Assessing and Creating Awareness About the Tobacco LawNCT01275950
A Study to Evaluate the Impact of Direct and Surrogate Advertising and Compliance With the Bill With the Respect to Sale of Tobacco Products Around Educational Institutes
A study testing Health Education in people with Assessing and Creating Awareness About the Tobacco Law, run by Tata Memorial Hospital at 1 site in India.
Trial summary
The Project aims at enlisting the outlets selling tobacco in any form and enlisting the tobacco based advertisements (Direct and Surrogate) directed towards the community, within 100 yards of the selected educational institutes and studying their impact on the students of that institute. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assessing and Creating Awareness About the Tobacco Law
- What is being tested?
- Health Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 480 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to Apr 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Shop owners of the outlets selling tobacco/ tobacco based products, the outlets lying within 100 yards radius of the selected educational institute.
- Students in the age- group of 18-25 years from within the selected educational institute.
Who cannot join
- Students outside the 18-25 yrs age group
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Sharmila A Pimple, MD, 912224154379 ext. 4631, drsharmilapatil@yahoo.com
Gauravi A Mishra, MD, 912224157532, gauravi2005@yahoo.co.in
About this study
Official title: An Intervention Study To Evaluate The Impact Of Direct and Surrogate Advertising And Compliance With The Bill With The Respect To Sale Of Tobacco Products Around Educational Institutes
The Project aims at enlisting the outlets selling tobacco in any form and enlisting the tobacco based advertisements (Direct and Surrogate) directed towards the community, within 100 yards of the selected educational institutes and studying their impact on the students of that institute. This will further be followed by an intervention program directed at the outlet owners which entails creating awareness about the harmful effects of tobacco and the existing bill and thereby assessing any change in Knowledge, Attitude and Practice. The results thus obtained will facilitate implementation of the existing Bill.
Read the detailed description
- Preparatory Phase
- Selection of Four Educational Institutions for Intervention by Randomized Stratified Sampling Method. Mumbai is divided into four zones as being South Mumbai, North Mumbai, East Mumbai and West Mumbai. We shall enumerate all the institutions in these areas and by randomized stratified sampling we shall select one institution from every area resulting in selection of four educational institutions.
- Recruitment and Training of Staff This involves the recruitment of project personnel and their training. Training would involve the theoretical and practical teaching about health hazards and legal aspects of tobacco use, collecting information by introducing questionnaire, conducting survey, method of area mapping of 100 yards around the educational institution. They would also be trained in identifying establishments selling tobacco based products, identifying direct and indirect tobacco based advertisements.
- Preparation of Resource Materials and Questionnaire Formats Resource materials to educate the shop owners would be prepared. Questionnaires would be designed to asses the pre and post intervention knowledge of shop owners regarding harmful effects of tobacco and the anti-tobacco bill. A questionnaire to assess the impact of tobacco based advertisements on them would also be designed.
- Sector wise mapping Mapping of 100 yards of area around the selected education institutions will be conducted by social workers and health care workers.
II. Activity Phase
- Enlisting of Tobacco/Tobacco Products Selling Establishments within 100 Yards of an Educational Institution
- Enlisting of Advertisements (direct or indirect) Within 100 yards of an Educational Institution The above two activities will be conducted by social workers and healthcare workers. They would survey 100 yards around the selected institution for area mapping and enlisting the hoardings or any other form of advertisements of tobacco or tobacco based products and shops where these products are sold.
- Pre-Intervention Phase
- Observation of compliance with the law. This would involve observation of compliance with the law with respect to presence of signage at the shops as per the current regulations.
- Awareness Assessment. Assess awareness of shopkeepers (selling tobacco or tobacco based products) about the harmful effects of tobacco and anti-tobacco law regarding sale of tobacco products.
Here a questionnaire would be administered to the shopkeepers to assess their KAP regarding harmful effects of tobacco and tobacco based products and the law.
- Intervention Phase
- Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the shop-owners.
- Administering the questionnaire to objectively asses the impact of direct/ surrogate tobacco advertisements influencing student behavior and perception about tobacco and tobacco products.
- Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the students through interactive sessions with students in their respective educational institute.
- Post-Intervention Phase
- Administering the questionnaire to objectively asses the impact of intervention programme on the shop owners of tobacco and tobacco products selling outlets.
III. Evaluation Phase
Outcome measures:
- The proportion of direct to surrogate advertisements.
- Compliance of the educational institute with the Tobacco Bill.
- The proportion of surrogate advertisements which could be recalled with the original tobacco brand, by the students of the selected educational institute.
Pre-assessment and post-assessment of the impact of the intervention programme on the enlisted shop-owners regarding the knowledge, attitude and practices regarding tobacco sale.
- Being tested
- Health Education
- Keywords
- Tobacco vendor, students, knowledge, attitude, practice, direct advertisements, surrogate advertisements
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
- Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the shop-owners.
- Administering the questionnaire to objectively asses the impact of direct/ surrogate tobacco advertisements influencing student behavior and perception about tobacco and tobacco products.
- Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the students through interactive sessions with students in their respective educational institute.
What is being measured
The primary outcome is the main question the study is designed to answer.
KAP of tobacco vendors about Tobacco Bill
The primary outcome is assessment of the Knowledge, Attitude and Practice of shop owners towards tobacco ill-effects and the existing Bill and to determine the impact of our intervention on their knowledge regarding the same. Evaluation of the impact these outlets and the advertisements on the students of the selected educational institutes.
