NCT05878340

Brief 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 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

April 25, 2023

Last Update Submit

May 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    Two sessions (30 minuntes) in two weeks

Study Arms (3)

Miffy intervention

EXPERIMENTAL

story of miffy, rewards based on colour they ate

Behavioral: Miffy

Reward intervetion

ACTIVE COMPARATOR

no story, rewards not assigned to colours

Behavioral: Reward

Control

NO INTERVENTION

no story, no rewards

Interventions

MiffyBEHAVIORAL

A method to stimulate children to try different fruits and vegetables using reward and role modelling

Miffy intervention
RewardBEHAVIORAL

Reference method to stimulate children to try fruits and vegetables using reward alone

Reward intervetion

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708 WE, Netherlands

RECRUITING

Study Officials

  • Guido Camps

    Wageningen University, Division of Human Nutrition and Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Femke J de Gooijer, MSc

CONTACT

Guido Camps, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel intervention study design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 26, 2023

Study Start

October 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations