Evaluation of a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan

NCT ID: NCT04378725

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-01-30

Brief Summary

School-based smoking cessation programmes stretched longer than a year had 12% reduction in preventing smoking uptake. With regards to smoking intervention programme among adolescents, there is a lack of evidences regarding its long-term effectiveness. This was due to lack of clear guidelines, methodological issues and the fact that adolescents were likely to be sporadic or non-daily smoker, leading to discrepancies in their self-reported claim. Adolescent's smoking relapse rate was at 47% while those who never smoke have a 13% chance to become smoker. Light and regular smokers have 30% and 75% chance becoming an adult smoker respectively. A review paper in smoking research in Malaysia showed that the provision of anti-smoking education in school was associated with reduced susceptibility in female smoking.Male students perceived printable media, radio and the Internet as effective in delivering anti-smoking messages.School-based smoking cessation programme has been shown to be cost-effective in helping the students to quit smoking both in developed and developing countries.For this reason, it is essential to explore what are the factors that amplify the success rate of smoking cessation effect of the KOTAK programme.

Detailed Description

Through this study the investigators will seek to answer the following questions:

• To determine the quit-smoking rate of the KOTAK programme
• To determine the factors associated with quitting smoking with the KOTAK programme

Important aspects of the KOTAK programme evaluation will involve assessing its impacts on preventing smoking initiation and promoting smoking cessation among the adolescents. This form of assessment is vital in achieving the KOTAK's objectives to reduce the prevalence of smokers in Malaysian schools. An average of 8 hours of training were required for dental officers and dental nurses to deliver the modules in the KOTAK programme. This programme has an important financial implication as it involved almost 4 thousand dental officers and 3 thousand dental nurses to screen almost 4.6 million Malaysian schoolchildren in 2018.

Factors yielding promising results for adolescents to quit smoking are important to be researched. This will provide us with valuable insights from the perspectives of the stakeholders pertaining on areas that needed improvement. Despite the existence of various tobacco-prevention program in public schools, KOTAK is deemed significant as it is a yearly collaboration of School Dental Services with the schools. This study will compare the quit smoking rate between Intervention (with KOTAK Programme) and Control (without KOTAK programme ) schools. The sampling unit was the school.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control School

When a student is screened as a smoker. The student will only be receiving Brief Intervention Advice from the dentist.

Brief Intervention advice: delivered to all schoolchildren regardless of smoking status by the dentist. Brief information of dangers of smoking was embedded in the generic lecture of Dental Health Education given to the whole school in large group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention School

The Intervention schools: Screened smokers were given Advanced Intervention sessions. After discussion with the State's oral health deputy director and district's programme coordinator, for the purpose of this study, the interval of the Advance Intervention session was decided at 1-month interval.

Group Type: EXPERIMENTAL

School-based smoking prevention and cessation program (The KOTAK program)

Intervention Type: BEHAVIORAL

Advance Intervention: Following the screening process, this intervention package was inclusive of group-briefing for the smokers in at least 3 subsequent sessions in one academic year. The content delivered by the dentist were based on the KOTAK guidebook consisted of 8 Modules.The modules were as follows:

1. Introduction: Identifying students who smoke

2. Cigarette and addiction

3. The danger of smoking and passive smokers

4. Advantages of smoke-free lifestyle and adolescent perception on smoking

5. Legal and religious perception of smoking

6. The benefits of smoking cessation

7. Preparation and how to stop smoking

8. Nicotine withdrawal symptom and relapse prevention

The Intervention schools: Screened smokers were given Advanced Intervention sessions. After discussion with the State's oral health deputy director and district's programme coordinator, for the purpose of this study, the interval of the Advance Intervention session was decided at 1-month interval.

Interventions

School-based smoking prevention and cessation program (The KOTAK program)

Advance Intervention: Following the screening process, this intervention package was inclusive of group-briefing for the smokers in at least 3 subsequent sessions in one academic year. The content delivered by the dentist were based on the KOTAK guidebook consisted of 8 Modules.The modules were as follows:

1. Introduction: Identifying students who smoke

2. Cigarette and addiction

3. The danger of smoking and passive smokers

4. Advantages of smoke-free lifestyle and adolescent perception on smoking

5. Legal and religious perception of smoking

6. The benefits of smoking cessation

7. Preparation and how to stop smoking

8. Nicotine withdrawal symptom and relapse prevention

The Intervention schools: Screened smokers were given Advanced Intervention sessions. After discussion with the State's oral health deputy director and district's programme coordinator, for the purpose of this study, the interval of the Advance Intervention session was decided at 1-month interval.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Smoker, medically fit and consented (parental) students enrolled in;

1. Public funded school

2. Daily school

3. Non- same gendered schools (co-ed )

4. Multiracial school

Exclusion Criteria

Students who were a smoker enrolled in;

1. Private schools

2. Boarding school

3. Same-gendered school

4. Vernacular schools

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roslan Saub, BDS MDSc PhD

Role: STUDY_CHAIR

University of Malaya

Locations

Faculty of Dentistry, University of Malaya

Kuala Lumpur, Petaling Jaya, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

DFC01811/0080(P)

Identifier Type: -

Identifier Source: org_study_id