TobaccoNCT02697409
Education Against Tobacco Randomized Trial
A study testing Education Against Tobacco intervention in people with Tobacco and Prevention, run by University of Giessen at 1 site in Germany.
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 7th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco, Prevention, Adolescents
- What is being tested?
- Education Against Tobacco intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Jul 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pupils of 7th grade of regular secondary schools in Germany
Who cannot join
- Not fulfilling the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical-student-delivered Smoking Prevention Program for Secondary Schools: The Education Against Tobacco 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 7th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups.
- Conditions
- Tobacco, Prevention, Adolescents, Schools
- Being tested
- Education Against Tobacco intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Against Tobacco interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group receives two school-based modules taking less than two hours each delivered by medical students in the schools. Receives: Behavioral: Education Against Tobacco 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.
The difference in smoking prevalence at 24 months follow-up is the primary endpoint measured via questionnaires.
Measured: 24 months post baseline
Secondary outcomes (2)
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 24 months follow-up measured via questionnaires.
Measured: 24 months follow-up
Changes in smoking behavior
The changes in smoking behavior (smoking onset, quitting) are studied as a secondary outcome measure.
Measured: 24 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TobaccoStudies 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, Universities of Giessen and Marburg Lung Center
- Responsible party
- Principal investigator, Titus J. Brinker, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697409
- Sponsor's protocol ID
- EATRCT
- Status last verified
- May 2016
- First submitted
- 27 Feb 2016
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical-student-delivered Smoking Prevention Program for Secondary Schools: The Education Against Tobacco Randomized Trial
- ClinicalTrials.gov ID
- NCT02697409
- Acronym / sponsor ID
- EATRCT
- Conditions
- Tobacco, Prevention, Adolescents, Schools
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, Universities of Giessen and Marburg Lung Center
- Study start
- Mar 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 3 Mar 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 7th grade of secondary school. 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 interventionThe intervention group receives two school-based modules taking less than two hours each delivered by medical students in the schools. |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pupils of 7th grade of regular secondary schools in Germany
Key exclusion criteria (1 listed)
- Not fulfilling the 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 intervention | Behavioural | Intervention group |
Primary outcome
Smoking prevalence measured via questionnaire.
Time frame: 24 months post baseline
The difference in smoking prevalence at 24 months follow-up is the primary endpoint measured via questionnaires.
2 secondary outcomes
Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.
Time frame: 24 months follow-up
Changes in smoking behavior
Time frame: 24 months post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Against Tobacco intervention in people with Tobacco and Prevention, run by University of Giessen at 1 site in Germany.
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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 24 months post baseline). 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 5 Jun 2017.