Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
SFC shows a preventive effect on knowledge, attitudes and smoking behaviour
Ethics approval
Bioethics Commission of the University of Medical Sciences in Poznan, Poland. Date of approval: 15 May 2008 (ref: 511/08)
Study design
Prospective, cluster-randomized, controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
15/10/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
81 schools / 142 classes / 2,940 students
Participant exclusion criteria
1. Students of schools with special pedagogic needs
2. Missing parental consent
Recruitment start date
15/10/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Poland
Trial participating centre
Institute for Therapy and Health Research (IFT- Nord)
Kiel
24105
Germany
Sponsor information
Organisation
European Commission
Sponsor details
DG Health and Consumer Protection
Brussels
1049
Belgium
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
European Commission
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Belgium
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary