Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai

NCT02397369 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2017-12-22

No results posted yet for this study

Summary

Tobacco use is the single most preventable cause of premature adult death globally. It is one of the major causes of death and disease in India, accounting for nearly 0.9 million deaths every year.

Bombay Electric Supply and Transport (BEST), one of the biggest public transport undertaking in Mumbai City, has imposed a ban on tobacco use in public transport buses and under Motor Vehicle Act has empowered the drivers and bus conductors to take suitable action against commuters found to be using tobacco. However in addition to commuters using tobacco in the BEST premises, large number of bus drivers and conductors are known to use tobacco on the job. There are various approaches to a tobacco cessation programme, like behavioural therapy, pharmacotherapy, providing self help material, telephone counseling, quit lines etc.

Hence in terms of the workplace environment, understanding the factors leading to tobacco use maintenance and the effective approaches for cessation is of critical importance for formulating workplace tobacco prevention and cessation interventions that are applicable to transport work employee settings. The success of these methods needs to be comparatively evaluated among the different forms of tobacco users. Hence, the present study will be undertaken with the following objectives:

Conditions

  • Compliance
  • Tobacco Use Cessation

Interventions

OTHER

Tobacco users: Self Help

This group will be given pictorial material and minimal written materials/ pamphlets describing health hazards of smokeless forms of tobacco and tips on tobacco cessation in general. The material will be interactively tailored to individual tobacco consumption characteristics and they will be followed up after 12 months.

BEHAVIORAL

Tobacco users:Telephonic counseling

This group will be given proactive as well as reactive counseling. Medical social workers will proactively call all participants regularly and offer tobacco cessation counseling. In addition, they will call those participants who have planned their quit dates. Dedicated independent mobile numbers with 12 hours help lines will be made available to the participants to maximise the level of support. It will be scheduled in response to the needs to answer any type of help pertaining to quitting tobacco.

BEHAVIORAL

Tobacco users:Behavioural therapy Only

1. Focus Group discussion: This tobacco cessation intervention session will involve thirty minutes of focus group discussion with group behavioral therapy in groups of 5-10 individuals for reinforcement of tobacco use prevention and cessation advice. Group discussion is intended to improve understanding by exploring, sharing and reflecting psychosocial, familial, environmental issues which attribute to the problem. 2. Individual tobacco cessation counseling sessions: Individual counseling is commonly used to help people who are trying to quit tobacco. The counseling adopting an interactive problem-solving approach will be done by trained Medical Social Workers providing face-to-face sessions for 10-15 minutes per participant.

OTHER

Tobacco users:Pharmacologic

Pharmaco Therapy will consist of: Nicotine Chewing Gums: Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months Side effects: Bad taste, Throat irritation, burning in mouth, nausea, vomiting, hiccups, increased heart beat etc Nicotine Transdermal patches: Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks Side effects: Skin irritation, dizziness, sleep problems, increased heart beat etc

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Gauravi A Mishra, Assoc Prof · Tata Memorial Hospital, Mumbai

  • Sharmila A Pimple, Professor · Tata Memorial Hospital, Mumbai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397369 on ClinicalTrials.gov