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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: % COMPX (low ED vs. high ED preload); Behavioral: EAH (low ED vs. high ED snacks)

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: % COMPX (low ED vs. high ED preload)
Experimental: 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.	Behavioral: EAH (low ED vs. high ED snacks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent caloric compensation index (%COMPX)		Baseline
Appetite ratings assessed via Visual Analog Scales	Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.	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.	Baseline
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
Percentage body fat		Change from baseline percentage body fat at 1-year follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Eating in the absence of hunger (kcal)	Baseline (number of calories consumed from snacks)
Home food environment	Baseline home food environment assessed using the Home Food Inventory

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Tanja Kral, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 820661