NCT00617266

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

Enrollment Period

8 months

First QC Date

February 4, 2008

Last Update Submit

February 14, 2008

Conditions

Keywords

tobacco, cessation, BPO, RCT, KAP

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Secondary Outcomes (3)

  • The prevalence of tobacco and alcohol addiction among the BPO employees.

    10 months

  • The prevalence of addiction to different forms of tobacco products.

    10 months

  • Analysis of the factors responsible for initiation and continuation of tobacco habit.

    10 months

Study Arms (4)

Arm 1 Control Group

ACTIVE COMPARATOR

Distribution of pamphlets containing information on the hazards of tobacco

Other: Tobacco cessation intervention

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

Arm 3

EXPERIMENTAL

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

Other: tobacco cessation intervention

Arm 4

EXPERIMENTAL

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

Other: Tobacco cessation intervention

Interventions

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

Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study participants will be apparently healthy males and females above 18 years of age working in the selected BPO units in Mumbai.

You may not qualify if:

  • There will be no minors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Gauravi A Mishra, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

August 1, 2007

Primary Completion

April 1, 2008

Study Completion

February 1, 2009

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations