Effect of Portion Size Over 5 Days in Preschool Children

May 30, 2019 updated by: Barbara J. Rolls, Penn State University
In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Laboratory for the Study of Human Ingestive Behavior
      • 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 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attending one of the designated childcare centers

Exclusion Criteria:

  • Food Allergies
  • Food Restrictions
  • Health Issues that Preclude Participation
  • Not available for duration of the study

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% Food and Beverage Portion Size
Other: Food and Beverage Portion Size
Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)
Experimental: 150% Portion Size
150% Food and Beverage Portion Size
Other: Food and Beverage Portion Size
Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Food and Beverage Intake by Energy
Time Frame: Days 1-5 in Periods 1 and 2
Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages
Days 1-5 in Periods 1 and 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Food and Beverage Intake by Energy Density
Time Frame: Days 1-5 in Periods 1 and 2
Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages
Days 1-5 in Periods 1 and 2
Differences in Food and Beverage Intake by Weight
Time Frame: Days 1-5 in Periods 1 and 2
Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g)
Days 1-5 in Periods 1 and 2

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)
United States Department of Agriculture (USDA)

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 (Actual)

June 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ChildFood501
  • R01DK082580 (U.S. NIH Grant/Contract)
  • 2011-67001-30117 (Other Grant/Funding Number: United States Department of Agriculture)

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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