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CompletedNCT01252433Updated Mar 16, 2012

Children's Intake of Foods Reduced in Energy Density

An interventional study of Energy density feeding study in Vegetable Intake, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-16.

Sponsored by Penn State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vegetable Intake
03

In context

Lead sponsor

Penn State University is the lead sponsor of 269 studies on the registry; 52 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.

Browse Penn State University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • enrolled in daycare centers at Penn State University

Exclusion criteria

Exclusion Criteria:

  • food allergies or intolerances
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Entree energy density 100%

    100% energy density

    Other: Energy density feeding study

  • Experimental
    Entree energy density 85%

    85% energy density

    Other: Energy density feeding study

  • Experimental
    Entree energy density 75%

    75% energy density

    Other: Energy density feeding study

Interventions

  • OtherEnergy density feeding study

    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%).

06

What researchers measure

Primary outcomes

  1. Food intake

    Time frame: 1 month

Secondary outcomes

  1. Energy intake

    Time frame: 1 month

07

Study locations

1 site
  • The Pennsylvania State University
    University Park, Pennsylvania 16802, United States
08

References and documents

Publications

  • 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. PubMed 21775554 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of May 2010 and a completion of May 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2010
First posted
Dec 3, 2010
Start
Jan 2010
Primary completionActual
May 2010
CompletionActual
May 2010
Last update
Mar 16, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01252433
Lead sponsor
Penn State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Barbara J. Rolls (Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior, Penn State University) — Principal investigator
First posted
Dec 3, 2010
Start date
Jan 2010
Primary completion
May 2010
Completion
May 2010
Last update
Mar 16, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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