Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers
MultiTex-RCT
Multifaceted Intervention Package for Protection Against Cotton Dust Exposure Among Textile Workers - a Cluster Randomised Controlled Trial
1 other identifier
interventional
2,031
1 country
1
Brief Summary
Textile workers are exposed to various harmful substances during work, including cotton dust, which is the dust present in air during the handling or processing of cotton. Previous research found a link between cotton dust exposure and impaired respiratory health. This study will comprise of administration and workers' training regarding preventive measures for protection against respiratory illnesses. Workers will be provided free, disposable face masks and measures to reduce cotton dust exposure will be introduced at the textile mills. The study would then determine the effectiveness of this intervention on reduction in cotton dust levels in the mills, and improvement in respiratory health of workers. This study would help the cotton textile workers and managers reduce the health hazards of cotton dust exposure and also guide researchers from Pakistan and other low-resource countries towards developing relevant strategies for health protection of these workers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2018
CompletedFirst Posted
Study publicly available on registry
November 13, 2018
CompletedStudy Start
First participant enrolled
June 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedAugust 4, 2023
August 1, 2023
3.1 years
November 8, 2018
August 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in cotton dust personal exposure levels expressed as mg/m3
Will be assessed through the use of IOM samplers
24 months
Changes in the prevalence of respiratory symptoms
Will be assessed through MRC respiratory questionnaire; symptoms include chest tightness, cough, phlegm, chronic bronchitis, wheezing and shortness of breath.
24 months
Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml
Will be assessed through spirometry
24 months
Study Arms (2)
Intervention
EXPERIMENTALMultifaceted intervention package will be implemented at textile mills in the intervention arm.
Control
NO INTERVENTIONNo intervention will be provided to mills in the control arm.
Interventions
Multifaceted intervention package will comprise following strategies: 1. Initial training for all workers and managers on occupational health and safety (OHS) 2. Follow-up refresher sessions every three months 3. Formation of workplace committees (including worker representatives) to draw up, agree and promote a health and safety plan that includes wet mopping, safe disposal of cotton dust, and the use of simple face masks, as well as further publicity about the risks from cotton dust. 4. Provision of adequate supplies of face masks to support the health and safety plan
Eligibility Criteria
You may qualify if:
- Mills from the formal sector will be included.
- Mills which have either spinning or weaving sections, or both.
- Mills that have at least 50-100 workers (primarily labourers/machine operators) in the spinning and weaving sections.
- Mills with a more stable working population will be preferred.
- Willingness of management to participate in planning and implementation of the study.
- Those ≥18 years and employed in the bale opening, blowing, carding, spinning, weaving and waste recycling sections (and related sub-sections).
You may not qualify if:
- Textile workers from the wet-processing areas as well as support or administrative staff will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aga Khan Universitylead
- Wellcome Trustcollaborator
- Imperial College Londoncollaborator
Study Sites (1)
Aga Khan University
Karachi, Pakistan
Related Publications (5)
Nafees AA, De Matteis S, Kadir MM, Burney P, Coggon D, Semple S, Cullinan P. MultiTex RCT - a multifaceted intervention package for protection against cotton dust exposure among textile workers - a cluster randomized controlled trial in Pakistan: study protocol. Trials. 2019 Dec 16;20(1):722. doi: 10.1186/s13063-019-3743-3.
PMID: 31842937BACKGROUNDNafees AA, Matteis S, Burney P, Cullinan P. Contemporary Prevalence of Byssinosis in Low- and Middle-Income Countries: A Systematic Review. Asia Pac J Public Health. 2022 Jul;34(5):483-492. doi: 10.1177/10105395211073051. Epub 2022 Jan 24.
PMID: 35073782BACKGROUNDNafees AA, Iqbal AR, Cullinan P, De Matteis S, Burney P, Semple S. Use of Low-Cost Particle Counters for Cotton Dust Exposure Assessment in Textile Mills in Low- and Middle-Income Countries. Ann Work Expo Health. 2022 Apr 22;66(4):537-542. doi: 10.1093/annweh/wxab102.
PMID: 34791042RESULTNafees AA, Muneer MZ, De Matteis S, Amaral A, Burney P, Cullinan P. Impact of using different predictive equations on the prevalence of chronic byssinosis in textile workers in Pakistan. Occup Environ Med. 2022 Apr;79(4):242-244. doi: 10.1136/oemed-2021-107680. Epub 2021 Nov 19.
PMID: 34799440RESULTNafees AA, Muneer MZ, Irfan M, Kadir MM, Semple S, De Matteis S, Burney P, Cullinan P. Byssinosis and lung health among cotton textile workers: baseline findings of the MultiTex trial in Karachi, Pakistan. Occup Environ Med. 2023 Mar;80(3):129-136. doi: 10.1136/oemed-2022-108533. Epub 2023 Jan 30.
PMID: 36717255RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asaad A Nafees
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 8, 2018
First Posted
November 13, 2018
Study Start
June 15, 2019
Primary Completion
July 15, 2022
Study Completion
July 15, 2022
Last Updated
August 4, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
This may be possible at the conclusion of the study and would depend on the guidelines of the funding agency and the publishing journal(s).