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Tobacco Control Among Business Process Outsourcing (BPO) Employees

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ClinicalTrials.gov Identifier: NCT00617266
Recruitment Status : Unknown
Verified February 2008 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 15, 2008
Last Update Posted : February 15, 2008
Sponsor:
Information provided by:
Tata Memorial Hospital

Tracking Information
First Submitted Date  ICMJE February 4, 2008
First Posted Date  ICMJE February 15, 2008
Last Update Posted Date February 15, 2008
Study Start Date  ICMJE August 2007
Estimated Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2008)
  • The prevalence of tobacco and alcohol addiction among the BPO employees. [ Time Frame: 10 months ]
  • The prevalence of addiction to different forms of tobacco products. [ Time Frame: 10 months ]
  • Analysis of the factors responsible for initiation and continuation of tobacco habit. [ Time Frame: 10 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tobacco Control Among Business Process Outsourcing (BPO) Employees
Official Title  ICMJE Tobacco Control Among Business Process Outsourcing (BPO) Employees
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tobacco Use Cessation
Intervention  ICMJE
  • Other: tobacco cessation intervention
    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 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
Study Arms  ICMJE
  • Active Comparator: Arm 1 Control Group
    Distribution of pamphlets containing information on the hazards of tobacco
    Intervention: Other: Tobacco cessation intervention
  • Experimental: Arm 2
    Active Health Education sessions (harmful effects of tobacco addiction) followed by focus group discussion for all BPO employees
    Intervention: Other: Tobacco cessation intervention
  • Experimental: Arm 3
    Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural Therapy only
    Intervention: Other: tobacco cessation intervention
  • Experimental: Arm 4
    Active Health Education and Tobacco Cessation Programme for tobacco users using Behavioural and Pharmaco-therapy
    Intervention: Other: Tobacco cessation intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 14, 2008)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2009
Estimated Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00617266
Other Study ID Numbers  ICMJE 351
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gauravi Ashish Mishra, Tata Memorial Hospital
Study Sponsor  ICMJE Tata Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tata Memorial Hospital
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP