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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928874
• Other study ID #: 820661
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• % COMPX (low ED vs. high ED preload)

• EAH (low ED vs. high ED snacks)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent caloric compensation index (%COMPX)		Baseline
Primary	Appetite ratings assessed via Visual Analog Scales	Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.	Baseline
Primary	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
Primary	BMI z-score		Change from baseline BMI z-score at 1-year follow-up
Primary	Waist circumference (cm)		Change from baseline waist circumference at 1-year follow-up
Primary	Percentage body fat		Change from baseline percentage body fat at 1-year follow-up
Secondary	Eating in the absence of hunger (kcal)		Baseline (number of calories consumed from snacks)
Secondary	Home food environment		Baseline home food environment assessed using the Home Food Inventory