Effectiveness of the "Smoke-Free Class Competition" (SFC) in delaying the onset of smoking in Polish students: a cluster-randomized controlled trial

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Reiner Hanewinkel
Scientific

Institute for Therapy and Health Research (IFT- Nord)
Düsternbrooker Weg 2
Kiel
24105
Germany

Primary study design	Interventional
Study design	Prospective, cluster-randomized, controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	SFC shows a preventive effect on knowledge, attitudes and smoking behaviour
Ethics approval(s)	Bioethics Commission of the University of Medical Sciences in Poznan, Poland. Date of approval: 15 May 2008 (ref: 511/08)
Health condition(s) or problem(s) studied	Smoking prevention
Intervention	Participating schools will be randomised to the intervention and control groups. Intervention group: "Smoke-Free Class Competition" ("Wspólzawodnictwo Klasa Wolna od Dymu") Control group: Treatment as usual Description of the intervention: 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.
Intervention type	Other
Primary outcome measure(s)	The following will be assessed by questionnaires at the end of intervention and at 12- and 18-month follow-up: 1. Knowledge on smoking consequences 2. Attitudes towards smoking 3. Intention to use tobacco 4. Smoking status
Key secondary outcome measure(s)	The following will be assessed by questionnaires at the end of intervention and at 12- and 18-month follow-up: 1. Class climate 2. Bullying
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	13 Years
Sex	All
Target sample size at registration	2940
Key inclusion criteria	1. Students of public schools 2. Age between 1013 years old (10 year on the beginning of the study, 4th grade) 3. Written consent of parents
Key exclusion criteria	1. Students of schools with special pedagogic needs 2. Missing parental consent
Date of first enrolment	15/10/2007
Date of final enrolment	31/12/2009

Institute for Therapy and Health Research (IFT- Nord)

Kiel
24105
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan