Interventional Study to Determine the Effectiveness of Medium Intensity Verses Low Intensity Tobacco Use Prevention and Cessation Intervention in the Unorganized Sector of Zari Workers in Mumbai
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Tobacco Quit Rate
Study Overview
Brief Summary
Zari workers in Mumbai city will be assessed for tobacco consumption habit. They will be divided into 3 arms as - 1) First arm will get Medium intensity tobacco cessation intervention 2) Second arm will get low intensity tobacco cessation intervention 3) Control arm. At the end of 12 months of intervention quit rates will be compared.
Detailed Description
Aims and Objectives
Broad objective:
The proposed study is planned to understand prevalence and practices related to tobacco use among workers of the informal sector of Zari Industry and to assess the feasibility and acceptability of effective strategies of a programmatic approach towards tobacco use prevention and cessation intervention model in this by assessment of pre and post-intervention knowledge, attitude and perception of tobacco use, followed by offering education and cessation and finally assessing the impact and outcomes by changes in the attitudes towards tobacco use and quit rates among tobacco users.
Specific objectives:
Primary Objectives:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who are willing to participate
- •All workers employed in each of the listed zari units.
- •Who are willing to give informed consent.
Exclusion Criteria
- •Who are NOT willing to give informed consent.
Arms & Interventions
Control
No active intervention will be given for tobacco cessation.
Medium Intervention
Tobacco Cessation Counseling : Medium intervention in the form of 3 contact sessions will be given for tobacco cessation.
Intervention: Tobacco Cessation Counseling (Behavioral)
Low intensity intervention
Tobacco Cessation Counseling: Only a single contact session will be done for tobacco cessation.
Intervention: Tobacco Cessation Counseling (Behavioral)
Outcomes
Primary Outcomes
Tobacco Quit Rate
Time Frame: 12 Months
Tobacco quit rates in moderate intensity behavioural intervention, low intensity behavioral intervention and control group will be compared at the end of 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Sharmila Pimple
Professor in Preventive Oncology
Tata Memorial Hospital