Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT07097194
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Be A Quitter: Illinois Small Business EX Program Dissemination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant enrollment', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of individuals that enroll'}, {'measure': 'Quit planning', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of steps completed for quit plan'}, {'measure': 'Business enrollment', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of businesses that enroll'}], 'secondaryOutcomes': [{'measure': 'General Quality of Life', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': '1 item quality of life measure from World Health Organization brief quality of life assessment (1-5, higher is better quality of life)'}, {'measure': 'General Health', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': '4 items from RAND (Research and Development) Corporation Short Form Health Survey (1-4, higher is better health)'}, {'measure': 'Work functioning', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': '1 item of general ability to function at work (1-5 scale, higher is better working functioning)'}, {'measure': 'Exercise', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': '1 item of frequency of exercise (1-6, higher is more weekly exercise)'}, {'measure': 'Psychological distress', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': 'Kessler 6 item psychological distress (1-5, higher is more distress)'}, {'measure': 'Alcohol Use', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': 'PROMIS (Patient-Reported Outcomes Measurement Information System) 7 item problematic alcohol use (1-5, higher is more problematic alcohol use)'}, {'measure': 'Anger', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': 'NIH PROMIS 5 item anger measure (1-5, higher is more anger)'}, {'measure': 'Couple Relationship Satisfaction', 'timeFrame': 'Baseline, 3 month, 6 month, 9 month, and 12 month follow-up', 'description': '4 item Couple Satisfaction Index (3-21 \\[summed score\\], higher is more satisfaction)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use']}, 'descriptionModule': {'briefSummary': 'Disseminate the EX tobacco cessation program to Illinois small businesses', 'detailedDescription': "This project is designed to provide small businesses throughout Illinois the opportunity to provide a proven tobacco cessation program to their employees at no or reduced cost to the business. The investigators will examine practices that facilitate dissemination of the program, employee usage, as well as benefits of enrollment for individual's mental health, workplace functioning, and family relationships."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Illinois\n* 18 years of age or older\n* Current tobacco user\n* Seeking to quit tobacco use and willing to participate in the EX program\n* Willing to answer surveys at 5 occasions over the course of a year\n* Employed at collaborating business in Illinois\n\nExclusion Criteria:\n\n* Not employed at collaborating business in Illinois'}, 'identificationModule': {'nctId': 'NCT07097194', 'briefTitle': 'Be A Quitter: Illinois Small Business EX Program Dissemination', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Be A Quitter: Illinois Small Business EX Program Dissemination', 'orgStudyIdInfo': {'id': '21520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EX program participant', 'description': 'Individual who signs up for digital tobacco cessation program (EX program)', 'interventionNames': ['Behavioral: EX program']}], 'interventions': [{'name': 'EX program', 'type': 'BEHAVIORAL', 'description': 'Quit plan with interactive exercises, educational videos, and tailored text messages and emails; peer support; coach chatting; nicotine replacement therapy (patches, gum, or lozenges). All components are self-selected.', 'armGroupLabels': ['EX program participant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Extension', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}