Individual Differences in Children's Susceptibility to Overeating
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feeding Study
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 8 to 10 years of age
- normal-weight or obese
- like most foods that were served in the study
Exclusion Criteria:
- serious medical conditions or medication use known to affect appetite, food intake, and body weight
- developmental or psychiatric conditions
- learning disability
- sight or hearing impairment
- food allergies or nutrient intolerances (including lactose intolerance)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
100% portion size
150% portion size
200% portion size
Arm Description
100% portion size condition
150% portion size condition
200% portion size condition
Outcomes
Primary Outcome Measures
Total energy intake
Secondary Outcome Measures
Energy intake from food
Energy intake from beverage
Percent estimated energy requirement (%EER)
Relative reinforcing value of food (RRVF)
Full Information
NCT ID
NCT01905293
First Posted
July 11, 2013
Last Updated
July 18, 2013
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01905293
Brief Title
Individual Differences in Children's Susceptibility to Overeating
Official Title
Individual Differences in Children's Susceptibility to Overeating
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The portion size of foods has been identified as an important determinant of energy intake in children. It remains to be determined to what extent child weight status and the relative reinforcing value of food may interact with the obesogenic food environment to affect energy intake. The primary aim of this study was to compare energy intake at a meal in normal-weight and obese children when the portion size of palatable, energy-dense foods and a sugar-sweetened beverage was systematically increased. We hypothesized that increasing the portion size of all foods and the beverage at a meal will lead to a significant increase in energy intake in both normal-weight and obese children. Obese children, however, will show a significantly greater increase in energy intake than will normal-weight children. A second aim of this study was to test if children's response to increases in portion size was affected by how reinforcing they find food to be. We hypothesized that, when controlling for BMI, children who find food very reinforcing relative to nonfood alternatives will show a significantly greater increase in energy intake than will children who find food less reinforcing.
Detailed Description
The prevalence of childhood and adolescent obesity has reached an all-time high. There is a pressing need to better understand the behavioral mechanisms that control appetite and eating in children and to identify children who are most susceptible to overeating in the current obesogenic food environment. Obesogenic environments offer convenient access to large portions of palatable, energy-dense foods. The portion size of foods has been identified as an important determinant of energy intake in adults and children. While portion size effects have been found in heterogenous groups of healthy individuals, some evidence points to possible individual differences in the magnitude of children's responsiveness to large food portions. For example, data from a previous laboratory study suggest that overweight and obese children may be particularly vulnerable to overeating when presented with large food portions. Further, the magnitude of a portion size effect on intake may also depend on how reinforcing (or rewarding) children find food to be. It is possible that the relative reinforcing value of food may interact with environmental cues, such as the portion size of food, to affect children's energy intake when large portions of palatable, energy-dense foods are available. The primary aim of this study is to compare the effects of increasing the portion size of all foods and a beverage served at a meal on energy intake in normal-weight and obese children. A second aim is to test if children who find food very reinforcing relative to an appealing nonfood alternative will show a significantly greater increase in energy intake in response to increasing portion sizes than will children who find food less reinforcing. The findings from this study are expected to extend previous findings to test how environmental factors, such as food portion size, may interact with individual differences in weight status or food reinforcement to affect energy intake in children.
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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100% portion size
Arm Type
Experimental
Arm Description
100% portion size condition
Arm Title
150% portion size
Arm Type
Experimental
Arm Description
150% portion size condition
Arm Title
200% portion size
Arm Type
Experimental
Arm Description
200% portion size condition
Intervention Type
Other
Intervention Name(s)
Feeding Study
Primary Outcome Measure Information:
Title
Total energy intake
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Energy intake from food
Time Frame
Up to 3 weeks
Title
Energy intake from beverage
Time Frame
Up to 3 weeks
Title
Percent estimated energy requirement (%EER)
Time Frame
Up to 3 weeks
Title
Relative reinforcing value of food (RRVF)
Time Frame
Up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
8 to 10 years of age
normal-weight or obese
like most foods that were served in the study
Exclusion Criteria:
serious medical conditions or medication use known to affect appetite, food intake, and body weight
developmental or psychiatric conditions
learning disability
sight or hearing impairment
food allergies or nutrient intolerances (including lactose intolerance)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja VE Kral, Ph.D.
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
Links:
URL
http://www2.niddk.nih.gov
Description
National Institute of Diabetes and Digestive and Kidney Diseases
Learn more about this trial
Individual Differences in Children's Susceptibility to Overeating
We'll reach out to this number within 24 hrs