Mumbai Worksite Tobacco Control Study

NCT ID: NCT01841879

Last Updated: 2017-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Program

Receives the full Healthy, Safe, and Tobacco-Free Worksites intervention

Group Type EXPERIMENTAL

Intervention Program

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Delayed Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Healthy, Safe, and Tobacco-Free Worksites Program

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Healis-Sekhsaria Institute for Public Health

OTHER

Sponsor Role collaborator

Carelon Research

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Glorian Sorensen

Professor of Society, Human Development, and Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Glorian Sorensen, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health, Dana-Farber Cancer Institute

Locations

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Healis-Sekhsaria Institute for Public Health

Navi Mumbai, Maharshtra, India

Site Status

Countries

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India

References

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Sorensen G, Pednekar M, Cordeira LS, Pawar P, Nagler EM, Stoddard AM, Kim HY, Gupta PC. Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial. Tob Control. 2017 Mar;26(2):210-216. doi: 10.1136/tobaccocontrol-2015-052671. Epub 2016 Feb 16.

Reference Type DERIVED
PMID: 26883793 (View on PubMed)

Related Links

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http://www.healis.org

Healis-Sekhsaria Institute for Public Health's website

http://www.community-based-research.org/

The Center for Community-Based Research's website

Other Identifiers

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R01CA140304

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA140304

Identifier Type: NIH

Identifier Source: org_study_id

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