Clinical trial NCT02976636: Reinforced Enhanced - Families Responsibility Education Support and Health
Official title: Parent Training Program to Improve Outcomes in Childhood Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Obesity treatment
Parenting training
Parenting style
Family-based behavioral therapy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-11-29
Enrollment: 140
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in BMI percentile
timeFrame: 6 months and 18 months
Secondary outcomes:
measure: Percent of families who Drop-out of study
timeFrame: 6 months
measure: Child Report of Parent Behavior Inventory
timeFrame: 6 months and 18 months
measure: Percentage of sessions attended between groups
timeFrame: 6 months
measure: Percent of families who adhered to treatment goals
timeFrame: 6 months
measure: Child feeding questionnaire
timeFrame: 6 months and 18 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References: