SMS Turkey: Harnessing the Power of Text Messaging to Promote Smoking Cessation

• Sponsor: Center for Innovative Public Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00912795
• Collaborator: Hacettepe University (Other), Fogarty International Center of the National Institute of Health (NIH)
• Enrollment: 151
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Behavioral: SMS Turkey	N/A

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

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: SMS Turkey: Harnessing the Power of TXT Messaging to Promote Smoking Cessation
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SMS Turkey 6-week smoking cessation program delivered via daily text messages	Behavioral: SMS Turkey; 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).; Other Names: Cebiniz birakin diyor
No Intervention: Brochure control 7-page brochure that provided general information and tips on how to quit smoking

Outcome Measures

Primary Outcome Measures

1. Carbon Monoxide-verified Continuous Abstinence at 12 Weeks [12-weeks post-quit day]

   self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)

Secondary Outcome Measures

1. CO-verified 7-day Point Prevalence Abstinence at 4 Weeks [4 weeks]

   self-reported continuous abstinence in the past 7 days at 4 weeks (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)

2. Self-reported 7-day Point Prevalence Abstinence at 12 Weeks [12 weeks]

   self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)

3. Self-reported 30-day Point Prevalence Abstinence at 12 Weeks [12 weeks]

   self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• No chronic disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey

Sponsors and Collaborators

• Center for Innovative Public Health Research
• Hacettepe University
• Fogarty International Center of the National Institute of Health

Investigators

• Principal Investigator: Michele Ybarra, MPH PhD, Center for Innovative Public Health Research

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• SMS Turkey study documents and publications

Publications

• Ybarra ML, Bağci 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;9:10. doi: 10.1186/1617-9625-9-10.
• Ybarra ML, Holtrop JS, Bağci 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.

• Responsible Party: Center for Innovative Public Health Research
• ClinicalTrials.gov Identifier: NCT00912795
• Other Study ID Numbers: ISK-NIH-FIC7918; 5R01TW007918
• First Posted: Jun 3, 2009
• Last Update Posted: Oct 5, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Center for Innovative Public Health Research: Smoking Cessation; technology; developing countries

Study Results

Participant Flow

Recruitment Details	Participants were recruited in Ankara, Turkey between December 2010 & June 2011, through in-person outreach at local shopping malls and local newspapers advertisements. Flyers were also posted at Hacettepe University. Smokers indicated their interest by calling the study office or speaking directly with the research assistant at the shopping mall.
Pre-assignment Detail	Of the 247 people who expressed interest in participating, 230 were eligible for the study. A total of 151 adults (66% of those eligible) attended the enrollment meeting, where they consented to take part in the research study and were randomly assigned to either the intervention or control group.

Arm/Group Title	SMS Turkey	Brochure Control
Arm/Group Description	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).	A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter.
Period Title: Overall Study
STARTED	76	75
COMPLETED	29	17
NOT COMPLETED	47	58

Baseline Characteristics

Arm/Group Title	SMS Turkey	Brochure Control	Total
Arm/Group Description	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).	A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter.	Total of all reporting groups
Overall Participants	76	75	151
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (10.3)	36.1 (9.5)	35.89 (9.89)
Sex: Female, Male (Count of Participants)
Female	35 46.1%	24 32%	59 39.1%
Male	41 53.9%	51 68%	92 60.9%
Income (participants) [Number]
Less than 2000 Turkish lira per month	23 30.3%	37 49.3%	60 39.7%
2000 - 4000 Turkish lira per month	34 44.7%	28 37.3%	62 41.1%
More than 4000 Turkish lira per month	16 21.1%	9 12%	25 16.6%
Do not want to answer	3 3.9%	1 1.3%	4 2.6%
Martial status (participants) [Number]
Married	42 55.3%	49 65.3%	91 60.3%
Single	30 39.5%	25 33.3%	55 36.4%
Divorced	4 5.3%	0 0%	4 2.6%
Widowed	0 0%	1 1.3%	1 0.7%
Educational attainment (participants) [Number]
High school or less	28 36.8%	38 50.7%	66 43.7%
Two-year college	13 17.1%	10 13.3%	23 15.2%
University degree	27 35.5%	23 30.7%	50 33.1%
Post graduate degree	8 10.5%	4 5.3%	12 7.9%
Average Number of cigarettes smoked per day (number of cigarettes per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of cigarettes per day]	18.7 (7.2)	20.4 (9.2)	19.53 (8.27)
Age at first cigarette (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17.5 (3.7)	17.1 (3.6)	17.3 (3.6)
Fagerström score (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	4.8 (2.3)	4.9 (2.5)	4.8 (2.4)
Importance of quitting to self (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	8.9 (1.6)	9.0 (1.4)	8.9 (1.5)
Confidence in one's ability to quit (score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score]	6.0 (2.4)	6.0 (2.5)	6.0 (2.5)
Number of quit attempts in the past year (number of quit attempts) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of quit attempts]	2.4 (1.5)	2.4 (1.5)	2.4 (1.5)

Outcome Measures

1. Primary Outcome

Title	Carbon Monoxide-verified Continuous Abstinence at 12 Weeks
Description	self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)
Time Frame	12-weeks post-quit day

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).

Arm/Group Title	SMS Turkey	Brochure Control
Arm/Group Description	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).	A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter.
Measure Participants	76	75
Number [participants]	8 10.5%	4 5.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SMS Turkey, Brochure Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; 0.62 to 6.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	CO-verified 7-day Point Prevalence Abstinence at 4 Weeks
Description	self-reported continuous abstinence in the past 7 days at 4 weeks (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).

Arm/Group Title	SMS Turkey	Brochure Control
Arm/Group Description	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).	A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter.
Measure Participants	76	75
Number [participants]	9 11.8%	7 9.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SMS Turkey, Brochure Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.50 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
Description	self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).

Arm/Group Title	SMS Turkey	Brochure Control
Arm/Group Description	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).	A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter.
Measure Participants	76	75
Number [participants]	10 13.2%	4 5.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SMS Turkey, Brochure Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; 0.81 to 7.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Self-reported 30-day Point Prevalence Abstinence at 12 Weeks
Description	self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).

Arm/Group Title	SMS Turkey	Brochure Control
Arm/Group Description	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).	A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter.
Measure Participants	76	75
Number [participants]	8 10.5%	4 5.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SMS Turkey, Brochure Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; .62 to 6.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data were collected through the study period (i.e., from baseline to 12-week follow-up).
Arm/Group Title	SMS Turkey		Brochure Control
Arm/Group Description	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).		A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages. The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter.
All Cause Mortality
	SMS Turkey		Brochure Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SMS Turkey		Brochure Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	SMS Turkey		Brochure Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/75 (0%)

Limitations/Caveats

An imbalance favoring the intervention was detected after approximately 100 participants were enrolled. To ensure a 1:1 match, the procedure was modified so that the RA pulled a slip of paper from a hat that read either "SMS Turkey" or "brochure."

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.