Reinforced Enhanced - Families Responsibility Education Support and Health

Pediatric Obesity Clinical Trial

— Re-FRESH  

Official title:

Parent Training Program to Improve Outcomes in Childhood Obesity Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976636
• Other study ID #: 1R01DK106157
• Secondary ID: R01DK106157
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: November 2, 2022

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI percentile	Change in BMI percentile at the end of treatment and follow-up period	6 months and 18 months
Secondary	Percent of families who Drop-out of study	Difference in percent of families who drop-out between groups	6 months
Secondary	Child Report of Parent Behavior Inventory	Change in parenting style from baseline to post-treatment and follow-up between groups	6 months and 18 months
Secondary	Percentage of sessions attended between groups	Difference in percentage of sessions attended between groups	6 months
Secondary	Percent of families who adhered to treatment goals	Difference in percent of families who adhered to treatment goals between groups	6 months
Secondary	Child feeding questionnaire	Change in child feed behaviors from baseline to post-treatment and follow-up between groups	6 months and 18 months