Healthy NutritionNCT05173311
Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance
A study testing Intervention arm in people with Healthy Nutrition and Eating Behavior, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition, Eating Behavior
- What is being tested?
- Intervention arm
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children in the participating early childhood education and care (ECEC) groups
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Nutrition, Eating Behavior
- Being tested
- Intervention arm
- Keywords
- Games for health, Mobile application, Smartphone application, Randomized trial
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention armBehavioural
Also called Mole's Veggie Adventures
The intervention arm groups were instructed to use the Mole's Veggie Adventures mobile application for 3-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Application use arm | Experimental | 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. Receives: Behavioral: Intervention arm |
| Control arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
Secondary outcomes (2)
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).
Measured: The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
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).
Measured: The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warsaw, University of Eastern Finland, Folkhälsan Research Center, Tampere University, EIT Food
- Responsible party
- Principal investigator, Henna Vepsalainen, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173311
- Sponsor's protocol ID
- 19057
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vepsalainen H, Skaffari E, Wojtkowska K, Barlinska J, Kinnunen S, Makkonen R, Heikkila M, Lehtovirta M, Ray C, Suhonen E, Nevalainen J, Sajaniemi N, Erkkola M. A Mobile App to Increase Fruit and Vegetable Acceptance Among Finnish and Polish Preschoolers: Randomized Trial. JMIR Mhealth Uhealth. 2022 Jan 4;10(1):e30352. doi: 10.2196/30352.
PubMed 34982718
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance
- ClinicalTrials.gov ID
- NCT05173311
- Acronym / sponsor ID
- 19057
- Conditions
- Healthy Nutrition, Eating Behavior
- Keywords
- Games for health, Mobile application, Smartphone application, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University of Warsaw, University of Eastern Finland, Folkhälsan Research Center, Tampere University, EIT Food
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application use arm | Experimental | Behavioral: Intervention armThe 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. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children in the participating early childhood education and care (ECEC) groups
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention armAlso: Mole's Veggie AdventuresThe intervention arm groups were instructed to use the Mole's Veggie Adventures mobile application for 3-4 weeks. | Behavioural | Application use arm |
Primary outcome
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).
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.
2 secondary outcomes
Emotionality (post intervention)
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Derived from this study: PubMed 34982718Vepsalainen H, Skaffari E, Wojtkowska K, Barlinska J, Kinnunen S, Makkonen R, Heikkila M, Lehtovirta M, Ray C, Suhonen E, Nevalainen J, Sajaniemi N, Erkkola M. A Mobile App to Increase Fruit and Vegetable Acceptance Among Finnish and Polish Preschoolers: Randomized Trial. JMIR Mhealth Uhealth. 2022 Jan 4;10(1):e30352. doi: 10.2196/30352.
- A video demonstrating the most important sections of the current version of the Mole's Veggie Adventures application.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm in people with Healthy Nutrition and Eating Behavior, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.