Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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30 March 2020 |
Main ID: |
ISRCTN75766527 |
Date of registration:
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04/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of the effectiveness of a SMS based smoking cessation intervention among university students in Sweden - the NEXit trial
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Scientific title:
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SMS-based smoking cessation intervention among university students -? the NEXit trial: a two-arm randomized controlled trial from Sweden |
Date of first enrolment:
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20/10/2014 |
Target sample size:
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1354 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN75766527 |
Study type:
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Interventional |
Study design:
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Two-arm randomized controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Preben
Bendtsen |
Address:
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Linköpings University IMH/SAM
SE-581 83
Linköping
Sweden |
Telephone:
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+46 (0) 702324615 |
Email:
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preben.bendtsen@liu.se |
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Key inclusion & exclusion criteria
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Inclusion criteria: All students (age range approx 18-30) that are daily or weekly smokers and willing to set a quit date for stop smoking within a 4 weeks period. There is no restriction on the use of other smoking cessation treatments or methods.
Exclusion criteria: Non-smokers/occasional smokers not smoking every week and smokers not willing to set a stop date within 4 weeks after informed consent to participate.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tobacco smoking Mental and Behavioural Disorders
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Intervention(s)
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After randomisation and signing on, the intervention starts with a motivational phase of between one to four weeks depending on when the participants set a quit date. The participants are given an opportunity to set a quit date every week during this 4 weeks motivational phase. If no active quit date is set with this 4 week period the participant is given a quit date immediately after the 4 week motivational phase in accordance with the inclusion criteria and informed consent.
In this first motivational phase the participants receive 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.
Before the quit day the participants will receive dedicated messages five times a day during three days immediately before the quit date in order to prepare the smokers for quitting smoking. These messages will prompt participants to get rid of cigarettes, ashtrays and lighters and to avoid environments where they could normally smoke, and encouraged to overcome challenges of quitting
After setting a quit date the core intervention runs for twelve weeks. The participants will receive 3-5 text messages per day for the first week, 2-4 messages the next 2-4 weeks, and then 10 text messages per week the following eight weeks. Messages will encourage participants to persevere with the quite attempt and focused on their success so far. They will be prepared with coping messages for handling cravings, motivational messages, encouragement to prese
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Primary Outcome(s)
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1. Self-reported prolonged abstinence (defined as having not smoked more than 5 cigarettes the last 8 weeks) 2. Self-reported 4 weeks point prevalence of smoking abstinence (not having smoked a single cigarette).
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Secondary Outcome(s)
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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 since the first invitation to the study (19 weeks) 3. Use of other smoking cessation services (medication, counselling, calling help line etc.), since the first invitation to the study (19 weeks). 4. Number of daily smoked cigarettes at the time of follow-up among those who still smokes at the time of follow-up.
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Secondary ID(s)
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Version 1
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Source(s) of Monetary Support
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The Swedish Research Council (Sweden), Box 1035, SE-101 38 Stockholm, Sweden, +46 (0)8 54644000
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Ethics review
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Status:
Approval date:
Contact:
The Regional Ethics Committee in Linköping, 17/06/2014, ref Dnr: 2014/217-31
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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19/04/2015 |
URL:
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