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Clinical Trials/NCT01275950
NCT01275950UnknownNot Applicable

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

Tata Memorial Hospital2 sites in 1 country480 target enrollmentStarted: May 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
480
Locations
2
Primary Endpoint
KAP of tobacco vendors about Tobacco Bill

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Students outside the 18-25 yrs age group

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • post-intervention KAP(six months)

Investigators

Sponsor Class
Other Gov

Study Sites (2)

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