Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT01574560
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
P60 Program Project Grant-Outreach for Smoke-Free Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2012-04-05', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Home Secondhand Smoke levels', 'timeFrame': 'From Baseline to Week 26 Follow-Up', 'description': 'Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Child Cotinine Levels in Urine', 'timeFrame': 'From Baseline to Week 26 Follow-Up', 'description': 'Cotinine is an alkaloid found in tobacco and is also a metabolite of nicotine. Cotinine is used as a biomarker for exposure to tobacco smoke. Child (non-smoker) cotinine will be used as an objective measure of secondhand smoke exposure at baseline and again at end of study (week 26).'}, {'measure': 'Comparison of Questionnaire Results', 'timeFrame': 'Baseline, Week 16 and Week 26', 'description': 'Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoke-free', 'tobacco exposure', 'biomarker feedback', 'nicotine', 'cotinine', 'secondhand smoke'], 'conditions': ['Smoking Cessation', 'Tobacco Cessation']}, 'descriptionModule': {'briefSummary': "Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. This study focuses on learning how to make your home smoke-free.", 'detailedDescription': 'This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.\n\nThose randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (adult):\n\n* Age 18 years or older\n* Female\n* Smoked ≥ 1 cigarettes per day for at least the past 6 months\n* Smoked on 20 days or more in the last month\n* Smoking status confirmed via cotinine verification strips\n* Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver\n* Will agree to provide a urine sample at study enrollment\n* Will also agree to the child providing a urine sample at study enrollment and at follow-up visits (for children who are not toilet trained, a diaper sample will be collected in lieu of the urine sample)\n* Has a home address\n* Has a functioning home phone or cell phone\n* Provides written informed consent\n\nInclusion criteria (child):\n\n* \\< or = 10 years of age\n* Non-smoker -no cigarette use within prior 30 days to enrollment; however experimentation with smoking (a puff) will not exclude the child\n* Lives in the primary home with the adult study participant at least 5 days a week\n\nExclusion criteria (adult):\n\n* Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation\n* Planning to move outside of Minnesota within the next 3 months\n* Have complete home smoking restrictions currently in place verified by the nicotine dosimeter\n* Currently pregnant"}, 'identificationModule': {'nctId': 'NCT01574560', 'briefTitle': 'P60 Program Project Grant-Outreach for Smoke-Free Homes', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Community Outreach and Biomarker Feedback for Smoke-Free Homes', 'orgStudyIdInfo': {'id': '2009NTLS058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group - Health Education', 'description': 'This group is provided with information regarding secondhand smoke and creating a healthy home environment.', 'interventionNames': ['Behavioral: Brochure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group - Counseling', 'description': 'This group is provided with biomarker feedback on child exposure to secondhand smoke. Active participants receive 5 counseling sessions from a trained research counselor; 3 sessions in the home and 2 by phone. The counseling sessions focus on changing smoking behaviors and/or other behaviors that impact smoking.', 'interventionNames': ['Behavioral: Counseling']}], 'interventions': [{'name': 'Brochure', 'type': 'BEHAVIORAL', 'description': 'Information regarding secondhand smoke and creating a healthy home environment.', 'armGroupLabels': ['Control Group - Health Education']}, {'name': 'Counseling', 'type': 'BEHAVIORAL', 'description': 'Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.', 'armGroupLabels': ['Treatment Group - Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Janet L. Thomas, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}