FAB: Family Based Treatment for Weight Loss With Breakfast Prescription

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT02467036

Collaborator

American Egg Board (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Overeating Weight Childhood Obesity	Behavioral: Family Based Behavioral Treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study Examining the Impact of Eggs for Breakfast on Weight Loss and Hunger in Obese Children

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Family Based Behavioral Treatment Egg 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	Behavioral: Family Based Behavioral Treatment The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy. Treatment is provided in separate parent and child groups. Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity). Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention. Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.
Active Comparator: Family Based Behavioral Treatment Cereal 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.	Behavioral: Family Based Behavioral Treatment The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy. Treatment is provided in separate parent and child groups. Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity). Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention. Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.

Arm

Intervention/Treatment

Experimental: Family Based Behavioral Treatment Egg

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

Behavioral: Family Based Behavioral Treatment

The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy. Treatment is provided in separate parent and child groups. Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity). Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention. Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.

Active Comparator: Family Based Behavioral Treatment Cereal

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.

Behavioral: Family Based Behavioral Treatment

Outcome Measures

Primary Outcome Measures

Ratings of acceptability intervention [4 months]
Ratings of liking intervention [4 months]

Secondary Outcome Measures

Child weight [8 months]
Measured by Body Mass Index (BMI)
Parent weight [8 months]
Measured by Body Mass Index (BMI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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