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

NCT ID: NCT02755558

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Feeding Behaviors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Low energy density, small portion

Low milk energy density and small portion size

Group Type EXPERIMENTAL

Low energy density

Intervention Type BEHAVIORAL

Low energy density milk served

Small portion

Intervention Type BEHAVIORAL

Small portion of milk served

Low energy density, large portion

Low milk energy density and large portion size

Group Type EXPERIMENTAL

Low energy density

Intervention Type BEHAVIORAL

Low energy density milk served

Large portion

Intervention Type BEHAVIORAL

Large portion of milk served

High energy density, small portion

High milk energy density and small portion size

Group Type EXPERIMENTAL

High energy density

Intervention Type BEHAVIORAL

High energy density milk served

Small portion

Intervention Type BEHAVIORAL

Small portion of milk served

High energy density, large portion

High milk energy density and large portion size

Group Type EXPERIMENTAL

High energy density

Intervention Type BEHAVIORAL

High energy density milk served

Large portion

Intervention Type BEHAVIORAL

Large portion of milk served

Interventions

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Low energy density

Low energy density milk served

Intervention Type BEHAVIORAL

High energy density

High energy density milk served

Intervention Type BEHAVIORAL

Small portion

Small portion of milk served

Intervention Type BEHAVIORAL

Large portion

Large portion of milk served

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children must be enrolled in participating childcare centers

Exclusion Criteria

* Allergy or intolerance to any of the foods or beverages served
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Barbara J. Rolls

Professor of Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara J Rolls

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

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The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK082580

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-67001-30117

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ChildFood301

Identifier Type: -

Identifier Source: org_study_id

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