Plain English Summary
Background and study aims
To reduce tobacco-related disease it is crucial to prevent adolescents from starting smoking. Web-based interventions are suitable for health education and their effectiveness has been demonstrated across a wide range of conditions. They provide tailored feedback based on an individual’s answers to a questionnaire. These messages are more likely to influence the person’s behaviour. The aim of this study is to test a new web-based program called Smoke Alert at schools and to assess its effectiveness for the prevention of smoking uptake among adolescents.
Who can participate?
Students from high schools in the Netherlands, aged between 12 and 30.
What does the study involve?
Schools are randomly allocated into either the experimental group or the control group. The experimental group complete an online questionnaire and receive tailored advice. The control group complete a short questionnaire that measures smoking behaviour and intention to start smoking. Age, gender and educational level are also assessed. The students in the control group do not receive any advice. Assessments are made at the start of the study and after six months.
What are the possible benefits and risks of participating?
Students participating in this study have the opportunity to obtain free personal tailored advice with information on how to refuse a cigarette or how to stop smoking. Students in the control group were offered the chance to take part in the Smoke Alert intervention six months later. This way, all students who are participating are offered the Smoke Alert intervention. There are no risks of participating in this study.
Where is the study run from?
University Maastricht (Netherlands).
When is the study starting and how long is it expected to run for?
April to December 2011.
Who is funding the study?
Dutch Ministry of Health, Welfare and Sport (Netherlands).
Who is the main contact?
Sanne de Josselin de Jong (sanne@stivoro.nl).
Hein de Vries (hein.devries@gvo.unimaas.nl)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Hein de Vries
ORCID ID
Contact details
University Maastricht
P.O. Box 616
Maastricht
6200 MD
Netherlands
-
hein.devries@maastrichtuniversity.nl
Type
Public
Additional contact
Dr Sanne de Josselin de Jong
ORCID ID
Contact details
University Maastricht
Department of Health Promotion and Health Education
Maastricht
6200 MD
Netherlands
-
sanne@stivoro.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of a randomized web-based computer-tailored smoking prevention trial for Dutch adolescents: a cluster randomized controlled trial
Acronym
Study hypothesis
The personalized feedback messages that adolescents receive on their computer screen in the tailored condition result in lower uptake of smoking after six months compared to no feedback messages.
Ethics approval
Based on the guidelines of the local Ethics Committee (no treatment is involved and filling out the questionnaire do not cause mental load), medical ethical approval is not sought. The students, their parents and teachers receive written information on methods. The students voluntary take part in the intervention and they are guaranteed anonymity.
Study design
Cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking initiation
Intervention
The study compares the effect of a web-based tailored smoking prevention intervention with a control condition.
Participants in the experimental condition receive a web-based tailored intervention called 'Smoke Alert', consisting of a questionnaire followed by a tailored advice. The intervention incorporates concepts from several cognitive models. Smoke Alert measures attitude towards smoking and quitting, perceived social influence -consisting of social pressure, social modeling and social norms- and self-efficacy not to smoke. Smoke Alert also tailors to intention to start or quit smoking and actions plans to quit smoking or refuse a cigarette. Other factors that are assessed in the Smoke Alert-questionnaire are age, gender, educational level and level of physical activity.
After filling out the questionnaire, respondents receive personal, automatized feedback. This feedback is provided on each specific determinant and the students' response to specific items is used for this (e.g. a chapter for feedback on action plans with a short advice for each specific action plan).
Participants in the control condition do not receive a tailored advice.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Smoking behaviour - Respondents are asked to select a statement that best described their behaviour. They are categorised as non-smokers if they indicate to have never smoked a puff; to have tried smoking but not anymore or to have stopped smoking.
Baseline assessment and follow-up measurement at six months
Secondary outcome measures
Intention to start smoking. The students are asked to select a statement that best described their situation with options ranging from 'I think I will start smoking within 1 month' (7) to 'I know for sure I won't ever start smoking' (1).
Baseline assessment and follow-up measurement at six months
Overall trial start date
01/04/2011
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants in this study were students from high schools in the Netherlands, aged between 12 and 30.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1940 students
Participant exclusion criteria
Self-reported smoking and previous exposure to the intervention
Recruitment start date
01/04/2011
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
University Maastricht (Netherlands)
Sponsor details
P.O. Box 616
Maastricht
6200 MD
Netherlands
-
info@unimaas.nl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Dutch Ministry of Health, Welfare and Sport (Netherlands)
Alternative name(s)
VWS
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Netherlands
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24657434
Publication citations
-
Results
de Josselin de Jong S, Candel M, Segaar D, Cremers HP, de Vries H, Efficacy of a Web-based computer-tailored smoking prevention intervention for Dutch adolescents: randomized controlled trial., J. Med. Internet Res., 2014, 16, 3, e82, doi: 10.2196/jmir.2469.