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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738202
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
Wellcome Trust
Imperial College London
Information provided by (Responsible Party):
Asaad Ahmed Nafees, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Occupational Diseases Occupational Lung Disease Behavioral: Multifaceted intervention package Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1708 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multifaceted Intervention Package for Protection Against Cotton Dust Exposure Among Textile Workers - a Cluster Randomised Controlled Trial
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Intervention 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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738202


Contacts
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Contact: Asaad A Nafees 009234864884 asaad.nafees@aku.edu

Locations
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Pakistan
Aga Khan University Recruiting
Karachi, Pakistan
Contact: Asaad A Nafees    009234864884    asaad.nafees@aku.edu   
Sponsors and Collaborators
Aga Khan University
Wellcome Trust
Imperial College London
Investigators
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Principal Investigator: Asaad A Nafees Aga Khan University

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asaad Ahmed Nafees, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03738202    
Other Study ID Numbers: MultiTex-RCT
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asaad Ahmed Nafees, Aga Khan University:
Randomized controlled trial
Textile industry
Cotton fiber
Byssinosis
Additional relevant MeSH terms:
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Lung Diseases
Occupational Diseases
Respiratory Tract Diseases