Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-01 @ 2:30 PM
Study NCT ID:
NCT05273450
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention to Promote Use of Smoking Cessation Resources Among Adults Using Community Food Pantries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-17', 'size': 287295, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-07T10:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Awareness of the quitline', 'timeFrame': '3 months', 'description': 'How familiar are you with the Ohio Tobacco Quitline? (a) Not familiar at all - I have not heard about the quitline, (b) Somewhat familiar - I have heard of the quit line but have not used it, (c) Familiar - I have used their services but it was over a year ago, (d) Very familiar - I am currently connected to their services'}, {'measure': 'Use of the quitline', 'timeFrame': '3 months', 'description': 'After enrolling in this research study \\[past 3 months\\], did you receive a referral to the Ohio Tobacco Quitline? (a) Yes, and I enrolled, (b) Yes, but I did not enroll, (c) No'}, {'measure': 'Use of the quitline', 'timeFrame': '3 months', 'description': "In the past 3 months, which of the following methods did you try to stop smoking? 'Called the Ohio Tobacco Quitline' is checked"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation', 'Food Insecurity']}, 'descriptionModule': {'briefSummary': 'The primary objective of this pilot randomized controlled study is to raise awareness and use of an evidence-based tobacco cessation resource that is underutilized among smokers (the Ohio Tobacco Quitline), specifically targeting Cleveland-area residents who have experiences with food insecurity. The study will assess the feasibility and acceptability of conducting informational outreach on tobacco cessation resources in community settings in which there is a relatively high proportion of tobacco users (i.e., food pantries). The study will derive preliminary estimates regarding the effectiveness of tobacco cessation outreach, by assessing whether outreach activities result in changes in awareness/knowledge of the quitline and use/engagement of the quitline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 21 or older\n* Current tobacco smoker willing to receive information about quitting resources\n* Lives in Cuyahoga County, Ohio\n* Has a reliable telephone number and an email address\n\nExclusion Criteria:\n\n* Aged 20 or younger\n* Current non-smoker, or current smoking who is not willing to receive information about quitting resources\n* Lives outside Cuyahoga County, Ohio\n* Does not have a reliable telephone number and an email address'}, 'identificationModule': {'nctId': 'NCT05273450', 'briefTitle': 'An Intervention to Promote Use of Smoking Cessation Resources Among Adults Using Community Food Pantries', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Promoting Smoking Cessation Among Individuals With Food Insecurity: Promoting the Use of Evidence-Based Tobacco Cessation Resources Through Community Food Pantries', 'orgStudyIdInfo': {'id': 'Kim-MozeleskiStudy20211283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quitline Information with Reinforcement', 'interventionNames': ['Behavioral: Quitline Information with Reinforcement']}, {'type': 'NO_INTERVENTION', 'label': 'Quitline Information Only'}], 'interventions': [{'name': 'Quitline Information with Reinforcement', 'type': 'BEHAVIORAL', 'description': 'The intervention arm involves direct referral to the Ohio Tobacco Quitline, with up to two brief follow-up telephone calls from the research team to elicit motivation to quit, emphasize benefits of calling the quitline, encourage use and address concerns. Participants are surveyed at baseline and at 3-month follow-up to assess awareness and use of the quitline.', 'armGroupLabels': ['Quitline Information with Reinforcement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jin Kim-Mozeleski', 'investigatorAffiliation': 'Case Western Reserve University'}}}}