Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children

Feeding Behavior Clinical Trial

Official title:

Strategies to Moderate Energy Intake for the Prevention of Obesity in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242863
• Other study ID #: ChildFood503
• Secondary ID: R01DK082580
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: May 2, 2019

Study information

• Verified date: October 2020
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators will vary the proportions of high- and low-energy-dense foods served to preschool children at all meals and snacks during three 5-day periods. In the three experimental conditions, the same foods will be served; only the amounts and proportions of foods will be varied. In the Baseline condition, typical proportions of age-appropriate foods will be served. In the Addition condition, the portion sizes of low-energy-dense foods will be increased, and in the Substitution condition, the portions of low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in energy density. The primary aim is to determine the effect on children's energy intake of varying the proportion of low- and high-energy-dense foods served, either by addition or substitution, over 5 days. It is hypothesized that children will consume less energy when they are served meals in which low-energy-dense foods are substituted for foods higher in energy density over 5 days and that children will consume more energy when served meals to which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily energy intake in the three conditions will begin to converge across the 5-day period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behavior

Intervention

Other:
• Food proportionality
Proportions of high and low energy dense foods manipulated

Locations

Country	Name	City	State
United States	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	Differences in Food and Beverage Intake by Energy	Differences in daily energy consumed of food and beverages, in kilocalories	Day 1-5 in weeks 1, 2, and 3
Primary	Differences in Food and Beverage Intake by Weight	Differences in daily weight consumed of food and beverages, in grams	Day 1-5 in weeks 1, 2, and 3
Primary	Differences in Food and Beverage Intake by Weight	Differences in daily weight consumed of vegetables and fruit, in grams	Day 1-5 in weeks 1, 2, and 3
Secondary	Differences in Food and Beverage Intake by Energy Density	Differences in daily energy density consumed of food and beverages, in kilocalories/gram	Day 1-5 in weeks 1, 2, and 3