Health626 GiochiamoNCT06060379
Giochiamo 626 - Gaming for Health and Safety in Workplaces
A study testing GiochiAMO a 626 in people with Health and Safety, run by Universitas Mercatorum at 1 site in Italy.
Trial summary
The aim of the "626 Giochiamo" project is to realise and evaluate the effectiveness of a training course involving the use of games, which helps to convey the basic principles of health and safety in the workplace. Read more about this study
- Who is it for?
- Ages 17 to 69 yearsHealthy volunteers can take part
- What is being tested?
- GiochiAMO a 626
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2023to Sep 2024
- 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 17 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- No worker
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Alice Mannocci
Roma, RM, 00186
Alice MANNOCCI, PhD, alice.mannocci@unimercatorum.it
Giuseppe LA TORRE, PhD
About this study
The aim of the "626 Giochiamo" project is to realise and evaluate the effectiveness of a training course involving the use of games, which helps to convey the basic principles of health and safety in the workplace.
Read the detailed description
The seminar on health and safety in the workplace and basic principles will be presented to the recruited workers. At the end of the intervention they will be divided into two groups: the control group and the intervention group. The intervention group will be involved in a meeting dedicated to games in three different types, board, card and role-playing games.
A questionnaire on occupational health and safety knowledge will be administered to all study participants before the seminar (T=0), after the seminar (T=1) and after the intervention group has played (T=2).
- Being tested
- GiochiAMO a 626
- Keywords
- Health and Safety workplace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GiochiAMO a 626Other
The subjects of the intervention group will play three different games: a role-playing game, a card game and a board game.
| Study group | Role | What they receive |
|---|---|---|
| Intervention gruop | Experimental | Partecipant will participate in playful encounters Receives: Other: GiochiAMO a 626 |
| Control group | No intervention | Subjects will not partecipate in the games |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of knowledge increased as a result of participation in the games
Effectiveness is understood as acquiring and increasing knowledge of key concepts on safety in the workplace, the roles of key persons who can influence health and safety, and the tools available for evaluation and monitoring.
Measured: Participants are assessed by means of a questionnaire administered at the beginning of the trial (t=0), one day after the seminar (t=1) and after one month (t=2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start9 Oct 2023
- Primary completionFeb 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial consists of three meetings. In the first meeting all enrolled participants will take part in a seminar. Before the seminar starts and at the end, a questionnaire will be administered to them to investigate their prior and acquired knowledge on the subject. At the end the participants will be divided into two groups, the control group will not participate in the second phase, the intervention group will be invited to a game meeting. The third meeting will take place days later, where the third and final game will be conducted with the intervention group. At the end of the game, the questionnaire will be administered.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Mercatorum
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Alice Mannocci, Universitas Mercatorum
- Investigators
- Alice Mannocci, Principal investigator, Universitas Mercatorum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060379
- Sponsor's protocol ID
- 6-FIN/RIC2023
- Acronym
- 626 Giochiamo
- Status last verified
- Feb 2024
- First submitted
- 18 Sep 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share aggregated data, individual data will be submitted upon request by the individual concerned to the Research Contact Person (principal investigator: Alice Mannocci).
Publications
Cocchiara RA, Sestili C, Di Bella O, Backhaus I, Sinopoli A, D'Egidio V, Lia L, Saulle R, Mannocci A, La Torre G. "GiochiAMO," a Gaming Intervention to Prevent Smoking and Alcohol Habits Among Children: A Single-Arm Field Trial. Games Health J. 2020 Apr;9(2):113-120. doi: 10.1089/g4h.2019.0125. Epub 2019 Nov 26.
PubMed 31770005D'Egidio V, Lia L, Sinopoli A, Backhaus I, Mannocci A, Saulle R, Sestili C, Cocchiara R, Di Bella O, Yordanov T, Mazzacane M, La Torre G. Results of the Italian project 'GiochiAMO' to improve nutrition and PA among children. J Public Health (Oxf). 2021 Jun 7;43(2):405-412. doi: 10.1093/pubmed/fdz129.
PubMed 31786612La Torre G, Mannocci A, Saulle R, Sinopoli A, D'Egidio V, Sestili C, Manfuso R, Masala D. [GiochiAMO! The protocol of a school based intervention for the promotion of physical activity and nutrition among children]. Clin Ter. 2016 Sep-Oct;167(5):152-155. doi: 10.7417/CT.2016.1947. Italian.
PubMed 27845482La Torre G, Sinopoli A, Sestili C, D'Egidio V, Di Bella O, Cocchiara RA, Sciarra I, Saulle R, Backhaus I, Mannocci A. "GiochiAMO": a school-based smoking and alcohol prevention program for children - a pilot randomized field trial. Part 2. Ann Ig. 2018 Jul-Aug;30(4):273-284. doi: 10.7416/ai.2018.2219.
PubMed 29895045La Torre G, Mannocci A, Saulle R, Sinopoli A, D'Egidio V, Sestili C, Manfuso R, Masala D. Improving knowledge and behaviors on diet and physical activity in children: results of a pilot randomized field trial. Ann Ig. 2017 Nov-Dec;29(6):584-594. doi: 10.7416/ai.2017.2187.
PubMed 29048455La Torre G, D'Egidio V, Sestili C, Cocchiara RA, Cianfanelli S, Di Bella O, Lia L, Dorelli B, Cammalleri V, Backhaus I, Pagano F, Anguissola C, Vitiello A, Carsetti R, Mannocci A, Giochiamo Collaborative Group. ImmunizziAMO: A School-Based Field Trial to Teach New Generations the Importance of Vaccination through Games and to Fight Vaccine Hesitancy in Italy. Vaccines (Basel). 2020 Jun 5;8(2):280. doi: 10.3390/vaccines8020280.
