Tobacco UseNCT03579355
Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia
A study testing DFND Program in people with Tobacco Use, run by King Abdulaziz University.
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. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- DFND Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2012to 15 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students in 7th grade
- Gave verbal assent
Who cannot join
- no assent
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use
- Being tested
- DFND Program
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFND ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DFND Program | Experimental | "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. Receives: Behavioral: DFND Program |
| Informational Booklet | No intervention | Fourteen classrooms in four schools represented the No Intervention arm (control). They received only an informational booklet about tobacco adverse health effects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One week and Two years after the completion of the intervention
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: One week and two years after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start10 Feb 2012
- Primary completion30 Mar 2012
- Study completion15 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dania Alagili, King Abdulaziz University
- Investigators
- Dania E Alagili, DrPH, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579355
- Sponsor's protocol ID
- 554/254/1432/1
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for sharing IPD with other researchers.
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.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia: A Controlled Trial.
- ClinicalTrials.gov ID
- NCT03579355
- Acronym / sponsor ID
- 554/254/1432/1
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 10 Feb 2012 (actual)
- Primary completion
- 30 Mar 2012 (actual)
- Study completion
- 15 Apr 2014 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DFND Program | Experimental | Behavioral: 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. |
| Informational Booklet | No intervention | –Fourteen classrooms in four schools represented the No Intervention arm (control). They received only an informational booklet about tobacco adverse health effects. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students in 7th grade
- Gave verbal assent
Key exclusion criteria (1 listed)
- no assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFND ProgramThe 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. | Behavioural | DFND Program |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 33605440Holliday 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.
- Individual participant dataSharing planned: No. There is no plan for sharing IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dania E Alagili, DrPH principal investigator
King Abdulaziz University
Questions about this trial
What is this clinical trial studying?
A study testing DFND Program in people with Tobacco Use, run by King Abdulaziz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.