Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00169260
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proactive Health Intervention for Tobacco Users (Get PHIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 536}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivation to quit smoking, utilization of available resources, smoking cessation rate', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Measurement of emotional distress, and mediators/moderators of primary outcomes', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking', 'tobacco', 'behavior therapy'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '20434863', 'type': 'DERIVED', 'citation': 'McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of spirometry feedback and brief motivational counseling on long-term smoking outcomes: a comparison of smokers with and without lung impairment. Patient Educ Couns. 2010 Aug;80(2):280-3. doi: 10.1016/j.pec.2009.11.002.'}, {'pmid': '19524389', 'type': 'DERIVED', 'citation': 'McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of a brief motivational smoking cessation intervention the Get PHIT randomized controlled trial. Am J Prev Med. 2009 Aug;37(2):116-23. doi: 10.1016/j.amepre.2009.03.018. Epub 2009 Jun 12.'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.", 'detailedDescription': "The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old,\n* smoke greater than or equal to 15 cigarettes a day,\n* have an expired CO level greater than or equal to 10 ppm,\n* are not currently being treated for smoking cessation,\n* can read and write in English,\n* provide contact information,\n* agree to the study requirements,\n* have no medical contraindications for spirometry assessment,\n* and no an obvious cognitive or physical impairment that would preclude their ability to comprehend or fully participate in the study.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00169260', 'briefTitle': 'Proactive Health Intervention for Tobacco Users (Get PHIT)', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Proactive Cessation Intervention With Biomarker Feedback', 'orgStudyIdInfo': {'id': '5R01CA100341-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA100341-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intervention', 'interventionNames': ['Behavioral: motivational counseling']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Control', 'interventionNames': ['Behavioral: placebo']}], 'interventions': [{'name': 'motivational counseling', 'type': 'BEHAVIORAL', 'description': 'behavioral motivational counselling', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Group Health Cooperative', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jennifer B McClure, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}