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Clinical Trials/NCT03010501
NCT03010501CompletedNot Applicable

Effect of Energy Density Over 5 Days in Preschool Children

Penn State University2 sites in 1 country56 target enrollmentStarted: August 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
2
Primary Endpoint
Differences in Food and Beverage Intake by Weight

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
3 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

120% Food Energy Density

Experimental

Higher Food Energy Density

Intervention: Food Energy Density (Other)

100% Food Energy Density

Experimental

Baseline Food Energy Density

Intervention: Food Energy Density (Other)

80% Food Energy Density

Experimental

Lower Food Energy Density

Intervention: Food Energy Density (Other)

Outcomes

Primary Outcomes

Differences in Food and Beverage Intake by Weight

Time Frame: Days 1-5 in weeks 1, 2, and 3

Differences in daily intake of food and beverages by weight, in grams

Differences in Food and Beverage Intake by Energy

Time Frame: Days 1-5 in Weeks 1, 2, and 3

Differences in daily intake of food and beverages by energy, in kcal

Secondary Outcomes

  • Differences in Food and Beverage Intake by Energy Density(Days 1-5 in weeks 1, 2, and 3)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Barbara J. Rolls

Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Penn State University

Study Sites (2)

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