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

August 3, 2023 updated by: Asaad Ahmed Nafees, Aga Khan University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2031

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Multifaceted intervention package will be implemented at textile mills in the intervention arm.
Behavioral: 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
No Intervention: Control
No intervention will be provided to mills in the control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cotton dust personal exposure levels expressed as mg/m3
Time Frame: 24 months
Will be assessed through the use of IOM samplers
24 months
Changes in the prevalence of respiratory symptoms
Time Frame: 24 months
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
Time Frame: 24 months
Will be assessed through spirometry
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

Imperial College London
Wellcome Trust

Investigators

  • Principal Investigator: Asaad A Nafees, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MultiTex-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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