An interventional study of Multifaceted intervention package in Occupational Diseases and Occupational Lung Disease, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-04.
Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 2,031 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Inclusion Criteria:
Exclusion Criteria:
Multifaceted intervention package will be implemented at textile mills in the intervention arm.
Behavioral: Multifaceted intervention package
No intervention will be provided to mills in the control arm.
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
Changes in cotton dust personal exposure levels expressed as mg/m3
Will be assessed through the use of IOM samplers
Time frame: 24 months
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.
Time frame: 24 months
Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml
Will be assessed through spirometry
Time frame: 24 months
Plan to share: No — 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).
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Aga Khan University