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Completed

NCT Number: NCT03738202

Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers

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.

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Key information

Conditions

Occupational Diseases Byssinosis Lung Diseases Lung Diseases, Interstitial Lung Injury Occupational Lung Disease Pneumoconiosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multifaceted intervention package

Behavioral

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 outcomes

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

    Time frame: 24 months

    Will be assessed through the use of IOM samplers

  2. 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.

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

    Time frame: 24 months

    Will be assessed through spirometry

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Imperial College London
  • Wellcome Trust

Registry information

Official study title

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

Acronym: MultiTex-RCT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2018
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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