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Family Based Treatment for Weight Loss With Breakfast Prescription (FAB)

Primary Purpose

Obesity, Overweight, Overeating

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Family Based Behavioral Treatment

About this trial

This is an interventional treatment trial for Obesity focused on measuring overweight children, overweight parents, eating in the absence of hunger, families with overweight child, bmi, body mass index, treatment, behavioral treatment, family based treatment, experiments, intervention, psychophysiological response to food cues

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Center for Healthy Eating and Activity Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Based Behavioral Treatment Egg

Family Based Behavioral Treatment Cereal

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Ratings of acceptability intervention

Ratings of liking intervention

Secondary Outcome Measures

Child weight

Measured by Body Mass Index (BMI)

Parent weight

Measured by Body Mass Index (BMI)

Full Information

NCT ID

NCT02467036

First Posted

October 28, 2014

Last Updated

October 16, 2017

Sponsor

University of California, San Diego

Collaborators

American Egg Board

1. Study Identification

Unique Protocol Identification Number

NCT02467036

Brief Title

Family Based Treatment for Weight Loss With Breakfast Prescription

Acronym

FAB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

American Egg Board

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight, Overeating, Weight, Childhood Obesity

Keywords

overweight children, overweight parents, eating in the absence of hunger, families with overweight child, bmi, body mass index, treatment, behavioral treatment, family based treatment, experiments, intervention, psychophysiological response to food cues

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Family Based Behavioral Treatment Egg

Arm Type

Experimental

Arm Description

Arm Title

Family Based Behavioral Treatment Cereal

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Family Based Behavioral Treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ratings of acceptability intervention

Time Frame

4 months

Title

Ratings of liking intervention

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Child weight

Description

Measured by Body Mass Index (BMI)

Time Frame

8 months

Title

Parent weight

Description

Measured by Body Mass Index (BMI)

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerri Boutelle, Ph.D.

Organizational Affiliation

UCSD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Healthy Eating and Activity Research

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

http://obesitytreatment.ucsd.edu

Description

Center for Healthy Eating and Activity Research

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Family Based Treatment for Weight Loss With Breakfast Prescription

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