{"protocolSection":{"identificationModule":{"nctId":"NCT03950427","orgStudyIdInfo":{"id":"T29IP0235"},"secondaryIdInfos":[{"id":"22637","type":"OTHER","domain":"University of California, San Francisco"},{"id":"NCI-2022-02281","type":"REGISTRY","domain":"NCI Clinical Trials Reporting Program (CTRP)"}],"organization":{"fullName":"University of California, San Francisco","class":"OTHER"},"briefTitle":"PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness","officialTitle":"PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness","acronym":"PARQuit"},"statusModule":{"statusVerifiedDate":"2026-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-07-08","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-07-30","type":"ACTUAL"},"completionDateStruct":{"date":"2025-07-30","type":"ACTUAL"},"studyFirstSubmitDate":"2019-05-13","studyFirstSubmitQcDate":"2019-05-13","studyFirstPostDateStruct":{"date":"2019-05-15","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-27","resultsFirstSubmitQcDate":"2026-07-15","resultsFirstPostDateStruct":{"date":"2026-07-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-07-15","lastUpdatePostDateStruct":{"date":"2026-07-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of California, San Francisco","class":"OTHER"},"collaborators":[{"name":"Tobacco Related Disease Research Program","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a research study investigating a smoking cessation program tailored for adults with serious mental illness (SMI). The program uses a Videogame-based Physical (VIP) activity, smoking cessation counseling, and medication (bupropion),","detailedDescription":"The purpose of this study is to learn more about how adults with serious mental illness respond to a smoking cessation program combining a game-based Physical activity, counseling for smoking cessation, and a medication (bupropion or NRT) for smoking cessation.\n\nStudy participants will receive counseling to quit smoking and a medication to help decrease cravings and withdrawal. Additionally, participants will be randomly selected to participate in either a game-based physical activity group or a game group where the participants sit to play the games.\n\nParticipants will be in this study for 12 weeks total. There are 3 assessment visits (2 hours each) at the beginning of the study, 6 weeks after starting, and at the end of the 12 weeks. There will be 8 30- minute counseling sessions during the 12 weeks. The hour-long videogame groups will be held 3 times a week for 12 weeks (36 sessions). Upon completion of the 12-week program, there will be a 1-2 hour group interview. The total time commitment is 48 hours over the course of the 12-week study."},"conditionsModule":{"conditions":["Smoking Cessation","Smoking, Tobacco","Mental Illness","Tobacco Use Disorder"],"keywords":["Smoking cessation","Serious mental illness"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"This study is a pilot, randomized controlled trial (RCT) to examine the feasibility and potential efficacy of an application of a videogame-based group physical activity intervention for smoking cessation in adults with SMI.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":108,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Game-based Physical Activity Group","type":"ACTIVE_COMPARATOR","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.","interventionNames":["Behavioral: Videogame-based physical activity","Drug: Bupropion","Behavioral: Counseling"]},{"label":"Sedentary Videogame Group","type":"PLACEBO_COMPARATOR","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.","interventionNames":["Behavioral: Sedentary videogame","Drug: Bupropion","Behavioral: Counseling"]},{"label":"CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID","type":"ACTIVE_COMPARATOR","description":"The videogame-based physical activity group will play active videogames using the Kinect for Xbox 360 game system and participate in physical activity. Each videogame group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.","interventionNames":["Behavioral: Videogame-based physical activity","Drug: Bupropion","Behavioral: Counseling"]},{"label":"CLOSED - VIP Sedentary Group, Pre-COVID","type":"PLACEBO_COMPARATOR","description":"The sedentary videogame group will play videogames while seated using the Xbox 360 game system using the Kinect sensor. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.","interventionNames":["Behavioral: Sedentary videogame","Drug: Bupropion","Behavioral: Counseling"]}],"interventions":[{"type":"BEHAVIORAL","name":"Videogame-based physical activity","description":"videogame-based physical activity","armGroupLabels":["CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID","Game-based Physical Activity Group"]},{"type":"BEHAVIORAL","name":"Sedentary videogame","description":"sedentary videogame","armGroupLabels":["CLOSED - VIP Sedentary Group, Pre-COVID","Sedentary Videogame Group"]},{"type":"DRUG","name":"Bupropion","description":"Bupropion","armGroupLabels":["CLOSED - VIP Sedentary Group, Pre-COVID","CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID","Game-based Physical Activity Group","Sedentary Videogame Group"],"otherNames":["Wellbutrin","Zyban"]},{"type":"BEHAVIORAL","name":"Counseling","description":"Counseling for smoking cessation","armGroupLabels":["CLOSED - VIP Sedentary Group, Pre-COVID","CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID","Game-based Physical Activity Group","Sedentary Videogame Group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Total Number of Videogame Sessions Attended","description":"Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.","timeFrame":"Up to 12 weeks"},{"measure":"Total Minutes of Videogame Sessions Attended","description":"Feasibility will be measured with a sum of minutes attended. The GSR will monitor and document the times when participants enter and leave the sessions.","timeFrame":"Up to 12 weeks"},{"measure":"Mean Score on a Self-report Acceptability Question at Week 6","description":"Acceptability was assessed through a single question asked of participants \"How enjoyable were the games?\" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.","timeFrame":"At week 6"},{"measure":"Mean Score on a Self-report Acceptability Question at Week 12","description":"Acceptability was assessed through a single question asked of participants \"How enjoyable were the games?\" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.","timeFrame":"At week 12"},{"measure":"Mean Number of Cigarettes Smoked by Group at Week 6","description":"The investigators will record the number of cigarettes per participant, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.","timeFrame":"At week 6"},{"measure":"Mean Number of Cigarettes Smoked by Group at Week 12","description":"The investigators will record the number of cigarettes per participant, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.","timeFrame":"At week 12"},{"measure":"Point-prevalent Abstinence (PPA)","description":"Number of participants reporting not using tobacco at week 12","timeFrame":"At week 12"},{"measure":"Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)","description":"The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.","timeFrame":"At Baseline (1 day)"},{"measure":"Mean Scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)","description":"The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.","timeFrame":"At week 6"},{"measure":"Mean Scores at Week-12 on the Brief Psychiatric Rating Scale (BPRS)","description":"The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.","timeFrame":"At week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* A diagnosis of a Serious Mental Illness (SMI)\\*\n* 18 years and older\n* Smoking at least five cigarettes per day for the past 6 months\n* Willingness to set a quit date\n* Not currently taking bupropion or using nicotine replacement therapy (NRT)\n* Current participant in the residential or day treatment program at a Progress Foundation program with the intention to continue in the residential or day treatment program for at least the 12 week intervention period\n* Capacity to consent.\n\n  * SMI is characterized by the American Psychological Association as distinct conditions that require routine management, produce functional impairment, and interfere with quality of life. Individuals that typically meet the criteria of SMI have illnesses that include schizophrenia, schizoaffective disorder, psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder.\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding\n* Diagnosis of seizure disorder, history of anorexia/bulimia, undergoing abrupt discontinuation of ethanol or sedatives, other conditions that increase seizure risk (e.g., arteriovenous malformation (AVM), severe head injury, central nervous system (CNS) tumor)\n* use of Monoamine oxidase (MAO) inhibitors (concurrently or within 14 days of discontinuing either bupropion or the MAO inhibitor)\n* Planning to become pregnant during the study period\n* Previous participation in the videogame-based physical activity intervention.\n* Known medical conditions or other physical problems that need special attention in an exercise program (e.g. prior myocardial infarction, uncontrolled hypertension, history of angioplasty, history of angina, use of nitroglycerin to treat angina)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Heather Leutwyler, PhD","affiliation":"University of California, San Francisco","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","zip":"94143-0610","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}}]},"referencesModule":{"references":[{"pmid":"42143578","type":"DERIVED","citation":"Whitmore H, Hubbard E, Cooper B, Leutwyler H. Randomized Controlled Trial of a Group-Based Smoking Cessation Intervention for Adults With Serious Mental Illness. Nicotine Tob Res. 2026 May 17:ntag110. doi: 10.1093/ntr/ntag110. Online ahead of print."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"131 potential participants consented, but 23 participants were lost to contact prior to being randomized to any study intervention. These 23 participants are not considered enrolled due to the fact they were never assigned to, nor received, any study intervention. The pre-covid version of the interventions were dropped from the protocol and analyses due to the extensive changes and were amended to include an outdoor park-based intervention implemented after covid.","groups":[{"id":"FG000","title":"PARQuit - Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation."},{"id":"FG001","title":"PARQuit -Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"FG002","title":"CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system using the Kinect sensor. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation."},{"id":"FG003","title":"CLOSED - Videogame-based Physical (VIP) Sedentary Group, Pre-COVID","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system using the Kinect sensor. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation."}],"periods":[{"title":"Baseline","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Week 6","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Week 12","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The pre-covid version of the interventions (VIP groups) were removed from the protocol and analyses plan via an amendment, due to the extensive changes to the intervention introduced to accommodate concerns regarding COVID restrictions at the time the study was enrolling (2020) which was re-designed to include an outdoor park-based intervention and re-named PARQuit. Only participants enrolled in the PARQuit conditions are included in the analyses per protocol.","groups":[{"id":"BG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"BG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"99"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"96"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40.7","spread":"11.2"},{"groupId":"BG001","value":"49.9","spread":"11.9"},{"groupId":"BG002","value":"45.4","spread":"12.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"34"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"65"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"90"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"24"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"45"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"24"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"99"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Total Number of Videogame Sessions Attended","description":"Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Sessions attended","timeFrame":"Up to 12 weeks","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"10"}]}]}]},{"type":"PRIMARY","title":"Total Minutes of Videogame Sessions Attended","description":"Feasibility will be measured with a sum of minutes attended. The GSR will monitor and document the times when participants enter and leave the sessions.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Minutes","timeFrame":"Up to 12 weeks","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"560.9"},{"groupId":"OG001","value":"473.7"}]}]}]},{"type":"PRIMARY","title":"Mean Score on a Self-report Acceptability Question at Week 6","description":"Acceptability was assessed through a single question asked of participants \"How enjoyable were the games?\" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.","populationDescription":"There were a large number of participants who did not complete the acceptability questionnaire at week 6","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"At week 6","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.7","spread":".67"},{"groupId":"OG001","value":"4.6","spread":".80"}]}]}]},{"type":"PRIMARY","title":"Mean Score on a Self-report Acceptability Question at Week 12","description":"Acceptability was assessed through a single question asked of participants \"How enjoyable were the games?\" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.","populationDescription":"There were a large number of participants who did not complete the questionnaire at week 12","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"At week 12","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.8","spread":".37"},{"groupId":"OG001","value":"4.8","spread":".58"}]}]}]},{"type":"PRIMARY","title":"Mean Number of Cigarettes Smoked by Group at Week 6","description":"The investigators will record the number of cigarettes per participant, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cigarettes smoked in past week","timeFrame":"At week 6","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38","spread":"38.9"},{"groupId":"OG001","value":"34","spread":"40.1"}]}]}]},{"type":"PRIMARY","title":"Mean Number of Cigarettes Smoked by Group at Week 12","description":"The investigators will record the number of cigarettes per participant, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cigarettes smoked in past week","timeFrame":"At week 12","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27","spread":"22.3"},{"groupId":"OG001","value":"41","spread":"49.7"}]}]}]},{"type":"PRIMARY","title":"Point-prevalent Abstinence (PPA)","description":"Number of participants reporting not using tobacco at week 12","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 12","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}]}]},{"type":"PRIMARY","title":"Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)","description":"The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"At Baseline (1 day)","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40.2","spread":"9.5"},{"groupId":"OG001","value":"43.1","spread":"11.3"}]}]}]},{"type":"PRIMARY","title":"Mean Scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)","description":"The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"At week 6","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.3","spread":"10.8"},{"groupId":"OG001","value":"37.2","spread":"10.6"}]}]}]},{"type":"PRIMARY","title":"Mean Scores at Week-12 on the Brief Psychiatric Rating Scale (BPRS)","description":"The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"At week 12","groups":[{"id":"OG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"},{"id":"OG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.2","spread":"11.8"},{"groupId":"OG001","value":"38.2","spread":"9.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Up to 12 weeks","eventGroups":[{"id":"EG000","title":"PARQuit: Game-based Physical Activity Group","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nVideogame-based physical activity: videogame-based physical activity\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation","deathsNumAffected":0,"deathsNumAtRisk":49,"seriousNumAffected":0,"seriousNumAtRisk":49,"otherNumAffected":0,"otherNumAtRisk":49},{"id":"EG001","title":"PARQuit: Sedentary Videogame Group","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.\n\nSedentary videogame: sedentary videogame\n\nBupropion: Bupropion\n\nCounseling: Counseling for smoking cessation","deathsNumAffected":0,"deathsNumAtRisk":50,"seriousNumAffected":0,"seriousNumAtRisk":50,"otherNumAffected":0,"otherNumAtRisk":50},{"id":"EG002","title":"CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID","description":"The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system using the Kinect sensor. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.","deathsNumAffected":0,"deathsNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":0,"otherNumAtRisk":4},{"id":"EG003","title":"CLOSED - Videogame-based Physical (VIP) Sedentary Group, Pre-COVID","description":"The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff.\n\nParticipants in this group will also receive bupropion and counseling for smoking cessation.","deathsNumAffected":0,"deathsNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":0,"otherNumAtRisk":5}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Heather Leutwyler, PhD, RN, NP","organization":"University of California, San Francisco","email":"heather.leutwyler@ucsf.edu","phone":"415-514-1524"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2019-02-25","uploadDate":"2026-03-20T21:02","filename":"Prot_SAP_000.pdf","size":3012791}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2026-05-20","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D016540","term":"Smoking Cessation"},{"id":"D000073869","term":"Tobacco Smoking"},{"id":"D001523","term":"Mental Disorders"},{"id":"D014029","term":"Tobacco Use Disorder"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"},{"id":"D012907","term":"Smoking"},{"id":"D064424","term":"Tobacco Use"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"},{"id":"D003376","term":"Counseling"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D008605","term":"Mental Health Services"},{"id":"D004191","term":"Behavioral Disciplines and Activities"},{"id":"D003153","term":"Community Health Services"},{"id":"D006296","term":"Health Services"},{"id":"D005159","term":"Health Care Facilities Workforce and Services"}]}},"hasResults":true}