NCT03513081

Brief Summary

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 in order to capture the influence of this environments 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

April 16, 2018

Last Update Submit

March 9, 2023

Conditions

Keywords

food neophobiapreschoolchildren

Outcome Measures

Primary Outcomes (2)

  • Child Food Neophobia

    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

    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 Outcomes (1)

  • Intake of an unfamiliar salad

    4 months

Study Arms (2)

Educative Session

EXPERIMENTAL

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.

Behavioral: Educative session

Control

NO INTERVENTION

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.

Interventions

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.

Educative Session

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children attending an educational institution

You may not qualify if:

  • children with cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Luis Cunha, PhD

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 1, 2018

Study Start

October 1, 2015

Primary Completion

February 1, 2016

Study Completion

September 1, 2018

Last Updated

March 13, 2023

Record last verified: 2023-03