- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04378725
Evaluation of a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan
Evaluation of The KOTAK, a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan, Malaysia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Petaling Jaya
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Kuala Lumpur, Petaling Jaya, Malaysia, 50603
- Faculty of Dentistry, University of Malaya
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Smoker, medically fit and consented (parental) students enrolled in;
- Public funded school
- Daily school
- Non- same gendered schools (co-ed )
- Multiracial school
Exclusion Criteria:
Students who were a smoker enrolled in;
- Private schools
- Boarding school
- Same-gendered school
- Vernacular schools
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: 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. |
|
EXPERIMENTAL: 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.
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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:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported prolonged smoking abstinence for 7 days
Time Frame: 6 month follow-up
|
Prolonged smoking abstinence (self-reported) for 7 days was validated by breath carbon monoxide reading (ppm) and salivary cotinine concentration (ng/ml). The cut-off points for both clinical measure were as follows;
|
6 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Roslan Saub, BDS MDSc PhD, University of Malaya
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DFC01811/0080(P)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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