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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03400566
Other study ID # ULeeds
Secondary ID
Status Completed
Phase N/A
First received January 8, 2018
Last updated January 12, 2018
Start date October 2, 2017
Est. completion date January 5, 2018

Study information

Verified date January 2018
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 337
Est. completion date January 5, 2018
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 5 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United Kingdom School of Psychology, University of Leeds Leeds West Yorkshire

Sponsors (3)

Lead Sponsor Collaborator
University of Leeds Economic and Social Research Council, United Kingdom, Purely Nutrition Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Knowledge of the target vegetable 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)
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