HealthyMiffyNCT05878340
Miffy Eats the Rainbow
A study testing Miffy and Reward in people with Healthy, run by Wageningen University at 1 site in Netherlands.
Trial summary
Fruit and vegetable (F\&V) intake among children in western countries is below recommended levels. To increase F\&V consumption in children (3-6 years), a novel method is proposed based on the concepts of repetitive taste exposure, role models, and non-food rewards guided by the dietary advice: "Eat the rainbow: go… Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Miffy and Reward
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2022to 31 May 2023
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in early childhood education and in the first year of primary school within the age range of 3-7.
- Both caregivers as well as the child are willing to comply to the study procedure;
Who cannot join
- Children who have any allergies or intolerances to the fruits and vegetables used in the study;
- Not willing to eat the test foods because of eating habits or beliefs as indicated by parent or caregiver;
Trial locations and contacts
1 site in 1 country.
Guido Camps, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University and Research
Wageningen, Gelderland, 6708 WE
Femke J de Gooijer, MSc, +31612156023, femke.degooijer@wur.nl
Guido Camps, PhD, guido.camps@wur.nl
About this study
Official title: "Miffy Eats the Rainbow!" Efficiency of Stimulating Colour Consumption as Strategy to Increase Fruit and Vegetable Intake in Children
Fruit and vegetable (F\&V) intake among children in western countries is below recommended levels. To increase F\&V consumption in children (3-6 years), a novel method is proposed based on the concepts of repetitive taste exposure, role models, and non-food rewards guided by the dietary advice: "Eat the rainbow: go for color!" The aim is to determine the effect of this intervention to stimulate the consumption of color on the willingness to try different fruits and vegetables in 210 children aged 3-7 years old
Read the detailed description
Rationale: A diet rich in fruits and vegetables (F\&V) has many health benefits in early childhood. Nevertheless, F\&V intake among children in western countries is below recommended levels. To increase F\&V consumption in children (3-6 years), a novel method is proposed based on the concepts of repetitive taste exposure, role models, and non-food rewards guided by the dietary advice: "Eat the rainbow: go for color!" Objective: To determine the effect of a modeling- and reward-based intervention to stimulate the consumption of color on the willingness to try different fruits and vegetables in children aged 3-7 years old.
Study design: The study follows a parallel study design. All participants will participate in a baseline session after which they are exposed to a color intervention, a reference intervention, or a control session. Each of the three conditions will be randomly assigned to one of the groups (classrooms) in the participating preschools.
Intervention: The color intervention group listens to a story of Miffy who eats vegetables and fruits in all colors of the rainbow. Afterward, subjects are invited to taste different F\&Vs. They are rewarded with a sticker for each color they have eaten. The reference intervention group does not listen to a story and is given a sticker for each type of F\&V they have eaten. In the control session, the children are invited to eat F\&Vs without any introduction story or reward.
Main study parameters/endpoints: The number of pieces of F\&Vs and the number of different types of F\&Vs selected, tried, and consumed by the children.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study is non-therapeutic to the subjects. No immediate benefits for the subjects are expected from participation in this study, and the risk associated with participation can be considered negligible. In terms of time, the subject's burden is as follows: 30 minutes for the questionnaires prior to the intervention sessions for the caregiver and 15 minutes for the child; 30 minutes for each of the two intervention sessions, however, this coincides with the regular morning break of the children and therefore does not cost extra time, and lastly, 15 minutes for the questionnaire after the intervention sessions for both the child and the caregiver. In total, the time burden amounts to 45 minutes for the participating caregiver and 1 hour and 30 minutes for the participating child.
- Conditions
- Healthy
- Being tested
- Miffy, Reward
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiffyBehavioural
A method to stimulate children to try different fruits and vegetables using reward and role modelling
RewardBehavioural
Reference method to stimulate children to try fruits and vegetables using reward alone
| Study group | Role | What they receive |
|---|---|---|
| Miffy intervention | Experimental | story of miffy, rewards based on colour they ate Receives: Behavioral: Miffy |
| Reward intervetion | Active comparator | no story, rewards not assigned to colours Receives: Behavioral: Reward |
| Control | No intervention | no story, no rewards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Willingness to try between
Children's' willingness to try pieces of fruit and vegetables is measured in three levels. Children can either eat the study foods or try the study foods:
A study food is considered as eaten when:
- The piece of food is completely swallowed by the child;
A study food is considered as tried when:
- The piece of food has entered the mouth, but is spit out again;
- The piece of food is eaten and swallowed, but only partly; The measures are taken by counting the number of pieces of F\&V, each of around 30 grams.
Change in willingness to try is taken between the baseline session (week 1) and the intervention session (week 2)
Measured: Two sessions (30 minuntes) in two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Oct 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel intervention study design.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Camps, Wageningen University
- Investigators
- Guido Camps, Principal investigator, Wageningen University, Division of Human Nutrition and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878340
- Sponsor's protocol ID
- Miffy Study
- Acronym
- Miffy
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 26 May 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 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Miffy Eats the Rainbow!" Efficiency of Stimulating Colour Consumption as Strategy to Increase Fruit and Vegetable Intake in Children
- ClinicalTrials.gov ID
- NCT05878340
- Acronym / sponsor ID
- Miffy / Miffy Study
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 26 May 2023 (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.
Fruit and vegetable (F\&V) intake among children in western countries is below recommended levels. To increase F\&V consumption in children (3-6 years), a novel method is proposed based on the concepts of repetitive taste exposure, role models, and non-food rewards guided by the dietary advice: "Eat the rainbow: go for color!" The aim is to determine the effect of this intervention to stimulate the consumption of color on the willingness to try different fruits and vegetables in 210 children aged 3-7 years old
Detailed description
Rationale: A diet rich in fruits and vegetables (F\&V) has many health benefits in early childhood. Nevertheless, F\&V intake among children in western countries is below recommended levels. To increase F\&V consumption in children (3-6 years), a novel method is proposed based on the concepts of repetitive taste exposure, role models, and non-food rewards guided by the dietary advice: "Eat the rainbow: go for color!" Objective: To determine the effect of a modeling- and reward-based intervention to stimulate the consumption of color on the willingness to try different fruits and vegetables in children aged 3-7 years old.
Study design: The study follows a parallel study design. All participants will participate in a baseline session after which they are exposed to a color intervention, a reference intervention, or a control session. Each of the three conditions will be randomly assigned to one of the groups (classrooms) in the participating preschools.
Intervention: The color intervention group listens to a story of Miffy who eats vegetables and fruits in all colors of the rainbow. Afterward, subjects are invited to taste different F\&Vs. They are rewarded with a sticker for each color they have eaten. The reference intervention group does not listen to a story and is given a sticker for each type of F\&V they have eaten. In the control session, the children are invited to eat F\&Vs without any introduction story or reward.
Main study parameters/endpoints: The number of pieces of F\&Vs and the number of different types of F\&Vs selected, tried, and consumed by the children.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study is non-therapeutic to the subjects. No immediate benefits for the subjects are expected from participation in this study, and the risk associated with participation can be considered negligible. In terms of time, the subject's burden is as follows: 30 minutes for the questionnaires prior to the intervention sessions for the caregiver and 15 minutes for the child; 30 minutes for each of the two intervention sessions, however, this coincides with the regular morning break of the children and therefore does not cost extra time, and lastly, 15 minutes for the questionnaire after the intervention sessions for both the child and the caregiver. In total, the time burden amounts to 45 minutes for the participating caregiver and 1 hour and 30 minutes for the participating child.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel intervention study design.
| Arm | Type | Receives |
|---|---|---|
| Miffy intervention | Experimental | Behavioral: Miffystory of miffy, rewards based on colour they ate |
| Reward intervetion | Active comparator | Behavioral: Rewardno story, rewards not assigned to colours |
| Control | No intervention | –no story, no rewards |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children in early childhood education and in the first year of primary school within the age range of 3-7.
- Both caregivers as well as the child are willing to comply to the study procedure;
Key exclusion criteria (2 listed)
- Children who have any allergies or intolerances to the fruits and vegetables used in the study;
- Not willing to eat the test foods because of eating habits or beliefs as indicated by parent or caregiver;
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 |
|---|---|---|
| MiffyA method to stimulate children to try different fruits and vegetables using reward and role modelling | Behavioural | Miffy intervention |
| RewardReference method to stimulate children to try fruits and vegetables using reward alone | Behavioural | Reward intervetion |
Primary outcome
Change in Willingness to try between
Time frame: Two sessions (30 minuntes) in two weeks
Children's' willingness to try pieces of fruit and vegetables is measured in three levels. Children can either eat the study foods or try the study foods: A study food is considered as eaten when: • The piece of food is completely swallowed by the child; A study food is considered as tried when: * The piece of food has entered the mouth, but is spit out again; * The piece of food is eaten and swallowed, but only partly; The measures are taken by counting the number of pieces of F\&V, each of around 30 grams. Change in willingness to try is taken between the baseline session (week 1) and the intervention session (week 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
Guido Camps, PhD contact
Guido Camps principal investigator
Wageningen University, Division of Human Nutrition and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miffy and Reward in people with Healthy, run by Wageningen University at 1 site in Netherlands.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Femke J de Gooijer, MSc (0612156023 ext. +31, femke.degooijer@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Willingness to try between (time frame: Two sessions (30 minuntes) in two weeks). 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 26 May 2023.