NCT03003923

Brief Summary

The aim of this cluster randomised control trial is to test the efficacy of a repeated taste exposure intervention, a nutritional educational intervention and combination of both to increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

December 15, 2016

Last Update Submit

January 8, 2018

Conditions

Food HabitsFood PreferencesBehaviorHealth Behavior

Keywords

Vegetable intakeTaste exposuresEducational interventionPreschool childrenHealthy eating intervention

Outcome Measures

Primary Outcomes (1)

  • Intake of an unfamiliar vegetable

    Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-ups 3 (week 24) and 6 months (week 36) later. Intake of unfamiliar vegetable will be measured individually and objectively using weight in grams.

    Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1), Week 36 (Follow up 2)

Secondary Outcomes (1)

  • Intake of usual vegetables

    Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1)

Study Arms (4)

Taste Exposure

EXPERIMENTAL

Children will be repeatedly offered the single vegetable which is unfamiliar to them over the 12 week period. Children will be in their natural setting at nursery and will be offered 40g of the vegetable by their usual nursery staff. The vegetable will be weighed before and after using a digital scale by the researcher.

Behavioral: Taste exposure

Nutritional Education

EXPERIMENTAL

Nursery staff will be trained by the PhunkyFoods team to deliver the nutritional education programme. Children will be taught Eat Well (learning about different food groups) and Strive for Five (learning about eating fruits and vegetables) components of the PhunkyFoods education programme by their usual nursery staff. Nurseries will be advised to deliver as much as possible of the two components over the 12 week period.

Behavioral: Nutritional education

Taste Exposure and Nutritional Education

EXPERIMENTAL

Children will be repeatedly offered a single unfamiliar vegetable over the 12 week period as well as receive the PhunkyFoods educational programme (Eat Well and Strive for Five components). Children will be in their natural setting at nursery and will be offered the vegetable and nutritional education by their usual nursery staff.

Behavioral: Taste exposureBehavioral: Nutritional education

Control

NO INTERVENTION

Children will be offered single unfamiliar vegetable at the beginning, end and at the follow-up. There will be no repeated taste exposure or education during the study phase or follow-up; they will be offered the nutritional education after the study has completed.

Interventions

Taste exposureBEHAVIORAL

Exposure to the same vegetable

Taste ExposureTaste Exposure and Nutritional Education
Nutritional educationBEHAVIORAL

Eat Well and Strive for Five nutritional education

Nutritional EducationTaste Exposure and Nutritional Education

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 5 years old
  • Attends nursery on selected test day

You may not qualify if:

  • Relevant food allergy (mooli / radish)
  • Medical condition which would prevent them from eating the test vegetable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology, University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Feeding BehaviorFood PreferencesBehaviorHealth Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal

Study Officials

  • Chandani Nekitsing, MSc

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 28, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)