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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,300

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

April 13, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed

17 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed

Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

2.4 years

First QC Date

April 13, 2010

Last Update Submit

December 16, 2013

Conditions

Smoking Cessation Smoking

Keywords

smoking cessationtelemedicinesmokingprevention interventioninternet-basedtext messagesbehavioral

Outcome Measures

Primary Outcomes (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).
30 months after inclusion

Secondary Outcomes (4)

Comparison between the arms of the trial regarding visits, time logged in, used elements of the website and overall adherence period.
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
30 months after inclusion
28 days of continuous smoking prevalence at 6 months after selfreported smoking cessation date
6 months after selfreported smoking cessation date
Selfreported involvement in any vehicle crashes during the last 6 months
6 months after selfreported smoking cessation date

Study Arms (4)

Internet-based coaching .

ACTIVE COMPARATOR

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

SMS based coaching

EXPERIMENTAL

Arm 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.

Device: SMS based coaching

SMS coaching UNN recruited

EXPERIMENTAL

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

Craving/Panic function. UNN recruited

EXPERIMENTAL

Arm 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.

Device: SMS craving function - UNN recruited

Interventions

Internet-based behavioral coachingDEVICE

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.

Also known as: slutta.no

Internet-based coaching .

SMS based coachingDEVICE

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.

Also known as: slutta.no

SMS based coaching

SMS coaching - UNN recruitedDEVICE

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.

Also known as: slutta.no/unn

SMS coaching UNN recruited

SMS craving function - UNN recruitedDEVICE

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.

Also known as: slutta.no/unn

Craving/Panic function. UNN recruited

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Tromsolead
The Royal Norwegian Ministry of Healthcollaborator
University Hospital of North Norwaycollaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (1)

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.
PMID: 31573935DERIVED

MeSH Terms

Conditions

Smoking CessationSmokingBehavior

Condition Hierarchy (Ancestors)

Health Behavior

Study Officials

Inger T Gram, MD, PhD
University of Tromso
PRINCIPAL INVESTIGATOR
Bjørn Engum
University Hospital of North Norway
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 14, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

NO(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Internet-based coaching .

SMS based coaching

SMS coaching UNN recruited

Craving/Panic function. UNN recruited

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations