- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00436878
Intake Promoting Effects of Large Portions in Children
July 10, 2018 updated by: Temple University
The purpose of this study is to test the effects of large food portions on children's eating.
Experiment 1 will test the effect of portion size on children's consumption of sweetened beverages; we hypothesize that serving large beverage portions will increase the amount of energy children consume from this food.
Experiment 2 will test the effects of portion size on children's intake of fruits and vegetables (FV) affect intake whether such effects are moderated by children's FV preferences and; we hypothesize that serving large fruit and vegetable portions will produce increases in children's intake of these foods, particularly for children who like fruit and vegetables.
Experiment 3 will evaluate how food energy density affects children's response to large portions; we hypothesize that large portions will have the greatest influence on children's energy consumption when foods are energy dense.
Experiment 4 will begin to address perceptual mechanisms by which large portions affect children's eating.
Study Overview
Detailed Description
The emerging epidemic of overweight among underscores the need to identify contributing environmental factors.
Marketplace trends for excessive and growing portion sizes in and outside the home have reinforced concerns that large portions may directly contribute by promoting excessive intake.
To date, however, systematic investigation of portion size effects on children's eating has been extremely limited.
Two laboratory studies have reported that serving large portions of macaroni and cheese to young children promoted energy consumption at meals.
Whether portion size effects would be seen with other foods of varying energy content and preference is unknown.
Of particular public health interest is whether serving large portions may affect children's intake of sweetened beverages, fruits and vegetables, and energy dense foods.
This study will address these questions using an experimental approach to test the effects of portion size on children's eating.
Study Type
Interventional
Enrollment (Actual)
100
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
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Center for Obesity Research, Temple University
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Texas
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Houston, Texas, United States, 77030
- USDA\ARS Children's Nutrition Research Center
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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
5 years to 6 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 5 to 6 years
Exclusion Criteria:
- severe food allergies
- chronic illnesses or medication use affecting food intake
- dislike of foods on the menu
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Portion Size
Each experiment manipulated food portion size of beverages, entrees, and side dishes
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Each of four experiments involves a 2 x 2 within-subjects factorial design, in which the first factor is the portion size of a food served to children: foods will be served in a reference amount (i.e.
250 g macaroni and cheese) or doubled in size(i.e.
500 g of macaroni and cheese).
In the Experiment 1, the second factor of the 2 x 2 design is meal type: whether the food is consumed at a meal or a snack.
In experiment #2, the second factor is food type: fruit vs. vegetable.
In experiment #3, the second factor is entree energy density: a regular energy density or a 40% greater energy density.
In experiment #4, the second factor is plate size: a 6 inch plate vs. a 10 inch plate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Intake of portion manipulated foods
Time Frame: In each experimental condition; 4 times in each 2 x 2 factorial experiment
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In each experimental condition; 4 times in each 2 x 2 factorial experiment
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Total energy consumed
Time Frame: In each experimental condition; 4 times in each 2 x 2 factorial experiment
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In each experimental condition; 4 times in each 2 x 2 factorial experiment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer O Fisher, PhD, Baylor College of Medicine
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
October 1, 2005
Primary Completion (ACTUAL)
April 1, 2011
Study Completion (ACTUAL)
April 1, 2011
Study Registration Dates
First Submitted
February 16, 2007
First Submitted That Met QC Criteria
February 16, 2007
First Posted (ESTIMATE)
February 19, 2007
Study Record Updates
Last Update Posted (ACTUAL)
July 12, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DK71095
- R01DK071095 (NIH)
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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