N/A
N=57
Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children
Feeding Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03242863 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Differences in Food and Beverage Intake by Energy — 1059; 1118; 977 kilocalories per day — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Food proportionality (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Food and Beverage Intake by Energy |
1059; 1118; 977 | <0.0001 sig |
| PRIMARY Differences in Food and Beverage Intake by Weight |
225; 296; 315 | <0.0001 sig |
| PRIMARY Differences in Food and Beverage Intake by Weight |
225; 296; 315 | <0.0001 sig |
| SECONDARY Differences in Food and Beverage Intake by Energy Density |
1.29; 1.21; 1.14 | <0.0001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03242863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.