NCT03643250

Brief Summary

The aim of the study is to determine the effect of varying both the portion size and the appeal (palatability and presentation) of foods served to preschool children at a meal on the outcomes of food and energy intake at the meal.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 21, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

28 days

First QC Date

August 21, 2018

Last Update Submit

April 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference between interventions in meal energy intake

    Energy consumed at the meal (kcal)

    Study weeks 1, 2, 3, 4, and 5

Secondary Outcomes (2)

  • Difference between interventions in food intake

    Study weeks 1, 2, 3, 4, and 5

  • Difference between interventions in meal energy density

    Study weeks 1, 2, 3, 4, and 5

Other Outcomes (2)

  • Liking of food served at the meal

    Study week 6

  • Preference of plate and vegetables served at the meal

    Study week 6

Study Arms (5)

Smaller Portion Size and Standard Appeal (non-divided plate)

EXPERIMENTAL

Food with Smaller Portion Size and Standard Appeal on a non-divided plate

Other: Smaller Portion Size and Standard Appeal (non-divided plate)

Smaller Portion Size and Enhanced Appeal (divided plate)

EXPERIMENTAL

Food with Smaller Portion Size and Enhanced Appeal on a divided plate

Other: Smaller Portion Size and Enhanced Appeal (divided plate)

Larger Portion Size and Standard Appeal (non-divided plate)

EXPERIMENTAL

Food with Larger Portion Size and Standard Appeal on a non-divided plate

Other: Larger Portion Size and Standard Appeal (non-divided plate)

Larger Portion Size and Enhanced Appeal (divided plate)

EXPERIMENTAL

Food with Larger Portion Size and Enhanced Appeal on a divided plate

Other: Larger Portion Size and Enhanced Appeal (divided plate)

Smaller Portion Size and Standard Appeal (divided plate)

EXPERIMENTAL

Food with Smaller Portion Size and Standard Appeal on a divided plate

Other: Smaller Portion Size and Standard Appeal (divided plate)

Interventions

Food with Smaller Portion Size and Standard Appeal on a non-divided plate

Smaller Portion Size and Standard Appeal (non-divided plate)

Food with Smaller Portion Size and Enhanced Appeal on a divided plate

Smaller Portion Size and Enhanced Appeal (divided plate)

Food with Larger Portion Size and Standard Appeal on a non-divided plate

Larger Portion Size and Standard Appeal (non-divided plate)

Food with Larger Portion Size and Enhanced Appeal on a divided plate

Larger Portion Size and Enhanced Appeal (divided plate)

Food with Smaller Portion Size and Standard Appeal on a divided plate

Smaller Portion Size and Standard Appeal (divided plate)

Eligibility Criteria

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

You may qualify if:

  • Children who are enrolled in a scheduled classroom of the designated childcare centers

You may not qualify if:

  • Children who are allergic to any of the foods served
  • Children whose diets exclude any of the foods served
  • Children who will not be present at the childcare center for all of the scheduled study days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

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

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 22, 2018

Study Start

March 12, 2019

Primary Completion

April 9, 2019

Study Completion

April 17, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations