SmokingSMS TurkeyNCT00912795
SMS Turkey: Harnessing the Power of Text Messaging to Promote Smoking Cessation
A study testing SMS Turkey in people with Smoking, run by Center for Innovative Public Health Research at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to develop and test a text messaging-based smoking cessation program for adults who are currently smoking and want to quit, living in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- SMS Turkey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Currently smoking every day
- Owning a TXT-capable cell phone
- Sent or received TXT messages at least once in the past year
- Living in Ankara (to ease technology support if necessary)
- Agreement to set quit day in 15 days from enrollment date
- Agreement to verification of smoking cessation using a carbon monoxide breath monitor
Who cannot join
- No chronic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SMS Turkey: Harnessing the Power of TXT Messaging to Promote Smoking Cessation
The purpose of this study is to develop and test a text messaging-based smoking cessation program for adults who are currently smoking and want to quit, living in Turkey.
Read the detailed description
Smoking has long been recognized as a significant public health concern associated with great morbidity and mortality. Although smoking rates have decreased in high income countries, these trends have not been noted for tow and middle income countries. This is especially true in Turkey, which was ranked 6th in the world in smoking consumption. Between 51-63% of Turkish men and 24-26% of Turkish women 15 years of age and older are smokers. With lung cancer the leading cancer-related cause of death for both men and women, effective and accessible smoking cessation interventions are needed. Cell phone technology represents a unique opportunity to deliver evidenced-based smoking cessation behavioral treatments through a delivery mechanism already widely adopted by adults. An estimated 35 million Turks were using cell phones, making them 1.8 times more common than land lines. Cell phone interventions are a unique delivery method because of their 'always on' capability. The rapid uptake of cell phones allows us to potentially reach those who might otherwise not utilize smoking cessation services.
We designed and evaluated SMS Turkey, an evidenced-based smoking intervention that takes advantage of technologies adopted by adult smokers in Turkey. The primary outcome measure is sustained abstinence 12 weeks after quit day, confirmed with a carbon monoxide (CO) reading of 8 ppm or less. Sustained abstinence was defined as 5 or fewer cigarettes smoked since the quit date, per West et al. Secondary outcome measures included: 7-day and 30-day point prevalence of smoking behavior at 3 months; CO-verified 7-day point prevalence at 4 weeks; and reduction in cigarettes per day for those who are smoking at 3 months.
- Conditions
- Smoking
- Being tested
- SMS Turkey
- Keywords
- Smoking Cessation, technology, developing countries
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS TurkeyBehavioural
Also called Cebiniz birakin diyor
6-week smoking cessation program delivered via daily text messages
SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.
Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.
Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages).
| Study group | Role | What they receive |
|---|---|---|
| SMS Turkey | Experimental | 6-week smoking cessation program delivered via daily text messages Receives: Behavioral: SMS Turkey |
| Brochure control | No intervention | 7-page brochure that provided general information and tips on how to quit smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Monoxide-verified Continuous Abstinence at 12 Weeks
self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)
Measured: 12-weeks post-quit day
Secondary outcomes (3)
CO-verified 7-day Point Prevalence Abstinence at 4 Weeks
self-reported continuous abstinence in the past 7 days at 4 weeks (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)
Measured: 4 weeks
Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)
Measured: 12 weeks
Self-reported 30-day Point Prevalence Abstinence at 12 Weeks
self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Michele Ybarra, MPH PhD, Principal investigator, Center for Innovative Public Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912795
- Sponsor's protocol ID
- ISK-NIH-FIC7918
- Other IDs
- 5R01TW007918
- Acronym
- SMS Turkey
- Status last verified
- Aug 2016
- First submitted
- 19 May 2009
- Last updated
- 5 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ybarra ML, Bagci Bosi AT, Bilir N, Holtrop JS, Korchmaros J, Emri S. Interest in technology-based and traditional smoking cessation programs among adult smokers in Ankara, Turkey. Tob Induc Dis. 2011 Aug 1;9(1):10. doi: 10.1186/1617-9625-9-10.
PubMed 21806793Ybarra ML, Holtrop JS, Bagci Bosi AT, Emri S. Design considerations in developing a text messaging program aimed at smoking cessation. J Med Internet Res. 2012 Jul 24;14(4):e103. doi: 10.2196/jmir.2061.
PubMed 22832182Ybarra M, Bagci Bosi AT, Korchmaros J, Emri S. A text messaging-based smoking cessation program for adult smokers: randomized controlled trial. J Med Internet Res. 2012 Dec 27;14(6):e172. doi: 10.2196/jmir.2231.
PubMed 23271159Ybarra ML, Holtrop JS, Bagci Bosi AT, Bilir N, Korchmaros JD, Salih Emri AK. Feasibility and acceptability of a text messaging-based smoking cessation program in ankara, Turkey. J Health Commun. 2013 Aug;18(8):960-73. doi: 10.1080/10810730.2012.757399. Epub 2013 Apr 29.
