NCT03010501

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 11, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

December 22, 2016

Results QC Date

May 17, 2019

Last Update Submit

July 10, 2019

Conditions

Feeding Behavior

Outcome Measures

Primary Outcomes (2)

  • Differences in Food and Beverage Intake by Energy

    Differences in daily intake of food and beverages by energy, in kcal

    Days 1-5 in Weeks 1, 2, and 3

  • Differences in Food and Beverage Intake by Weight

    Differences in daily intake of food and beverages by weight, in grams

    Days 1-5 in weeks 1, 2, and 3

Secondary Outcomes (1)

  • Differences in Food and Beverage Intake by Energy Density

    Days 1-5 in weeks 1, 2, and 3

Study Arms (3)

100% Food Energy Density

EXPERIMENTAL

Baseline Food Energy Density

Other: Food Energy Density

80% Food Energy Density

EXPERIMENTAL

Lower Food Energy Density

Other: Food Energy Density

120% Food Energy Density

EXPERIMENTAL

Higher Food Energy Density

Other: Food Energy Density

Interventions

Food Energy DensityOTHER

Food Energy density manipulated

100% Food Energy Density120% Food Energy Density80% Food Energy Density

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Attending one of the designated daycare centers

You may not qualify if:

  • Food Allergies
  • Food restrictions
  • Health Issues that Preclude Participation
  • Not available for duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Location

Related Publications (2)

  • Rolls BJ, Roe LS, Keller KL. Children's Energy Intake Generally Increases in Response to the Energy Density of Meals but Varies with the Amounts and Types of Foods Served. Am J Clin Nutr. 2024 Jan;119(1):185-195. doi: 10.1016/j.ajcnut.2023.10.019. Epub 2023 Oct 27.

    PMID: 37890673DERIVED

  • Roe LS, Keller KL, Rolls BJ. Food Properties and Individual Characteristics Influence Children's Intake Across Multiple Days of Weighed Assessments in Childcare Programs. J Nutr. 2023 May;153(5):1646-1655. doi: 10.1016/j.tjnut.2023.03.025. Epub 2023 Mar 24.

    PMID: 36965692DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Results Point of Contact

Title
Dr. Barbara J. Rolls
Organization
Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
bjr4@psu.edu
814-863-8481

Study Officials

  • Barbara J Rolls

    Penn State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 5, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 11, 2019

Results First Posted

July 11, 2019

Record last verified: 2019-07

Locations

US(1)