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Smoking CessationNCT01103427

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

A study testing Internet-based behavioral coaching, SMS based coaching and SMS coaching - UNN recruited in people with Smoking Cessation and Smoking, run by University of Tromso at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Smoking
What is being tested?
Internet-based behavioral coaching, SMS based coaching and SMS coaching - UNN recruited
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,300 participants
Where
1 siteNorway
Study dates
May 2010to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • Less than 16 years of age
  • No personal e-mail address
  • No personal mobile cell phone
  • Not able to give the informed consent

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University Hospital of North Norway

    Tromsø, 9038

Other trials in Norway

About this study

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.

Read the 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.

Being tested
Internet-based behavioral coaching, SMS based coaching, SMS coaching - UNN recruited, SMS craving function - UNN recruited
Keywords
smoking cessation, telemedicine, smoking, prevention intervention, internet-based, text messages, behavioral
Medical subject headings
Smoking Cessation, Smoking, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based behavioral coachingDevice

    Also called slutta.no

    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.

  • SMS based coachingDevice

    Also called slutta.no

    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.

  • SMS coaching - UNN recruitedDevice

    Also called slutta.no/unn

    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.

  • SMS craving function - UNN recruitedDevice

    Also called slutta.no/unn

    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.

Study groups in NCT01103427
Study groupRoleWhat they receive
Internet-based coaching .Active comparatorArm 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.
Receives: Device: Internet-based behavioral coaching
SMS based coachingExperimentalArm 2. The subjects will receive automated "coaching"by 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.
Receives: Device: SMS based coaching
SMS coaching UNN recruitedExperimentalArm 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.
Receives: Device: SMS coaching - UNN recruited
Craving/Panic function. UNN recruitedExperimentalArm 4. The subjects will in addition to the automated "coaching"by 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.
Receives: Device: SMS craving function - UNN recruited

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 30 months after inclusion

Secondary outcomes (4)

  1. 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.

    Measured: 30 months after inclusion

  2. 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.

    Measured: 30 months after inclusion

  3. 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

    Measured: 6 months after selfreported smoking cessation date

  4. 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.

    Measured: 6 months after selfreported smoking cessation date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01103427
Sponsor's protocol ID
TFP-743-08
Status last verified
Dec 2013
First submitted
13 Apr 2010
Last updated
17 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31573935

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based behavioral coaching, SMS based coaching and SMS coaching - UNN recruited in people with Smoking Cessation and Smoking, run by University of Tromso at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 30 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01103427, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.

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