Condition category
Mental and Behavioural Disorders
Date applied
11/04/2007
Date assigned
23/04/2007
Last edited
19/10/2012
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

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

http://www.krebshilfe.de/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes