Contact information
Type
Scientific
Primary contact
Dr Reiner Hanewinkel
ORCID ID
Contact details
Düsternbrooker Weg 2
Kiel
24105
Germany
hanewinkel@ift-nord.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
"Smoke-Free Class competition" (SFC) shows a preventive effect on knowledge on smoking, attitudes towards smoking, and smoking behaviour.
Ethics approval
Approved by state administration department of Saxony-Anhalt (Landesverwaltungsamt Sachsen-Anhalt) on the 31st August 2006 (ref: Reg.-Nr. 504-50/06).
Study design
Prospective, cluster-randomised, controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
15/10/2006
Overall trial end date
01/03/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
84 schools/206 classes/3,497 students (already recruited)
Participant 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
Recruitment start date
15/10/2006
Recruitment end date
01/03/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Düsternbrooker Weg 2
Kiel
24105
Germany
Sponsor information
Organisation
German Cancer Aid (Deutsche Krebshilfe) (Germany)
Sponsor details
Buschstr. 32
Bonn
53113
Germany
ek@krebshilfe.de
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
German Cancer Aid (Deutsche Krebshilfe) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21071561
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/19767320
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21071561
Publication citations
-
Results
Isensee B, Morgenstern M, Stoolmiller M, Maruska K, Sargent JD, Hanewinkel R, Effects of Smokefree Class Competition 1 year after the end of intervention: a cluster randomised controlled trial., J Epidemiol Community Health, 2012, 66, 4, 334-341, doi: 10.1136/jech.2009.107490.
-
Results
Hanewinkel R, Isensee B, Maruska K, Sargent JD, Morgenstern M, Denormalising smoking in the classroom: does it cause bullying?, J Epidemiol Community Health, 2010, 64, 3, 202-208, doi: 10.1136/jech.2009.089185.
-
Results
Isensee B, Morgenstern M, Stoolmiller M, Maruska K, Sargent JD, Hanewinkel R, Effects of Smokefree Class Competition 1 year after the end of intervention: a cluster randomised controlled trial., J Epidemiol Community Health, 2012, 66, 4, 334-341, doi: 10.1136/jech.2009.107490.