Tobacco Use CessationPhase 3NCT00617266
Tobacco Control Among Business Process Outsourcing (BPO) Employees
A Phase 3 study testing tobacco cessation intervention in people with Tobacco Use Cessation, run by Tata Memorial Hospital at 1 site in India.
Trial summary
The Business Process Outsourcing BPO industry has been rapidly expanding in India over the last 10 years. There is a concern regarding issues of health and safety that are unique to this new and developing industry. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- tobacco cessation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2007to Feb 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study participants will be apparently healthy males and females above 18 years of age working in the selected BPO units in Mumbai.
Who cannot join
- There will be no minors.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Gauravi A Mishra, MD, +91-22-4157532, gauravi2005@yahoo.co.in
Gauravi A Mishra, MD
About this study
The Business Process Outsourcing BPO industry has been rapidly expanding in India over the last 10 years. There is a concern regarding issues of health and safety that are unique to this new and developing industry. The lack of reliable and relevant information on which to base the response to this concern poses a challenge for safeguarding the health of BPO employees. Elevated stress levels, shift duties, high work targets, lofty income may force many towards addictions to keep them going.
Use of tobacco, which is very common addiction in India, is associated with several health hazards. Anecdotal evidence suggests that smoking and other forms of addictions are at its peak in the BPO industries. We are conducting a research on the tobacco habits among Business Process Outsourcing (BPO) employees to understand the prevalence of different forms of tobacco addiction and the reasons for initiation and continuation of the habit. We will also offer different interventions as a measure of tobacco cessation.
Read the detailed description
This is a four arm randomized controlled trial among Business Process Outsourcing (BPO) employees working in four different BPO units. The trial is undertaken with the objective to explore the prevalence of tobacco use in its various forms along with factors responsible for initiation and continuation of the habit. This trial also aims to study the change in the knowledge, attitudes and practices among BPO employees after intervention with different tobacco cessation strategies.
Four BPO units with work force of approximately 200 employees each, with the management and employees that consent to participate in the study will be selected for the trial. The aim and purpose of the study will be explained and a written informed consent form in English will be offered. The employees who are willing to participate in the trial, will be recruited after signing the informed consent form.
The subjects involved in the research will be expected to answer a few questions about their socio-demographic, occupational, medical, risk factor history and some questions to assess their knowledge, attitude and practice regarding tobacco use. Following this the tobacco users will be offered one of the tobacco cessation interventions to help them quit tobacco.
Regular follow-up visits will be conducted through out the period of the study. The same questionnaire as the pre intervention will be repeated post intervention, ten months later to assess change in their knowledge, attitude and practice regarding tobacco use.
- Conditions
- Tobacco Use Cessation
- Being tested
- tobacco cessation intervention
- Keywords
- tobacco, cessation, BPO, RCT, KAP
- 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.
tobacco cessation interventionOther
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only
Tobacco cessation interventionOther
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
Tobacco cessation interventionOther
Distribution of pamphlets containing information on the hazards of tobacco
Tobacco cessation interventionOther
Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Control Group | Active comparator | Distribution of pamphlets containing information on the hazards of tobacco Receives: Other: Tobacco cessation intervention |
| Arm 2 | Experimental | Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees Receives: Other: Tobacco cessation intervention |
| Arm 3 | Experimental | Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only Receives: Other: tobacco cessation intervention |
| Arm 4 | Experimental | Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy Receives: Other: Tobacco cessation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the post-intervention knowledge, attitudes and practices regarding tobacco addiction and the change as compared with the pre-intervention records by analysing the outcome with respect to different intervention strategies.
Measured: 18 months
Secondary outcomes (3)
The prevalence of tobacco and alcohol addiction among the BPO employees.
Measured: 10 months
The prevalence of addiction to different forms of tobacco products.
