Effectiveness of the "Smoke-Free Class Competition" (SFC) in delaying the onset of smoking in Polish students: a cluster-randomized controlled trial
| ISRCTN | ISRCTN39902015 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39902015 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/12/2007
- Registration date
- 14/01/2008
- Last edited
- 28/05/2008
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Reiner Hanewinkel
Scientific
Scientific
Institute for Therapy and Health Research (IFT- Nord)
Düsternbrooker Weg 2
Kiel
24105
Germany
Study information
| Study design | Prospective, cluster-randomized, controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | 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 study start date | 15/10/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 81 schools / 142 classes / 2,940 students |
| 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 |
Locations
Countries of recruitment
- Germany
- Poland
Study participating centre
Institute for Therapy and Health Research (IFT- Nord)
Kiel
24105
Germany
24105
Germany
Sponsor information
European Commission
Other
Other
DG Health and Consumer Protection
Brussels
1049
Belgium
| Website | http://ec.europa.eu/index_en.htm |
|---|---|
"ROR" |
https://ror.org/00k4n6c32 |
Funders
Funder type
Other
European Commission
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
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 |
