Effects of Experiential Learning on Vegetable Intake in Preschool Children

January 12, 2018 updated by: Chandani Nekitsing, University of Leeds

Effects of Congruent and In-congruent Experiential Learning on Intake of a Novel Vegetable in Preschool Children

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).

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 aim of this study 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). In particular, the study will assess whether these strategies are effective to encourage intake of an unfamiliar vegetable in children who are fussy eaters.

There are two manipulations in this study - the provision of a story which features either a target vegetable (celeriac) or a control vegetable (carrot) and the presence of experiential learning (smelling, touching, looking at the vegetable) with either the target vegetable or the control vegetable.

Baseline consumption and familiarity of the target veg will be assessed for all children, before the intervention. The intervention consists of two familiarization trials, and 2-weeks of access to a story book featuring vegetables. Following the final familiarization trial, consumption and familiarity will be assessed again. Each familiarization trial consists of a story in class, and depending on condition, an experiential learning episode in class. During the 2 week interval between familiarization sessions nurseries will be requested to ready the story book 5 times in the preschool room (at times convenient to them).

Participants will be cluster randomized into 4 groups (2X2 between subjects design): 1) target vegetable narrative, 2) target vegetable narrative + experiential, 3) control vegetable narrative 4) control vegetable narrative + experiential

Child's food fussiness data will be collected by parents using the Food Fussiness sub scale of the Child Eating Behaviour Questionnaire. Their usual consumption of the target vegetable will also be measured using parent report.

Nursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.

It is predicted that children's intake of the novel vegetable will vary by intervention. The primary hypothesis to be tested is that providing experience of a target novel vegetable within the context of an interactive story time will encourage preschoolers to taste, try and eat the target vegetable.

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.
337

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 Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9JT
        • School of Psychology, University of Leeds

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

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

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: Narrative (target)
Children will receive the story featuring the target vegetable and NO sensory experience.
Behavioral: Narrative
Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).
EXPERIMENTAL: Narrative+ experiential (target)
Children will receive the story featuring the target vegetable and experiential learning with the target vegetable.
Behavioral: Narrative
Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).
Behavioral: Experiential
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.
ACTIVE_COMPARATOR: Narrative (control)
Children will receive the story featuring the control vegetable and NO sensory experience.
Behavioral: Narrative
Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).
ACTIVE_COMPARATOR: Narrative+ experiential (control)
Children will receive the story featuring the control vegetable and experiential learning with the control vegetable.
Behavioral: Narrative
Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).
Behavioral: Experiential
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.

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 intake of the target vegetable
Time Frame: Change in intake of the target vegetable from Baseline to day 14
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge of the target vegetable
Time Frame: Knowledge of the target vegetable at day 14 (post intervention)
Children's knowledge of the target vegetable will be assessed at baseline (day 1) and post intervention (day 14). Children will be asked to name the photo card featuring the target vegetable.
Knowledge of the target vegetable at day 14 (post 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.
University of Leeds

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Economic and Social Research Council, United Kingdom
Purely Nutrition Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 2, 2017

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 30, 2017

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.
January 5, 2018

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).
January 8, 2018

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.
January 12, 2018

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.
January 17, 2018

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.
January 17, 2018

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.
January 12, 2018

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.
January 1, 2018

More Information

Terms related to this study

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.
  • ULeeds

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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