Evaluation of QUIT's Break Free smoking cessation intervention for young people
| ISRCTN | ISRCTN25181936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25181936 |
| Secondary identifying numbers | N/A |
- 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
Scientific
School of Health and Social Studies
The University of Warwick
Warwick
CV4 7AL
United Kingdom
| wolf.markham@warwick.ac.uk |
Study information
| Study design | Cluster-randomised single-centre controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2006 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 200 (100 intervention/100 control) |
| 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
- England
- United Kingdom
Study participating centre
The University of Warwick
Warwick
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
London
WC2A 3PX
United Kingdom
| Website | http://www.cancerresearchuk.org |
|---|---|
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: A7201)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol and preliminary results | 14/12/2010 | Yes | No |
