Tobacco Control Among Business Process Outsourcing (BPO) Employees - Full Text View

Sponsored by:	Tata Memorial Hospital
Information provided by:	Tata Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00617266

Purpose

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.

Condition	Intervention	Phase
Tobacco Use Cessation	Other: tobacco cessation intervention Other: Tobacco cessation intervention	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Tobacco Control Among Business Process Outsourcing (BPO) Employees

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The prevalence of tobacco and alcohol addiction among the BPO employees. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
The prevalence of addiction to different forms of tobacco products. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Analysis of the factors responsible for initiation and continuation of tobacco habit. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	August 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1 Control Group: Active Comparator Distribution of pamphlets containing information on the hazards of tobacco	Other: Tobacco cessation intervention Distribution of pamphlets containing information on the hazards of tobacco
Arm 2: Experimental 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 sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
Arm 3: Experimental 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
Arm 4: Experimental 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617266

Contacts

Contact: Gauravi A Mishra, MD

+91-22-24157532

gauravi2005@yahoo.co.in

Locations

India, Maharashtra
Tata Memorial Hospital	Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Gauravi A Mishra, MD +91-22-4157532 gauravi2005@yahoo.co.in
Principal Investigator: Gauravi A Mishra, MD

Sponsors and Collaborators

Tata Memorial Hospital

More Information

No publications provided

Responsible Party:	Tata Memorial Hospital ( Gauravi Ashish Mishra )
Study ID Numbers:	351
Study First Received:	February 4, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00617266 History of Changes
Health Authority:	India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:

tobacco, cessation, BPO, RCT, KAP

ClinicalTrials.gov processed this record on May 07, 2009