- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129372
New Foods Take Time, a Curriculum Designed to Promote Tasting and Liking of Fruits and Vegetables
September 10, 2021 updated by: Jennifer Savage Williams, Penn State University
Evaluating "New Foods Take Time", a Classroom-based Curriculum Designed to Promote Tasting and Liking of Fruits and Vegetables Among Head Start Preschool Children
The overall objective of this project is to conduct a preliminary evaluation of the "New Foods Take Time" Intervention in Head Start preschool classrooms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
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
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Pennsylvania State University
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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
7 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: New Foods Take Time
Head Start classrooms will receive "New Foods Take Time", a series of five interactive weekly lessons designed to promote children's willingness to try new foods, particularly fruits and vegetables.
Lessons will be delivered by nutrition educations.
Children will also receive three tastings per week of the new foods discussed during the lessons.
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New Foods Take Time is a series of 5 classroom lessons focused on increasing children's willingness to try fruits and vegetables.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of foods tasted
Time Frame: Pre intervention and at conclusion of 5 week intervention
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Children will be presented with small portions of familiar and novel fruits and vegetables and be asked if they would like to taste them
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Pre intervention and at conclusion of 5 week intervention
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Change in liking of study foods
Time Frame: Pre intervention and at conclusion of 5 week intervention
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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")
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Pre intervention and at conclusion of 5 week intervention
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Change in self-competence to try new foods
Time Frame: Pre intervention and at conclusion of 5 week intervention
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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.
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Pre intervention and at conclusion of 5 week intervention
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Teacher acceptability of intervention
Time Frame: At conclusion of 5 week intervention
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Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention
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At conclusion of 5 week intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child body mass index
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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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.
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Parent report of child neophobia
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete a survey about their child's eating behavior
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Parent report of food insecurity
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
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Parents will complete the USDA food security questionnaire
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Measured once at any time between enrollment and conclusion of 5 week intervention
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Change in intake of study foods
Time Frame: Pre intervention and at conclusion of 5 week intervention
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The number of pieces of each food eaten during the tasting procedure
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Pre intervention and at conclusion of 5 week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Savage, PhD, Penn State University
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)
October 1, 2019
Primary Completion (Actual)
November 25, 2019
Study Completion (Actual)
November 25, 2019
Study Registration Dates
First Submitted
October 9, 2019
First Submitted That Met QC Criteria
October 14, 2019
First Posted (Actual)
October 16, 2019
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 10, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00013066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Deidentified individual participant data will be available from the principal investigator upon request
IPD Sharing Time Frame
Data will be available after publication of primary outcomes
IPD Sharing Access Criteria
Requests for access to the data will be reviewed and approved at the principal investigator's discretion.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
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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