Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01275950 |
| Other study ID # |
647 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
June 11, 2010 |
| Last updated |
January 12, 2011 |
| Start date |
May 2010 |
| Est. completion date |
April 2011 |
Study information
| Verified date |
June 2010 |
| Source |
Tata Memorial Hospital |
| Contact |
Sharmila A Pimple, MD |
| Phone |
912224154379 |
| Email |
drsharmilapatil[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
India: Institutional Review Board |
| Study type |
Interventional
|
Clinical 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. 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.
Description:
I. Preparatory Phase
1. 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.
2. 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.
3. 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.
4. 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
1. Enlisting of Tobacco/Tobacco Products Selling Establishments within 100 Yards of an
Educational Institution
2. 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.
A. Pre-Intervention Phase
1. 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.
2. 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.
B. Intervention Phase
1. 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.
C. Post-Intervention Phase
1. 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:
1. The proportion of direct to surrogate advertisements.
2. Compliance of the educational institute with the Tobacco Bill.
3. 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.
