NCT02963987

Brief Summary

In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 29, 2019

Completed
Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

November 10, 2016

Results QC Date

May 8, 2019

Last Update Submit

May 30, 2019

Conditions

Feeding Behavior

Outcome Measures

Primary Outcomes (1)

  • Differences in Food and Beverage Intake by Energy

    Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages

    Days 1-5 in Periods 1 and 2

Secondary Outcomes (2)

  • Differences in Food and Beverage Intake by Energy Density

    Days 1-5 in Periods 1 and 2

  • Differences in Food and Beverage Intake by Weight

    Days 1-5 in Periods 1 and 2

Study Arms (2)

100% Portion Size

EXPERIMENTAL

100% Food and Beverage Portion Size

Other: Food and Beverage Portion Size

150% Portion Size

EXPERIMENTAL

150% Food and Beverage Portion Size

Other: Food and Beverage Portion Size

Interventions

Food and Beverage Portion SizeOTHER

Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)

100% Portion Size150% Portion Size

Eligibility Criteria

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

You may qualify if:

  • Attending one of the designated childcare 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 (2)

Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Location

The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Location

Related Publications (2)

  • Smethers AD, Roe LS, Sanchez CE, Zuraikat FM, Keller KL, Kling SMR, Rolls BJ. Portion size has sustained effects over 5 days in preschool children: a randomized trial. Am J Clin Nutr. 2019 May 1;109(5):1361-1372. doi: 10.1093/ajcn/nqy383.

    PMID: 30976782RESULT

  • 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

Interventions

Food

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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

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

November 10, 2016

First Posted

November 15, 2016

Study Start

June 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 11, 2019

Results First Posted

May 29, 2019

Record last verified: 2019-05

Locations

US(2)