{"protocolSection":{"identificationModule":{"nctId":"NCT02873754","orgStudyIdInfo":{"id":"Pro00074576"},"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Smoking Treatment and Exercise Program for Underserved Populations (STEP UP)","officialTitle":"Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase Physical Activity"},"statusModule":{"statusVerifiedDate":"2018-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-07","type":"ACTUAL"},"completionDateStruct":{"date":"2017-07","type":"ACTUAL"},"studyFirstSubmitDate":"2016-08-17","studyFirstSubmitQcDate":"2016-08-17","studyFirstPostDateStruct":{"date":"2016-08-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-05-10","resultsFirstSubmitQcDate":"2018-06-15","resultsFirstPostDateStruct":{"date":"2018-07-13","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-06-15","lastUpdatePostDateStruct":{"date":"2018-07-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and increase physical activity among low-income persons. The intervention is called Smoking Treatment and Exercise Program for Underserved Populations (STEP UP).","detailedDescription":"This pilot project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and physical activity among low-income persons. The intervention, named Smoking Treatment and Exercise Program for Underserved Populations (STEP UP), combines a smartphone-based contingency-management application (app), which provides monetary reinforcement for smoking abstinence and physical activity, 5 weeks of telephone-based cognitive-behavioral therapy (CBT) to prevent relapse, nicotine replacement pharmacotherapy, and text-messaging to support physical-activity goals. Participants are given a smartphone, a compact carbon-monoxide (CO) monitor, with which recency of smoking can by determined, and a Garmin Vivosmart wristband step-tracker. Twice a day at semi-random intervals, participants are prompted by the app to submit a video of themselves blowing into the CO monitor. Monetary reinforcement is then immediately provided contingent upon a below-threshold CO reading. The app also continuously syncs with the Garmin step-tracker, providing supportive messaging and bonus incentives-namely doubled reinforcement for smoking abstinence among participants who meet personalized daily step goals. The expected outcome of the project is to provide information to evaluate the efficacy of an innovative approach in preparation for a subsequent larger clinical trial that builds upon the capabilities of mHealth technology to reduce the prevalence of smoking among low income smokers."},"conditionsModule":{"conditions":["Smoking"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":11,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"STEP UP","type":"EXPERIMENTAL","description":"STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.","interventionNames":["Behavioral: Cognitive Behavioral Counseling","Behavioral: Mobile Contingency Management","Drug: Bupropion","Drug: Transdermal nicotine patch","Drug: Nicotine polacrilex","Drug: Nicotine lozenge"]}],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive Behavioral Counseling","description":"Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.","armGroupLabels":["STEP UP"]},{"type":"BEHAVIORAL","name":"Mobile Contingency Management","description":"Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggest increased physical activity.","armGroupLabels":["STEP UP"]},{"type":"DRUG","name":"Bupropion","description":"All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.","armGroupLabels":["STEP UP"],"otherNames":["Zyban"]},{"type":"DRUG","name":"Transdermal nicotine patch","description":"Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant","armGroupLabels":["STEP UP"]},{"type":"DRUG","name":"Nicotine polacrilex","description":"Nicotine gum will be initiated at smoking quit date; 4 mg dose administered as needed","armGroupLabels":["STEP UP"],"otherNames":["Nicotine gum; nicorette"]},{"type":"DRUG","name":"Nicotine lozenge","description":"Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed","armGroupLabels":["STEP UP"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Self-report Prolonged Abstinence From Smoking","description":"Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","timeFrame":"6 month follow up"},{"measure":"Number of Participants Whose Prolonged Abstinence is Bio-verified","description":"Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","timeFrame":"6 month follow up"},{"measure":"Number of Participants Who Self-report Prolonged Abstinence From Smoking","description":"Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","timeFrame":"3 month follow up"},{"measure":"Number of Participants Whose Prolonged Abstinence is Bio-verified","description":"Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","timeFrame":"3 month follow up"}],"secondaryOutcomes":[{"measure":"Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking","description":"7-day point prevalence abstinence is defined as no smoking in the prior 7 days.","timeFrame":"6 month follow up"},{"measure":"Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking","description":"30-day point prevalence abstinence is defined as no smoking in the prior 30 days.","timeFrame":"6 month follow up"},{"measure":"Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking","description":"7-day point prevalence abstinence is defined as no smoking in the prior 7 days.","timeFrame":"3 month follow up"},{"measure":"Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking","description":"30-day point prevalence abstinence is defined as no smoking in the prior 30 days.","timeFrame":"3 month follow up"},{"measure":"Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.","description":"Participants will be interviewed about the amount of time spent in light, moderate, and hard physical activity during the past 7 days. Total number of days of moderate and hard exercise in last 7 days will be compared to self-reported values at baseline (i.e., # of days of exercise in past 7 days at 3-month follow-up minus # of days of exercise in past 7 days at baseline).","timeFrame":"baseline and 3 month follow up"},{"measure":"Change in the Number of Days in Which Smoked Compared to Pre-quit Use","description":"Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked in 30 days prior to quit.","timeFrame":"3 month follow up"},{"measure":"Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit","description":"Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date","timeFrame":"3 month follow up"},{"measure":"Number of Quit Smoking Attempts","description":"Participants will self-report the number of quit attempts they've had since baseline.","timeFrame":"3 month follow up"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* current household income less than twice the federal poverty guidelines (Finer \\& Henshaw, 2006; for instance, someone from a family of 4 must have a household income less than $48,500 to be eligible)\n* currently smoke \\>10 cigarettes a day\n* smoking for at least the past year\n* can speak and write fluent conversational English\n* are 18-70 years of age\n* are willing to make an attempt to quit smoking and increase physical activity\n\nExclusion Criteria:\n\n* inability to walk\n* expected to have unstable medication regimen during the study\n* currently receiving non-study behavioral treatment for smoking\n* myocardial infarction in the past 6 months\n* contraindication to nicotine replacement therapy (NRT) or bupropion with no medical clearance\n* exclusive use of other forms of nicotine such as cigars, pipes, e-cigarettes, or chewing tobacco\n* current pregnancy\n* current imprisonment or psychiatric hospitalization","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Paul Dennis, PhD","affiliation":"Study Principal Investigator","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","zip":"27706","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"STEP UP","description":"STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via smart-phone.