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

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ClinicalTrials.gov Identifier: NCT02397369
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Gauravi Ashish Mishra, Tata Memorial Hospital

Study Description
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Brief 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:


Condition or disease Intervention/treatment Phase
Compliance Tobacco Use Cessation Other: Tobacco users: Self Help Behavioral: Tobacco users:Telephonic counseling Behavioral: Tobacco users:Behavioural therapy Only Other: Tobacco users:Pharmacologic Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparative Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai : A Randomized Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Tobacco users: Self Help
Self-help intervention is defined as any manual or programme to be used by individuals to assist a quit attempt not aided by counsellors or group support.They include written materials on the health effects of tobacco, audio-or video tape or computer programmes.
 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.
Other Name: Self help
Experimental: Tobacco users:Telephonic counseling
Telephone counseling is a way of providing individual counseling via telephone conversation or telephone hotlines. It can be proactive or reactive.
 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.
Other Name: Telephonic
Experimental: Tobacco users:Behavioural therapy Only
Behavioural therapy includes multiple sessions of Focus Group Discussion (FGD) and individual tobacco cessation counseling sessions. The participants in this group will be given advice to quit tobacco via multisession formal cognitive-behavioural therapy as per the Tobacco Cessation Clinic (TCC) guidelines.
 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.
Experimental: Tobacco users:Pharmacologic
Pharmacotherapy in the form of Nicotine Replacement Therapy based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit.
 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

Other Name: Drug


Outcome Measures
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Primary Outcome Measures :
  1. Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees. [ Time Frame: 60 months ]
    To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai


Other Outcome Measures:
  1. Compliance for availing the services at Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital [ Time Frame: 60 months ]
    randomly assign the BEST employees using tobacco to one of the four tobacco cessation interventions and study the compliance to the same.

  2. Rate of oral pre-cancers among BEST employees [ Time Frame: 60 months ]
    To assesses rate of precancer among BEST employees

  3. Rate of tobacco cessation after one year follow-up [ Time Frame: 60 months ]
    . To determine the rate of tobacco cessation after twelve months of follow-up.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BEST employees in Mumbai

Exclusion Criteria:

  • BEST employees not willing to give consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397369


Contacts
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Contact: Gauravi A Mishra, Assoc Prof +912224177000 ext 4634 gauravi2005@yahoo.co.in
Contact: Sharmila A Pimple, Professor +912224154379 drsharmilapatil@yahoo.com

Locations
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India
Tata Memorial Hospital, Parel Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Gauravi A Mishra, M.D. PSM    +9102224177000 ext 4634    gauravi2005@yahoo.co.in   
Principal Investigator: Gauravi A Mishra, M.D.PSM         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
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Principal Investigator: Gauravi A Mishra, Assoc Prof Tata Memorial Hospital, Mumbai
Principal Investigator: Sharmila A Pimple, Professor Tata Memorial Hospital, Mumbai
More Information
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Responsible Party: Gauravi Ashish Mishra, Associate Professor & Physician, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02397369     History of Changes
Other Study ID Numbers: TMHPOBEST2015
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Keywords provided by Gauravi Ashish Mishra, Tata Memorial Hospital:
Education and evaluate post intervention KAP
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action