Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: % COMPX (low ED vs. high ED preload); Behavioral: EAH (low ED vs. high ED snacks)

• Registration Number: NCT02928874
• Lead Sponsor: University of Pennsylvania

Brief Summary

Using an integrated approach, this study examines multiple eating traits concurrently under states of hunger and satiety. It examines the impact of short-term appetite and intake regulation on longer-term energy intake control and weight development in a cohort of ethnically diverse normal-weight and obese boys and girls with different familial predispositions to obesity.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Primary Completion: 2018-08-30
• Study Completion: 2019-08-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• 7-9 years of age
• Normal-weight or overweight/obese who are at low risk or high risk for obesity based on maternal BMI
• Like most foods served during the study
• Be regular breakfast eaters

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Exclusion Criteria

• Have serious medical conditions known to affect food intake or body weight
• Have any developmental, medical, or psychiatric conditions that might impact study compliance
• Have a learning disability or poor reading ability/comprehension
• Have visual or auditory impairment
• Are taking medications associated with developmental, medical, or psychiatric disorders or medications known to affect appetite, food intake or body weight
• Are underweight
• Have food allergies related to the foods served in the study or are lactose intolerant
• Do not regularly eat breakfast
• Do not like or cannot eat foods served during experimental meal or are unable to finish compulsory preload
• Mothers who are pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Caloric compensation	% COMPX (low ED vs. high ED preload)	Twenty-five minutes before breakfast, participants will be asked to consume in full one of two oatmeal preloads that will vary in ED. The order of preload conditions will be randomized across groups of children participating in the visits.
Eating in the absence of hunger (EAH)	EAH (low ED vs. high ED snacks)	During both study visits, children's EAH will be assessed after lunch and again after dinner. The order of presenting the low and high ED snacks will be counterbalanced across meals.

Primary Outcome Measures

Name	Time	Method
Waist circumference (cm)	Change from baseline waist circumference at 1-year follow-up
Appetite ratings assessed via Visual Analog Scales	Baseline	Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.
Percent caloric compensation index (%COMPX)	Baseline
Total energy intake per day (number of calories consumed over 24-hours)	Baseline	Number of calories consumed over 24-hours assessed via measured food intake in the laboratory and via parent-reported food intake at home.
BMI z-score	Change from baseline BMI z-score at 1-year follow-up
Percentage body fat	Change from baseline percentage body fat at 1-year follow-up

Secondary Outcome Measures

Name	Time	Method
Eating in the absence of hunger (kcal)	Baseline (number of calories consumed from snacks)
Home food environment	Baseline home food environment assessed using the Home Food Inventory

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States