Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02299531
Other study ID # ChildFood201
Secondary ID R01DK082580
Status Completed
Phase N/A
First received November 19, 2014
Last updated November 21, 2014
Start date May 2013

Study information

Verified date November 2014
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria:

- Children must be enrolled in participating childcare centers.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Varying meal energy density and portion size


Locations

Country Name City State
United States The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior University Park Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Food and energy intake (Food weight (grams) and energy (kcal) Once a week for four weeks No
Secondary Meal energy density (Energy density (kcal/g) Energy density (kcal/g) Once a week for four weeks No
See also
  Status Clinical Trial Phase
Completed NCT02755558 - Effects of Energy Density and Portion Size of Milk in Preschool Children N/A
Completed NCT01684332 - Postprandial Response to Different Jams N/A
Completed NCT01525186 - Observational Study of Parental Feeding Practices to Improve Child's Food Intake and Weight Status N/A
Completed NCT02897570 - Metabolic and Neurofunctional Responses to Breakfasts N/A
Completed NCT02369588 - Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults N/A
Completed NCT01557218 - Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack N/A
Completed NCT02942589 - Effect of Portion-control Training on Food Intake N/A
Completed NCT01725347 - Validation of a Digital Diet Method for Use With Preschoolers N/A
Terminated NCT02568007 - Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders Phase 4
Completed NCT02745405 - Implications of Wearing a Fat Suit N/A