- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643250
Effects of Varying Portion Size and Palatability on Food Intake of Preschool Children
April 18, 2019 updated by: Barbara J. Rolls, Penn State University
Lunch Feeding Study for Preschool Children
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
- Other: Smaller Portion Size and Standard Appeal (non-divided plate)
- Other: Smaller Portion Size and Enhanced Appeal (divided plate)
- Other: Larger Portion Size and Standard Appeal (non-divided plate)
- Other: Larger Portion Size and Enhanced Appeal (divided plate)
- Other: Smaller Portion Size and Standard Appeal (divided plate)
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children who are enrolled in a scheduled classroom of the designated childcare centers
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Smaller Portion Size and Standard Appeal (non-divided plate)
Food with Smaller Portion Size and Standard Appeal on a non-divided plate
|
Food with Smaller Portion Size and Standard Appeal on a non-divided plate
|
Experimental: Smaller Portion Size and Enhanced Appeal (divided plate)
Food with Smaller Portion Size and Enhanced Appeal on a divided plate
|
Food with Smaller Portion Size and Enhanced Appeal on a divided plate
|
Experimental: Larger Portion Size and Standard Appeal (non-divided plate)
Food with Larger Portion Size and Standard Appeal on a non-divided plate
|
Food with Larger Portion Size and Standard Appeal on a non-divided plate
|
Experimental: Larger Portion Size and Enhanced Appeal (divided plate)
Food with Larger Portion Size and Enhanced Appeal on a divided plate
|
Food with Larger Portion Size and Enhanced Appeal on a divided plate
|
Experimental: Smaller Portion Size and Standard Appeal (divided plate)
Food with Smaller Portion Size and Standard Appeal on a divided plate
|
Food with Smaller Portion Size and Standard Appeal on a divided plate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference between interventions in meal energy intake
Time Frame: Study weeks 1, 2, 3, 4, and 5
|
Energy consumed at the meal (kcal)
|
Study weeks 1, 2, 3, 4, and 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference between interventions in food intake
Time Frame: Study weeks 1, 2, 3, 4, and 5
|
Weight of food consumed at the meal (g)
|
Study weeks 1, 2, 3, 4, and 5
|
Difference between interventions in meal energy density
Time Frame: Study weeks 1, 2, 3, 4, and 5
|
Energy density of the food consumed at the meal (kcal/g)
|
Study weeks 1, 2, 3, 4, and 5
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liking of food served at the meal
Time Frame: Study week 6
|
The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy)
|
Study week 6
|
Preference of plate and vegetables served at the meal
Time Frame: Study week 6
|
Preferred version of plate (1=non-divided plate, 2=divided plate), broccoli (1=standard appeal, 2=enhanced appeal), and corn (1=standard appeal, 2=enhanced appeal) of the two versions presented
|
Study week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2019
Primary Completion (Actual)
April 9, 2019
Study Completion (Actual)
April 17, 2019
Study Registration Dates
First Submitted
August 21, 2018
First Submitted That Met QC Criteria
August 21, 2018
First Posted (Actual)
August 22, 2018
Study Record Updates
Last Update Posted (Actual)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 18, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- ChildFood401
- R01DK082580 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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