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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04129372
Other study ID # STUDY00013066
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date November 25, 2019

Study information

Verified date September 2021
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall objective of this project is to conduct a preliminary evaluation of the "New Foods Take Time" Intervention in Head Start preschool classrooms.


Description:

The overall objective of this project is to conduct a preliminary evaluation of the "New Foods Take Time" Intervention. This curriculum is designed to increase children's preference for and consumption of fruits and vegetables (FV) by encouraging children to try new FV and repeatedly taste these foods.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 25, 2019
Est. primary completion date November 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility Child Inclusion Criteria: - Enrolled in a Head Start preschool center - Between the ages of 2 and 5 years old Child Exclusion Criteria: - Food allergy or restriction to foods in the tastings Parent Inclusion Criteria: - Parent or primary caregiver of a child enrolled in the study - Age 18 years or older - English speaking Parent Exclusion Criteria: - None Teacher Inclusion Criteria: - Actively employed as an early childhood education provider in the Head Start classroom where the intervention is delivered - Age 18 years or older Teacher Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
New Foods Take Time
New Foods Take Time is a series of 5 classroom lessons focused on increasing children's willingness to try fruits and vegetables.

Locations

Country Name City State
United States Pennsylvania State University University Park Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Child body mass index Height and weight will be measured and used to calculate body mass index (BMI). Age and sex specific percentiles/z-scores will be calculated using CDC growth standards. Measured once at any time between enrollment and conclusion of 5 week intervention
Other Parent report of child neophobia Parents will complete a survey about their child's eating behavior Measured once at any time between enrollment and conclusion of 5 week intervention
Other Parent report of food insecurity Parents will complete the USDA food security questionnaire Measured once at any time between enrollment and conclusion of 5 week intervention
Other Change in intake of study foods The number of pieces of each food eaten during the tasting procedure Pre intervention and at conclusion of 5 week intervention
Primary Change in number of foods tasted Children will be presented with small portions of familiar and novel fruits and vegetables and be asked if they would like to taste them Pre intervention and at conclusion of 5 week intervention
Primary Change in liking of study foods For foods that children agree to taste, they will be asked to rate their liking of them on a three point likert-type scale ("Yummy", "Just ok", or "Yucky") Pre intervention and at conclusion of 5 week intervention
Primary Change in self-competence to try new foods Children will be presented with a series pairs of drawings with descriptions (e.g., "This boy likes to try new foods" and "This boy does not like to try new foods") and asked to select which is most like them. Pre intervention and at conclusion of 5 week intervention
Primary Teacher acceptability of intervention Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention At conclusion of 5 week intervention
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