- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03926065
Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children
September 4, 2020 updated by: Barbara J. Rolls, Penn State University
Lunchtime Meal Feeding Study for Preschool Children
The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
67
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Standard Palatability and Standard Portion Size
Vegetables with Standard Palatability and Standard Portion Size
|
Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables
|
EXPERIMENTAL: Standard Palatability and Larger Portion Size
Vegetables with Standard Palatability and Larger Portion Size
|
Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables
|
EXPERIMENTAL: Enhanced Palatability and Standard Portion Size
Vegetables with Enhanced Palatability and Standard Portion Size
|
Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables
|
EXPERIMENTAL: Enhanced Palatability and Larger Portion Size
Vegetables with Enhanced Palatability and Larger Portion Size
|
Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference Between Interventions in Vegetable Intake
Time Frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Weight of vegetables consumed at the meal (grams)
|
One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference Between Interventions in Food Intake
Time Frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Weight of food (including milk) consumed at the meal (grams)
|
One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Difference Between Interventions in Meal Energy Intake
Time Frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Energy consumed at the meal (kilocalories)
|
One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Difference Between Interventions in Meal Energy Density
Time Frame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Energy density of the food consumed at the meal (kilocalories/gram)
|
One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preference of Vegetables Served at the Meal
Time Frame: Study week 5
|
Preferred version of vegetables (1=standard palatability, 2=enhanced palatability)
|
Study week 5
|
Liking of All Foods Served at the Meal
Time Frame: Study week 5
|
The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy)
|
Study week 5
|
Ranking of All Foods Served at the Meal
Time Frame: Study week 5
|
Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.)
|
Study week 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
May 28, 2019
Primary Completion (ACTUAL)
October 24, 2019
Study Completion (ACTUAL)
October 29, 2019
Study Registration Dates
First Submitted
April 19, 2019
First Submitted That Met QC Criteria
April 23, 2019
First Posted (ACTUAL)
April 24, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2020
Last Update Submitted That Met QC Criteria
September 4, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- ChildFood402
- 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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