NCT02299531

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

November 19, 2014

Last Update Submit

November 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Food and energy intake (Food weight (grams) and energy (kcal)

    Once a week for four weeks

Secondary Outcomes (1)

  • Meal energy density (Energy density (kcal/g)

    Once a week for four weeks

Study Arms (6)

Low Energy Density, Small Portions

EXPERIMENTAL

Low meal energy density and small portion sizes

Other: Varying meal energy density and portion size

Low Energy Density, Medium Portions

EXPERIMENTAL

Low meal energy density and medium portion sizes

Other: Varying meal energy density and portion size

Low Energy Density, Large Portions

EXPERIMENTAL

Low meal energy density and large portion sizes

Other: Varying meal energy density and portion size

High Energy Density, Small Portions

EXPERIMENTAL

High meal energy density and small portion sizes

Other: Varying meal energy density and portion size

High Energy Density, Medium Portions

EXPERIMENTAL

High meal energy density and medium portion sizes

Other: Varying meal energy density and portion size

High Energy Density, Large Portions

EXPERIMENTAL

High meal energy density and large portion sizes

Other: Varying meal energy density and portion size

Interventions

High Energy Density, Large PortionsHigh Energy Density, Medium PortionsHigh Energy Density, Small PortionsLow Energy Density, Large PortionsLow Energy Density, Medium PortionsLow Energy Density, Small Portions

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children must be enrolled in participating childcare centers.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • Kling SM, Roe LS, Keller KL, Rolls BJ. Double trouble: Portion size and energy density combine to increase preschool children's lunch intake. Physiol Behav. 2016 Aug 1;162:18-26. doi: 10.1016/j.physbeh.2016.02.019. Epub 2016 Feb 12.

MeSH Terms

Conditions

Feeding Behavior

Interventions

Portion Size

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Barbara J Rolls, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of The Laboratory for the Study of Human Ingestive Behavior

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 24, 2014

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations