Miffy Eats the Rainbow (Miffy)

May 17, 2023 updated by: Guido Camps, Wageningen University

"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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6708 WE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Miffy intervention
story of miffy, rewards based on colour they ate
Behavioral: Miffy
A method to stimulate children to try different fruits and vegetables using reward and role modelling
Active Comparator: Reward intervetion
no story, rewards not assigned to colours
Behavioral: Reward
Reference method to stimulate children to try fruits and vegetables using reward alone
No Intervention: Control
no story, no rewards

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Two sessions (30 minuntes) in two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Investigators

  • Principal Investigator: Guido Camps, Wageningen University, Division of Human Nutrition and Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

May 31, 2023

Study Completion (Estimated)

May 31, 2023

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Miffy Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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