Family Based Treatment for Weight Loss With Breakfast Prescription

Not Applicable

Completed

• Conditions: Obesity; Overeating; Weight; Overweight; Childhood Obesity
• Interventions: Behavioral: Family Based Behavioral Treatment

• Registration Number: NCT02467036
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to evaluate whether a behavioral weight loss group in conjunction with a prescribed breakfast can help children between 8 and 12 years of age change their behaviors to help them lose weight and become healthier.

Detailed Description

The purpose of this application is to evaluate the acceptability and initial efficacy of consumption of an egg breakfast, compared to a cereal breakfast, in the context of Family-based Behavioral Treatment (FBT) with overweight and obese children and their parents. Investigators will randomize 66 parents and their overweight and obese child (85-99.9%BMI) to FBT+egg or FBT+cereal groups. Families will eat their assigned breakfast (eggs or cereal) 5 out of 7 days during the 4 month FBT treatment. However, all other aspects of FBT will be the same in the two groups. Children and parents will complete assessments at three time points; baseline, post-treatment and 4-months post-treatment.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Children between the ages of 8 and 12 years old;
2. BMI ≥85th% and <100% overweight
3. Children with parents who are willing to attend 16 weekly group sessions and be randomized to either treatment arm;
4. Have at least one parent who is overweight or obese (BMI≥25);
5. Children and parent who endorse liking of both eggs and cereal
6. 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 plan to move out of the area within the time frame of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Based Behavioral Treatment Egg	Family Based Behavioral Treatment	The FBT+Egg group will participate in group-based FBT and will be assigned to eat eggs a minimum of 5 days a week for breakfast. Families are provided eggs each week to facilitate compliance, along with recipes
Family Based Behavioral Treatment Cereal	Family Based Behavioral Treatment	The FBT+Cereal group will participate in group-based FBT and will be assigned to eat cereal a minimum of 5 days a week for breakfast. Families are provided cereal each week to facilitate compliance.

Primary Outcome Measures

Name	Time	Method
Ratings of acceptability intervention	4 months
Ratings of liking intervention	4 months

Secondary Outcome Measures

Name	Time	Method
Child weight	8 months	Measured by Body Mass Index (BMI)
Parent weight	8 months	Measured by Body Mass Index (BMI)

Trial Locations

Locations (1)

Center for Healthy Eating and Activity Research; 🇺🇸 La Jolla, California, United States