Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05878340
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-04-25
Brief Title:
Miffy Eats the Rainbow
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
Miffy Eats the Rainbow Efficiency of Stimulating Colour Consumption as Strategy to Increase Fruit and Vegetable Intake in Children
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Miffy
Brief Summary:
Fruit and vegetable FV intake among children in western countries is below recommended levels To increase FV 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 FV has many health benefits in early childhood Nevertheless FV intake among children in western countries is below recommended levels To increase FV 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 FVs 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 FV they have eaten In the control session the children are invited to eat FVs without any introduction story or reward
Main study parametersendpoints The number of pieces of FVs and the number of different types of FVs 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 subjects 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 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 FVs 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 FV they have eaten In the control session the children are invited to eat FVs without any introduction story or reward
Main study parametersendpoints The number of pieces of FVs and the number of different types of FVs 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None