Effect of Energy Density Over 5 Days in Preschool Children

NCT ID: NCT03010501

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Feeding Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

100% Food Energy Density

Baseline Food Energy Density

Group Type: EXPERIMENTAL

Food Energy Density

Intervention Type: OTHER

Food Energy density manipulated

80% Food Energy Density

Lower Food Energy Density

Group Type: EXPERIMENTAL

Food Energy Density

Intervention Type: OTHER

Food Energy density manipulated

120% Food Energy Density

Higher Food Energy Density

Group Type: EXPERIMENTAL

Food Energy Density

Intervention Type: OTHER

Food Energy density manipulated

Interventions

Food Energy Density

Food Energy density manipulated

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Barbara J. Rolls

Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara J Rolls

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37890673 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36965692 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK082580

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ChildFood502

Identifier Type: -

Identifier Source: org_study_id