Smoking Cessation Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 4300 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Norway | University Hospital of North Norway | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University of Tromso | The Royal Norwegian Ministry of Health, University Hospital of North Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | Yes |
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