Clinical trial NCT00973570: Smoking Cessation Program Among Adolescents in Vocational Training Centers
Official title: Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: tobacco cessation
evaluation
epidémiology
adolescent
apprentices
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: University of Nancy
name: Central Hospital, Nancy, France
First posted: 2009-09-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion criteria:

* All students, males and females, registered in the VTC for at least a 2-year training period
* Aged from 15 to 20 years

Exclusion criteria:

* 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.

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: Overall prevalence of tobacco use in the institutions concerned at 12 months.
timeFrame: 12 months
measure: Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention
timeFrame: 12 months
measure: Rate of withdrawal from the program among the volunteers after 12 months.
timeFrame: 12 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU Nancy
state: Lorraine
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: François ALLA, MD/ PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.