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

NCT03242863 | Completed Results

• 2 other identifiers: ChildFood503R01DK082580
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Differences in Food and Beverage Intake by Energy

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

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

• Differences in Food and Beverage Intake by Weight

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

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

• Differences in Food and Beverage Intake by Weight

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

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

Secondary Outcomes (1)

• Differences in Food and Beverage Intake by Energy Density

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

Study Arms (3)

Control

EXPERIMENTAL

Baseline proportions of high and low energy dense foods.

Other: Food proportionality

Addition

EXPERIMENTAL

Increased portion of low energy dense foods.

Other: Food proportionality

Substitution

EXPERIMENTAL

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

Other: Food proportionality

Interventions

Food proportionality OTHER

Proportions of high and low energy dense foods manipulated

Addition; Control; Substitution

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Penn State University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

• 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: 37890673 DERIVED

• 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: 36965692 DERIVED

• 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.

  PMID: 34550306 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

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, PhD

  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: August 3, 2017
• First Posted: August 8, 2017
• Study Start: November 27, 2017
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: November 18, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-10

Locations

US (1)