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Eating BehaviorNCT04129372

New Foods Take Time, a Curriculum Designed to Promote Tasting and Liking of Fruits and Vegetables

A study testing New Foods Take Time in people with Eating Behavior, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for
Eating Behavior
What is being tested?
New Foods Take Time
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 25 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pennsylvania State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Eating Behavior
Being tested
New Foods Take Time
Keywords
fruits, vegetables, food neophobia, preschool, children
Medical subject headings
Feeding Behavior, Avoidant Restrictive Food Intake Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New Foods Take TimeBehavioural

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

Study groups in NCT04129372
Study groupRoleWhat they receive
New Foods Take TimeExperimentalHead 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.
Receives: Behavioral: New Foods Take Time

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Pre intervention and at conclusion of 5 week intervention

  2. 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")

    Measured: Pre intervention and at conclusion of 5 week intervention

  3. 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.

    Measured: Pre intervention and at conclusion of 5 week intervention

  4. Teacher acceptability of intervention

    Teachers will complete a questionnaire with scaled and open-ended questions about the feasibility and acceptability of the intervention

    Measured: At conclusion of 5 week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study start1 Oct 2019
  3. Primary completion25 Nov 2019
  4. Study completion25 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Classrooms will receive "New Foods Take Time", a series of 5 interactive lessons. Children, parents, and teachers will participate in the research
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129372
Sponsor's protocol ID
STUDY00013066
Status last verified
Sep 2021
First submitted
9 Oct 2019
Last updated
14 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data will be available from the principal investigator upon request

Questions about this trial

What is this clinical trial studying?

A study testing New Foods Take Time in people with Eating Behavior, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in number of foods tasted (time frame: Pre intervention and at conclusion of 5 week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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