Mumbai Worksite Tobacco Control Study

Tobacco Use Cessation Clinical Trial

Official title:

Mumbai Worksite Tobacco Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841879
• Other study ID #: R01CA140304
• Secondary ID: R01CA140304
• Status: Completed
• Phase: N/A
• First received: March 19, 2013
• Last updated: April 14, 2017
• Start date: June 2010
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2017
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6880
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

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.
• 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.

Locations

Country	Name	City	State
India	Healis-Sekhsaria Institute for Public Health	Navi Mumbai	Maharshtra

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health	Dana-Farber Cancer Institute, Healis-Sekhsaria Institute for Public Health, National Cancer Institute (NCI), New England Research Institutes

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use cessation		6-month post intervention
Secondary	Changes in company tobacco policy		6-month post intervention

External Links

•   Healis-Sekhsaria Institute for Public Health's website
•   The Center for Community-Based Research's website