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

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: DFND Program

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.

• Study Type: Interventional
• Enrollment (Actual): 634
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Students in 7th grade
• Gave verbal assent

Exclusion Criteria:

• no assent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DFND Program; "Dentist Fighting Nicotine Dependence, (DFND)" intervention 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. DFND was administered over 5 weeks, at a rate of 2 sessions per week. Each session lasts an hour. Fourteen classrooms in four schools represented the experimental arm and received DFND.	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.
NO_INTERVENTION: Informational Booklet; Fourteen classrooms in four schools represented the No Intervention arm (control). They received only an informational booklet about tobacco adverse health effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Dania E Alagili, DrPH, King Abdulaziz University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2012
• Primary Completion (ACTUAL): March 30, 2012
• Study Completion (ACTUAL): April 15, 2014

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 554/254/1432/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan for sharing IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No