Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-30 @ 8:39 PM
Study NCT ID:
NCT01242657
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2010-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quit and Fit: Teen Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2010-11-11', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking cessation: quit and reduction rates', 'timeFrame': '6 months', 'description': 'The primary aim of the current research project is to reduce smoking among West Virginia teens.'}], 'secondaryOutcomes': [{'measure': 'Participants´ physical activity behavior', 'timeFrame': '6 months', 'description': 'Increase participants´ physical activity behavior by supplementing the intervention with a physical activity component.'}, {'measure': 'Impact of physical activity on cessation outcomes', 'timeFrame': '6 months', 'description': 'Assess the mediating/moderating impact of physical activity on cessation outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tobacco Use Cessation', 'Youth Tobacco Use', 'Physical Activity', 'Smoking Cessation Intervention'], 'conditions': ['Tobacco Use Cessation']}, 'referencesModule': {'references': [{'pmid': '11716656', 'type': 'BACKGROUND', 'citation': 'Dino G, Horn K, Goldcamp J, Fernandes A, Kalsekar I, Massey C. A 2-year efficacy study of Not On Tobacco in Florida: an overview of program successes in changing teen smoking behavior. Prev Med. 2001 Dec;33(6):600-5. doi: 10.1006/pmed.2001.0932.'}, {'pmid': '18286372', 'type': 'BACKGROUND', 'citation': 'Dino G, Horn K, Abdulkadri A, Kalsekar I, Branstetter S. Cost-effectiveness analysis of the Not On Tobacco program for adolescent smoking cessation. Prev Sci. 2008 Mar;9(1):38-46. doi: 10.1007/s11121-008-0082-0. Epub 2008 Feb 20.'}, {'pmid': '18804924', 'type': 'BACKGROUND', 'citation': 'Branstetter SA, Horn K, Dino G, Zhang J. Beyond quitting: predictors of teen smoking cessation, reduction and acceleration following a school-based intervention. Drug Alcohol Depend. 2009 Jan 1;99(1-3):160-8. doi: 10.1016/j.drugalcdep.2008.07.011. Epub 2008 Sep 19.'}, {'pmid': '23578440', 'type': 'DERIVED', 'citation': 'Horn K, Branstetter S, Zhang J, Jarrett T, Tompkins NO, Anesetti-Rothermel A, Olfert M, Richards T, Dino G. Understanding physical activity outcomes as a function of teen smoking cessation. J Adolesc Health. 2013 Jul;53(1):125-31. doi: 10.1016/j.jadohealth.2013.01.019. Epub 2013 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The long term goal of the study entitled "Quit \\& Fit" was to revise, evaluate, and disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not On Tobacco (N-O-T), with an added physical activity module. The physical activity module was intended to encourage youth to adopt a more physically active lifestyle. Research showed that physical activity may increase the odds of smoking cessation. The general N-O-T program goals are to help adolescents quit smoking; reduce cigarette use (for participants who are unable to completely quit); increase healthy lifestyle behaviors; and improve life skills such as stress management, decision making, communication, and interpersonal skills. The primary aim of the current research project was to reduce smoking among West Virginia teens. A two-prong secondary aim was to (a) increase participants´ physical activity behavior by supplementing the intervention with a physical activity component and (b) assess the mediating/moderating impact of physical activity on cessation outcomes. If participants quit smoking, the likelihood that they will develop smoking-related diseases is diminished. Participating in this project may aid smoking cessation and therefore improve participants´ health. Research was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited to participate in the study over 3 years. This study is a clinical behavioral trial using a 3-group design, with subsequent random assignment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be eligible to participate in this study if they:\n\n 1. Volunteer to participate\n 2. Are between the ages of 14-18\n 3. Obtain written parental consent•\n 4. Provide written assent\n 5. Report smoking on at least 1 day in the past 30 days\n 6. Speak and understand English •NOTE: Teens ages 18 or older will provide consent rather than assent. Parental consent will not be required.\n\nExclusion Criteria:\n\n* WV high schools will be excluded from participating in the research study if school enrollment does not meet or exceed 300 students in grades 9-12.'}, 'identificationModule': {'nctId': 'NCT01242657', 'briefTitle': 'Quit and Fit: Teen Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Quit and Fit: Exploring the Effects of Physical Activity on Teen Smoking Cessation', 'orgStudyIdInfo': {'id': 'CDCU48/CCU310821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Brief Advice', 'description': 'Standard of care arm with no intervention; includes standard communication regarding youth tobacco cessation such as a brief discussion and printed materials'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Not On Tobacco (N-O-T) Program', 'description': 'Teens randomized to this arm participated in the N-O-T program, a proven teen cessation program.', 'interventionNames': ['Behavioral: Not On Tobacco (N-O-T) Program']}, {'type': 'EXPERIMENTAL', 'label': 'Quit & Fit', 'description': 'Teens randomized to this arm participated in the Not On Tobacco (N-O-T) program with an added physical activity module.', 'interventionNames': ['Behavioral: Physical Activity Module', 'Behavioral: Not On Tobacco (N-O-T) Program']}], 'interventions': [{'name': 'Physical Activity Module', 'type': 'BEHAVIORAL', 'description': 'Participants were provided pedometers in order to track specific "Step Goals", which were defined for male or female participants. In addition, each participant recorded other forms of physical activity in a "Challenge Log".', 'armGroupLabels': ['Quit & Fit']}, {'name': 'Not On Tobacco (N-O-T) Program', 'type': 'BEHAVIORAL', 'description': 'Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program', 'armGroupLabels': ['Not On Tobacco (N-O-T) Program', 'Quit & Fit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Kimberly Horn, EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}, {'name': 'Melissa Taylor, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'West Virginia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Penn State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}