NCT01841879

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,880

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 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

Study Start

First participant enrolled

June 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

6.1 years

First QC Date

March 19, 2013

Last Update Submit

April 14, 2017

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

  • Tobacco use cessation

    6-month post intervention

Secondary Outcomes (1)

  • Changes in company tobacco policy

    6-month post intervention

Study Arms (2)

Intervention Program

EXPERIMENTAL

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

Behavioral: Intervention Program

Delayed Intervention Control

OTHER

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

Interventions

Intervention ProgramBEHAVIORAL

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.

Also known as: Healthy, Safe, and Tobacco-Free Worksites Program
Intervention Program
Delayed InterventionBEHAVIORAL

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.

Delayed Intervention Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Employees do not speak English, Hindi, or Marathi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healis-Sekhsaria Institute for Public Health

Navi Mumbai, Maharshtra, India

Location

Related Publications (1)

  • 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.

    PMID: 26883793DERIVED

Related Links

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Glorian Sorensen, PhD, MPH

    Harvard School of Public Health, Dana-Farber Cancer Institute

    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
Professor of Society, Human Development, and Health

Study Record Dates

First Submitted

March 19, 2013

First Posted

April 29, 2013

Study Start

June 1, 2010

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

April 17, 2017

Record last verified: 2017-04

Locations

IN(1)