Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)

Study Overview
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Brief Summary
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The purpose of the study is to investigate the effectiveness of a smoking cessation intervention delivered through a technological web based platform (www.slutta.no) with or without a supportive SMS function.

Detailed Description
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The study has two arms and are conducted in Norwegian. Users who registered with a new username on www.slutta.no, after study start May 12th 2010 and before November 1st 2012, are eligible. All phases of the trial, from randomization and informed consent procedures to data collection, are automated and conducted online. The following inclusion criteria are used: age 16 years or older, access to a mobile phone with a Norwegian phone number and they must submit an informed consent form.

Official Title
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Mobile Text Messaging as an Adjunct Function to an Internet-based Smoking Cessation Intervention Implemented in the General Population and in a Health Care Setting

Conditions
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Smoking Cessation, Smoking

Intervention / Treatment
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* Device: Internet-based behavioral coaching
* Device: SMS based coaching
* Device: SMS coaching - UNN recruited
* Device: SMS craving function - UNN recruited


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (all arms): Aged 16 and older Current smoker: Willing to quit smoking within the next 12 weeks Former smokers; Having quit smoking within the previous six months Having a regular access to Internet Having a personal e-mail address Having a personal mobile cell phone with a Norwegian number Given informed consent Can read and understand Norwegian Reporting no association with the University Hospital of North Norway (arm1&2) Reporting an association with the University Hospital of North Norway (arm3&4) Exclusion Criteria: Less than 16 years of age No personal e-mail address No personal mobile cell phone Not able to give the informed consent

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Internet-based coaching .<br>Arm 1. Those in the active comparator arm will benefit from automated internet-based coaching. The subjects will be recruited from the general population reporting not to be associated with the University Hospital of North Norway and randomized to arm 1 or 2. | Device: Internet-based behavioral coaching<br>* Those in the active comparator arm will benefit from automated coaching by e-mails with advice, information and support for smoking cessation. These e-mails will be adapted to their personal profile.<br>* Other names: slutta.no;|
| Experimental: SMS based coaching<br>Arm 2. The subjects will receive automated coachingby SMS.The subjects will be recruited from the general population reporting not to be associated with the University Hospital of North Norway and randomized to arm 1 or 2. | Device: SMS based coaching<br>* Those in the experimental SMS based coaching arm will benefit from automated coaching by SMS with advice, information and support for smoking cessation. These SMS's will be adapted to their personal profile.<br>* Other names: slutta.no;|
| Experimental: SMS coaching UNN recruited<br>Arm 3.The subjects will be recruited from those reporting to be associated with the University Hospital of North Norway and randomized to arm 3 or 4. | Device: SMS coaching - UNN recruited<br>* Those in the experimental SMS based coaching arm- UNN recruited - will benefit from automated coaching by SMS with advice, information and support for smoking cessation. These SMS's will be adapted to their personal profile.<br>* Other names: slutta.no/unn;|
| Experimental: Craving/Panic function. UNN recruited<br>Arm 4. The subjects will in addition to the automated coachingby SMS get a SMS panic/craving function. The subjects will be recruited from subjects reporting to be associated with the University Hospital of North Norway and randomized to arm 3 or 4. | Device: SMS craving function - UNN recruited<br>* Those in the experimental SMS based craving/panic function arm - will in addition to the automated coaching by SMS have a panic/craving SMS function. Thus by sending a SMS they will receive instant advise and support for smoking cessation by SMS.<br>* Other names: slutta.no/unn;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the percentage of abstinent people between the arms of the trial,1,3,6 and 12 months after self-reported smoking cessation date | The investigators will compare the percentage of smokers who successfully quit. Point prevalence abstinence will be measured (not smoking, event a puff, in the week preceding the questioning). | 30 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period. | Number of visits to the website, time logged in, used elements of the website and adherence to the program will be measured utilizing the registrations on the server. | 30 months after inclusion | 
| Comparison between the arms of the trial regarding satisfaction with website and mobile text messages at the time of the 4 questionnaires | The 4 questionnaires comprise questions regarding satisfaction with website or text messages for the different arms depending om which device they have been utilizing. | 30 months after inclusion | 
| 28 days of continuous smoking prevalence at 6 months after selfreported smoking cessation date | Comparison between the four arms regarding self-reported 28 days continuous smoking abstinence through questionnaire | 6 months after selfreported smoking cessation date | 
| Selfreported involvement in any vehicle crashes during the last 6 months | Involvement in any vehicle crashes (this is the only rare adverse health effects of using a mobile phone)during the 6 months after selfreported smoking cessation date. | 6 months after selfreported smoking cessation date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, telemedicine, smoking, prevention intervention, internet-based, text messages, behavioral