Condition category
Mental and Behavioural Disorders
Date applied
11/05/2009
Date assigned
04/06/2009
Last edited
06/03/2015
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 Wolf Markham

ORCID ID

Contact details

School of Health and Social Studies
The University of Warwick
Warwick
CV4 7AL
United Kingdom
-
wolf.markham@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of QUIT's Break Free smoking cessation intervention for young people: a cluster-randomised controlled trial

Acronym

Study hypothesis

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

London MREC, 09/08/2007, ref: 07/H0718/45

Study design

Cluster-randomised single-centre controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2006

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

200 (100 intervention/100 control)

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

31/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Warwick
Warwick
CV4 7AL
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
London
WC2A 3PX
United Kingdom

Sponsor type

Charity

Website

http://www.cancerresearchuk.org

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: A7201)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2010 protocol and preliminary results in: http://www.ncbi.nlm.nih.gov/pubmed/21156068

Publication citations

Additional files

Editorial Notes