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Mumbai Worksite Tobacco Control Study

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ClinicalTrials.gov Identifier: NCT01841879
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : April 17, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Healis-Sekhsaria Institute for Public Health
New England Research Institutes
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Glorian Sorensen, Harvard School of Public Health

Brief Summary:
The investigators are designing and testing the effectiveness of an integrated tobacco control and occupational health (OH) intervention aimed at promoting tobacco cessation among workers and supporting the adoption, implementation, and enforcement of tobacco control policies in 20 manufacturing worksites in the greater Mumbai region of India.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Behavioral: Intervention Program Behavioral: Delayed Intervention Not Applicable

Detailed Description:

Through 6 health education events at the worksites, blue-collar workers (who face dual health risks through their exposures to occupational hazards and their high rates of tobacco use) will gain the knowledge, skills, and social support needed to quit tobacco use.

Simultaneously, management will receive OH and tobacco policy consultations to help build a healthy and safe work environment, where workers' hazardous exposures are reduced.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mumbai Worksite Tobacco Control Study
Study Start Date : June 2010
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Arm Intervention/treatment
Experimental: Intervention Program
Receives the full Healthy, Safe, and Tobacco-Free Worksites intervention
Behavioral: Intervention Program

Receives an integrated tobacco control and occupational health (OH) intervention (The Healthy, Safe, and Tobacco-Free Worksites program) aimed at promoting tobacco cessation among workers and supporting the adoption, implementation, and enforcement of tobacco control policies.

Through six health education events at the worksites, blue-collar workers (who face dual health risks through their exposures to occupational hazards and their high rates of tobacco use) will gain the knowledge, skills, and social support needed to quit tobacco use.

Simultaneously, management will receive OH and tobacco policy consultations to help build a healthy and safe work environment, where workers' hazardous exposures are reduced.

Other Name: Healthy, Safe, and Tobacco-Free Worksites Program

Delayed Intervention Control
Receives abbreviated 2-month delayed intervention designed to provide employees with knowledge and skills to quit tobacco after final data collection time point, as well as one non-tobacco event in between data collection points.
Behavioral: Delayed Intervention
Receives abbreviated 2-month delayed intervention designed to provide employees with knowledge and skills to quit tobacco after final data collection time point, as well as one non-tobacco event in between data collection points.




Primary Outcome Measures :
  1. Tobacco use cessation [ Time Frame: 6-month post intervention ]

Secondary Outcome Measures :
  1. Changes in company tobacco policy [ Time Frame: 6-month post intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Manufacturing worksites located in the Mumbai, Thane, or Raigad districts of India
  • Employ at least 60% production workers/40% administrative staff OR at employ at least 200 production workers on staff. NOTE: We are defining "workers" as anyone who is on the company roster, regardless of whether they're permanent or contractual
  • Companies must be autonomous decision-makers and allow us to function at their worksite
  • Companies must be willing to provide us with a current employee roster

Exclusion Criteria:

  • Employees do not speak English, Hindi, or Marathi

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): NCT01841879


Locations
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India
Healis-Sekhsaria Institute for Public Health
Navi Mumbai, Maharshtra, India
Sponsors and Collaborators
Harvard School of Public Health
National Cancer Institute (NCI)
Healis-Sekhsaria Institute for Public Health
New England Research Institutes
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Glorian Sorensen, PhD, MPH Harvard School of Public Health, Dana-Farber Cancer Institute

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glorian Sorensen, Professor of Society, Human Development, and Health, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01841879     History of Changes
Other Study ID Numbers: R01CA140304 ( U.S. NIH Grant/Contract )
R01CA140304 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017