- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173311
Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance
December 10, 2021 updated by: Henna Vepsalainen, University of Helsinki
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
326
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 Locations
-
-
-
Helsinki, Finland
- University of Helsinki
-
-
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
3 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All children in the participating early childhood education and care (ECEC) groups
Exclusion Criteria:
- None
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Application use arm
The early childhood education and care (ECEC) professionals in the intervention arm groups were instructed to use the application with a tablet computer at least 1-2 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, we recommended that each group focus on at least six vegetables or fruits during the intervention period.
|
The intervention arm groups were instructed to use the Mole's Veggie Adventures mobile application for 3-4 weeks.
Other Names:
|
No Intervention: Control arm
The control arm groups were instructed to continue their normal routines during the intervention period.
They were instructed to refrain from introducing any novel food education methods during the intervention period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fruit and vegetable acceptance (post intervention)
Time Frame: The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the 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).
|
Relative fruit and vegetable acceptance (post intervention)
Time Frame: The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotionality (post intervention)
Time Frame: The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the 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).
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The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
|
Emotion regulation (post intervention)
Time Frame: The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the 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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 1, 2019
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
November 29, 2021
First Submitted That Met QC Criteria
December 10, 2021
First Posted (Actual)
December 29, 2021
Study Record Updates
Last Update Posted (Actual)
December 29, 2021
Last Update Submitted That Met QC Criteria
December 10, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 19057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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