Evaluation of QUIT's Break Free smoking cessation intervention for young people

ISRCTN	ISRCTN25181936
DOI	https://doi.org/10.1186/ISRCTN25181936
Protocol serial number	N/A
Sponsor	Cancer Research UK (CRUK) (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: A7201)

Submission date: 11/05/2009
Registration date: 04/06/2009
Last edited: 06/03/2015

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 Wolf Markham
Scientific

School of Health and Social Studies
The University of Warwick
Warwick
CV4 7AL
United Kingdom

Email	wolf.markham@warwick.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster-randomised single-centre controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Evaluation of QUIT's Break Free smoking cessation intervention for young people: a cluster-randomised controlled trial
Study objectives	1. A stop smoking support group, run by the national charity QUIT, will help more young people to stop smoking than getting advice on how to do so on their own 2. The running of a smoking cessation group will have an effect on the whole school smoking prevalence (a population effect)
Ethics approval(s)	London MREC, 09/08/2007, ref: 07/H0718/45
Health condition(s) or problem(s) studied	Smoking prevalence and cessation
Intervention	The intervention will consist of QUIT's Break Free smoking cessation programme for groups of young people. The intervention will occur on the school premises and will be administered by the staff of QUIT. It will take place over 7 weeks with each session lasting approximately 30 - 50 minutes. The control will consist of one-to-one advice given to young people over the same period of time.
Intervention type	Behavioural
Primary outcome measure(s)	Success of quitting smoking four weeks post quit day (the standard used by the NHS). This will be defined as self declared abstinence from smoking on days 21 - 28, confirmed by an exhaled carbon monoxide concentration of less than 10 parts per million.
Key secondary outcome measure(s)	1. Seven-day point prevalence abstinence at four weeks and six months 2. Sustained abstinence at six months, measured according to the Russell Standard 3. Young people's evaluations of the value of the QUIT's Break Free smoking cessation course
Completion date	31/05/2008

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	11 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Pupils (aged 11 - 16 years) of schools who agree to participate in the study will be offered access to either the intervention or control 2. Pupils of participating schools will be judged as competent to make their own decisions as to whether they wish to participate in the programme; no parental consent is required
Key exclusion criteria	1. Schools who only agree to participate if they are offered either the control or intervention will be excluded 2. Pupils of participating school whose parents object to their participation will be excluded from the programme
Date of first enrolment	01/06/2006
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The University of Warwick

Warwick
CV4 7AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol and preliminary results	14/12/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes