An interventional study of % COMPX (low ED vs. high ED preload) and EAH (low ED vs. high ED snacks) in Obesity, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 7 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-16.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 212 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria:
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)
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)
Percent caloric compensation index (%COMPX)
Time frame: Baseline
Appetite ratings assessed via Visual Analog Scales
Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.
Time frame: 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.
Time frame: Baseline
BMI z-score
Time frame: Change from baseline BMI z-score at 1-year follow-up
Waist circumference (cm)
Time frame: Change from baseline waist circumference at 1-year follow-up
Percentage body fat
Time frame: Change from baseline percentage body fat at 1-year follow-up
Eating in the absence of hunger (kcal)
Time frame: Baseline (number of calories consumed from snacks)
Home food environment
Time frame: Baseline home food environment assessed using the Home Food Inventory
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania