Obesity
Conditions
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.
Interventions
BEHAVIORAL% COMPX (low ED vs. high ED preload)
BEHAVIORALEAH (low ED vs. high ED snacks)
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage body fat | Change from baseline percentage body fat at 1-year follow-up | — |
| 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 | — |
| Percent caloric compensation index (%COMPX) | Baseline | — |
| Appetite ratings assessed via Visual Analog Scales | Baseline | Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness. |
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Home food environment | Baseline home food environment assessed using the Home Food Inventory |
| Eating in the absence of hunger (kcal) | Baseline (number of calories consumed from snacks) |
Countries
United States
Outcome results
None listed