- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513081
Children Food Neophobia - a Playful Intervention at a Kindergarten
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Food neophobia, understood as the rejection of novel foods, is considered one of the biggest barriers to the consumption of fruits and vegetables in preschool children. Some factors like food preferences, gender, genetic characteristics, psychological factors and family factors are also crucial for the acceptance of vegetable in childhood. Some strategies used to modify food preferences of children are repeated exposure and the use of rewards. The aim of this project is to investigate the efficacy of taste exposure-plus small reward in acceptance and consumption of vegetables among preschool children at school. In this context, interventions were attended at school to capture the influence of this environment towards consumption of vegetables among preschool children.
For this, the methodology applied will be a repeated exposure protocol by introducing small rewards to encourage children to taste an unfamiliar or dislike food. Child intake (weight or number of pieces) and liking (hedonic scale) will be assessed at baseline sessions and exposure sessions. Moreover, child's neophobia will be evaluated and additional determinants of child neophobia, such as child's eating behaviour. Quantitative data analysis will be performed by software IBM-SPSS Statistics®. In conducting this research is expected to achieve techniques to overcome neophobia in preschool children and promote vegetable consumption in school and at home. The results may contribute to improve food quality in childhood and consequently in adulthood.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children attending an educational institution
Exclusion Criteria:
- children with cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educative Session
The experimental group receive nine educational sessions (one per week) about different vegetables and, at lunch time, they are exposed to a different vegetable.
If they try it, they will receive a sticker.
In each session, researcher will record their preference for the vegetable and the quantity that they consumed in a scale from one to three (1- the child tasted it; 2 - the child repeated it; 3 - the child ate all the quantity).
In the end of 9 sessions, all children (experimental and control group) will receive the same salad that they had eaten at baseline and the procedure will be the same: the salad is weighted before and after the consumption of each child to verify the quantity of each one ate.
|
The experimental group receive nine educational sessions (one per week) about different vegetables and, at lunch time, they are exposed to a different vegetable.
If they try it, they will receive a sticker.
In each session, researcher will record their preference for the vegetable and the quantity that they consumed in a scale from one to three (1- the child prooved it; 2 - the child repeated it; 3 - the child ate all the quantity).
In the end of 9 sessions, all children (experimental and control group) will receive the same salad that they had eaten at baseline and the procedure will be the same: the salad is weighted before and after the consumption of each child to verify the quantity of each one ate.
|
No Intervention: Control
Children in the control group don´t receive an educative session.
Before the study starts children are asked to eat a salad.
After 9 weeks, all children in the control group will receive the same salad that they had eaten at baseline and the procedure will be the same: the salad is weighted before and after the consumption of each child to verify the quantity of each one ate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Food Neophobia
Time Frame: 4 months
|
Child Food Neophobia Scale (Pliner 1994) - this scale is composed of ten questions, being answered by parents in a scale from one to seven, in which number one means "very similar to the reality of my child" and seven means "extremely distant to the reality of my child".
This scale is able to evaluate child's food neophobia and child's food neophilia
|
4 months
|
Child Eating Behaviour
Time Frame: 4 months
|
Child Eating Behaviour Questionnaire (Wardle, Guthrie et al. 2001) translated and adapted for portuguese reality by Viana et al (Viana and Sinde 2008).
This questionnaire is answered by parents to evaluate child's eating behaviour and is composed of 35 questions.
In each question the answer is in a scale from one to five, in which one means "never" and five means "always".
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intake of an unfamiliar salad
Time Frame: 4 months
|
Assessing intake of an unfamiliar salad served at lunch at three distinct moments: baseline (T0), immediately following intervention with the experimental group (T1) and ten weeks after (T2) (immediately following the intervention with the control group).
This third evaluation will allow measuring the impact of the intervention at a longer period of time (Laureati, Bergamaschi et al. 2014)
|
4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChildNeophobia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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