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

NCT ID: NCT02928874

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-08-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Caloric compensation

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.

Group Type: EXPERIMENTAL

% COMPX (low ED vs. high ED preload)

Intervention Type: BEHAVIORAL

Eating in the absence of hunger (EAH)

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.

Group Type: EXPERIMENTAL

EAH (low ED vs. high ED snacks)

Intervention Type: BEHAVIORAL

Interventions

% COMPX (low ED vs. high ED preload)

Intervention Type: BEHAVIORAL

EAH (low ED vs. high ED snacks)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanja Kral, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32289325 (View on PubMed)

Other Identifiers

820661

Identifier Type: -

Identifier Source: org_study_id