Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:19 AM
Study NCT ID:
NCT07375459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-based Mobile-assisted Brief Intervention for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically validated smoking abstinence rate', 'timeFrame': '6 months', 'description': 'Defined as an exhaled carbon monoxide level of \\<5 parts per million or a negative salivary cotinine test (cut off 30ng/mL)'}, {'measure': 'Recruitment rate', 'timeFrame': '6 months', 'description': 'Number of participants divided by the number of eligible subjects'}, {'measure': 'Retention rate', 'timeFrame': '6 months', 'description': 'Number of participants completed the follow-up divided by the number of participants'}], 'secondaryOutcomes': [{'measure': 'Self-reported 7-day point-prevalence smoking abstinence rate', 'timeFrame': '3 months', 'description': 'Being completely smoke-free in the past 7 days'}, {'measure': 'Self-reported 7-day point-prevalence smoking abstinence rate', 'timeFrame': '6 months', 'description': 'Being completely smoke-free in the past 7 days'}, {'measure': 'Self-reported smoking reduction rate', 'timeFrame': '3 months', 'description': 'Smoking reduction by at least half of the baseline daily number of cigarettes in individuals who continue to smoke'}, {'measure': 'Self-reported smoking reduction rate', 'timeFrame': '6 months', 'description': 'Smoking reduction by at least half of the baseline daily number of cigarettes in individuals who continue to smoke'}, {'measure': 'Self-reported quit attempt rate', 'timeFrame': '3 months', 'description': 'Serious quit attempt that lasted 24 hours or longer'}, {'measure': 'Self-reported quit attempt rate', 'timeFrame': '6 months', 'description': 'Serious quit attempt that lasted 24 hours or longer'}, {'measure': 'Smoking cessation service use rate', 'timeFrame': '3 months', 'description': 'Use of any smoking cessation service during the follow-up period'}, {'measure': 'Smoking cessation service use rate', 'timeFrame': '6 months', 'description': 'Use of any smoking cessation service during the follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mHealth', 'WhatsApp', 'smoking cessation', 'chat-based intervention', 'Singapore'], 'conditions': ['Smoking &Amp; Tobacco Cessation']}, 'descriptionModule': {'briefSummary': "The goal of this pilot trial is to evaluate the feasibility of a mobile-assisted brief intervention for smoking cessation in community-based individuals in Singapore. Specific aims include:\n\n1. To assess how many eligible individuals accept the invitation to participate in the trial\n2. To assess the retention of the participants through 6 months after treatment initiation\n3. To assess the acceptability of the intervention in terms of participants' engagement and ratings\n4. To examine the intervention effect on abstinence outcomes\n\nParticipants will be randomly assigned to either the intervention group or control group and followed for 6 months from randomisation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 21 to 80 years\n* Smoked at least one cigarette daily\n* Able to communicate and read in English or Chinese\n* Own a smartphone with WhatsApp installed\n\nExclusion Criteria:\n\n* Exposed to any smoking cessation treatment in the past 3 months\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT07375459', 'briefTitle': 'Community-based Mobile-assisted Brief Intervention for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Mobile-assisted Brief Intervention for Smoking Cessation in Community-based Setting: a Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'NUS-IRB-2025-690'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile-assisted brief intervention', 'interventionNames': ['Behavioral: Brief cessation advice + self-help booklet', 'Behavioral: Opt-out referral', 'Behavioral: Mobile chat messaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief advice', 'interventionNames': ['Behavioral: Brief cessation advice + self-help booklet']}], 'interventions': [{'name': 'Brief cessation advice + self-help booklet', 'type': 'BEHAVIORAL', 'description': 'Participants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model and a 24-page self-help booklet.', 'armGroupLabels': ['Brief advice', 'Mobile-assisted brief intervention']}, {'name': 'Opt-out referral', 'type': 'BEHAVIORAL', 'description': 'Research personnel will assist the participant in signing up for the I Quit Programme to receive additional cessation support, unless they decline', 'armGroupLabels': ['Mobile-assisted brief intervention']}, {'name': 'Mobile chat messaging', 'type': 'BEHAVIORAL', 'description': "Participants will receive personalised chat-based support delivered by a live counsellor for 3 months via WhatsApp. The message will incorporate behaviour change techniques for smoking cessation and mindfulness principles to strengthen participants' capacity to quit smoking.", 'armGroupLabels': ['Mobile-assisted brief intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'contacts': [{'name': 'Tzu Tsun Luk, PhD, RN', 'role': 'CONTACT', 'email': 'luktt@nus.edu.sg', 'phone': '65-66015938'}, {'name': 'Joey TW Tyoh, BSc, RN', 'role': 'CONTACT', 'email': 'joey.tyoh@nus.edu.sg'}, {'name': 'Tzu Tsun Luk, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Tzu Tsun Luk, PhD, RN', 'role': 'CONTACT', 'email': 'luktt@nus.edu.sg', 'phone': '65-66015938'}, {'name': 'Joey TW Tyoh, BSc, RN', 'role': 'CONTACT', 'email': 'joey.tyoh@nus.edu.sg'}], 'overallOfficials': [{'name': 'Tzu Tsun Luk, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'LUK Tzu Tsun', 'investigatorAffiliation': 'National University of Singapore'}}}}