Condition category
Mental and Behavioural Disorders
Date applied
18/12/2007
Date assigned
14/01/2008
Last edited
28/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Reiner Hanewinkel

ORCID ID

Contact details

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

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 10–13 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

http://ec.europa.eu/index_en.htm

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

Publication citations

Additional files

Editorial Notes