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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: % COMPX (low ED vs. high ED preload)
* Behavioral: EAH (low ED vs. high ED snacks)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caloric compensation<br>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. | Behavioral: % COMPX (low ED vs. high ED preload)<br> <br> |
| Experimental: Eating in the absence of hunger (EAH)<br>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. | Behavioral: EAH (low ED vs. high ED snacks)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |