Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT01634334
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2012-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Household Air Quality in Homes With Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-13', 'studyFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Secondhand Smoke Reduction', 'timeFrame': 'Measured from baseline upto 5 months', 'description': 'Parental report and child urine cotinine.'}], 'secondaryOutcomes': [{'measure': 'Home Smoking Ban', 'timeFrame': 'Measured from baseline upto 5 months.', 'description': 'Parental report of home smoking ban and environmental data collection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Secondhand smoke'], 'conditions': ['Lung Diseases', 'Asthma']}, 'referencesModule': {'references': [{'pmid': '30770436', 'type': 'DERIVED', 'citation': 'Hovell MF, Bellettiere J, Liles S, Nguyen B, Berardi V, Johnson C, Matt GE, Malone J, Boman-Davis MC, Quintana PJE, Obayashi S, Chatfield D, Robinson R, Blumberg EJ, Ongkeko WM, Klepeis NE, Hughes SC; Fresh Air Research Group. Randomised controlled trial of real-time feedback and brief coaching to reduce indoor smoking. Tob Control. 2020 Mar;29(2):183-190. doi: 10.1136/tobaccocontrol-2018-054717. Epub 2019 Feb 15.'}, {'pmid': '29305069', 'type': 'DERIVED', 'citation': 'Hughes SC, Bellettiere J, Nguyen B, Liles S, Klepeis NE, Quintana PJE, Berardi V, Obayashi S, Bradley S, Hofstetter CR, Hovell MF. Randomized Trial to Reduce Air Particle Levels in Homes of Smokers and Children. Am J Prev Med. 2018 Mar;54(3):359-367. doi: 10.1016/j.amepre.2017.10.017. Epub 2018 Jan 2.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if real-time feedback (lights/sounds) from small smoke particle monitors and brief coaching will encourage parents to reduce young children's secondhand tobacco smoke exposure in their home.", 'detailedDescription': "The purpose of this efficacy study is to test whether children's home secondhand tobacco smoke exposure (measured by cotinine \\& nicotine assays, fine particulates and reports of smoking in the home and/or home smoking bans) can be reduced by using custom particle monitors to provide real-time feedback to household residents plus brief advice/praise."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Families with at least one parent or guardian (18 years of age or older),\n* Household resident who smokes tobacco,\n* Child under fourteen years old exposed to tobacco smoking in the home\n* Plans to live in San Diego County for at least three months.'}, 'identificationModule': {'nctId': 'NCT01634334', 'acronym': 'ProjFreshAir', 'briefTitle': 'Improving Household Air Quality in Homes With Children', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Innovation for Smoke-Free Homes: Real-Time Feedback', 'orgStudyIdInfo': {'id': 'R01HL103684', 'link': 'https://reporter.nih.gov/quickSearch/R01HL103684', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real-time Intervention', 'interventionNames': ['Behavioral: Real-Time Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Education', 'description': 'Participants will receive usual education about secondhand and thirdhand smoke.', 'interventionNames': ['Behavioral: Usual Education']}], 'interventions': [{'name': 'Real-Time Intervention', 'type': 'BEHAVIORAL', 'description': 'Lights and Sound Brief Coaching', 'armGroupLabels': ['Real-time Intervention']}, {'name': 'Usual Education', 'type': 'BEHAVIORAL', 'description': 'Participants will receive usual education about secondhand smoke and thirdhand smoke.', 'armGroupLabels': ['Usual Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'SDSU - Center for Behavioral Epidemiology and Community Health', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Melbourne F Hovell, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SDSU - Center for Behavioral Epidemiology and Community Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Melbourne Hovell', 'investigatorAffiliation': 'San Diego State University'}}}}