Tobacco Control Among Business Process Outsourcing (BPO) Employees

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00617266
First received: February 4, 2008
Last updated: February 14, 2008
Last verified: February 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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
Active Comparator: Arm 1 Control Group
Distribution of pamphlets containing information on the hazards of tobacco
Other: Tobacco cessation intervention
Distribution of pamphlets containing information on the hazards of tobacco
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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Tata Memorial Hospital:
tobacco, cessation, BPO, RCT, KAP

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014