Overview

This trial is active, not recruiting.

Condition tobacco use cessation
Treatments intervention program, delayed intervention
Sponsor Harvard School of Public Health
Collaborator National Cancer Institute (NCI)
Start date June 2010
End date July 2016
Trial size 6880 participants
Trial identifier NCT01841879, R01 CA140304, R01CA140304

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Receives the full Healthy, Safe, and Tobacco-Free Worksites intervention
intervention program Healthy, Safe, and Tobacco-Free Worksites 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)
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
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 Outcomes

Measure
Tobacco use cessation
time frame: 6-month post intervention

Secondary Outcomes

Measure
Changes in company tobacco policy
time frame: 6-month post intervention

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Mumbai Worksite Tobacco Control Study
Principal investigator Glorian Sorensen, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Harvard School of Public Health.