Clinical trial NCT03242863: Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children
Official title: Strategies to Moderate Energy Intake for the Prevention of Obesity in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-08-08
Enrollment: 57
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Differences in Food and Beverage Intake by Energy
timeFrame: Day 1-5 in weeks 1, 2, and 3
measure: Differences in Food and Beverage Intake by Weight
timeFrame: Day 1-5 in weeks 1, 2, and 3
measure: Differences in Food and Beverage Intake by Weight
timeFrame: Day 1-5 in weeks 1, 2, and 3
Secondary outcomes:
measure: Differences in Food and Beverage Intake by Energy Density
timeFrame: Day 1-5 in weeks 1, 2, and 3
Other outcomes:
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Barbara J Rolls, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roe LS, Sanchez CE, Smethers AD, Keller KL, Rolls BJ. Portion size can be used strategically to increase intake of vegetables and fruits in young children over multiple days: a cluster-randomized crossover trial. Am J Clin Nutr. 2022 Jan 11;115(1):272-283. doi: 10.1093/ajcn/nqab321.