Condition category
Mental and Behavioural Disorders
Date applied
21/11/2012
Date assigned
03/12/2012
Last edited
03/12/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cigarette smoking is the biggest preventable cause of illness and death in the UK. Most smokers start smoking when they are still at secondary (high) school. Smokers who start at this early age are less likely to quit and more likely to be affected by smoking-related illness during their lives. It is therefore important to try to prevent children taking up smoking. Following a period of development work we will investigate a smoking prevention package which combines educational resources for use in schools with materials for use with children’s families or caregivers to reinforce the anti-smoking message.

Who can participate?
The trial will include 40 schools in the East Midlands area. Approximately 150 students per school (6000 students in total) will take part in the study.

What does the study involve?
The trial will include 40 schools in the East Midlands area, half of which will receive the smoking prevention package and half of which will not. We will test the effectiveness of a teaching resource called Operation Smoke Storm, developed by Kick It, the Hammersmith and Fulham Stop Smoking Service, in which young people act the role of secret agents working undercover in the tobacco industry. The resource provides information on the health impacts of active and passive smoking along with content not used before in youth smoking prevention in the UK. This includes insights into company tactics, the effect of the tobacco industry on the environment and exploitation of developing country populations. We will trial the use of Operation Smoke Storm with Year 7 students (aged 11-12), along with a booster session when students are in Year 8 (aged 12-13) and additional materials for use with children’s families or caregivers to reinforce the anti-smoking message. The package will be evaluated using data collected from questionnaires and focus groups with students, teachers and family members.

What are the possible benefits and risks of participating?
Students may benefit from a new way of teaching a topic which is already covered in the curriculum, and if our package is more effective than current practice they will benefit if they do not start smoking. We will provide information for any students, teachers or family members who smoke and who express a desire to quit after receiving the educational package.
There are no risks for students, family members or teachers who receive or teach the educational package.

Where is the study run from?
The study will be run by researchers at the University of Nottingham, in collaboration with the Universities of Stirling, York and King’s College London, and Kick It, the Hammersmith and Fulham Stop Smoking Service.

When is the study starting and how long is it expected to run?
We plan to start the study in January 2013 and it will run until approximately July 2016. However, the early part of the project will focus on designing and testing the package in a limited number of schools, with the larger-scale trial due to commence in January 2015.

Who is funding the study?
The study is funded by the National Institute for Health Research’s Public Health programme.

Who is the main contact?
Graeme Docherty
graeme.docherty@nottingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lisa Szatkowski

ORCID ID

Contact details

City Hospital
Epidemiology & Public Health
Clinical Sciences Building
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Development and evaluation of a novel intervention providing insight into the tobacco industry to prevent the uptake of smoking in school-aged children

Acronym

Study hypothesis

To assess whether a multi-component intervention involving education resources for use in schools, alongside family components, is effective and cost-effective in preventing the uptake of smoking in school-aged children.

Ethics approval

University of Nottingham Medical School Research Ethics Committee approval pending

Study design

Cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Tobacco control intervention in schools

Intervention

Schools are randomised 1:1 to delivery of the package (intervention) or to control (no intervention). We aim to recruit 40 schools in the East Midlands, with 20 receiving a package based on Operation Smoke Storm, an educational resource highlighting the manipulative tactics of the tobacco industry. 20 schools will acting as controls (they will be offered the intervention at the end of the trial if its effectiveness is proven).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The proportion of students who are current smokers or susceptible to smoking at the final follow-up point in Year 8 and compare this between those who have and have not received the intervention.

Secondary outcome measures

1. Attitudes to smoking including situational self-efficacy
2. Smoking experimentation and uptake; cessation attempts
3. Smoking in students’ homes
4. Exposure to second hand smoke
5. Perceived acceptability of the intervention
6. Cost-effectiveness

Overall trial start date

02/01/2013

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

For the cluster-randomised controlled trial we aim to recruit 40 schools in the East Midlands, with 20 receiving the intervention and 20 acting as controls (who will be offered the intervention at the end of the trial if its effectiveness is proven).
1. All mainstream secondary schools (both private and non-private) with students in at least Years 7 to 11
2. In Leicestershire many areas have linked middle (aged 10-14) and high schools (14-18) with students progressing automatically from one to the other. In these areas, schools will only be recruited in linked pairs to ensure longer-term follow up of students is possible.
3. All students in Year 7 at the start of the trial will be eligible for inclusion

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Approximately 6000 students in 40 schools (average 150 per school) will be included in the trial.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

02/01/2013

Recruitment end date

31/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

City Hospital
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Mr Paul Cartledge
Research & Graduate Services
King's Meadow campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/fabs/rgs/home.aspx

Funders

Funder type

Government

Funder name

National Institute for Health Research [NIHR] - Public Health Research Programme (UK)

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

Publication citations

Additional files

Editorial Notes