Preschool ChildrenNCT03513081
Children Food Neophobia - a Playful Intervention at a Kindergarten
A study testing Educative session in people with Preschool Children, run by Instituto Politécnico de Leiria.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Preschool Children
- What is being tested?
- Educative session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children attending an educational institution
Who cannot join
- children with cognitive impairment
About this study
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
Read the 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.
- Conditions
- Preschool Children
- Being tested
- Educative session
- Keywords
- food neophobia, preschool, children
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educative sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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".
Measured: 4 months
Secondary outcomes (1)
Intake of an unfamiliar salad
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Oct 2015
- Primary completion1 Feb 2016
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preschool ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Responsible party
- Principal investigator, Cátia Braga-Pontes, Instituto Politécnico de Leiria
- Investigators
- Luis Cunha, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513081
- Sponsor's protocol ID
- ChildNeophobia
- Status last verified
- Mar 2023
- First submitted
- 16 Apr 2018
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Food Neophobia - a Playful Intervention at a Kindergarten
- ClinicalTrials.gov ID
- NCT03513081
- Acronym / sponsor ID
- ChildNeophobia
- Conditions
- Preschool Children
- Keywords
- food neophobia, preschool, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educative Session | Experimental | Behavioral: Educative sessionThe 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. |
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children attending an educational institution
Key exclusion criteria (1 listed)
- children with cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educative sessionThe 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. | Behavioural | Educative Session |
Primary outcome
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
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".
1 secondary outcome
Intake of an unfamiliar salad
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Cunha, PhD principal investigator
Universidade do Porto
Questions about this trial
What is this clinical trial studying?
A study testing Educative session in people with Preschool Children, run by Instituto Politécnico de Leiria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Food Neophobia (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.