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Reinforced Enhanced - Families Responsibility Education Support and Health (Re-FRESH)

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ClinicalTrials.gov Identifier: NCT02976636
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kay Rhee, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Family-based behavioral therapy Behavioral: Parenting training Not Applicable

Detailed Description:
Authoritative parenting style has been associated with decreased obesity risk in children, increased weight loss during interventions, and can modify the delivery and impact of weight control strategies, making them more effective. At this time, gold-standard treatment for childhood obesity is family-based behavioral therapy (FBT). This treatment relies on behavioral strategies and the use of praise and a positive reinforcement system to change eating and activity behaviors, but does not target other aspects of parenting. Broadening parenting instruction to include effective limit-setting behaviors, parent-child communication, and authoritative parenting may increase parents' confidence and ability to successfully make behavior changes and modify the impact of the behavioral strategies being used. In this application, the investigators propose to test the efficacy of a 20-week weight control program that combines traditional family-based behavioral therapy with comprehensive parenting training (FBT-PT) and compare it to traditional family-based behavioral therapy (FBT). The investigators hypothesize that there will be an additive effect of parenting training such that FBT-PT will have a greater effect on child weight loss (measured by BMI z-score) than traditional FBT. In addition, the investigators will measure parenting style, parenting strategies, behavioral strategies, and child factors (like impulsive behavior and temperament) to better understand the mediators and moderators of weight loss. These measures will be obtained by standard self-report measures and videotape encounters, allowing one to more objectively measure parenting dimensions. Clinical outcomes, like drop-out and acceptability, will also be assessed from the two treatment arms. The purpose of this study is to evaluate the effect of adding a comprehensive parenting training to traditional FBT. If successful, this program will be able to increase our ability to help children successfully lose weight.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The assessors will not know which arm of the study each family is in.
Primary Purpose: Treatment
Official Title: Parent Training Program to Improve Outcomes in Childhood Obesity Treatment
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Active Comparator: Family-based behavioral therapy (FBT)
Family-based behavioral therapy for pediatric weight loss
Behavioral: Family-based behavioral therapy
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.
Other Names:
  • FBT
  • FRESH

Experimental: Parenting training and FBT
Family-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes
Behavioral: Family-based behavioral therapy
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.
Other Names:
  • FBT
  • FRESH

Behavioral: Parenting training
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.
Other Names:
  • Re-FRESH
  • FBT + PT




Primary Outcome Measures :
  1. Change in BMI percentile [ Time Frame: 6 months and 18 months ]
    Change in BMI percentile at the end of treatment and follow-up period


Secondary Outcome Measures :
  1. Percent of families who Drop-out of study [ Time Frame: 6 months ]
    Difference in percent of families who drop-out between groups

  2. Child Report of Parent Behavior Inventory [ Time Frame: 6 months and 18 months ]
    Change in parenting style from baseline to post-treatment and follow-up between groups

  3. Percentage of sessions attended between groups [ Time Frame: 6 months ]
    Difference in percentage of sessions attended between groups

  4. Percent of families who adhered to treatment goals [ Time Frame: 6 months ]
    Difference in percent of families who adhered to treatment goals between groups

  5. Child feeding questionnaire [ Time Frame: 6 months and 18 months ]
    Change in child feed behaviors from baseline to post-treatment and follow-up between groups



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children between the ages of 7 and 12 years old;
  2. 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;
  3. Children with mothers who are willing to attend 20 weekly group sessions and be randomized to either treatment arm;
  4. Have at least one parent who is overweight or obese (BMI≥25); and
  5. Parents who speak English at a 5th grade level.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976636


Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Martina Cotton    858-534-5207    mcotton@ucsd.edu   
Contact: Stephanie Kessl, MPH    858-534-5207    skessl@ucsd.edu   
Principal Investigator: Kyung E Rhee, MD, MSc         
Sponsors and Collaborators
University of California, San Diego
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Responsible Party: Kay Rhee, Associate Professor of Pediatrics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02976636     History of Changes
Other Study ID Numbers: 1R01DK106157 ( U.S. NIH Grant/Contract )
R01DK106157 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kay Rhee, University of California, San Diego:
Obesity treatment
Parenting training
Parenting style
Family-based behavioral therapy

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms