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

NCT ID: NCT03579355

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-10

Study Completion Date

2014-04-15

Brief Summary

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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

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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.

Conditions

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Tobacco Use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DFND Program

Intervention Type BEHAVIORAL

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.

Informational Booklet

Fourteen classrooms in four schools represented the No Intervention arm (control). They received only an informational booklet about tobacco adverse health effects.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Students in 7th grade
* Gave verbal assent

Exclusion Criteria

* no assent
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Dania Alagili

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dania E Alagili, DrPH

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

References

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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.

Reference Type DERIVED
PMID: 33605440 (View on PubMed)

Other Identifiers

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554/254/1432/1

Identifier Type: -

Identifier Source: org_study_id

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