Measured: 10 months
Analysis of the factors responsible for initiation and continuation of tobacco habit.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionApr 2008 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617266
- Sponsor's protocol ID
- 351
- Status last verified
- Feb 2008
- First submitted
- 4 Feb 2008
- Last updated
- 15 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Control Among Business Process Outsourcing (BPO) Employees
- ClinicalTrials.gov ID
- NCT00617266
- Acronym / sponsor ID
- 351
- Conditions
- Tobacco Use Cessation
- Keywords
- tobacco, cessation, BPO, RCT, KAP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 15 Feb 2008 (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 Business Process Outsourcing BPO industry has been rapidly expanding in India over the last 10 years. There is a concern regarding issues of health and safety that are unique to this new and developing industry. The lack of reliable and relevant information on which to base the response to this concern poses a challenge for safeguarding the health of BPO employees. Elevated stress levels, shift duties, high work targets, lofty income may force many towards addictions to keep them going.
Use of tobacco, which is very common addiction in India, is associated with several health hazards. Anecdotal evidence suggests that smoking and other forms of addictions are at its peak in the BPO industries. We are conducting a research on the tobacco habits among Business Process Outsourcing (BPO) employees to understand the prevalence of different forms of tobacco addiction and the reasons for initiation and continuation of the habit. We will also offer different interventions as a measure of tobacco cessation.
Detailed description
This is a four arm randomized controlled trial among Business Process Outsourcing (BPO) employees working in four different BPO units. The trial is undertaken with the objective to explore the prevalence of tobacco use in its various forms along with factors responsible for initiation and continuation of the habit. This trial also aims to study the change in the knowledge, attitudes and practices among BPO employees after intervention with different tobacco cessation strategies.
Four BPO units with work force of approximately 200 employees each, with the management and employees that consent to participate in the study will be selected for the trial. The aim and purpose of the study will be explained and a written informed consent form in English will be offered. The employees who are willing to participate in the trial, will be recruited after signing the informed consent form.
The subjects involved in the research will be expected to answer a few questions about their socio-demographic, occupational, medical, risk factor history and some questions to assess their knowledge, attitude and practice regarding tobacco use. Following this the tobacco users will be offered one of the tobacco cessation interventions to help them quit tobacco.
Regular follow-up visits will be conducted through out the period of the study. The same questionnaire as the pre intervention will be repeated post intervention, ten months later to assess change in their knowledge, attitude and practice regarding tobacco use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Control Group | Active comparator | Other: Tobacco cessation interventionDistribution of pamphlets containing information on the hazards of tobacco |
| Arm 2 | Experimental | Other: Tobacco cessation interventionActive Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees |
| Arm 3 | Experimental | Other: tobacco cessation interventionActive Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only |
| Arm 4 | Experimental | Other: Tobacco cessation interventionActive Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study participants will be apparently healthy males and females above 18 years of age working in the selected BPO units in Mumbai.
Key exclusion criteria (1 listed)
- There will be no minors.
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 |
|---|---|---|
| tobacco cessation interventionActive Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only | Other | Arm 3 |
| Tobacco cessation interventionActive Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy | Other | Arm 4 |
| Tobacco cessation interventionDistribution of pamphlets containing information on the hazards of tobacco | Other | Arm 1 Control Group |
| Tobacco cessation interventionActive Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees | Other | Arm 2 |
Primary outcome
To assess the post-intervention knowledge, attitudes and practices regarding tobacco addiction and the change as compared with the pre-intervention records by analysing the outcome with respect to different intervention strategies.
Time frame: 18 months
3 secondary outcomes
The prevalence of tobacco and alcohol addiction among the BPO employees.
Time frame: 10 months
The prevalence of addiction to different forms of tobacco products.
Time frame: 10 months
Analysis of the factors responsible for initiation and continuation of tobacco habit.
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tobacco cessation intervention in people with Tobacco Use Cessation, run by Tata Memorial Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 2008. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gauravi A Mishra, MD (+91-22-24157532, gauravi2005@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the post-intervention knowledge, attitudes and practices regarding tobacco addiction and the change as compared with the pre-intervention records by analysing the outcome with respect to different intervention strategies. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2008.