Effects of Portion Size and Energy Density of a Single Meal in Preschool Children

November 21, 2014 updated by: Barbara J. Rolls, Penn State University
This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

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

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior

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

3 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children must be enrolled in participating childcare centers.

Exclusion Criteria:

  • Allergy or intolerance to any of the foods or beverages served.

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Energy Density, Small Portions
Low meal energy density and small portion sizes
Other: Varying meal energy density and portion size
Experimental: Low Energy Density, Medium Portions
Low meal energy density and medium portion sizes
Other: Varying meal energy density and portion size
Experimental: Low Energy Density, Large Portions
Low meal energy density and large portion sizes
Other: Varying meal energy density and portion size
Experimental: High Energy Density, Small Portions
High meal energy density and small portion sizes
Other: Varying meal energy density and portion size
Experimental: High Energy Density, Medium Portions
High meal energy density and medium portion sizes
Other: Varying meal energy density and portion size
Experimental: High Energy Density, Large Portions
High meal energy density and large portion sizes
Other: Varying meal energy density and portion size

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Food and energy intake (Food weight (grams) and energy (kcal)
Time Frame: Once a week for four weeks
Once a week for four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meal energy density (Energy density (kcal/g)
Time Frame: Once a week for four weeks
Energy density (kcal/g)
Once a week for four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Barbara J Rolls, PhD, Penn State University

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.

General Publications

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, 2013

Primary Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 21, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • ChildFood201
  • R01DK082580 (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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