Reinforced Enhanced - Families Responsibility Education Support and Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2022-11-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The assessors will not know which arm of the study each family is in.

Study Groups

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Family-based behavioral therapy (FBT)

Family-based behavioral therapy for pediatric weight loss

Group Type ACTIVE_COMPARATOR

Family-based behavioral therapy

Intervention Type 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.

Parenting training and FBT

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

Group Type EXPERIMENTAL

Family-based behavioral therapy

Intervention Type 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.

Parenting training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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FBT FRESH Re-FRESH FBT + PT

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes