Clinical trial NCT03579355: Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia
Official title: Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia: A Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 634
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A quasi-experimental, controlled trial design was utilized to evaluate the effectiveness of a school-based tobacco program, "Dentists Fighting Nicotine Dependence (DFND)", to prevent the initiation of tobacco use among middle school students (grades 7-9) in Jeddah, Saudi Arabia.

Eight middle schools were selected from the regional education registry; four allocated to treatment arm (n=379) and four to control arm (n=255). The treatment arm received the new tobacco prevention program (DFND) whereas the control arm received only the regular tobacco prevention program administered by the Department of Education. DFND was delivered by trained health educators over 5 weeks, two sessions per week.
Primary purpose: PREVENTION

Brief summary: This study evaluated a school-based tobacco program, "Dentists Fighting Nicotine Dependence (DFND)", to prevent the initiation of tobacco use among middle school students in Saudi Arabia using a social competences/social influence approaches.

Detailed description: A quasi-experimental controlled trial design was utilized. Eight middle schools were selected from the regional education registry; four allocated to treatment arm and four to control arm.

A total of 28 seventh grade classes were included in the study; 14 served as treatment and 14 as control arms. All students present in these classes on the initial visit were invited to take part in the study \[Treatment=379; Control=255\].

The treatment arm received the new tobacco prevention program (DFND) whereas the control arm received only the regular tobacco prevention program administered by the Department of Education. DFND was delivered by trained health educators over 5 weeks, two sessions per week. Two follow up surveys were administered; at one week and at two years post-intervention. Study outcomes were current tobacco use, knowledge about tobacco, attitude toward not using tobacco, and perceived behavioral control (PBC) of tobacco use. Covariates included sex, parent education, academic performance, absenteeism, student allowance, and religiosity.

Eligibility criteria: Inclusion Criteria:

* Students in 7th grade
* Gave verbal assent

Exclusion Criteria:

* no assent

Primary outcomes:
measure: Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire]
timeFrame: One week and Two years after the completion of the intervention
Secondary outcomes:
measure: Change from baseline knowledge about tobacco at one week and at 2 years [Questionnaire]
timeFrame: One week and two years after the completion of the intervention
measure: Change from baseline in perceived behavioral control at one week and at 2 years [Questionnaire]
timeFrame: One week and two years after the completion of the intervention
measure: Change from baseline in attitude towards not using tobacco at one week and at two years[Questionnaire]
timeFrame: One week and two years after the completion of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: King Abdulaziz University
name: Dania E Alagili, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.