Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai
Comparative Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai : A Randomized Controlled Trial
1 other identifier
interventional
4,000
1 country
1
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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
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
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedDecember 22, 2017
December 1, 2017
5 years
March 2, 2015
December 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees.
To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai
60 months
Other Outcomes (3)
Compliance for availing the services at Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital
60 months
Rate of oral pre-cancers among BEST employees
60 months
Rate of tobacco cessation after one year follow-up
60 months
Study Arms (4)
Tobacco users: Self Help
EXPERIMENTALSelf-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.
Tobacco users:Telephonic counseling
EXPERIMENTALTelephone counseling is a way of providing individual counseling via telephone conversation or telephone hotlines. It can be proactive or reactive.
Tobacco users:Behavioural therapy Only
EXPERIMENTALBehavioural 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.
Tobacco users:Pharmacologic
EXPERIMENTALPharmacotherapy in the form of Nicotine Replacement Therapy based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit.
Interventions
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.
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.
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.
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
Eligibility Criteria
You may qualify if:
- BEST employees in Mumbai
You may not qualify if:
- BEST employees not willing to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tata Memorial Hospital, Parel
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gauravi A Mishra, Assoc Prof
Tata Memorial Hospital, Mumbai
- PRINCIPAL INVESTIGATOR
Sharmila A Pimple, Professor
Tata Memorial Hospital, Mumbai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor & Physician
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 24, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
December 22, 2017
Record last verified: 2017-12