PubMed 23627304
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS Turkey: Harnessing the Power of TXT Messaging to Promote Smoking Cessation
- ClinicalTrials.gov ID
- NCT00912795
- Acronym / sponsor ID
- SMS Turkey / ISK-NIH-FIC7918
- Conditions
- Smoking
- Keywords
- Smoking Cessation, technology, developing countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Collaborators
- Hacettepe University, Fogarty International Center of the National Institute of Health
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and test a text messaging-based smoking cessation program for adults who are currently smoking and want to quit, living in Turkey.
Detailed description
Smoking has long been recognized as a significant public health concern associated with great morbidity and mortality. Although smoking rates have decreased in high income countries, these trends have not been noted for tow and middle income countries. This is especially true in Turkey, which was ranked 6th in the world in smoking consumption. Between 51-63% of Turkish men and 24-26% of Turkish women 15 years of age and older are smokers. With lung cancer the leading cancer-related cause of death for both men and women, effective and accessible smoking cessation interventions are needed. Cell phone technology represents a unique opportunity to deliver evidenced-based smoking cessation behavioral treatments through a delivery mechanism already widely adopted by adults. An estimated 35 million Turks were using cell phones, making them 1.8 times more common than land lines. Cell phone interventions are a unique delivery method because of their 'always on' capability. The rapid uptake of cell phones allows us to potentially reach those who might otherwise not utilize smoking cessation services.
We designed and evaluated SMS Turkey, an evidenced-based smoking intervention that takes advantage of technologies adopted by adult smokers in Turkey. The primary outcome measure is sustained abstinence 12 weeks after quit day, confirmed with a carbon monoxide (CO) reading of 8 ppm or less. Sustained abstinence was defined as 5 or fewer cigarettes smoked since the quit date, per West et al. Secondary outcome measures included: 7-day and 30-day point prevalence of smoking behavior at 3 months; CO-verified 7-day point prevalence at 4 weeks; and reduction in cigarettes per day for those who are smoking at 3 months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS Turkey | Experimental | Behavioral: SMS Turkey6-week smoking cessation program delivered via daily text messages |
| Brochure control | No intervention | –7-page brochure that provided general information and tips on how to quit smoking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Currently smoking every day
- Owning a TXT-capable cell phone
- Sent or received TXT messages at least once in the past year
- Living in Ankara (to ease technology support if necessary)
Key exclusion criteria (1 listed)
- No chronic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS TurkeyAlso: Cebiniz birakin diyor6-week smoking cessation program delivered via daily text messages SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory. Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. Depending on the participant's content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages). | Behavioural | SMS Turkey |
Primary outcome
Carbon Monoxide-verified Continuous Abstinence at 12 Weeks
Time frame: 12-weeks post-quit day
self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)
3 secondary outcomes
CO-verified 7-day Point Prevalence Abstinence at 4 Weeks
Time frame: 4 weeks
Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
Time frame: 12 weeks
Self-reported 30-day Point Prevalence Abstinence at 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21806793Ybarra ML, Bagci Bosi AT, Bilir N, Holtrop JS, Korchmaros J, Emri S. Interest in technology-based and traditional smoking cessation programs among adult smokers in Ankara, Turkey. Tob Induc Dis. 2011 Aug 1;9(1):10. doi: 10.1186/1617-9625-9-10.
- Background: PubMed 22832182Ybarra ML, Holtrop JS, Bagci Bosi AT, Emri S. Design considerations in developing a text messaging program aimed at smoking cessation. J Med Internet Res. 2012 Jul 24;14(4):e103. doi: 10.2196/jmir.2061.
- Results publication: PubMed 23271159Ybarra M, Bagci Bosi AT, Korchmaros J, Emri S. A text messaging-based smoking cessation program for adult smokers: randomized controlled trial. J Med Internet Res. 2012 Dec 27;14(6):e172. doi: 10.2196/jmir.2231.
- Results publication: PubMed 23627304Ybarra ML, Holtrop JS, Bagci Bosi AT, Bilir N, Korchmaros JD, Salih Emri AK. Feasibility and acceptability of a text messaging-based smoking cessation program in ankara, Turkey. J Health Commun. 2013 Aug;18(8):960-73. doi: 10.1080/10810730.2012.757399. Epub 2013 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Ybarra, MPH PhD principal investigator
Center for Innovative Public Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Turkey in people with Smoking, run by Center for Innovative Public Health Research at 1 site in Turkey (Türkiye).
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 7 inclusion and 1 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 5 Oct 2016. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 5 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (time frame: 12-weeks post-quit day). 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 NCT00912795, which also lists 4 linked publications.
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 5 Oct 2016.