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Smoking cessation intervention among university students in Sweden. A study of the effectiveness of a text messaging (short message service [SMS]) based stop smoking application
ISRCTN ISRCTN96350682
DOI 10.1186/ISRCTN96350682
ClinicalTrials.gov identifier
EudraCT number
Public title Smoking cessation intervention among university students in Sweden. A study of the effectiveness of a text messaging (short message service [SMS]) based stop smoking application
Scientific title Effectiveness of a text messaging (SMS) smoking cessation intervention among university students in Sweden: a pilot randomized controlled trial
Acronym NEXit (Nicotine EXit) 2.0 study
Serial number at source 1
Study hypothesis The study aims to develop a SMS-based stop smoking application, and to undertake a pilot randomized controlled trial (RCT) study to prepare for the evaluation of the effectiveness of such a program in a future main trial. The pilot trial is undertaken with smokers who are students at the University of Luleå in Sweden. The study will randomise smokers willing to participate to an intervention group or a waiting list group that will have access to the intervention after 15 weeks. The primary hypothesis is that a greater proportion of the intervention group will have stopped smoking during the follow-up time than the waiting list group.
Lay summary Background and study aims
Smoking is responsible for more than 60 diseases and globally is the most important preventable cause of ill health and death. So far most public health smoking efforts targeted at young people have been focused on prevention of initiation of smoking, whereas smoking cessation programmes have been targeted at the adult population. There are not many proven effective smoking cessation interventions targeting young people.
The stop-smoking-program NEXit, “Nicotine exit”, is an 8-12 week smoking cessation intervention based on phone text messages (SMS). The messages incorporate elements from initiatives that have worked, official manuals on smoking cessation, other literature and guidance from smoking cessation experts.

Who can participate?
Eligible participants are all students that are daily or occasional smokers.

What does the study involve?
The students will receive invitation to participate in the study by e-mail. Students who are daily or occasional smokers and who consent to participate are then randomly allocated to an intervention group which will have access to the stop-smoking-program immediately or to a control group that will have access to the intervention after 15 weeks (after follow-up for research purposes).

What are the possible benefits and risks of participating?
The possible benefits are support to stop smoking. There are no known side effects.

Where is the study run from?
The study is carried out by researchers at Linköping University, Sweden, using students from one university, Luleå Technical University in the northern part of Sweden.

When is the study starting and how long is it expected to run for?
The study will start in January 2014 and will end in June 2014.

Who is funding the study?
The study is funded by The Swedish Research Council.

Who is the main contact?
Professor Preben Bendtsen
preben.bendtsen@liu.se
Ethics approval Ethics Committee in Linköping, 04/03/2013, ref: 2013/406-31.
Study design Randomized controlled trial
Countries of recruitment Sweden
Disease/condition/study domain Tobacco smoking
Participants - inclusion criteria All students who are daily or occasional smokers at Luleå University will be invited to participate via an e-mail, aged 18-65
Participants - exclusion criteria Non-smokers
Anticipated start date 20/01/2014
Anticipated end date 15/06/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a participant information sheet
Target number of participants 8000
Interventions After randomisation and signing on, the intervention starts with a motivational phase of between 1 to 4 weeks, when the participants are given the opportunity to set a quit date. In this first phase the participants receive two SMS of motivating messages with information relevant for quitting, i.e. symptoms to expect on quitting, in other words biofeedback messages about what happens in the body after a quit attempt, tips to avoid weight gain, tips to cope with cravings, avoiding smoking triggers, motivational support, and how to distract one’s mind from smoking. Once a week during this first phase the participants will be asked if they are ready to decide a quit date, and if doing so then pass into a second phase with dedicated messages five times a day during the three days immediately before the quit date in order to prepare the smokers for quitting smoking. The quit dates are to be set within 1-4 weeks after having signed up. After setting a quit date the core interventions run for 8 weeks. The participants are able to restart the intervention and discontinue the intervention at any time.
Primary outcome measure(s) 1. Self-reported prolonged smoking abstinence of 8 weeks (defined as having not smoked more than five cigarettes)
2. Self-reported point prevalence of smoking abstinence (not having smoked a single cigarette) in the previous 4 weeks
Secondary outcome measure(s) 1. Self-reported 7-days point prevalence smoking abstinence (defined as not smoking any cigarettes in the past 7 days)
2. Number of quit attempts during the 15 weeks after the invitation to participate
3. Use of other smoking cessation services (medication, counselling, calling help line etc) during the 15 weeks after the invitation to participate
Sources of funding Swedish Research Council (Sweden), grant number 2012-39665-92722-49
Trial website http://www.nexit.nu
Publications
Contact name Prof  Preben  Bendtsen
  Address Institutionen för Medicin och Hälsa
Linköpings Universitet
  City/town Linköping
  Zip/Postcode S-581 83
  Country Sweden
  Tel +46 (0) 7 023 24 615
  Email preben.bendtsen@liu.se
Sponsor Swedish Research Council (Sweden)
  Address Box 1035
  City/town Stockholm
  Zip/Postcode S-10138
  Country Sweden
  Tel +46 (0) 8 546 44 000
  Fax +46 (0) 8 546 44 180
  Email vetenskapsradet@vr.se
  Sponsor website: http://www.vr.se/
Date applied 12/02/2014
Last edited 27/03/2014
Date ISRCTN assigned 27/03/2014
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