PubMed 32517111
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giochiamo 626 - Gaming for Health and Safety in Workplaces
- ClinicalTrials.gov ID
- NCT06060379
- Acronym / sponsor ID
- 626 Giochiamo / 6-FIN/RIC2023
- Keywords
- Health and Safety workplace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas MercatorumUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 Sep 2023 (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 aim of the "626 Giochiamo" project is to realise and evaluate the effectiveness of a training course involving the use of games, which helps to convey the basic principles of health and safety in the workplace.
Detailed description
The seminar on health and safety in the workplace and basic principles will be presented to the recruited workers. At the end of the intervention they will be divided into two groups: the control group and the intervention group. The intervention group will be involved in a meeting dedicated to games in three different types, board, card and role-playing games.
A questionnaire on occupational health and safety knowledge will be administered to all study participants before the seminar (T=0), after the seminar (T=1) and after the intervention group has played (T=2).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial consists of three meetings. In the first meeting all enrolled participants will take part in a seminar. Before the seminar starts and at the end, a questionnaire will be administered to them to investigate their prior and acquired knowledge on the subject. At the end the participants will be divided into two groups, the control group will not participate in the second phase, the intervention group will be invited to a game meeting. The third meeting will take place days later, where the third and final game will be conducted with the intervention group. At the end of the game, the questionnaire will be administered.
| Arm | Type | Receives |
|---|---|---|
| Intervention gruop | Experimental | Other: GiochiAMO a 626Partecipant will participate in playful encounters |
| Control group | No intervention | –Subjects will not partecipate in the games |
Who may qualify
- Ages
- 17 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- No worker
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 |
|---|---|---|
| GiochiAMO a 626The subjects of the intervention group will play three different games: a role-playing game, a card game and a board game. | Other | Intervention gruop |
Primary outcome
The percentage of knowledge increased as a result of participation in the games
Time frame: Participants are assessed by means of a questionnaire administered at the beginning of the trial (t=0), one day after the seminar (t=1) and after one month (t=2).
Effectiveness is understood as acquiring and increasing knowledge of key concepts on safety in the workplace, the roles of key persons who can influence health and safety, and the tools available for evaluation and monitoring.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 31770005Cocchiara RA, Sestili C, Di Bella O, Backhaus I, Sinopoli A, D'Egidio V, Lia L, Saulle R, Mannocci A, La Torre G. "GiochiAMO," a Gaming Intervention to Prevent Smoking and Alcohol Habits Among Children: A Single-Arm Field Trial. Games Health J. 2020 Apr;9(2):113-120. doi: 10.1089/g4h.2019.0125. Epub 2019 Nov 26.
- Background: PubMed 31786612D'Egidio V, Lia L, Sinopoli A, Backhaus I, Mannocci A, Saulle R, Sestili C, Cocchiara R, Di Bella O, Yordanov T, Mazzacane M, La Torre G. Results of the Italian project 'GiochiAMO' to improve nutrition and PA among children. J Public Health (Oxf). 2021 Jun 7;43(2):405-412. doi: 10.1093/pubmed/fdz129.
- Background: PubMed 27845482La Torre G, Mannocci A, Saulle R, Sinopoli A, D'Egidio V, Sestili C, Manfuso R, Masala D. [GiochiAMO! The protocol of a school based intervention for the promotion of physical activity and nutrition among children]. Clin Ter. 2016 Sep-Oct;167(5):152-155. doi: 10.7417/CT.2016.1947. Italian.
- Background: PubMed 29895045La Torre G, Sinopoli A, Sestili C, D'Egidio V, Di Bella O, Cocchiara RA, Sciarra I, Saulle R, Backhaus I, Mannocci A. "GiochiAMO": a school-based smoking and alcohol prevention program for children - a pilot randomized field trial. Part 2. Ann Ig. 2018 Jul-Aug;30(4):273-284. doi: 10.7416/ai.2018.2219.
- Background: PubMed 29048455La Torre G, Mannocci A, Saulle R, Sinopoli A, D'Egidio V, Sestili C, Manfuso R, Masala D. Improving knowledge and behaviors on diet and physical activity in children: results of a pilot randomized field trial. Ann Ig. 2017 Nov-Dec;29(6):584-594. doi: 10.7416/ai.2017.2187.
- Background: PubMed 32517111La Torre G, D'Egidio V, Sestili C, Cocchiara RA, Cianfanelli S, Di Bella O, Lia L, Dorelli B, Cammalleri V, Backhaus I, Pagano F, Anguissola C, Vitiello A, Carsetti R, Mannocci A, Giochiamo Collaborative Group. ImmunizziAMO: A School-Based Field Trial to Teach New Generations the Importance of Vaccination through Games and to Fight Vaccine Hesitancy in Italy. Vaccines (Basel). 2020 Jun 5;8(2):280. doi: 10.3390/vaccines8020280.
- Individual participant dataSharing planned: No. We will share aggregated data, individual data will be submitted upon request by the individual concerned to the Research Contact Person (principal investigator: Alice Mannocci).
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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.
Alice Mannocci principal investigator
Universitas Mercatorum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GiochiAMO a 626 in people with Health and Safety, run by Universitas Mercatorum at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Mannocci (+39.06.499790978, alice.mannocci@unimercatorum.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of knowledge increased as a result of participation in the games (time frame: Participants are assessed by means of a questionnaire administered at the beginning of the trial (t=0), one day after the seminar (t=1) and after one month (t=2).). 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 NCT06060379, which also lists 6 linked publications.
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 12 Feb 2024.