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Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers (MultiTex-RCT)

Primary Purpose

Occupational Diseases, Occupational Lung Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Multifaceted intervention package
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Occupational Diseases focused on measuring Randomized controlled trial, Textile industry, Cotton fiber, Byssinosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria for textile mills:
  • 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.
  • Inclusion criteria for textile workers:
  • 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.

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in cotton dust personal exposure levels expressed as mg/m3
Will be assessed through the use of IOM samplers
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.
Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml
Will be assessed through spirometry

Secondary Outcome Measures

Full Information

First Posted
November 8, 2018
Last Updated
August 3, 2023
Sponsor
Aga Khan University
Collaborators
Wellcome Trust, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03738202
Brief Title
Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers
Acronym
MultiTex-RCT
Official Title
Multifaceted Intervention Package for Protection Against Cotton Dust Exposure Among Textile Workers - a Cluster Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Wellcome Trust, Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Diseases, Occupational Lung Disease
Keywords
Randomized controlled trial, Textile industry, Cotton fiber, Byssinosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2031 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Multifaceted intervention package will be implemented at textile mills in the intervention arm.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be provided to mills in the control arm.
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted intervention package
Intervention Description
Multifaceted intervention package will comprise following strategies: Initial training for all workers and managers on occupational health and safety (OHS) Follow-up refresher sessions every three months 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. Provision of adequate supplies of face masks to support the health and safety plan
Primary Outcome Measure Information:
Title
Changes in cotton dust personal exposure levels expressed as mg/m3
Description
Will be assessed through the use of IOM samplers
Time Frame
24 months
Title
Changes in the prevalence of respiratory symptoms
Description
Will be assessed through MRC respiratory questionnaire; symptoms include chest tightness, cough, phlegm, chronic bronchitis, wheezing and shortness of breath.
Time Frame
24 months
Title
Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml
Description
Will be assessed through spirometry
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for textile mills: 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. Inclusion criteria for textile workers: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asaad A Nafees
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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).
Citations:
PubMed Identifier
31842937
Citation
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.
Results Reference
background
PubMed Identifier
35073782
Citation
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.
Results Reference
background
PubMed Identifier
34791042
Citation
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.
Results Reference
result
PubMed Identifier
34799440
Citation
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.
Results Reference
result
PubMed Identifier
36717255
Citation
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.
Results Reference
result
Links:
URL
http://www.lungsatwork.org.uk/our-team/asaad-nafees
Description
Author information

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Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers

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