Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers

NCT ID: NCT03738202

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2031 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2022-07-15

Brief Summary

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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.

Detailed Description

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The textile, clothing and footwear sector provides employment to more than 60 million people worldwide, mostly in developing countries. Pakistan's textile industry accounts for 8.5% of the national GDP and employs around 40% of the industrial workforce. High burden of respiratory illnesses, including byssinosis and lung function decrements has been reported among cotton textile workers in developing countries and previous work undertaken by Dr Nafees found a high burden in Pakistan. Dr Nafees recently implemented an interventional study designed to improve workers' knowledge, attitude and practices and respiratory health, and reduce dust exposure at cotton textile mills through a multifaceted intervention (MultiTex pilot study). The preliminary findings from the pilot were helpful in improving the overall design and implementation of a larger and more definitive study (cluster randomised controlled trial). The aim of the trial would be to determine the effectiveness of a multifaceted interventional package for improvement in reducing dust levels at the cotton textile mills as well as improvement in respiratory health of textile workers.This study will add important context-specific knowledge regarding preventive strategies in cotton mills with policy implications for Pakistan and other developing countries.

Conditions

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Occupational Diseases Occupational Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Multifaceted intervention package will be implemented at textile mills in the intervention arm.

Group Type EXPERIMENTAL

Multifaceted intervention package

Intervention Type BEHAVIORAL

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

Control

No intervention will be provided to mills in the control arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multifaceted intervention package

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Textile workers from the wet-processing areas as well as support or administrative staff will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Asaad Ahmed Nafees

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asaad A Nafees

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan University

Karachi, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 31842937 (View on PubMed)

Nafees 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.

Reference Type BACKGROUND
PMID: 35073782 (View on PubMed)

Nafees 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.

Reference Type RESULT
PMID: 34791042 (View on PubMed)

Nafees 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.

Reference Type RESULT
PMID: 34799440 (View on PubMed)

Nafees 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.

Reference Type RESULT
PMID: 36717255 (View on PubMed)

Other Identifiers

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MultiTex-RCT

Identifier Type: -

Identifier Source: org_study_id

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