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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01275950
First received: June 11, 2010
Last updated: January 12, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention
Assessing and Creating Awareness About the Tobacco Law
Behavioral: Health Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • KAP of tobacco vendors about Tobacco Bill [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • post-intervention KAP [ Time Frame: six months ] [ Designated as safety issue: No ]
    To evaluate the change in the knowledge attitude and practice six months after our planned intervention.


Estimated Enrollment: 480
Study Start Date: May 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: 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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275950

Contacts
Contact: Sharmila A Pimple, MD 912224154379 ext 4631 drsharmilapatil@yahoo.com
Contact: Gauravi A Mishra, MD 912224157532 gauravi2005@yahoo.co.in

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Sharmila A Pimple, MD    912224154379 ext 4631    drsharmilapatil@yahoo.com   
Contact: Gauravi A Mishra, MD    912224157532    gauravi2005@yahoo.co.in   
Principal Investigator: Sharmila A Pimple, MD         
Principal Investigator: Gauravi A Mishra, MD         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Sharmila A Pimple, MD Tata Memorial Hospital
Principal Investigator: Gauravi A Mishra, MD Tata Memorial Hospital
  More Information

No publications provided

Responsible Party: Sharmila Pimple, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT01275950     History of Changes
Other Study ID Numbers: 647
Study First Received: June 11, 2010
Last Updated: January 12, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:
Tobacco vendor
students
knowledge
attitude
practice
direct advertisements
surrogate advertisements

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014