Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-07 @ 2:53 PM
Study NCT ID:
NCT00912795
Status:
COMPLETED
Last Update Posted:
2016-10-05
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SMS Turkey: Harnessing the Power of Text Messaging to Promote Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michele@innovativepublichealth.org', 'phone': '877-302-6858', 'title': 'Dr. Michele Ybarra', 'phoneExt': '1 - 801#', 'organization': 'Center for Innovative Public Health Research'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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."'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected through the study period (i.e., from baseline to 12-week follow-up).', 'eventGroups': [{'id': 'EG000', 'title': 'SMS Turkey', 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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).", 'otherNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brochure Control', 'description': 'A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.\n\nThe 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.', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Carbon Monoxide-verified Continuous Abstinence at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Turkey', 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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)."}, {'id': 'OG001', 'title': 'Brochure Control', 'description': 'A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.\n\nThe 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '0.62', 'ciUpperLimit': '6.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12-weeks post-quit day', 'description': 'self-reported continuous abstinence since quit day (\\<=5 cigarettes) verified with carbon monoxide reading (\\<=8ppm)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'CO-verified 7-day Point Prevalence Abstinence at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Turkey', 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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)."}, {'id': 'OG001', 'title': 'Brochure Control', 'description': 'A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.\n\nThe 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.50', 'ciUpperLimit': '3.2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'self-reported continuous abstinence in the past 7 days at 4 weeks (\\<=5 cigarettes) verified with carbon monoxide reading (\\<=8ppm)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Self-reported 7-day Point Prevalence Abstinence at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Turkey', 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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)."}, {'id': 'OG001', 'title': 'Brochure Control', 'description': 'A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.\n\nThe 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '0.81', 'ciUpperLimit': '7.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'self-reported smoking abstinence in the past 7 days at 12 weeks (\\<=5 cigarettes)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Self-reported 30-day Point Prevalence Abstinence at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMS Turkey', 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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)."}, {'id': 'OG001', 'title': 'Brochure Control', 'description': 'A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.\n\nThe 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '.62', 'ciUpperLimit': '6.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'self-reported smoking abstinence in the past 30 days at 12 weeks (\\<=5 cigarettes)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SMS Turkey', 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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)."}, {'id': 'FG001', 'title': 'Brochure Control', 'description': 'A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.\n\nThe 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '58'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SMS Turkey', 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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)."}, {'id': 'BG001', 'title': 'Brochure Control', 'description': 'A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.\n\nThe 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.6', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '36.1', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '35.89', 'spread': '9.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Income', 'classes': [{'title': 'Less than 2000 Turkish lira per month', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': '2000 - 4000 Turkish lira per month', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'More than 4000 Turkish lira per month', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Do not want to answer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Martial status', 'classes': [{'title': 'Married', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': 'Single', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Divorced', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Widowed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Educational attainment', 'classes': [{'title': 'High school or less', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Two-year college', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'University degree', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Post graduate degree', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average Number of cigarettes smoked per day', 'classes': [{'categories': [{'measurements': [{'value': '18.7', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '20.4', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '19.53', 'spread': '8.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at first cigarette', 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '17.1', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '17.3', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fagerström score', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', '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.', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Importance of quitting to self', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measure has scores possibly ranging form 4 to 10 with higher scores reflecting more importance', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Confidence in one's ability to quit", 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measure has scores possibly ranging form 0 to 10 with higher scores reflecting more confidence', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of quit attempts in the past year', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of quit attempts', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2009-05-19', 'resultsFirstSubmitDate': '2016-03-29', 'studyFirstSubmitQcDate': '2009-05-31', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-11', 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carbon Monoxide-verified Continuous Abstinence at 12 Weeks', 'timeFrame': '12-weeks post-quit day', 'description': 'self-reported continuous abstinence since quit day (\\<=5 cigarettes) verified with carbon monoxide reading (\\<=8ppm)'}], 'secondaryOutcomes': [{'measure': 'CO-verified 7-day Point Prevalence Abstinence at 4 Weeks', 'timeFrame': '4 weeks', 'description': 'self-reported continuous abstinence in the past 7 days at 4 weeks (\\<=5 cigarettes) verified with carbon monoxide reading (\\<=8ppm)'}, {'measure': 'Self-reported 7-day Point Prevalence Abstinence at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'self-reported smoking abstinence in the past 7 days at 12 weeks (\\<=5 cigarettes)'}, {'measure': 'Self-reported 30-day Point Prevalence Abstinence at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'self-reported smoking abstinence in the past 30 days at 12 weeks (\\<=5 cigarettes)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'technology', 'developing countries'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '21806793', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22832182', 'type': 'BACKGROUND', 'citation': 'Ybarra 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.'}, {'pmid': '23271159', 'type': 'RESULT', 'citation': 'Ybarra 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.'}, {'pmid': '23627304', 'type': 'RESULT', 'citation': 'Ybarra 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nWe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Currently smoking every day\n* Owning a TXT-capable cell phone\n* Sent or received TXT messages at least once in the past year\n* Living in Ankara (to ease technology support if necessary)\n* Agreement to set quit day in 15 days from enrollment date\n* Agreement to verification of smoking cessation using a carbon monoxide breath monitor\n\nExclusion Criteria:\n\n• No chronic disease.'}, 'identificationModule': {'nctId': 'NCT00912795', 'acronym': 'SMS Turkey', 'briefTitle': 'SMS Turkey: Harnessing the Power of Text Messaging to Promote Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Center for Innovative Public Health Research'}, 'officialTitle': 'SMS Turkey: Harnessing the Power of TXT Messaging to Promote Smoking Cessation', 'orgStudyIdInfo': {'id': 'ISK-NIH-FIC7918'}, 'secondaryIdInfos': [{'id': '5R01TW007918', 'link': 'https://reporter.nih.gov/quickSearch/5R01TW007918', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMS Turkey', 'description': '6-week smoking cessation program delivered via daily text messages', 'interventionNames': ['Behavioral: SMS Turkey']}, {'type': 'NO_INTERVENTION', 'label': 'Brochure control', 'description': '7-page brochure that provided general information and tips on how to quit smoking'}], 'interventions': [{'name': 'SMS Turkey', 'type': 'BEHAVIORAL', 'otherNames': ['Cebiniz birakin diyor'], 'description': "6-week smoking cessation program delivered via daily text messages\n\nSMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.\n\nContent 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.\n\nDepending 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).", 'armGroupLabels': ['SMS Turkey']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Michele Ybarra, MPH PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Innovative Public Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Innovative Public Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hacettepe University', 'class': 'OTHER'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}