Does Portion Size Influence Intake of Low-Energy-Dense Foods in Preschool-Aged Children?

This study has been completed.

Sponsor:

Information provided by:

University of Tennessee

ClinicalTrials.gov Identifier:

NCT00936507

First received: July 8, 2009

Last updated: July 9, 2009

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	July 8, 2009
Last Updated Date	July 9, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00936507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Does Portion Size Influence Intake of Low-Energy-Dense Foods in Preschool-Aged Children?
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this randomized controlled study using a crossover design is to investigate the main effect of portion size and food type (low-energy dense vs. high-energy dense) on caloric intake.
Detailed Description	The purpose of this investigation is to examine the impact of portion size on intake of a low energy dense food (fruit). Preschool-aged children will be provided with a small and large portion of applesauce (low-energy-dense food) and chocolate pudding (higher-energy-dense food) and allowed to eat the foods ad libitum during an afternoon snack in their usual preschool classroom. Measures of the amount of each food (grams and kilocalories) consumed will be taken. The following hypotheses are proposed: A significant main effect of portion size will occur, such that children will consume more food, both in grams and kilocalories, in the large portion as compared to the small portion conditions. A main effect of food type on caloric intake will occur, such that children will consume less calories in the applesauce condition as compared to the pudding condition, due to the differences in energy density of these foods. It is not anticipated that a difference in grams consumed from each food will occur.
Study Type ^ICMJE	Interventional
Study Phase	Phase 0
Study Design ^ICMJE	Intervention Model: Crossover Assignment
Condition ^ICMJE	Caloric Intake
Intervention ^ICMJE	Other: Energy Density/Portion Size
Study Arm (s)	Experimental: Energy Density/Portion Size Intervention: Other: Energy Density/Portion Size
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: All children that are ≥3 years of age enrolled in the ELC preschool with parental consent can participate. Eligible children must also like both the applesauce and the pudding, and be able to consume foods with a spoon. Exclusion Criteria: Children allergic to applesauce or chocolate pudding or who are lactose- intolerant will not be included in the study. Did not attend all feeding sessions. Did not consume more than 5 grams from any of the foods on an occasion.
Gender	Both
Ages	3 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00936507
Other Study ID Numbers ^ICMJE	1-Smith
Has Data Monitoring Committee	Not Provided
Responsible Party	Shannon Looney, BS/Hollie Raynor, PhD, RD Assistant Professor, University of Tennessee
Study Sponsor ^ICMJE	University of Tennessee
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Tennessee
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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