Measured: one year
Secondary outcomes (1)
post-intervention KAP
To evaluate the change in the knowledge attitude and practice six months after our planned intervention.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessing and Creating Awareness About the Tobacco LawStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Sharmila A Pimple, MD, Principal investigator, Tata Memorial HospitalGauravi A Mishra, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275950
- Sponsor's protocol ID
- 647
- Status last verified
- Jun 2010
- First submitted
- 11 Jun 2010
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study To Evaluate The Impact Of Direct and Surrogate Advertising And Compliance With The Bill With The Respect To Sale Of Tobacco Products Around Educational Institutes
- ClinicalTrials.gov ID
- NCT01275950
- Acronym / sponsor ID
- 647
- Keywords
- Tobacco vendor, students, knowledge, attitude, practice, direct advertisements, surrogate advertisements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- May 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 13 Jan 2011 (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 Project aims at enlisting the outlets selling tobacco in any form and enlisting the tobacco based advertisements (Direct and Surrogate) directed towards the community, within 100 yards of the selected educational institutes and studying their impact on the students of that institute. This will further be followed by an intervention program directed at the outlet owners which entails creating awareness about the harmful effects of tobacco and the existing bill and thereby assessing any change in Knowledge, Attitude and Practice. The results thus obtained will facilitate implementation of the existing Bill.
Detailed description
- Preparatory Phase
- Selection of Four Educational Institutions for Intervention by Randomized Stratified Sampling Method. Mumbai is divided into four zones as being South Mumbai, North Mumbai, East Mumbai and West Mumbai. We shall enumerate all the institutions in these areas and by randomized stratified sampling we shall select one institution from every area resulting in selection of four educational institutions.
- Recruitment and Training of Staff This involves the recruitment of project personnel and their training. Training would involve the theoretical and practical teaching about health hazards and legal aspects of tobacco use, collecting information by introducing questionnaire, conducting survey, method of area mapping of 100 yards around the educational institution. They would also be trained in identifying establishments selling tobacco based products, identifying direct and indirect tobacco based advertisements.
- Preparation of Resource Materials and Questionnaire Formats Resource materials to educate the shop owners would be prepared. Questionnaires would be designed to asses the pre and post intervention knowledge of shop owners regarding harmful effects of tobacco and the anti-tobacco bill. A questionnaire to assess the impact of tobacco based advertisements on them would also be designed.
- Sector wise mapping Mapping of 100 yards of area around the selected education institutions will be conducted by social workers and health care workers.
II. Activity Phase
- Enlisting of Tobacco/Tobacco Products Selling Establishments within 100 Yards of an Educational Institution
- Enlisting of Advertisements (direct or indirect) Within 100 yards of an Educational Institution The above two activities will be conducted by social workers and healthcare workers. They would survey 100 yards around the selected institution for area mapping and enlisting the hoardings or any other form of advertisements of tobacco or tobacco based products and shops where these products are sold.
- Pre-Intervention Phase
- Observation of compliance with the law. This would involve observation of compliance with the law with respect to presence of signage at the shops as per the current regulations.
- Awareness Assessment. Assess awareness of shopkeepers (selling tobacco or tobacco based products) about the harmful effects of tobacco and anti-tobacco law regarding sale of tobacco products.
Here a questionnaire would be administered to the shopkeepers to assess their KAP regarding harmful effects of tobacco and tobacco based products and the law.
- Intervention Phase
- Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the shop-owners.
- Administering the questionnaire to objectively asses the impact of direct/ surrogate tobacco advertisements influencing student behavior and perception about tobacco and tobacco products.
- Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the students through interactive sessions with students in their respective educational institute.
- Post-Intervention Phase
- Administering the questionnaire to objectively asses the impact of intervention programme on the shop owners of tobacco and tobacco products selling outlets.
III. Evaluation Phase
Outcome measures:
- The proportion of direct to surrogate advertisements.
- Compliance of the educational institute with the Tobacco Bill.
- The proportion of surrogate advertisements which could be recalled with the original tobacco brand, by the students of the selected educational institute.
Pre-assessment and post-assessment of the impact of the intervention programme on the enlisted shop-owners regarding the knowledge, attitude and practices regarding tobacco sale.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Shop owners of the outlets selling tobacco/ tobacco based products, the outlets lying within 100 yards radius of the selected educational institute.
- Students in the age- group of 18-25 years from within the selected educational institute.
Key exclusion criteria (1 listed)
- Students outside the 18-25 yrs age group
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 |
|---|---|---|
| Health Education1. Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the shop-owners. 2. Administering the questionnaire to objectively asses the impact of direct/ surrogate tobacco advertisements influencing student behavior and perception about tobacco and tobacco products. 3. Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the students through interactive sessions with students in their respective educational institute. | Behavioural | – |
Primary outcome
KAP of tobacco vendors about Tobacco Bill
Time frame: one year
The primary outcome is assessment of the Knowledge, Attitude and Practice of shop owners towards tobacco ill-effects and the existing Bill and to determine the impact of our intervention on their knowledge regarding the same. Evaluation of the impact these outlets and the advertisements on the students of the selected educational institutes.
1 secondary outcome
post-intervention KAP
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
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.
Sharmila A Pimple, MD principal investigator
Tata Memorial Hospital
Gauravi A Mishra, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education in people with Assessing and Creating Awareness About the Tobacco Law, 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 2 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: status not confirmed, as of the sponsor's last update on 13 Jan 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharmila A Pimple, MD (912224154379 ext. 4631, drsharmilapatil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KAP of tobacco vendors about Tobacco Bill (time frame: one year). 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 13 Jan 2011.