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

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ClinicalTrials.gov Identifier: NCT02467036
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Ratings of acceptability intervention [ Time Frame: 4 months ]
  2. Ratings of liking intervention [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Child weight [ Time Frame: 8 months ]
    Measured by Body Mass Index (BMI)

  2. Parent weight [ Time Frame: 8 months ]
    Measured by Body Mass Index (BMI)


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467036


Locations
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United States, California
Center for Healthy Eating and Activity Research
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
American Egg Board
Investigators
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Principal Investigator: Kerri Boutelle, Ph.D. UCSD
More Information
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Additional Information:

Publications:

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Responsible Party: Kerri Boutelle, Dr. Kerri Boutelle, Ph.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT02467036    
Other Study ID Numbers: 131519
20133198 ( Other Grant/Funding Number: American Egg Board )
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kerri Boutelle, University of California, San Diego:
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
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Body Weight
Overweight
Weight Loss
 Hyperphagia
Overnutrition
Nutrition Disorders
Body Weight Changes
Signs and Symptoms, Digestive