Efficacy of a web-based computer-tailored smoking prevention intervention for Dutch adolescents

ISRCTN ISRCTN77864351
DOI https://doi.org/10.1186/ISRCTN77864351
Secondary identifying numbers N/A
Submission date
16/07/2012
Registration date
14/09/2012
Last edited
29/10/2015
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

Plain English summary of protocol

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)

Study website

Contact information

Prof Hein de Vries
Scientific

University Maastricht
P.O. Box 616
Maastricht
6200 MD
Netherlands

Email hein.devries@maastrichtuniversity.nl
Dr Sanne de Josselin de Jong
Public

University Maastricht
Department of Health Promotion and Health Education
Maastricht
6200 MD
Netherlands

Email sanne@stivoro.nl

Study information

Study designCluster randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects of a randomized web-based computer-tailored smoking prevention trial for Dutch adolescents: a cluster randomized controlled trial
Study objectivesThe 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(s)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.
Health condition(s) or problem(s) studiedSmoking initiation
InterventionThe 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 typeBehavioural
Primary outcome measureSmoking 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 measuresIntention 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 study start date01/04/2011
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants1940 students
Key inclusion criteriaParticipants in this study were students from high schools in the Netherlands, aged between 12 and 30.
Key exclusion criteriaSelf-reported smoking and previous exposure to the intervention
Date of first enrolment01/04/2011
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (Netherlands)
University/education

P.O. Box 616
Maastricht
6200 MD
Netherlands

Email info@unimaas.nl
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Government

Dutch Ministry of Health, Welfare and Sport (Netherlands)
Government organisation / National government
Alternative name(s)
Dutch Ministry of Health, Welfare and Sport, VWS
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/03/2014 Yes No