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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03003923
Other study ID # Chandani Nekitsing
Secondary ID
Status Completed
Phase N/A
First received December 15, 2016
Last updated January 8, 2018
Start date September 2016
Est. completion date August 2017

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 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).


Description:

The aim of this study 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). In particular the study will assess whether these strategies are effective to encourage intake of an unfamiliar vegetable in children who are fussy eaters or going through the food neophobia phase. The effectiveness of these interventions will also be observed overtime at 3 and 6 months post intervention.

Nurseries will be randomised into one of four conditions over the 12 week intervention period; these include educational intervention only, taste exposures only, taste exposures and educational intervention or no intervention (control group). All children will be offered an unfamiliar vegetable prior to the intervention and after the intervention to evaluate changes in intake of the unfamiliar vegetable. The repeated taste exposure groups will be offered the novel vegetable repeatedly (1 exposure per week) over the 12 week period. For the educational intervention nursery staff will be advised to deliver two components of an existing PhunkyFoods educational programme over the same period.

Parents will be asked some general demographic questions, child food behaviour questions and questions about their feeding practices. Finally nursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.

It is predicted that children's intake of the unfamiliar vegetable will vary by intervention. The primary hypothesis to be tested is that children who receive the repeated taste exposures are more likely to increase their intake of the unfamiliar vegetable compared to those in educational only or control conditions. The second hypothesis is that repeated taste exposures will increase intake of an unfamiliar vegetable in fussy eaters more than education.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date August 2017
Est. primary completion date December 2016
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 (mooli / radish)

- Medical condition which would prevent them from eating the test vegetable

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Taste exposure
Exposure to the same vegetable
Nutritional education
Eat Well and Strive for Five nutritional education

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 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 Intake of usual vegetables Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-up 3 months later (week 24). Intake of usual vegetable will be measured using a Food Frequency Questionnaire. Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1)
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