## Protocol Section
### Identification Module
**NCT ID:** NCT06060379

**Acronym:** 626 Giochiamo

**Brief Title:** Giochiamo 626 - Gaming for Health and Safety in Workplaces

**Official Title:** Giochiamo 626 - Gaming for Health and Safety in Workplaces

#### Organization Study ID Info
**ID:** 6-FIN/RIC2023
#### Organization
**Class:** OTHER
**Full Name:** Universitas Mercatorum
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-09

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2023-09-29
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-18
**Study First Submit QC Date:** 2023-09-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Roma La Sapienza

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitas Mercatorum

#### Responsible Party

**Investigator Affiliation:** Universitas Mercatorum

**Investigator Full Name:** Alice Mannocci

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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).

### Conditions Module

**Conditions:**

- Health

- Safety

- Workplace

**Keywords:**

- Health and Safety workplace

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Partecipant will participate in playful encounters

**Intervention Names:**

- Other: GiochiAMO a 626

**Label:** Intervention gruop

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects will not partecipate in the games

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention gruop

**Description:** The subjects of the intervention group will play three different games: a role-playing game, a card game and a board game.

**Name:** GiochiAMO a 626

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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).

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

-

Exclusion Criteria:

* No worker

**Healthy Volunteers:** True

**Maximum Age:** 69 Years

**Minimum Age:** 17 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alice.mannocci@unimercatorum.it

**Name:** Alice Mannocci

**Phone:** +39.06.499790978

**Role:** CONTACT

**Contact 2:**

**Email:** giuseppe.latorre@uniroma1.it

**Name:** Giuseppe La Torre

**Phone:** +39.06.499790978

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Roma

**Contacts:**

***Contact 1:***

- **Email:** alice.mannocci@unimercatorum.it

- **Name:** Alice MANNOCCI, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Giuseppe LA TORRE, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Italy

**Facility:** Alice Mannocci

**State:** RM

**Status:** RECRUITING

**Zip:** 00186

#### Overall Officials

**Official 1:**

**Affiliation:** Universitas Mercatorum

**Name:** Alice Mannocci

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** 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).

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 31770005

**Citation:** D'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.

**PMID:** 31786612

**Citation:** La 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.

**PMID:** 27845482

**Citation:** La 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.

**PMID:** 29895045

**Citation:** La 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.

**PMID:** 29048455

**Citation:** La 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.

**PMID:** 32517111

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
