Reinforced Enhanced - Families Responsibility Education Support and Health (Re-FRESH)
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based behavioral therapy
Parenting training
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring Obesity treatment, Parenting training, Parenting style, Family-based behavioral therapy
Eligibility Criteria
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.
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Family-based behavioral therapy (FBT)
Parenting training and FBT
Arm Description
Family-based behavioral therapy for pediatric weight loss
Family-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes
Outcomes
Primary Outcome Measures
Change in BMI percentile
Change in BMI percentile at the end of treatment and follow-up period
Secondary Outcome Measures
Percent of families who Drop-out of study
Difference in percent of families who drop-out between groups
Child Report of Parent Behavior Inventory
Change in parenting style from baseline to post-treatment and follow-up between groups
Percentage of sessions attended between groups
Difference in percentage of sessions attended between groups
Percent of families who adhered to treatment goals
Difference in percent of families who adhered to treatment goals between groups
Child feeding questionnaire
Change in child feed behaviors from baseline to post-treatment and follow-up between groups
Full Information
NCT ID
NCT02976636
First Posted
November 21, 2016
Last Updated
May 15, 2023
Sponsor
University of California, San Diego
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02976636
Brief Title
Reinforced Enhanced - Families Responsibility Education Support and Health
Acronym
Re-FRESH
Official Title
Parent Training Program to Improve Outcomes in Childhood Obesity Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Obesity treatment, Parenting training, Parenting style, Family-based behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessors will not know which arm of the study each family is in.
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family-based behavioral therapy (FBT)
Arm Type
Active Comparator
Arm Description
Family-based behavioral therapy for pediatric weight loss
Arm Title
Parenting training and FBT
Arm Type
Experimental
Arm Description
Family-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes
Intervention Type
Behavioral
Intervention Name(s)
Family-based behavioral therapy
Other Intervention Name(s)
FBT, FRESH
Intervention Description
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
Intervention Name(s)
Parenting training
Other Intervention Name(s)
Re-FRESH, FBT + PT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BMI percentile
Description
Change in BMI percentile at the end of treatment and follow-up period
Time Frame
6 months and 18 months
Secondary Outcome Measure Information:
Title
Percent of families who Drop-out of study
Description
Difference in percent of families who drop-out between groups
Time Frame
6 months
Title
Child Report of Parent Behavior Inventory
Description
Change in parenting style from baseline to post-treatment and follow-up between groups
Time Frame
6 months and 18 months
Title
Percentage of sessions attended between groups
Description
Difference in percentage of sessions attended between groups
Time Frame
6 months
Title
Percent of families who adhered to treatment goals
Description
Difference in percent of families who adhered to treatment goals between groups
Time Frame
6 months
Title
Child feeding questionnaire
Description
Change in child feed behaviors from baseline to post-treatment and follow-up between groups
Time Frame
6 months and 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Reinforced Enhanced - Families Responsibility Education Support and Health
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