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OpenTrials
Completed

NCT Number: NCT03242863

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

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food proportionality

Other

Proportions of high and low energy dense foods manipulated

Primary outcomes

  1. Differences in Food and Beverage Intake by Energy

    Time frame: Day 1-5 in weeks 1, 2, and 3

    Differences in daily energy consumed of food and beverages, in kilocalories

  2. Differences in Food and Beverage Intake by Weight

    Time frame: Day 1-5 in weeks 1, 2, and 3

    Differences in daily weight consumed of food and beverages, in grams

  3. Differences in Food and Beverage Intake by Weight

    Time frame: Day 1-5 in weeks 1, 2, and 3

    Differences in daily weight consumed of vegetables and fruit, in grams

Secondary outcomes

  1. Differences in Food and Beverage Intake by Energy Density

    Time frame: Day 1-5 in weeks 1, 2, and 3

    Differences in daily energy density consumed of food and beverages, in kilocalories/gram

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2017
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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