NCT01252433

Brief Summary

The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 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

January 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

December 2, 2010

Last Update Submit

March 15, 2012

Conditions

Vegetable Intake

Outcome Measures

Primary Outcomes (1)

  • Food intake

    1 month

Secondary Outcomes (1)

  • Energy intake

    1 month

Study Arms (3)

Entree energy density 100%

EXPERIMENTAL

100% energy density

Other: Energy density feeding study

Entree energy density 85%

EXPERIMENTAL

85% energy density

Other: Energy density feeding study

Entree energy density 75%

EXPERIMENTAL

75% energy density

Other: Energy density feeding study

Interventions

Energy density feeding studyOTHER

In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).

Entree energy density 100%Entree energy density 75%Entree energy density 85%

Eligibility Criteria

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

You may qualify if:

  • enrolled in daycare centers at Penn State University

You may not qualify if:

  • food allergies or intolerances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • Spill MK, Birch LL, Roe LS, Rolls BJ. Hiding vegetables to reduce energy density: an effective strategy to increase children's vegetable intake and reduce energy intake. Am J Clin Nutr. 2011 Sep;94(3):735-41. doi: 10.3945/ajcn.111.015206. Epub 2011 Jul 20.

    PMID: 21775554DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
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

December 2, 2010

First Posted

December 3, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

US(1)