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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
% COMPX (low ED vs. high ED preload)
EAH (low ED vs. high ED snacks)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Caloric compensation

Eating in the absence of hunger (EAH)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent caloric compensation index (%COMPX)
Appetite ratings assessed via Visual Analog Scales
Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.
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.
BMI z-score
Waist circumference (cm)
Percentage body fat

Secondary Outcome Measures

Eating in the absence of hunger (kcal)
Home food environment

Full Information

First Posted
October 4, 2016
Last Updated
October 15, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02928874
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caloric compensation
Arm Type
Experimental
Arm Description
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.
Arm Title
Eating in the absence of hunger (EAH)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
% COMPX (low ED vs. high ED preload)
Intervention Type
Behavioral
Intervention Name(s)
EAH (low ED vs. high ED snacks)
Primary Outcome Measure Information:
Title
Percent caloric compensation index (%COMPX)
Time Frame
Baseline
Title
Appetite ratings assessed via Visual Analog Scales
Description
Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.
Time Frame
Baseline
Title
Total energy intake per day (number of calories consumed over 24-hours)
Description
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
Title
BMI z-score
Time Frame
Change from baseline BMI z-score at 1-year follow-up
Title
Waist circumference (cm)
Time Frame
Change from baseline waist circumference at 1-year follow-up
Title
Percentage body fat
Time Frame
Change from baseline percentage body fat at 1-year follow-up
Secondary Outcome Measure Information:
Title
Eating in the absence of hunger (kcal)
Time Frame
Baseline (number of calories consumed from snacks)
Title
Home food environment
Time Frame
Baseline home food environment assessed using the Home Food Inventory

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Kral, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32289325
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.
Results Reference
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Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk

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