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

NCT ID: NCT03242863

Last Updated: 2020-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2019-05-02

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.

Conditions

Feeding Behavior

Study Design

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

Study Groups

Control

Baseline proportions of high and low energy dense foods.

Group Type: EXPERIMENTAL

Food proportionality

Intervention Type: OTHER

Proportions of high and low energy dense foods manipulated

Addition

Increased portion of low energy dense foods.

Group Type: EXPERIMENTAL

Food proportionality

Intervention Type: OTHER

Proportions of high and low energy dense foods manipulated

Substitution

Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.

Group Type: EXPERIMENTAL

Food proportionality

Intervention Type: OTHER

Proportions of high and low energy dense foods manipulated

Interventions

Food proportionality

Proportions of high and low energy dense foods 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, PhD

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)

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.

Reference Type: DERIVED

PMID: 34550306 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK082580

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ChildFood503

Identifier Type: -

Identifier Source: org_study_id