NCT03738202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,031

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

November 8, 2018

Last Update Submit

August 3, 2023

Conditions

Keywords

Randomized controlled trialTextile industryCotton fiberByssinosis

Outcome Measures

Primary Outcomes (3)

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

    Will be assessed through the use of IOM samplers

    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.

    24 months

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

    Will be assessed through spirometry

    24 months

Study Arms (2)

Intervention

EXPERIMENTAL

Multifaceted intervention package will be implemented at textile mills in the intervention arm.

Behavioral: Multifaceted intervention package

Control

NO INTERVENTION

No intervention will be provided to mills in the control arm.

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Those ≥18 years and employed in the bale opening, blowing, carding, spinning, weaving and waste recycling sections (and related sub-sections).

You may not qualify if:

  • Textile workers from the wet-processing areas as well as support or administrative staff will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Pakistan

Location

Related 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.

    PMID: 31842937BACKGROUND
  • 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.

    PMID: 35073782BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Occupational DiseasesByssinosis

Condition Hierarchy (Ancestors)

PneumoconiosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung Injury

Study Officials

  • Asaad A Nafees

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 13, 2018

Study Start

June 15, 2019

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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).

Locations