- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905293
Individual Differences in Children's Susceptibility to Overeating
July 18, 2013 updated by: University of Pennsylvania
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100% portion size
100% portion size condition
|
|
Experimental: 150% portion size
150% portion size condition
|
|
Experimental: 200% portion size
200% portion size condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total energy intake
Time Frame: Up to 3 weeks
|
Up to 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Energy intake from food
Time Frame: Up to 3 weeks
|
Up to 3 weeks
|
Energy intake from beverage
Time Frame: Up to 3 weeks
|
Up to 3 weeks
|
Percent estimated energy requirement (%EER)
Time Frame: Up to 3 weeks
|
Up to 3 weeks
|
Relative reinforcing value of food (RRVF)
Time Frame: Up to 3 weeks
|
Up to 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tanja VE Kral, Ph.D., University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
July 11, 2013
First Submitted That Met QC Criteria
July 18, 2013
First Posted (Estimate)
July 23, 2013
Study Record Updates
Last Update Posted (Estimate)
July 23, 2013
Last Update Submitted That Met QC Criteria
July 18, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03DK091492 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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