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Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco

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ClinicalTrials.gov Identifier: NCT03418506
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Dow University of Health Sciences
Information provided by (Responsible Party):
Shafquat Rozi, Aga Khan University

Brief Summary:
Oral cancer is a serious and growing problem in many parts of the globe. Oral cancer is the eighth most common cancer worldwide.The annual estimated incidence is around 275,000 for oral and 130,300 for pharyngeal cancers excluding nasopharynx, two-thirds of these cases occurring in developing countries. In Pakistan, it is the second most common cancer in women and third most common cancer in men. The Age Standardized Rates (ASR) for oral cancers are 13.8 and 14.1 in males and females respectively.To the best of investigators knowledge, no intervention study has been done to improve knowledge and awareness of adults regarding association of areca nut/betel quid with oral cancer. Therefore, the study aims to implement a cluster randomized intervention trial in secondary schools to improve the knowledge and awareness regarding this association among children 11-16 years. For resource poor countries such as Pakistan, it is imperative to prevent oral cancer by improving knowledge about its important risk factor such as betel quid, areca nut and chew tobacco. A school-based intervention study will be carried out in secondary schools in Karachi. The target population will be male and female school students in school grades 6 to 10 with intervention group and control group at each site. School-based educational intervention will be given to the intervention group while no specific education will be given to the control group. Differences in attitudes, knowledge and behaviors between the intervention and control groups will be compared each site separately before and after the intervention. The minimum sample size required was 22 schools (clusters). The number of subjects in each arm will be 529 with average cluster size of 50. The selected schools will be randomly assigned to a control group or Interventions group. Randomization will be done at the school level to avoid contamination between groups.The health education programme will be conducted for 3 consecutive weeks in one academic year for all the selected schools.

Condition or disease Intervention/treatment Phase
Smokeless Tobacco Cessation Behavioral: SMOKELESS TOBACCO AWARENESS PROGRAM Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Knowledge and Awareness Regarding Association of Arecanut/Betel Quid and With Oral Cancer and Other Serious Illnesses Among Children 11-16 Years; A Cluster Randomized Intervention Study
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : November 30, 2017


Arm Intervention/treatment
Experimental: Intervention
A SMOKELESS TOBACCO AWARENESS PROGRAM was conducted for 2 consecutive weeks in all the selected schools. The intervention programme comprised of health education sessions that emphasized on the hazard of betel quid, areca-nut and smokeless tobacco. The sessions included 30 minutes power point presentation, posters, one pictorial booklets on the hazards of use of various tobacco products. Moreover we played a 30 minutes game show at follow-up visit. After completion of 2 weeks intervention programme, the same group of students completed the post-test questionnaire. Educational materials about hazards of betel quid, areca-nut and smokeless tobacco were distributed to both intervention and control groups.
Behavioral: SMOKELESS TOBACCO AWARENESS PROGRAM
A SMOKELESS TOBACCO AWARENESS PROGRAM was conducted for 2 consecutive weeks in all the selected schools. The intervention programme comprised of health education sessions that emphasized on the hazard of betel quid, areca-nut and smokeless tobacco. The sessions included 30 minutes power point presentation, posters, one pictorial booklets on the hazards of use of various tobacco products. Moreover we played a 30 minutes game show at follow-up visit. After completion of 2 weeks intervention programme, the same group of students completed the post-test questionnaire. Educational materials about hazards of betel quid, areca-nut and smokeless tobacco were distributed to both intervention and control groups.

No Intervention: Control
No specific education will be given to the control group.



Primary Outcome Measures :
  1. Knowledge about hazards of smokeless tobacco [ Time Frame: 6 months ]
    Knowledge about hazards of smokeless tobacco will be measured by a validated questionnaire from male and female school students studying in grades 6 to 10.


Secondary Outcome Measures :
  1. Attitude about hazards of smokeless tobacco [ Time Frame: 6 months ]
    Attitude about hazards of smokeless tobacco will be measured by a validated questionnaire from male and female school students studying in grades 6 to 10.

  2. Perception about hazards of smokeless tobacco [ Time Frame: 6 months ]
    Perception about hazards of smokeless tobacco will be measured by a validated questionnaire from male and female school students studying in grades 6 to 10.



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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria for cluster/school

    • High schools registered with Board of Secondary Education Karachi
    • The schools should have at least 15 students in each grade.
    • School authorities grant permission to conduct the research study in their school.

Inclusion criteria (For individual)

  • Both Male/ female students from grades 6-10.
  • Resident of selected areas where the schools are located for at least one year.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418506


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Dow University of Health Sciences
Investigators
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Study Director: Zahid Butt, PhD British Columbia

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Responsible Party: Shafquat Rozi, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03418506     History of Changes
Other Study ID Numbers: IRB-756DUHS/approval/2016/310
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It will depend on the requirement of the journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shafquat Rozi, Aga Khan University:
Smokeless tobacco
adolescent
oral cancer
betal quid
areca nut

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