Children's Intake of Foods Reduced in Energy Density

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University
ClinicalTrials.gov Identifier:
NCT01252433
First received: December 2, 2010
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Vegetable Intake
Other: Energy density feeding study

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Children's Intake of Foods Reduced in Energy Density

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Food intake [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Energy intake [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Entree energy density 100%
100% energy density
Other: Energy 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%).
Experimental: Entree energy density 85%
85% energy density
Other: Energy 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%).
Experimental: Entree energy density 75%
75% energy density
Other: Energy 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%).

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • enrolled in daycare centers at Penn State University

Exclusion Criteria:

  • food allergies or intolerances
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252433

Locations
United States, Pennsylvania
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
  More Information

No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara J. Rolls, Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior, Penn State University
ClinicalTrials.gov Identifier: NCT01252433     History of Changes
Other Study ID Numbers: FoodED201, R01DK082580
Study First Received: December 2, 2010
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014