NCT03400566

Brief Summary

The aim of this cluster randomized control trial is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

January 8, 2018

Last Update Submit

January 12, 2018

Conditions

Food HabitsFood PreferencesHealth BehaviorDiet HabitChild Behavior

Outcome Measures

Primary Outcomes (1)

  • Change in intake of the target vegetable

    Intake of the novel vegetable will be measured at baseline (day 1) and post intervention (day 14). Intake of the novel vegetable will be measured individually and objectively using weight in grams. Change in intake will be calculated by subtraction of baseline intake from post intervention intake.

    Change in intake of the target vegetable from Baseline to day 14

Secondary Outcomes (1)

  • Knowledge of the target vegetable

    Knowledge of the target vegetable at day 14 (post intervention)

Study Arms (4)

Narrative (target)

EXPERIMENTAL

Children will receive the story featuring the target vegetable and NO sensory experience.

Behavioral: Narrative

Narrative+ experiential (target)

EXPERIMENTAL

Children will receive the story featuring the target vegetable and experiential learning with the target vegetable.

Behavioral: NarrativeBehavioral: Experiential

Narrative (control)

ACTIVE COMPARATOR

Children will receive the story featuring the control vegetable and NO sensory experience.

Behavioral: Narrative

Narrative+ experiential (control)

ACTIVE COMPARATOR

Children will receive the story featuring the control vegetable and experiential learning with the control vegetable.

Behavioral: NarrativeBehavioral: Experiential

Interventions

NarrativeBEHAVIORAL

Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).

Narrative (control)Narrative (target)Narrative+ experiential (control)Narrative+ experiential (target)
ExperientialBEHAVIORAL

Children will receive hands on experience with the vegetable. They will get to listen, see, feel, touch and smell the actual vegetable during the two familiarization phases.

Narrative+ experiential (control)Narrative+ experiential (target)

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 (celeriac / celery)
  • 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

Related Publications (2)

  • Nekitsing C, Blundell-Birtill P, Cockroft JE, Fildes A, Hetherington MM. Increasing Intake of an Unfamiliar Vegetable in Preschool Children Through Learning Using Storybooks and Sensory Play: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2014-2027. doi: 10.1016/j.jand.2019.05.017. Epub 2019 Aug 1.

    PMID: 31378648DERIVED

  • Nekitsing C, Blundell-Birtill P, Cockroft JE, Hetherington MM. Taste Exposure Increases Intake and Nutrition Education Increases Willingness to Try an Unfamiliar Vegetable in Preschool Children: A Cluster Randomized Trial. J Acad Nutr Diet. 2019 Dec;119(12):2004-2013. doi: 10.1016/j.jand.2019.05.012. Epub 2019 Aug 1.

    PMID: 31378647DERIVED

MeSH Terms

Conditions

Feeding BehaviorFood PreferencesHealth BehaviorChild Behavior

Interventions

Narrative Therapy

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chandani Nekitsing, MSc

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Research Student

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

October 2, 2017

Primary Completion

November 30, 2017

Study Completion

January 5, 2018

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

GB(1)