Effect of Energy Density Over 5 Days in Preschool Children

Not Applicable

Completed

• Conditions: Feeding Behavior
• Interventions: Other: Food Energy Density

• Registration Number: NCT03010501
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2019-05-17
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Results First Posted: 2019-07-11
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
100% Food Energy Density	Food Energy Density	Baseline Food Energy Density
80% Food Energy Density	Food Energy Density	Lower Food Energy Density
120% Food Energy Density	Food Energy Density	Higher Food Energy Density

Primary Outcome Measures

Name	Time	Method
Differences in Food and Beverage Intake by Weight	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	Days 1-5 in Weeks 1, 2, and 3	Differences in daily intake of food and beverages by energy, in kcal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laboratory for the Study of Human Ingestive Behavior; 🇺🇸 University Park, Pennsylvania, United States