- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958255
Community Based Tobacco Cessation Programme Mumbai (CBTCP)
April 27, 2018 updated by: Gauravi Ashish Mishra, Tata Memorial Hospital
Community Based Tobacco Cessation Programme
The aim of this project was to provide tobacco cessation services to the women at the community level at their door steps and thus establish a model community based tobacco cessation programme which could be replicated in other communities and could be taken up by National Tobacco Control Programme (NTCP), in future.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was extended over a period of one year.
There were 3 interventions given at the interval of 3 months each.
The post intervention questionnaire regarding knowledge, attitude and practices was planned filled at the end of the programme i.e. 9th to 12th month from start of the programme.
A community based tobacco cessation programme, which has the potential of being first of its kind, for women, was planned by the department of Preventive Oncology for the women in a geographical community in and around Mankhurd in Mumbai,for providing tobacco cessation counseling services.
Doorstep services were provided to these women as they were unlikely to avail the tobacco cessation services at the clinic in TMH since their priority is managing household chores and caretaking of their family.
The selected community was a part of women cancer screening programme namely; Tata Memorial Hospital Mobile Outreach Programme (TMH-MOP).
The women who were current tobacco users at the time of screening under TMH-MOP were enrolled for this study.The women were intervened thrice at an interval of 3 months each and tobacco cessation counseling was provided at each intervention.
The post intervention data was collected at the end of all the 3 counseling sessions.
Sessions were held for rapport building with the participant women.
Questionnaire were filled to record the information on the details of different forms of tobacco usage, factors responsible for initiation and continuation of tobacco use, pre-intervention and post-intervention knowledge, attitudes and practices regarding tobacco habits and severity of tobacco use (Fagerstroms scale).
This programme was aimed at creating awareness and educating women regarding the health hazards of tobacco use, at the community level, at their door step.
Study Type
Interventional
Enrollment (Actual)
279
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400012
- Tata Memorial Hospital, Parel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
all current tobacco users at the time of screening under TMH-MOP project
Exclusion Criteria:
All those who refused to participate and those who could not be contacted during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Tobacco cessation counseling
planned intervention for tobacco cessation counseling
|
game session for rapport building followed by group discussion and tobacco cessation counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess tobacco quit rates
Time Frame: Baseline and 12 months
|
The participant women were intervened thrice for counseling about quitting tobacco and quit rates were assessed at the end of one year
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess pre-intervention knowledge, attitude and practices about tobacco use.
Time Frame: baseline
|
A questionnaire to assess the baseline knowledge, attitude and practices about tobacco use by participant women was filled during first intervention
|
baseline
|
To assess post-intervention knowledge, attitude and practices of tobacco use by participant women.
Time Frame: 9 month and 12 month
|
A questionnaire to assess the baseline knowledge, attitude and practices about tobacco use by participant women was filled during post intervention
|
9 month and 12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gauravi A Mishra, M.D.PSM, Tata Memorial Hospital, Parel, Mumbai,India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
September 27, 2013
First Submitted That Met QC Criteria
October 8, 2013
First Posted (Estimate)
October 9, 2013
Study Record Updates
Last Update Posted (Actual)
May 1, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TMHPO912
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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