Tobacco UseTABADONCT00973570
Smoking Cessation Program Among Adolescents in Vocational Training Centers
A study testing TABADO program in people with Tobacco Use, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed… Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- TABADO program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Jan 2010
- 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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All students, males and females, registered in the VTC for at least a 2-year training period
- Aged from 15 to 20 years
Who cannot join
- Subjects with current serious psychiatric disorders or who may be susceptible to decompensation upon quitting smoking (major depression)
- Smokers who are involved in an ongoing attempt to quit, with medical monitoring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers
Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed by a team of tobacco addiction specialist physicians. We developed a study to evaluate the efficacy of the program. Its main objective is to compare the efficacy of a smoking cessation program offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control population. The objective of this paper is to present the TABADO study protocol and the results of the pilot study.
Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months.
The pilot study is a descriptive monocentric cross-sectional study conducted among the whole group of students, completed by a longitudinal prospective study of smoker volunteers.
- Conditions
- Tobacco Use
- Being tested
- TABADO program
- Keywords
- tobacco cessation, evaluation, epidémiology, adolescent, apprentices
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TABADO programBehavioural
The intervention takes place in 3 stages: (i) a general information session on tobacco consumption is delivered to all teenagers, both smokers and nonsmokers. (ii) For smokers wishing to join the program, this session is followed by individualized consultations with a team of tobacco addiction physicians. (iii) The volunteers then benefit from a small group approach, consisting of discussion sessions to share experiences, strengthen motivation, and prevent relapse. There will be 4 sessions in total, comprising individual counseling and work in groups spread over 3 months (taking into account the availability of the trainees because of their alternate-week training schedule).
| Study group | Role | What they receive |
|---|---|---|
| "Intervention" group | Experimental | The "intervention" group benefits from the TABADO program Receives: Behavioral: TABADO program |
| "Control" group | No intervention | The "control" group not benefit from any specific intervention other than the treatment and education usually available |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the rate of smoking abstinence after 12 months, measured on the basis of the statements of the whole sample, not only among volunteers.
Measured: 12 months
Secondary outcomes (3)
Overall prevalence of tobacco use in the institutions concerned at 12 months.
Measured: 12 months
Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention
Measured: 12 months
Rate of withdrawal from the program among the volunteers after 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionJan 2010
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.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- University of Nancy, Central Hospital, Nancy, France
- Responsible party
- Sponsor
- Investigators
- François ALLA, MD/ PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973570
- Sponsor's protocol ID
- C07-43
- Acronym
- TABADO
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Minary L, Martini H, Wirth N, Thouvenot F, Acouetey DS, Martinet Y, Bohadana A, Zmirou-Navier D, Alla F. TABADO: "evaluation of a smoking cessation program among adolescents in vocational training centers": study protocol. BMC Public Health. 2009 Nov 13;9:411. doi: 10.1186/1471-2458-9-411.
PubMed 19912627
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers
- ClinicalTrials.gov ID
- NCT00973570
- Acronym / sponsor ID
- TABADO / C07-43
- Conditions
- Tobacco Use
- Keywords
- tobacco cessation, evaluation, epidémiology, adolescent, apprentices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- University of Nancy, Central Hospital, Nancy, France
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Sep 2009 (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.
Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed by a team of tobacco addiction specialist physicians. We developed a study to evaluate the efficacy of the program. Its main objective is to compare the efficacy of a smoking cessation program offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control population. The objective of this paper is to present the TABADO study protocol and the results of the pilot study.
Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months.
The pilot study is a descriptive monocentric cross-sectional study conducted among the whole group of students, completed by a longitudinal prospective study of smoker volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Intervention" group | Experimental | Behavioral: TABADO programThe "intervention" group benefits from the TABADO program |
| "Control" group | No intervention | –The "control" group not benefit from any specific intervention other than the treatment and education usually available |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All students, males and females, registered in the VTC for at least a 2-year training period
- Aged from 15 to 20 years
Key exclusion criteria (2 listed)
- Subjects with current serious psychiatric disorders or who may be susceptible to decompensation upon quitting smoking (major depression)
- Smokers who are involved in an ongoing attempt to quit, with medical monitoring.
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 |
|---|---|---|
| TABADO programThe intervention takes place in 3 stages: (i) a general information session on tobacco consumption is delivered to all teenagers, both smokers and nonsmokers. (ii) For smokers wishing to join the program, this session is followed by individualized consultations with a team of tobacco addiction physicians. (iii) The volunteers then benefit from a small group approach, consisting of discussion sessions to share experiences, strengthen motivation, and prevent relapse. There will be 4 sessions in total, comprising individual counseling and work in groups spread over 3 months (taking into account the availability of the trainees because of their alternate-week training schedule). | Behavioural | "Intervention" group |
Primary outcome
The primary outcome is the rate of smoking abstinence after 12 months, measured on the basis of the statements of the whole sample, not only among volunteers.
Time frame: 12 months
3 secondary outcomes
Overall prevalence of tobacco use in the institutions concerned at 12 months.
Time frame: 12 months
Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention
Time frame: 12 months
Rate of withdrawal from the program among the volunteers after 12 months.
Time frame: 12 months
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 28 Mar 2025.
- Results publication: PubMed 19912627Minary L, Martini H, Wirth N, Thouvenot F, Acouetey DS, Martinet Y, Bohadana A, Zmirou-Navier D, Alla F. TABADO: "evaluation of a smoking cessation program among adolescents in vocational training centers": study protocol. BMC Public Health. 2009 Nov 13;9:411. doi: 10.1186/1471-2458-9-411.
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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.
François ALLA, MD/ PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TABADO program in people with Tobacco Use, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 2 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 28 Mar 2025. 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 France. 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?
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?
The primary outcome is the rate of smoking abstinence after 12 months, measured on the basis of the statements of the whole sample, not only among volunteers. (time frame: 12 months). 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 NCT00973570, 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 28 Mar 2025.