Clinical trial NCT01103427: Usefulness of Supportive SMS in Addition to an Internet Based Quit Smoking Program (Www.Slutta.no)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking
Keywords: smoking cessation
telemedicine
smoking
prevention intervention
internet-based
text messages
behavioral
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
name: University Hospital of North Norway
First posted: 2010-04-14
Enrollment: 4300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 30 months after inclusion
Secondary outcomes:
measure: Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period.
timeFrame: 30 months after inclusion
measure: Comparison between the arms of the trial regarding satisfaction with website and mobile text messages at the time of the 4 questionnaires
timeFrame: 30 months after inclusion
measure: 28 days of continuous smoking prevalence at 6 months after selfreported smoking cessation date
timeFrame: 6 months after selfreported smoking cessation date
measure: Selfreported involvement in any vehicle crashes during the last 6 months
timeFrame: 6 months after selfreported smoking cessation date
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University of Tromso
name: Inger T Gram, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Bjørn Engum
role: STUDY_DIRECTOR
References:
citation: Gram IT, Larbi D, Wangberg SC. Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Sep 27;7(9):e12137. doi: 10.2196/12137.