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Completed

NCT Number: NCT02467036

Family Based Treatment for Weight Loss With Breakfast Prescription

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Healthy Eating and Activity Research

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Based Behavioral Treatment

Behavioral

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 outcomes

  1. Ratings of acceptability intervention

    Time frame: 4 months

  2. Ratings of liking intervention

    Time frame: 4 months

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • American Egg Board

Registry information

Official study title

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

Acronym: FAB

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2015
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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