Tobacco Control Among Business Process Outsourcing (BPO) Employees

NCT ID: NCT00617266

Last Updated: 2008-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-02-28

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1 Control Group

Distribution of pamphlets containing information on the hazards of tobacco

Group Type: ACTIVE_COMPARATOR

Tobacco cessation intervention

Intervention Type: OTHER

Distribution of pamphlets containing information on the hazards of tobacco

Arm 2

Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees

Group Type: EXPERIMENTAL

Tobacco cessation intervention

Intervention Type: OTHER

Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees

Arm 3

Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only

Group Type: EXPERIMENTAL

tobacco cessation intervention

Intervention Type: OTHER

Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only

Arm 4

Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy

Group Type: EXPERIMENTAL

Tobacco cessation intervention

Intervention Type: OTHER

Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy

Interventions

tobacco cessation intervention

Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only

Intervention Type: OTHER

Tobacco cessation intervention

Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy

Intervention Type: OTHER

Tobacco cessation intervention

Distribution of pamphlets containing information on the hazards of tobacco

Intervention Type: OTHER

Tobacco cessation intervention

Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tata Memorial Hospital

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Gauravi A Mishra, MD

Role: CONTACT

gauravi2005@yahoo.co.in

+91-22-24157532

Facility Contacts

Gauravi A Mishra, MD

Role: primary

gauravi2005@yahoo.co.in

+91-22-4157532

Other Identifiers

351

Identifier Type: -

Identifier Source: org_study_id