Tobacco Control Among Business Process Outsourcing (BPO) Employees

February 14, 2008 updated by: Tata Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 Control Group
Distribution of pamphlets containing information on the hazards of tobacco
Other: Tobacco cessation intervention
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
Other: Tobacco cessation intervention
Distribution of pamphlets containing information on the hazards of tobacco
Other: Tobacco cessation intervention
Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
Experimental: Arm 2
Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
Other: Tobacco cessation intervention
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
Other: Tobacco cessation intervention
Distribution of pamphlets containing information on the hazards of tobacco
Other: Tobacco cessation intervention
Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
Experimental: Arm 3
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only
Other: tobacco cessation intervention
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only
Experimental: Arm 4
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
Other: Tobacco cessation intervention
Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
Other: Tobacco cessation intervention
Distribution of pamphlets containing information on the hazards of tobacco
Other: Tobacco cessation intervention
Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The prevalence of tobacco and alcohol addiction among the BPO employees.
Time Frame: 10 months
10 months
The prevalence of addiction to different forms of tobacco products.
Time Frame: 10 months
10 months
Analysis of the factors responsible for initiation and continuation of tobacco habit.
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Anticipated)

April 1, 2008

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 15, 2008

Last Update Submitted That Met QC Criteria

February 14, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 351 (IRB Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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