Tobacco Use CessationNCT01841879
Mumbai Worksite Tobacco Control Study
A study testing Intervention Program and Delayed Intervention in people with Tobacco Use Cessation, run by Harvard School of Public Health (HSPH) at 1 site in India.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Intervention Program and Delayed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,880 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Employees do not speak English, Hindi, or Marathi
Trial locations and contacts
1 site in 1 country.
India1 site
Healis-Sekhsaria Institute for Public Health
Navi Mumbai, Maharshtra
About this study
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.
Read the 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
- Tobacco Use Cessation
- Being tested
- Intervention Program, Delayed Intervention
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ProgramBehavioural
Also called 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.
Delayed InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Program | Experimental | Receives the full Healthy, Safe, and Tobacco-Free Worksites intervention Receives: 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. Receives: Behavioral: Delayed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco use cessation
Measured: 6-month post intervention
Secondary outcomes (1)
Changes in company tobacco policy
Measured: 6-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startJun 2010
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Healis-Sekhsaria Institute for Public Health, Carelon Research, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Glorian Sorensen, Harvard School of Public Health (HSPH)
- Investigators
- Glorian Sorensen, PhD, MPH, Principal investigator, Harvard School of Public Health, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841879
- Sponsor's protocol ID
- R01CA140304
- Other IDs
- R01CA140304
- Status last verified
- Apr 2017
- First submitted
- 19 Mar 2013
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26883793
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mumbai Worksite Tobacco Control Study
- ClinicalTrials.gov ID
- NCT01841879
- Acronym / sponsor ID
- R01CA140304
- Conditions
- Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,880 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Healis-Sekhsaria Institute for Public Health, Carelon Research, Dana-Farber Cancer Institute
- Study start
- Jun 2010
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Program | Experimental | Behavioral: Intervention ProgramReceives the full Healthy, Safe, and Tobacco-Free Worksites intervention |
| Delayed Intervention Control | Other | Behavioral: Delayed InterventionReceives 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Employees do not speak English, Hindi, or Marathi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ProgramAlso: Healthy, Safe, and Tobacco-Free Worksites ProgramReceives 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. | Behavioural | Intervention Program |
| Delayed InterventionReceives 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. | Behavioural | Delayed Intervention Control |
Primary outcome
Tobacco use cessation
Time frame: 6-month post intervention
1 secondary outcome
Changes in company tobacco policy
Time frame: 6-month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Derived from this study: PubMed 26883793Sorensen 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.
- Healis-Sekhsaria Institute for Public Health's websiteLink provided by the sponsor.
- The Center for Community-Based Research's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glorian Sorensen, PhD, MPH principal investigator
Harvard School of Public Health, Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Program and Delayed Intervention in people with Tobacco Use Cessation, run by Harvard School of Public Health (HSPH) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco use cessation (time frame: 6-month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01841879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.