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Trial record 34 of 662 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT00912795
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Collaborators:
Hacettepe University
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Center for Innovative Public Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Smoking
Intervention Behavioral: SMS Turkey
Enrollment 151
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 Details 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
Hide 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
Arm/Group Title SMS Turkey Brochure Control Total
Hide 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 Number of Baseline Participants 76 75 151
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 75 participants 151 participants
35.6  (10.3) 36.1  (9.5) 35.89  (9.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
Female
35
  46.1%
24
  32.0%
59
  39.1%
Male
41
  53.9%
51
  68.0%
92
  60.9%
Income  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
Less than 2000 Turkish lira per month 23 37 60
2000 - 4000 Turkish lira per month 34 28 62
More than 4000 Turkish lira per month 16 9 25
Do not want to answer 3 1 4
Martial status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
Married 42 49 91
Single 30 25 55
Divorced 4 0 4
Widowed 0 1 1
Educational attainment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
High school or less 28 38 66
Two-year college 13 10 23
University degree 27 23 50
Post graduate degree 8 4 12
Average Number of cigarettes smoked per day  
Mean (Standard Deviation)
Unit of measure:  Number of cigarettes per day
Number Analyzed 76 participants 75 participants 151 participants
18.7  (7.2) 20.4  (9.2) 19.53  (8.27)
Age at first cigarette  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 75 participants 151 participants
17.5  (3.7) 17.1  (3.6) 17.3  (3.6)
Fagerström score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 76 participants 75 participants 151 participants
4.8  (2.3) 4.9  (2.5) 4.8  (2.4)
[1]
Measure Description: Tobacco dependence was assessed using the Fagerström Test of Nicotine Dependence (FTND). Scores range from 0-10. A score of 0-2 indicates low dependence, 3-4 indicates low to moderate dependence, 5-7 indicates moderate dependence, and 8-10 indicates high dependence.
Importance of quitting to self   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 76 participants 75 participants 151 participants
8.9  (1.6) 9.0  (1.4) 8.9  (1.5)
[1]
Measure Description: This measure has scores possibly ranging form 4 to 10 with higher scores reflecting more importance
Confidence in one's ability to quit   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 76 participants 75 participants 151 participants
6.0  (2.4) 6.0  (2.5) 6.0  (2.5)
[1]
Measure Description: This measure has scores possibly ranging form 0 to 10 with higher scores reflecting more confidence
Number of quit attempts in the past year  
Mean (Standard Deviation)
Unit of measure:  Number of quit attempts
Number Analyzed 76 participants 75 participants 151 participants
2.4  (1.5) 2.4  (1.5) 2.4  (1.5)
1.Primary Outcome
Title Carbon Monoxide-verified Continuous Abstinence at 12 Weeks
Hide Description self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)
Time Frame 12-weeks post-quit day
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 76 75
Measure Type: Number
Unit of Measure: participants
8 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Turkey, Brochure Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
0.62 to 6.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title CO-verified 7-day Point Prevalence Abstinence at 4 Weeks
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 76 75
Measure Type: Number
Unit of Measure: participants
9 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Turkey, Brochure Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.50 to 3.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
Hide Description self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 76 75
Measure Type: Number
Unit of Measure: participants
10 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Turkey, Brochure Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
0.81 to 7.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Self-reported 30-day Point Prevalence Abstinence at 12 Weeks
Hide Description self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 76 75
Measure Type: Number
Unit of Measure: participants
8 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMS Turkey, Brochure Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
.62 to 6.3
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected through the study period (i.e., from baseline to 12-week follow-up).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SMS Turkey Brochure Control
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SMS Turkey Brochure Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/75 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SMS Turkey Brochure Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)   0/75 (0.00%) 
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.”
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michele Ybarra
Organization: Center for Innovative Public Health Research
Phone: 877-302-6858 ext 1 – 801#
EMail: michele@innovativepublichealth.org
Layout table for additonal information
Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT00912795     History of Changes
Other Study ID Numbers: ISK-NIH-FIC7918
5R01TW007918 ( U.S. NIH Grant/Contract )
First Submitted: May 19, 2009
First Posted: June 3, 2009
Results First Submitted: March 29, 2016
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016