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Occupational DiseasesMultiTex-RCTNCT03738202

Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers

A study testing Multifaceted intervention package in people with Occupational Diseases and Occupational Lung Disease, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Multifaceted intervention package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,031 participants
Where
1 sitePakistan
Study dates
15 Jun 2019to 15 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Textile workers from the wet-processing areas as well as support or administrative staff will be excluded.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Aga Khan University

    Karachi

Other trials in Pakistan

About this study

Official title: Multifaceted Intervention Package for Protection Against Cotton Dust Exposure Among Textile Workers - a Cluster Randomised Controlled Trial

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.

Read the detailed description

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.

Being tested
Multifaceted intervention package
Keywords
Randomized controlled trial, Textile industry, Cotton fiber, Byssinosis
Medical subject headings
Occupational Diseases, Byssinosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multifaceted intervention packageBehavioural

    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
Study groups in NCT03738202
Study groupRoleWhat they receive
InterventionExperimentalMultifaceted intervention package will be implemented at textile mills in the intervention arm.
Receives: Behavioral: Multifaceted intervention package
ControlNo interventionNo intervention will be provided to mills in the control arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in cotton dust personal exposure levels expressed as mg/m3

    Will be assessed through the use of IOM samplers

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml

    Will be assessed through spirometry

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start15 Jun 2019
  3. Primary completion15 Jul 2022
  4. Study completion15 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,031 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738202
Sponsor's protocol ID
MultiTex-RCT
Acronym
MultiTex-RCT
Status last verified
Aug 2023
First submitted
8 Nov 2018
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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).

Publications

  • 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.

    PubMed 31842937

  • 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.

    PubMed 35073782

  • 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.

    PubMed 34791042

  • 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.

    PubMed 34799440

  • 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.

    PubMed 36717255

  • Nafees AA, Allana A, Kadir MM, Potts J, Minelli C, Semple S, De Matteis S, Burney P, Cullinan P. A cluster randomised controlled trial to reduce respiratory effects of cotton dust exposure among textile workers: the MultiTex RCT study. Eur Respir J. 2024 Jan 18;63(1):2301028. doi: 10.1183/13993003.01028-2023. Print 2024 Jan.

    PubMed 37857425

Questions about this trial

What is this clinical trial studying?

A study testing Multifaceted intervention package in people with Occupational Diseases and Occupational Lung Disease, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in cotton dust personal exposure levels expressed as mg/m3 (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03738202, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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