Effect of Energy Density Over 5 Days in Preschool Children

In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.

Study Overview

• Status: Completed
• Conditions: Feeding Behavior
• Intervention / Treatment: Other: Food Energy Density

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Laboratory for the Study of Human Ingestive Behavior

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Attending one of the designated daycare centers

Exclusion Criteria:

• Food Allergies
• Food restrictions
• Health Issues that Preclude Participation
• Not available for duration of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100% Food Energy Density; Baseline Food Energy Density	Other: Food Energy Density; Food Energy density manipulated
Experimental: 80% Food Energy Density; Lower Food Energy Density	Other: Food Energy Density; Food Energy density manipulated
Experimental: 120% Food Energy Density; Higher Food Energy Density	Other: Food Energy Density; Food Energy density manipulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Food and Beverage Intake by Energy	Differences in daily intake of food and beverages by energy, in kcal	Days 1-5 in Weeks 1, 2, and 3
Differences in Food and Beverage Intake by Weight	Differences in daily intake of food and beverages by weight, in grams	Days 1-5 in weeks 1, 2, and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Food and Beverage Intake by Energy Density	Differences in daily intake of food and beverages by energy density, in kcal/g	Days 1-5 in weeks 1, 2, and 3

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ChildFood502; R01DK082580 (U.S. NIH Grant/Contract)