## Protocol Section
### Identification Module
**NCT ID:** NCT01841879

**Brief Title:** Mumbai Worksite Tobacco Control Study

**Official Title:** Mumbai Worksite Tobacco Control Study

#### Organization Study ID Info
**ID:** R01CA140304
**Link:** https://reporter.nih.gov/quickSearch/R01CA140304
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Harvard School of Public Health (HSPH)
#### Secondary ID Infos
**ID:** R01CA140304
**Link:** https://reporter.nih.gov/quickSearch/R01CA140304
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2016-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-17

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2010-06

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2013-04-29
**Type:** ESTIMATED
**Study First Submit Date:** 2013-03-19
**Study First Submit QC Date:** 2013-04-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

**Class:** OTHER

**Name:** Healis-Sekhsaria Institute for Public Health

**Class:** OTHER

**Name:** Carelon Research

**Class:** OTHER

**Name:** Dana-Farber Cancer Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** Harvard School of Public Health (HSPH)

#### Responsible Party

**Investigator Affiliation:** Harvard School of Public Health (HSPH)

**Investigator Full Name:** Glorian Sorensen

**Investigator Title:** Professor of Society, Human Development, and Health

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Tobacco Use Cessation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 6880

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Intervention Program

**Label:** Intervention Program

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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 Names:**

- Behavioral: Delayed Intervention

**Label:** Delayed Intervention Control

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Program

**Description:** 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.

**Name:** Intervention Program

**Other Names:**

- Healthy, Safe, and Tobacco-Free Worksites Program

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Delayed Intervention Control

**Description:** 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.

**Name:** Delayed Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### 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 Module

**Eligibility 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

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Navi Mumbai

**Country:** India

**Facility:** Healis-Sekhsaria Institute for Public Health

**State:** Maharshtra

#### Overall Officials

**Official 1:**

**Affiliation:** Harvard School of Public Health, Dana-Farber Cancer Institute

**Name:** Glorian Sorensen, PhD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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:** 26883793

#### See Also Links

**Label:** Healis-Sekhsaria Institute for Public Health's website

**URL:** http://www.healis.org

**Label:** The Center for Community-Based Research's website

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

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
