N/A
N=56
Effect of Energy Density Over 5 Days in Preschool Children
Feeding Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03010501 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Differences in Food and Beverage Intake by Energy — 956; 884; 1041 kilocalories — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Food Energy Density (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Food and Beverage Intake by Energy |
956; 884; 1041 | < 0.0001 sig |
| PRIMARY Differences in Food and Beverage Intake by Weight |
997; 952; 988 | 0.10 |
| SECONDARY Differences in Food and Beverage Intake by Energy Density |
0.97; 0.93; 1.06 | < 0.0001 sig |
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.
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 (NCT03010501). 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.