Clinical trial NCT02467036: Family Based Treatment for Weight Loss With Breakfast Prescription
Official title: A Pilot Study Examining the Impact of Eggs for Breakfast on Weight Loss and Hunger in Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2015-06-09
Enrollment: 66
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Ratings of acceptability intervention
timeFrame: 4 months
measure: Ratings of liking intervention
timeFrame: 4 months
Secondary outcomes:
measure: Child weight
timeFrame: 8 months
measure: Parent weight
timeFrame: 8 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Center for Healthy Eating and Activity Research
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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