Tobacco PreventionNCT02731547
Education Against Tobacco Randomized Trial in Bosnia and Herzegovina
A study testing Education Against Tobacco School-Based Intervention in people with Tobacco Prevention and Tobacco, run by University of Giessen.
Trial summary
A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary schools in Bosnia and Herzegovina. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Prevention, Tobacco, Schools
- What is being tested?
- Education Against Tobacco School-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2018
- 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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Visiting grades 7-9 of regular secondary schools in Bosnia and Herzegovina.
Who cannot join
- Not fulfilling inclusion criteria.
About this study
Official title: Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Bosnia and Herzegovina - Randomized Trial
A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the change in smoking prevalence between the two groups.
- Conditions
- Tobacco Prevention, Tobacco, Schools
- Being tested
- Education Against Tobacco School-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Against Tobacco School-Based InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group receives a school-based module taking about two hours delivered by medical students in the schools. Receives: Behavioral: Education Against Tobacco School-Based Intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking prevalence measured via questionnaire.
Measured: 12 months follow-up
Secondary outcomes (3)
Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline
Measured: Baseline and 12 months
Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline
Measured: Baseline and 12 months
Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.
Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco PreventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dhaka
- Responsible party
- Principal investigator, Titus J. Brinker, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731547
- Sponsor's protocol ID
- RCTBosnia
- Status last verified
- Apr 2016
- First submitted
- 3 Apr 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Bosnia and Herzegovina - Randomized Trial
- ClinicalTrials.gov ID
- NCT02731547
- Acronym / sponsor ID
- RCTBosnia
- Conditions
- Tobacco Prevention, Tobacco, Schools
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- University of Dhaka
- Study start
- May 2016
- Primary completion
- Jun 2018 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- 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.
A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the change in smoking prevalence between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Education Against Tobacco School-Based InterventionThe intervention group receives a school-based module taking about two hours delivered by medical students in the schools. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Visiting grades 7-9 of regular secondary schools in Bosnia and Herzegovina.
Key exclusion criteria (1 listed)
- Not fulfilling inclusion criteria.
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 |
|---|---|---|
| Education Against Tobacco School-Based Intervention | Behavioural | Intervention group |
Primary outcome
Smoking prevalence measured via questionnaire.
Time frame: 12 months follow-up
3 secondary outcomes
Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline
Time frame: Baseline and 12 months
Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline
Time frame: Baseline and 12 months
Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Education Against Tobacco School-Based Intervention in people with Tobacco Prevention and Tobacco, run by University of Giessen.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Apr 2016. 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?
Results are not available in the source record.
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?
Smoking prevalence measured via questionnaire. (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2016.