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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in number of foods tasted
Time Frame: Pre intervention and at conclusion of 5 week intervention
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
Change in liking of study foods
Time Frame: Pre intervention and at conclusion of 5 week intervention
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
Change in self-competence to try new foods
Time Frame: Pre intervention and at conclusion of 5 week intervention
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
Teacher acceptability of intervention
Time Frame: At conclusion of 5 week 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
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
Parent report of child neophobia
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
Parents will complete a survey about their child's eating behavior
Measured once at any time between enrollment and conclusion of 5 week intervention
Parent report of food insecurity
Time Frame: Measured once at any time between enrollment and conclusion of 5 week intervention
Parents will complete the USDA food security questionnaire
Measured once at any time between enrollment and conclusion of 5 week intervention
Change in intake of study foods
Time Frame: Pre intervention and at conclusion of 5 week intervention
The number of pieces of each food eaten during the tasting procedure
Pre intervention and at conclusion of 5 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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