A cluster randomised controlled trial for evaluating a comprehensive smoking prevention intervention in students aged 13 - 14 years old

A cluster randomised controlled trial for evaluating a comprehensive smoking prevention intervention for students aged 13 - 14 years old: a check of the School Smoke-free Policy and Peer Education program at school and attendance to the "Smoking Prevention Track" at the "Prevention Place" of the Italian League Against Cancer (LILT) in Reggio Emilia, Italy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10561880

Enrollment

3500

Registered

2009-07-31

Start date

2008-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking prevention Mental and Behavioural Disorders Mental and behavioural disorders due to use of tobacco

Interventions

Eighteen participating secondary schools located in the province of Reggio Emilia, Italy, have been paired according to the type of secondary school (technical school

high school) and the size of the school (number of students attending the first class in the 2008 - 2009 school-year). In four pairs the pre-intervention survey has been conducted in the period Decem

the second follow-up survey in October - November 2010. The other five pairs of schools will be carried out the pre-intervention survey in December 2009 - January 2010. The intervention will be deliv

20 minutes of laboratory trials for separating different smoking substances (tar, particulate matters, nicotine, ca

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Students aged 13 - 14 years old attending the first class of 16 - 18 secondary schools (for students aged 14 - 18 years old) in the province of Reggio Emilia (about 513,000 inhabitants), Italy.

Exclusion criteria

Exclusion criteria: Students attending the first class of participating schools with documented psychological or cognitive problems. Students have to fill in a detailed questionnaire on smoking before and after the intervention.

Design outcomes

Primary

Measure	Time frame
1. Lifetime cigarette use 2. Current cigarette use (past 30 days) 3. Frequent use of cigarettes (20 or more days of cigarette smoking in past 30 days) 4. Lifetime use of greater than or equal to 100 cigarettes Primary outcome measures will be adjusted for recorded confounders (smoking prevalence in parents, siblings and friends; exposure to second-hand smoke at home and in cars; exposure to pro-tobacco and anti-tobacco advertisements; socio-economic level of the family). Timepoints: Before (first wave: December 2008 - January 2009; second wave: December 2009 - January 2010) and after the school intervention program: First wave first follow up: October - November 2009; first wave second follow-up: October - November 2010 Second wave first follow up: October - November 2010; second wave second follow-up: October - November 2011	—

Measure

Time frame

1. Lifetime cigarette use 2. Current cigarette use (past 30 days) 3. Frequent use of cigarettes (20 or more days of cigarette smoking in past 30 days) 4. Lifetime use of greater than or equal to 100 cigarettes Primary outcome measures will be adjusted for recorded confounders (smoking prevalence in parents, siblings and friends; exposure to second-hand smoke at home and in cars; exposure to pro-tobacco and anti-tobacco advertisements; socio-economic level of the family). Timepoints: Before (first wave: December 2008 - January 2009; second wave: December 2009 - January 2010) and after the school intervention program: First wave first follow up: October - November 2009; first wave second follow-up: October - November 2010 Second wave first follow up: October - November 2010; second wave second follow-up: October - November 2011

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Secondary

Measure	Time frame
Changes on attitudes and beliefs on tobacco smoking and on tobacco industry conduct: 1. Perceived health consequences from smoking (Do you think people addicted to nicotine smoke at least 20 cigarettes per day? Do you think that breathing passive smoking is dangerous for your health?) 2. Intent to use cigarettes in the near future (Do you think you will smoke a cigarette during the next year?) 3. Beliefs about using if a friend offers a cigarette (If one of your best friends offered you a cigarette, would you smoke it?) 4. Perceived social norm (In your opinion, how many adolescents smoke, in percentage?) 5. Perceived social acceptability of smoking (Do you think people who smoke cigarettes have more friends? Do you think smoking cigarettes makes young people look cool or fit in?) 6. Anti-tobacco industry norms (Do you think that tobacco companies try to get people addicted to cigarettes? Do you think tobacco companies would stop selling cigarettes if they know for sure that smoking hurts people?) Secondary outcome measures will be adjusted for recorded confounders (smoking prevalence in parents, siblings and friends; exposure to second-hand smoke at home and in cars; exposure to pro-tobacco and anti-tobacco advertisements; socio-economic level of the family). Timepoints: Before (first wave: December 2008 - January 2009; second wave: December 2009 - January 2010) and after the school intervention program: First wave first follow up: October - November 2009; first wave second follow-up: October - November 2010 Second wave first follow up: October - November 2010; second wave second follow-up: October - November 2011	—

Measure

Time frame

Changes on attitudes and beliefs on tobacco smoking and on tobacco industry conduct: 1. Perceived health consequences from smoking (Do you think people addicted to nicotine smoke at least 20 cigarettes per day? Do you think that breathing passive smoking is dangerous for your health?) 2. Intent to use cigarettes in the near future (Do you think you will smoke a cigarette during the next year?) 3. Beliefs about using if a friend offers a cigarette (If one of your best friends offered you a cigarette, would you smoke it?) 4. Perceived social norm (In your opinion, how many adolescents smoke, in percentage?) 5. Perceived social acceptability of smoking (Do you think people who smoke cigarettes have more friends? Do you think smoking cigarettes makes young people look cool or fit in?) 6. Anti-tobacco industry norms (Do you think that tobacco companies try to get people addicted to cigarettes? Do you think tobacco companies would stop selling cigarettes if they know for sure that smoking hurts people?) Secondary outcome measures will be adjusted for recorded confounders (smoking prevalence in parents, siblings and friends; exposure to second-hand smoke at home and in cars; exposure to pro-tobacco and anti-tobacco advertisements; socio-economic level of the family). Timepoints: Before (first wave: December 2008 - January 2009; second wave: December 2009 - January 2010) and after the school intervention program: First wave first follow up: October - November 2009; first wave second follow-up: October - November 2010 Second wave first follow up: October - November 2010; second wave second follow-up: October - November 2011

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026