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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05173311
Other study ID # 19057
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date November 30, 2019

Study information

Verified date December 2021
Source University of Helsinki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to examine the effectiveness of the Mole's Veggie Adventures mobile application in increasing fruit and vegetable acceptance among 3-6-year-olds.


Description:

After the parents of the participating children had signed an informed consent and filled in the baseline questionnaires, the participating early childhood education and care (ECEC) centers (in Finland) or groups within the ECEC centers (in Poland) were randomly allocated into intervention and control arms. Researchers visited the intervention arm groups and introduced the application to the ECEC professionals. The ECEC professionals were instructed to use the application with a tablet computer at least one to two times a week during the intervention period (3-4 weeks) and to record the number of tasks completed by their group in a logbook. In addition, the research team recommended that each group focuses on at least six vegetables or fruits during the intervention period. The control arm groups were instructed to continue their normal routines during the intervention period and to refrain from introducing any novel food education methods during the intervention period.


Recruitment information / eligibility

Status Completed
Enrollment 326
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria: - All children in the participating early childhood education and care (ECEC) groups Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention arm
The intervention arm groups were instructed to use the Mole's Veggie Adventures mobile application for 3-4 weeks.

Locations

Country Name City State
Finland University of Helsinki Helsinki

Sponsors (6)

Lead Sponsor Collaborator
University of Helsinki EIT Food, Folkhälsan Research Center, Tampere University, University of Eastern Finland, University of Warsaw

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fruit and vegetable acceptance (post intervention) The parents filled in a questionnaire listing 25 vegetables and fruits and inquiring whether these had been offered to the child during the past 4 weeks and how the child reacted to those that had been served. All the listed vegetables and fruits were introduced in the app. The answer options were 0=was not offered during the past four weeks, 1=refused to touch food, 2=touched food but did not put in/near mouth, 3=put food to lips but not in mouth, 4=put food in mouth but spat out/did not eat, and 5=ate food. For each participant, we calculated an fruit and vegetable acceptance score by summing the answers to each of the 25 vegetable and fruit items, with higher scores indicating a higher fruit and vegetable acceptance (theoretical range 0-125). The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
Primary Relative fruit and vegetable acceptance (post intervention) Using the same questionnaire, we calculated the number of fruits and vegetables served during the past 4 weeks (range 0-25) and used this information to create a relative fruits and vegetable acceptance score (range 0-5) by dividing the fruits and vegetable acceptance score by the number of fruits and vegetables served. The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
Secondary Emotionality (post intervention) The parents filled in a questionnaire describing the emotionality of the children using a Likert scale (1-5). The questionnaire covered four emotions. An average of two items per emotion were used to calculate the variables (scale 1-5). The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
Secondary Emotion regulation (post intervention) The parents filled in a questionnaire describing the emotion regulation of the children using a Likert scale (1-5). The questionnaire covered four emotions. An average of two items per emotion were used to calculate the variables (scale 1-5). The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
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