limit those children who are morbidly obese and are in need of more intense medical treatment;
• Children with mothers who are willing to attend 20 weekly group sessions and be randomized to either treatment arm;
• Have at least one parent who is overweight or obese (BMI≥25); and
• Parents who speak English at a 5th grade level.

You may not qualify if:

• Children with serious medical conditions that affect their weight;
• Children taking medication that affect appetite or weight;
• Children with severe developmental delay or disability that would affect participation;
• Children or parents with psychological illness that would limit treatment participation;
• Families who will move out of the area within the time frame of the study.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Rhee KE, Corbett T, Patel S, Eichen DM, Strong DR, Kang-Sim E, Anderson CAM, Marcus BH, Boutelle KN. Parenting Training Plus Behavioral Treatment for Children With Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258398. doi: 10.1001/jamanetworkopen.2025.8398.

  PMID: 40323600 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will not know which arm of the study each family is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: April 17, 2017
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)