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

NCT ID: NCT01275950

Last Updated: 2011-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Assessing and Creating Awareness About the Tobacco Law

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Health Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tata Memorial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tata Memorial Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sharmila A Pimple, MD

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital

Gauravi A Mishra, MD

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sharmila A Pimple, MD

Role: CONTACT

912224154379 ext. 4631

Gauravi A Mishra, MD

Role: CONTACT

912224157532

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sharmila A Pimple, MD

Role: primary

912224154379 ext. 4631

Gauravi A Mishra, MD

Role: backup

912224157532

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

647

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Promoting Smoking Cessation in Campus
NCT05777005 RECRUITING NA