Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT05777005
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Smoking Cessation in Campus
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation rate of eligible smokers', 'timeFrame': 'Baseline', 'description': 'the percentage of eligible smokers out of the total number of smokers screened'}, {'measure': 'Biochemical validated quit rate at 6 months follow-up', 'timeFrame': '6 months follow-up', 'description': 'The primary outcomes are biochemically validated quit rate (exhaled CO \\< 4 ppm or salivary cotinine \\< 30 ng/ml)'}], 'secondaryOutcomes': [{'measure': 'Biochemical validated quit rate at 3 months follow-up', 'timeFrame': '3 months follow-up', 'description': 'The primary outcomes are biochemically validated quit rate (exhaled CO \\< 4 ppm or salivary cotinine \\< 30 ng/ml) at 3-month in the two groups'}, {'measure': 'Self-reported 7-day point prevalence quit rate', 'timeFrame': '3 and 6 months follow-up', 'description': 'Self-reported 7-day point prevalence quit rate in the two groups'}, {'measure': 'Smoking reduction rate', 'timeFrame': '3 and 6 months follow-up', 'description': 'Rate of smoking reduction by at least half of baseline amount in the two groups'}, {'measure': 'Engagement in chatbot-led group support and/or counselor-led individual support', 'timeFrame': '3 and 6 months follow-up', 'description': 'Self-reported engagement in chatbot-led/counselor-led support in the two groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation', 'Mobile Health']}, 'referencesModule': {'references': [{'pmid': '39312291', 'type': 'DERIVED', 'citation': 'Weng X, Yin H, Liu K, Song C, Xie J, Guo N, Wang MP. Chatbot-Led Support Combined With Counselor-Led Support on Smoking Cessation in China: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 23;13:e58636. doi: 10.2196/58636.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to explore the feasibility, preliminary effectiveness, and implementation outcomes of chatbot-led smoking cessation support in community smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18 and above, reside in Zhuhai for the next 6 months;\n2. smoke at least 1 cigarette or use e-cigarettes daily;\n3. Having a smartphone and a WeChat account, being able to use WeChat skillfully.\n\nExclusion Criteria:\n\n1. Smokers who have communication barrier (either physically or cognitively);\n2. Smokers who are currently participating in other SC programmes or services'}, 'identificationModule': {'nctId': 'NCT05777005', 'briefTitle': 'Promoting Smoking Cessation in Campus', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Normal University'}, 'officialTitle': 'Promoting Smoking Cessation in Campus Via Smoking Cessation Contest: a Chatbot-based Smoking Cessation Intervention', 'orgStudyIdInfo': {'id': 'Smoking Cessation in Campus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': "5A's/5R's advice+ Chatbot-led group support+ Counselor-led individual support+ health warning leaflet+ Self-help booklet", 'interventionNames': ["Behavioral: 5A's/5R's advice", 'Other: Brief leaflet on health warning and smoking cessation', 'Other: Self-help smoking cessation booklet', 'Behavioral: Counselor-led individual support', 'Behavioral: Chatbot-led group support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': "5A's/5R's advice+ Chatbot-led group support+ health warning leaflet+ Self-help booklet", 'interventionNames': ["Behavioral: 5A's/5R's advice", 'Other: Brief leaflet on health warning and smoking cessation', 'Other: Self-help smoking cessation booklet', 'Behavioral: Chatbot-led group support']}], 'interventions': [{'name': "5A's/5R's advice", 'type': 'BEHAVIORAL', 'description': "5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.", 'armGroupLabels': ['Control group', 'Intervention group']}, {'name': 'Brief leaflet on health warning and smoking cessation', 'type': 'OTHER', 'description': 'The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.', 'armGroupLabels': ['Control group', 'Intervention group']}, {'name': 'Self-help smoking cessation booklet', 'type': 'OTHER', 'description': 'The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.', 'armGroupLabels': ['Control group', 'Intervention group']}, {'name': 'Counselor-led individual support', 'type': 'BEHAVIORAL', 'description': 'Participants will receive three months of counselor-led individual support via WeChat. The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.', 'armGroupLabels': ['Intervention group']}, {'name': 'Chatbot-led group support', 'type': 'BEHAVIORAL', 'description': 'Participants will receive three months of chatbot-led group support via WeChat.', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519087', 'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xue Weng', 'role': 'CONTACT', 'email': 'xueweng@bnu.edu.cn'}], 'facility': 'Beijing Normal University', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'Xue Weng', 'role': 'CONTACT', 'email': 'xueweng@bnu.edu.cn', 'phone': '3621259'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}