NCT04129372

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

October 9, 2019

Last Update Submit

September 10, 2021

Conditions

Keywords

fruitsvegetablesfood neophobiapreschoolchildren

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Other Outcomes (4)

  • Child body mass index

    Measured once at any time between enrollment and conclusion of 5 week intervention

  • Parent report of child neophobia

    Measured once at any time between enrollment and conclusion of 5 week intervention

  • Parent report of food insecurity

    Measured once at any time between enrollment and conclusion of 5 week intervention

  • +1 more other outcomes

Study Arms (1)

New Foods Take Time

EXPERIMENTAL

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

Interventions

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

New Foods Take Time

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in a Head Start preschool center
  • Between the ages of 2 and 5 years old

You may not qualify if:

  • Food allergy or restriction to foods in the tastings
  • Parent or primary caregiver of a child enrolled in the study
  • Age 18 years or older
  • English speaking
  • None
  • Actively employed as an early childhood education provider in the Head Start classroom where the intervention is delivered
  • Age 18 years or older
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding BehaviorAvoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorFeeding and Eating DisordersMental Disorders

Study Officials

  • Jennifer Savage, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Classrooms will receive "New Foods Take Time", a series of 5 interactive lessons. Children, parents, and teachers will participate in the research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 16, 2019

Study Start

October 1, 2019

Primary Completion

November 25, 2019

Study Completion

November 25, 2019

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data will be available from the principal investigator upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available after publication of primary outcomes
Access Criteria
Requests for access to the data will be reviewed and approved at the principal investigator's discretion.

Locations