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Completed

NCT Number: NCT02976636

Reinforced Enhanced - Families Responsibility Education Support and Health

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: FBT, FRESH

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.

Other names: Re-FRESH, FBT + PT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Official study title

Parent Training Program to Improve Outcomes in Childhood Obesity Treatment

Acronym: Re-FRESH

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2016
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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