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Completed

NCT Number: NCT03579355

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

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.

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Key information

Conditions

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Students in 7th grade
  • Gave verbal assent

Exclusion criteria

  • no assent

Treatment and study plan

DFND Program

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.

Primary outcomes

  1. Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire]

    Time frame: One week and Two years after the completion of the intervention

    Questionnaire administered one week and 2 years post-intervention: current use of tobacco

Secondary outcomes

  1. Change from baseline knowledge about tobacco at one week and at 2 years [Questionnaire]

    Time frame: One week and two years after the completion of the intervention

    Questionnaire administered at one week and 2 years: true/false statements on tobacco and its health effects

  2. Change from baseline in perceived behavioral control at one week and at 2 years [Questionnaire]

    Time frame: One week and two years after the completion of the intervention

    Questionnaire administered at one week and 2 years: a series of control beliefs about tobacco use

  3. Change from baseline in attitude towards not using tobacco at one week and at two years[Questionnaire]

    Time frame: One week and two years after the completion of the intervention

    Questionnaire administered at one week and two years: a series of attitudinal beliefs about tobacco use

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Jul 6, 2018
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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