NCT06060379

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

September 18, 2023

Last Update Submit

February 8, 2024

Conditions

Keywords

Health and Safety workplace

Outcome Measures

Primary Outcomes (1)

  • 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.

    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).

Study Arms (2)

Intervention gruop

EXPERIMENTAL

Partecipant will participate in playful encounters

Other: GiochiAMO a 626

Control group

NO INTERVENTION

Subjects will not partecipate in the games

Interventions

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

Intervention gruop

Eligibility Criteria

Age17 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • No worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Mannocci

Roma, RM, 00186, Italy

RECRUITING

Related Publications (6)

  • 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: 31770005BACKGROUND
  • 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: 31786612BACKGROUND
  • 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: 27845482BACKGROUND
  • 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: 29895045BACKGROUND
  • 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: 29048455BACKGROUND
  • 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: 32517111BACKGROUND

Study Officials

  • Alice Mannocci

    Universitas Mercatorum

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 29, 2023

Study Start

October 9, 2023

Primary Completion

February 1, 2024

Study Completion

September 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

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).

Locations