Effects of Energy Density and Portion Size of Milk in Preschool Children

March 17, 2017 updated by: Barbara J. Rolls, Penn State University
In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low energy density, small portion
Low milk energy density and small portion size
Behavioral: Low energy density
Low energy density milk served
Behavioral: Small portion
Small portion of milk served
EXPERIMENTAL: Low energy density, large portion
Low milk energy density and large portion size
Behavioral: Low energy density
Low energy density milk served
Behavioral: Large portion
Large portion of milk served
EXPERIMENTAL: High energy density, small portion
High milk energy density and small portion size
Behavioral: Small portion
Small portion of milk served
Behavioral: High energy density
High energy density milk served
EXPERIMENTAL: High energy density, large portion
High milk energy density and large portion size
Behavioral: Large portion
Large portion of milk served
Behavioral: High energy density
High energy density milk served

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between experimental conditions for milk, food, and total intake by weight
Time Frame: once a week for 4 weeks
Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams)
once a week for 4 weeks
Difference between experiential conditions for milk, food, and total intake by energy
Time Frame: once a week for 4 weeks
Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal)
once a week for 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meal energy density
Time Frame: once a week for 4 weeks
Meal energy density (energy density in kcal/g)
once a week for 4 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, The Pennsylvania State University

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

September 1, 2014

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (ESTIMATE)

April 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ChildFood301
  • R01DK082580 (U.S. NIH Grant/Contract)
  • 2011-67001-30117 (Other Grant/Funding Number: United States Department of Agriculture)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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