NCT03242863

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

Completed NA Results posted Last updated 18 November 2020

What this trial tests

NA trial testing Food proportionality in Feeding Behavior in 57 participants. Completed in 2 May 2019.

Timeline

27 November 2017

Primary endpoint
2 May 2019

2 May 2019

Quick facts

Lead sponsor	Penn State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	57
Start date	27 November 2017
Primary completion	2 May 2019
Estimated completion	2 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Food proportionality

Conditions studied

• Feeding Behavior — all drugs for Feeding Behavior →

Sponsor

Penn State University

Who can join

Adults 3 to 5, any sex, with Feeding Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Differences in Food and Beverage Intake by Energy Primary · Day 1-5 in weeks 1, 2, and 3

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

Group	Value	95% CI
Control	1059	± 33
Addition	1118	± 35
Substitution	977	± 34

Differences in Food and Beverage Intake by Weight Primary · Day 1-5 in weeks 1, 2, and 3

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

Group	Value	95% CI
Control	868	± 35
Addition	955	± 36
Substitution	908	± 35

Differences in Food and Beverage Intake by Weight Primary · Day 1-5 in weeks 1, 2, and 3

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

Group	Value	95% CI
Control	225	± 15
Addition	296	± 15
Substitution	315	± 15

Differences in Food and Beverage Intake by Energy Density Secondary · Day 1-5 in weeks 1, 2, and 3

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

Group	Value	95% CI
Control	1.29	± 0.038
Addition	1.21	± 0.039
Substitution	1.14	± 0.038

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Portion size can be used strategically to increase intake of vegetables and fruits in young children over multiple days: a cluster-randomized crossover trial.
   Roe LS, Sanchez CE, Smethers AD, Keller KL, et al · · 2022 · cited 15× · PMID 34550306 · DOI 10.1093/ajcn/nqab321
2. Children's Energy Intake Generally Increases in Response to the Energy Density of Meals but Varies with the Amounts and Types of Foods Served.
   Rolls BJ, Roe LS, Keller KL. · · 2024 · cited 4× · PMID 37890673 · DOI 10.1016/j.ajcnut.2023.10.019
3. Food Properties and Individual Characteristics Influence Children's Intake Across Multiple Days of Weighed Assessments in Childcare Programs.
   Roe LS, Keller KL, Rolls BJ. · · 2023 · PMID 36965692 · DOI 10.1016/j.tjnut.2023.03.025