Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco

NCT03418506 | Completed

• 1 other identifier: IRB-756DUHS/approval/2016/310
• Study Type: interventional
• Target: 1,327
• Locations: 1 country
• Sites: 1

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.

Conditions

Smokeless Tobacco Cessation

Keywords

Smokeless tobacco; adolescent; oral cancer; betal quid; areca nut

Outcome Measures

Primary Outcomes (1)

• Knowledge about hazards of smokeless tobacco

  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.

  6 months

Secondary Outcomes (2)

• Attitude about hazards of smokeless tobacco

  6 months

• Perception about hazards of smokeless tobacco

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

No specific education will be given to the control group.

Interventions

SMOKELESS TOBACCO AWARENESS PROGRAM BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead
• Dow University of Health Sciences: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• Rozi S, Zahid N, Roome T, Lakhdir MPA, Sawani S, Razzak A, Butt ZA. Effectiveness of a School Based Smokeless Tobacco Intervention: A Cluster Randomized Trial. J Community Health. 2019 Dec;44(6):1098-1110. doi: 10.1007/s10900-019-00689-8.

  PMID: 31267293 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zahid Butt, PhD

  British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 1, 2018
• Study Start: April 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)