Clinical trial NCT03738202: Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers
Official title: Multifaceted Intervention Package for Protection Against Cotton Dust Exposure Among Textile Workers - a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Diseases
Occupational Lung Disease
Keywords: Randomized controlled trial
Textile industry
Cotton fiber
Byssinosis
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Imperial College London
First posted: 2018-11-13
Enrollment: 2031
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes in cotton dust personal exposure levels expressed as mg/m3
timeFrame: 24 months
measure: Changes in the prevalence of respiratory symptoms
timeFrame: 24 months
measure: Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: Aga Khan University
name: Asaad A Nafees
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.