Tobacco Smoking BehaviorCBTCPNCT01958255
Community Based Tobacco Cessation Programme Mumbai
A study testing planned intervention for tobacco cessation counseling in people with Tobacco Smoking Behavior, run by Tata Memorial Hospital at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Tobacco Smoking Behavior
- What is being tested?
- planned intervention for tobacco cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteIndia
- Study dates
- May 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all current tobacco users at the time of screening under TMH-MOP project
Who cannot join
- All those who refused to participate and those who could not be contacted during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Smoking Behavior
- Being tested
- planned intervention for tobacco cessation counseling
- Keywords
- tobacco quit rates
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
planned intervention for tobacco cessation counselingBehavioural
game session for rapport building followed by group discussion and tobacco cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| Tobacco cessation counseling | Other | planned intervention for tobacco cessation counseling Receives: Behavioral: planned intervention for tobacco cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess tobacco quit rates
The participant women were intervened thrice for counseling about quitting tobacco and quit rates were assessed at the end of one year
Measured: Baseline and 12 months
Secondary outcomes (2)
To assess pre-intervention knowledge, attitude and practices about tobacco use.
A questionnaire to assess the baseline knowledge, attitude and practices about tobacco use by participant women was filled during first intervention
Measured: baseline
To assess post-intervention knowledge, attitude and practices of tobacco use by participant women.
A questionnaire to assess the baseline knowledge, attitude and practices about tobacco use by participant women was filled during post intervention
Measured: 9 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Smoking BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gauravi Ashish Mishra, Tata Memorial Hospital
- Investigators
- Gauravi A Mishra, M.D.PSM, Principal investigator, Tata Memorial Hospital, Parel, Mumbai,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958255
- Sponsor's protocol ID
- TMHPO912
- Acronym
- CBTCP
- Status last verified
- Apr 2018
- First submitted
- 27 Sep 2013
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Tobacco Cessation Programme
- ClinicalTrials.gov ID
- NCT01958255
- Acronym / sponsor ID
- CBTCP / TMHPO912
- Conditions
- Tobacco Smoking Behavior
- Keywords
- tobacco quit rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobacco cessation counseling | Other | Behavioral: planned intervention for tobacco cessation counselingplanned intervention for tobacco cessation counseling |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all current tobacco users at the time of screening under TMH-MOP project
Key exclusion criteria (1 listed)
- All those who refused to participate and those who could not be contacted during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| planned intervention for tobacco cessation counselinggame session for rapport building followed by group discussion and tobacco cessation counseling | Behavioural | Tobacco cessation counseling |
Primary outcome
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
2 secondary outcomes
To assess pre-intervention knowledge, attitude and practices about tobacco use.
Time frame: baseline
To assess post-intervention knowledge, attitude and practices of tobacco use by participant women.
Time frame: 9 month and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
Related trials for Tobacco Smoking Behavior
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
Physician's Role, Smoking Cessation
Active, not recruitingPhase 4
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
Smoking Cessation
Recruiting
EFFECTIVENESS OF VOLITIONAL HELP SHEETS AS AN ADJUNCT TO TREATMENT TO PROMOTE BEHAVIOR CHANGE: A PILOT STUDY ON SMOKING
Tobacco Dependence
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students in Cairo University
Conversational Agent, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gauravi A Mishra, M.D.PSM principal investigator
Tata Memorial Hospital, Parel, Mumbai,India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing planned intervention for tobacco cessation counseling in people with Tobacco Smoking Behavior, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess tobacco quit rates (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.