- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00973570
Smoking Cessation Program Among Adolescents in Vocational Training Centers (TABADO)
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Laetitia MINARY, MSc
- 이메일: l.minary@chu-nancy.fr
연구 연락처 백업
- 이름: François ALLA, MD/ PhD
- 이메일: f.alla@chu-nancy.fr
연구 장소
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Lorraine
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Nancy, Lorraine, 프랑스, 54000
- 모병
- CHU Nancy
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연락하다:
- Laetitia MINARY, MSc
- 이메일: l.minary@chu-nancy.fr
-
수석 연구원:
- François ALLA, MD/ PhD
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수석 연구원:
- Denis Zmirou-Navier, MD/ PhD
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부수사관:
- Yves MARTINET, MD/ PhD
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연락하다:
- François ALLA, MD/PhD
- 이메일: f.alla@chu-nancy.fr
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: "Intervention" group
The "intervention" group benefits from the TABADO program
|
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).
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간섭 없음: "Control" group
The "control" group not benefit from any specific intervention other than the treatment and education usually available
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
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.
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Overall prevalence of tobacco use in the institutions concerned at 12 months.
기간: 12 months
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12 months
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Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention
기간: 12 months
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12 months
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Rate of withdrawal from the program among the volunteers after 12 months.
기간: 12 months
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12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: François ALLA, MD/ PhD, Institut National de la Santé Et de la Recherche Médicale, France
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- C07-43
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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