Effectiveness of the "Smoke-Free Class competition" in delaying the onset of smoking in adolescence: a cluster-randomised controlled trial (Germany)

ISRCTN	ISRCTN27091233
DOI	https://doi.org/10.1186/ISRCTN27091233
Secondary identifying numbers	N/A

Submission date: 11/04/2007
Registration date: 23/04/2007
Last edited: 19/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Reiner Hanewinkel
Scientific

Düsternbrooker Weg 2
Kiel
24105
Germany

Email	hanewinkel@ift-nord.de

Study information

Study design	Prospective, cluster-randomised, controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title
Study objectives	"Smoke-Free Class competition" (SFC) shows a preventive effect on knowledge on smoking, attitudes towards smoking, and smoking behaviour.
Ethics approval(s)	Approved by state administration department of Saxony-Anhalt (Landesverwaltungsamt Sachsen-Anhalt) on the 31st August 2006 (ref: Reg.-Nr. 504-50/06).
Health condition(s) or problem(s) studied	Smoking prevention
Intervention	Since the intervention was planned to take place at the class level, schools were chosen as the unit of randomisation. Experimental schools would provide the SFC, while control schools would provide normal lessons. Intervention - Be Smart Don't Start (the German version of the Smoke-Free Class Competition): Each participating class has to decide if they want to be a Smoke-free Class for a six month period from fall to spring. Classes monitor their (non-)smoking behaviour and report it to the teacher regularly. Classes, in which pupils refrain from smoking for this period of time participate in a prize draw. Control - treatment as usual: Normal lessons.
Intervention type	Other
Primary outcome measure	1. Knowledge on smoking consequences 2. Attitudes towards smoking 3. Intention to use tobacco 4. Smoking status These will be measured at end of treatment, and at 12 and 18 months follow-up.
Secondary outcome measures	1. Class climate 2. Bullying These will be measured at end of treatment, and at 12 and 18 months follow-up.
Overall study start date	15/10/2006
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	11 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	84 schools/206 classes/3,497 students (already recruited)
Key inclusion criteria	1. Students of public schools 2. Age between 11 and 15 (grades 6 to 8) 3. No prior participation at Be Smart Don't Start 4. No shutdown of school planned in near future
Key exclusion criteria	1. Students of schools with special pedagogic needs 2. Students from schools currently conducting structured interventions against substance use 3. Missing parental consent
Date of first enrolment	15/10/2006
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

Germany

Study participating centre

Düsternbrooker Weg 2

Kiel
24105
Germany

Sponsor information

German Cancer Aid (Deutsche Krebshilfe) (Germany)
Charity

Buschstr. 32
Bonn
53113
Germany

Email	ek@krebshilfe.de
Website	http://www.krebshilfe.de/
"ROR"	https://ror.org/01wxdd722

Funders

Funder type

Charity

German Cancer Aid (Deutsche Krebshilfe) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/03/2010	Yes	No
Results article	results	01/04/2012	Yes	No
Results article	results	01/04/2012	Yes	No