Tobacco Control Among Business Process Outsourcing (BPO) Employees

Tobacco Use Cessation Clinical Trial

Official title:

Tobacco Control Among Business Process Outsourcing (BPO) Employees

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00617266
• Other study ID #: 351
• Status: Unknown status
• Phase: Phase 3
• First received: February 4, 2008
• Last updated: February 14, 2008
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2008
• Source: Tata Memorial Hospital
• Contact: Gauravi A Mishra, MD
• Phone: +91-22-24157532
• Email: gauravi2005[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 800
• Est. completion date: February 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The study participants will be apparently healthy males and females above 18 years of age working in the selected BPO units in Mumbai.

Exclusion Criteria:

• There will be no minors.

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Other:
• tobacco cessation intervention
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only
• Tobacco cessation intervention
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
• Tobacco cessation intervention
Distribution of pamphlets containing information on the hazards of tobacco
• Tobacco cessation intervention
Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		18 months
Secondary	The prevalence of tobacco and alcohol addiction among the BPO employees.		10 months
Secondary	The prevalence of addiction to different forms of tobacco products.		10 months
Secondary	Analysis of the factors responsible for initiation and continuation of tobacco habit.		10 months