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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03926065
Other study ID # ChildFood402
Secondary ID R01DK082580
Status Completed
Phase N/A
First received
Last updated
Start date May 28, 2019
Est. completion date October 29, 2019

Study information

Verified date September 2020
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date October 29, 2019
Est. primary completion date October 24, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Plain Vegetables Served in 100% Portion Size
Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables
Plain Vegetables Served in 200% Portion Size
Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables
Enhanced Vegetables Served in 100% Portion Size
Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables
Enhanced Vegetables Served in 200% Portion Size
Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables

Locations

Country Name City State
United States Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University University Park Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Preference of Vegetables Served at the Meal Preferred version of vegetables (1=standard palatability, 2=enhanced palatability) Study week 5
Other Liking of All Foods Served at the Meal The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy) Study week 5
Other Ranking of All Foods Served at the Meal Ranking of all foods in order of preference (1= most preferred, 2= next most preferred, etc.) Study week 5
Primary Difference Between Interventions in Vegetable Intake Weight of vegetables consumed at the meal (grams) One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Secondary Difference Between Interventions in Food Intake Weight of food (including milk) consumed at the meal (grams) One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Secondary Difference Between Interventions in Meal Energy Intake Energy consumed at the meal (kilocalories) One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Secondary Difference Between Interventions in Meal Energy Density 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)
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