NCT05571995

Brief Summary

Introduction: The food and beverages industry contributed a significant income to Malaysia's Gross Domestic Products. The contribution is projected to swell more in the upcoming years. As the industry expands, the demand for the workforce in the food premises will also continuously increase. They are exposed to risks arising from physical, chemical, biological, mechanical, and social hazards while performing their duties. Thus, it is essential for Food Industries Workers to be equipped with the proper knowledge, attitude, and practice (KAP) towards safety and health. Methods and analysis: Theory Based Intervention Module on Occupational Safety and Health (TRIMOSH) is a single blinded, cluster randomized controlled trial study will be implemented among Food Industries Workers in Selangor, Malaysia. Partnering with the Food Handler Training School in Selangor, 10 pairs of Food Handler Training School with 12 participants per group (n = 240) will be recruited for balanced randomization intervention and control conditions. Data collection of all participants will be at enrollment, one months and three months. Generalized Linear Mixed Model (GLMM) will be conducted to determine the effects of intervention within and between study groups. Primary outcomes are to increase knowledge, attitude, and practice (KAP) and secondary outcome is safe practice score at food premise. Ethic and Dissemination: his study has been submitted for approval by the Ethics Committee for Research involving Human Subject of Universiti Putra Malaysia (JKEUPM-2022-346). All participants will provide consent prior to participation. The results will be reported in international peer- reviewed journals and presented at conferences and other platforms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

September 29, 2022

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • knowledge on occupational safety and health

    Adopted, modified and validated knowledge score questionnaire on occupational safety and health will be used to meassure the knowledge level

    3 months

  • attitude on occupational safety and health

    Adopted, modified and validated attitude score questionnaire on occupational safety and health will be used to meassure the attitude level

    3 months

  • practice on occupational safety and health

    Adopted, modified and validated practice score questionnaire on occupational safety and health will be used to meassure the practice level

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive TRIMOSH

Behavioral: TRIMOSH

Control

NO INTERVENTION

The control group will receive no intervention.

Interventions

TRIMOSHBEHAVIORAL

TRIMOSH will improve the knowledge, attitude and practice on occupational and health

Also known as: Theory-Based Intervention Module on Occupational Safety and Health
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • food industries workers registered under food handler training course,
  • age 18-65 years

You may not qualify if:

  • not able to read in local language (Bahasa Melayu)
  • non-Malaysian resident.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (1)

  • Dapari R, Mahfot MH, Ahmad Zamzuri M'I, Md Isa Z, Hassan MR, Che Dom N, Syed Abdul Rahim SS. Theory-Based Intervention Module on Occupational Safety and Health (TRIMOSH) in improving knowledge, attitude, and practice among food industry workers: Study protocol for a randomised controlled trial. PLoS One. 2024 Jan 2;19(1):e0295771. doi: 10.1371/journal.pone.0295771. eCollection 2024.

MeSH Terms

Conditions

Occupational InjuriesOccupational Diseases

Interventions

Health

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Rahmat Dapari, DrPH

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahmat Dapari, DrPH

CONTACT

Mohd Hafizuddin Mahfot, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: single blinded cluster randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 7, 2022

Study Start

December 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

We are committed to sharing the individual participant data (IPD) collected during the course of this study upon request, to promote transparency and scientific collaboration

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After 1st publication of completed study

Locations