\n\nCognitive Behavioral Counseling: Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggested activity."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"}]},{"type":"Couldn't complete study procedures","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"STEP UP","description":"STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via smart-phone.\n\nCognitive Behavioral Counseling: Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggest activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.45","spread":"10.04"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"11"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"8"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Who Self-report Prolonged Abstinence From Smoking","description":"Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}]},{"type":"PRIMARY","title":"Number of Participants Whose Prolonged Abstinence is Bio-verified","description":"Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. Two participants didn't self-report abstinence, so bioverification was not completed.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants Who Self-report Prolonged Abstinence From Smoking","description":"Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants Whose Prolonged Abstinence is Bio-verified","description":"Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. No participants reported prolonged abstinence, so bioverification wasn't completed.","reportingStatus":"POSTED","timeFrame":"3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking","description":"7-day point prevalence abstinence is defined as no smoking in the prior 7 days.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking","description":"30-day point prevalence abstinence is defined as no smoking in the prior 30 days.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking","description":"7-day point prevalence abstinence is defined as no smoking in the prior 7 days.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking","description":"30-day point prevalence abstinence is defined as no smoking in the prior 30 days.","populationDescription":"5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.","description":"Participants will be interviewed about the amount of time spent in light, moderate, and hard physical activity during the past 7 days. Total number of days of moderate and hard exercise in last 7 days will be compared to self-reported values at baseline (i.e., # of days of exercise in past 7 days at 3-month follow-up minus # of days of exercise in past 7 days at baseline).","populationDescription":"Data are only available for two participants.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"baseline and 3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"4.24"}]}]}]},{"type":"SECONDARY","title":"Change in the Number of Days in Which Smoked Compared to Pre-quit Use","description":"Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked in 30 days prior to quit.","populationDescription":"These data were only available for one participant.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"days","timeFrame":"3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit","description":"Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date","populationDescription":"Only one participant completed the timeline follow-back procedure at 3 months","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"cigarettes","timeFrame":"3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-22"}]}]}]},{"type":"SECONDARY","title":"Number of Quit Smoking Attempts","description":"Participants will self-report the number of quit attempts they've had since baseline.","populationDescription":"These data were only available for 2 participants.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"quit attempts","timeFrame":"3 month follow up","groups":[{"id":"OG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.5","spread":"0.7"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"6 months","description":"n/a; We utilized clinicaltrials.gov definitions.","eventGroups":[{"id":"EG000","title":"STEP UP","description":"STEP UP combines the following:\n\nCognitive Behavioral Counseling: Participants received 5 cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.\n\nMobile Contingency Management via smart-phone: Participants provided video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence. They will also wore a fitness tracker to monitor steps walked. Participants were provided monetary reward for smoking abstinence and increased physical activity.\n\nBupropion: Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses).\n\nTransdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch.\n\nNicotine polacrilex or lozenge: Nicotine gum or lozenge; 4 mg dose administered as needed.","deathsNumAffected":0,"deathsNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":0,"otherNumAtRisk":5}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Several participants had early termination. For appropriate outcomes, intent-to-treat analyses were used, wherein missing=presumed smoking."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Angela Kirby","organization":"Duke University School of Medicine","email":"angela.kirby@duke.edu","phone":"919-286-0411","phoneExt":"5526"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2017-04-03","uploadDate":"2018-04-13T09:31","filename":"Prot_SAP_000.pdf","size":471650}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D012907","term":"Smoking"}],"ancestors":[{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"},{"id":"D061485","term":"Tobacco Use Cessation Devices"},{"id":"D000074164","term":"Nicotine Chewing Gum"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D013812","term":"Therapeutics"},{"id":"D002638","term":"Chewing Gum"},{"id":"D053149","term":"Plant Gums"},{"id":"D001704","term":"Biopolymers"},{"id":"D011108","term":"Polymers"},{"id":"D046911","term":"Macromolecular Substances"},{"id":"D011134","term":"Polysaccharides"},{"id":"D002241","term":"Carbohydrates"},{"id":"D002182","term":"Candy"},{"id":"D005502","term":"Food"},{"id":"D000066888","term":"Diet, Food, and Nutrition"},{"id":"D010829","term":"Physiological Phenomena"},{"id":"D019602","term":"Food and Beverages"}]}},"hasResults":true}