Clinical trial NCT02928874: Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk
Official title: Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 212
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent caloric compensation index (%COMPX)
timeFrame: Baseline
measure: Appetite ratings assessed via Visual Analog Scales
timeFrame: Baseline
measure: Total energy intake per day (number of calories consumed over 24-hours)
timeFrame: Baseline
measure: BMI z-score
timeFrame: Change from baseline BMI z-score at 1-year follow-up
measure: Waist circumference (cm)
timeFrame: Change from baseline waist circumference at 1-year follow-up
measure: Percentage body fat
timeFrame: Change from baseline percentage body fat at 1-year follow-up
Secondary outcomes:
measure: Eating in the absence of hunger (kcal)
timeFrame: Baseline (number of calories consumed from snacks)
measure: Home food environment
timeFrame: Baseline home food environment assessed using the Home Food Inventory
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Tanja Kral, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kral TVE, Moore RH, Chittams J, O'Malley L, Jones E, Quinn RJ, Fisher JO. Caloric compensation and appetite control in children of different weight status and predisposition to obesity. Appetite. 2020 Aug 1;151:104701. doi: 10.1016/j.appet.2020.104701. Epub 2020 Apr 11.