Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers

Occupational Diseases Clinical Trial

— MultiTex-RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738202
• Other study ID #: MultiTex-RCT
• Status: Completed
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: July 15, 2022

Study information

• Verified date: August 2023
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2031
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Occupational Diseases
• Occupational Lung Disease

Intervention

Behavioral:
• Multifaceted intervention package
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

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Imperial College London, Wellcome Trust

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View 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/an — View 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. — View 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-2021-1 — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cotton dust personal exposure levels expressed as mg/m3	Will be assessed through the use of IOM samplers	24 months
Primary	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.	24 months
Primary	Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml	Will be assessed through spirometry	24 months

External Links

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