Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia

Tobacco Use Clinical Trial

Official title:

Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia: A Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579355
• Other study ID #: 554/254/1432/1
• Status: Completed
• Phase: N/A
• Start date: February 10, 2012
• Est. completion date: April 15, 2014

Study information

• Verified date: June 2018
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: April 15, 2014
• Est. primary completion date: March 30, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

Inclusion Criteria:

• Students in 7th grade

• Gave verbal assent

Exclusion Criteria:

• no assent

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• DFND Program
The DFND program consisted primarily of a 10-session curriculum, each session lasting about an hour. The curriculum was comprehensive and incorporated information about tobacco and its adverse health effects, social influences, and social competence skills.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire]	Questionnaire administered one week and 2 years post-intervention: current use of tobacco	One week and Two years after the completion of the intervention
Secondary	Change from baseline knowledge about tobacco at one week and at 2 years [Questionnaire]	Questionnaire administered at one week and 2 years: true/false statements on tobacco and its health effects	One week and two years after the completion of the intervention
Secondary	Change from baseline in perceived behavioral control at one week and at 2 years [Questionnaire]	Questionnaire administered at one week and 2 years: a series of control beliefs about tobacco use	One week and two years after the completion of the intervention
Secondary	Change from baseline in attitude towards not using tobacco at one week and at two years[Questionnaire]	Questionnaire administered at one week and two years: a series of attitudinal beliefs about tobacco use	One week and two years after the completion of the intervention