Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-15 @ 2:16 AM
Study NCT ID:
NCT05732220
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile EMA-based Peer Counselling for Youth Smokers
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-04', 'studyFirstSubmitDate': '2023-02-05', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Through recruitment completion, about 6 months', 'description': 'Proportion of participants among all eligible subjects'}, {'measure': 'Retention rate', 'timeFrame': '6 months after randomisation', 'description': 'Proportion of participants responding to telephone follow-up'}], 'primaryOutcomes': [{'measure': 'Biochemically-validated tobacco abstinence', 'timeFrame': '6 months after randomisation', 'description': 'Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)'}], 'secondaryOutcomes': [{'measure': 'Self-reported 7-day point-prevalence tobacco abstinence', 'timeFrame': '3 months after randomisation', 'description': 'Being completely smoke-free in the past 7 days'}, {'measure': 'Self-reported 7-day point-prevalence tobacco abstinence', 'timeFrame': '6 months after randomisation', 'description': 'Being completely smoke-free in the past 7 days'}, {'measure': 'Self-reported 30-day point-prevalence tobacco abstinence', 'timeFrame': '3 months after randomisation', 'description': 'Being completely smoke-free in the past 30 days'}, {'measure': 'Self-reported 30-day point-prevalence tobacco abstinence', 'timeFrame': '6 months after randomisation', 'description': 'Being completely smoke-free in the past 30 days'}, {'measure': 'Smoking reduction by at least 50%', 'timeFrame': '3 months after randomisation', 'description': 'Smoking reduction by at least half of the baseline daily number of cigarettes'}, {'measure': 'Smoking reduction by at least 50%', 'timeFrame': '6 months after randomisation', 'description': 'Smoking reduction by at least half of the baseline daily number of cigarettes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['counselling', 'ecological momentary assessment', 'young smoker', 'mobile health', 'adolescsent', 'quitline', 'Chinese'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '18566161', 'type': 'BACKGROUND', 'citation': 'Chan SS, Wong DC, Fong DY, Leung AY, Lam DO, Mak YW, Lam TH. The establishment and promotion of the first Youth Quitline in Hong Kong: challenges and opportunities. Eval Health Prof. 2008 Sep;31(3):258-71. doi: 10.1177/0163278708320156. Epub 2008 Jun 19.'}, {'pmid': '18509902', 'type': 'BACKGROUND', 'citation': 'Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.'}, {'pmid': '21942749', 'type': 'BACKGROUND', 'citation': 'Van Zundert RM, Ferguson SG, Shiffman S, Engels R. Dynamic effects of craving and negative affect on adolescent smoking relapse. Health Psychol. 2012 Mar;31(2):226-34. doi: 10.1037/a0025204. Epub 2011 Sep 26.'}, {'pmid': '29737885', 'type': 'BACKGROUND', 'citation': 'McClure EA, Tomko RL, Carpenter MJ, Treiber FA, Gray KM. Acceptability and compliance with a remote monitoring system to track smoking and abstinence among young smokers. Am J Drug Alcohol Abuse. 2018;44(5):561-570. doi: 10.1080/00952990.2018.1467431. Epub 2018 May 8.'}, {'pmid': '29148565', 'type': 'BACKGROUND', 'citation': 'Fanshawe TR, Halliwell W, Lindson N, Aveyard P, Livingstone-Banks J, Hartmann-Boyce J. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD003289. doi: 10.1002/14651858.CD003289.pub6.'}]}, 'descriptionModule': {'briefSummary': 'This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers.', 'detailedDescription': 'Most smokers begin smoking during adolescence and early adulthood, a crucial period to prevent initiation and continuation of smoking. However, many proven smoking cessation interventions for adult smokers were not found effective in youth smokers, which may be partly explained by the vast differences in the pattern of tobacco use and determinants of quitting between adult and youth smokers. This calls for more research on novel intervention models to help young smokers quit.\n\nThe HKU Youth Quitline provides free smoking cessation support for smokers aged below 25 years since August 2005 in Hong Kong. The service provides multisession peer-led telephone counselling with an individualised quit plan devised for each young smoker according to their responses. Since the counselling model depends on the information retrospectively recalled by the smokers, it may be prone to recall and social desirability biases and fail to capture the variability of youth smoking patterns and momentary changes in personal (e.g., mood) and situational (e.g., peer smoking) antecedents of smoking episodes.\n\nRecent advances in mobile technologies have enabled the use of more advanced and robust data collection approaches like ecological momentary assessment (EMA), which may benefit the counselling model by providing more ecologically valid data than traditional surveys. Previous studies have demonstrated the feasibility of using EMA to collect data on psychosocial processes and smoking behaviours in adolescent smokers. Therefore, we propose to develop and test a mobile EMA-based counselling intervention for youth smokers by conducting a pilot RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 15 to 25 years\n2. Have smoked in the past 30 days\n3. Own a smartphone with an mobile instant messaging app installed\n4. Can communicate in Chinese\n\nExclusion Criteria:\n\nYouth smokers who are participating in other smoking cessation studies or program other than the HKU Youth Quitline'}, 'identificationModule': {'nctId': 'NCT05732220', 'briefTitle': 'Mobile EMA-based Peer Counselling for Youth Smokers', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Mobile Ecological Momentary Assessment-based Peer Counselling for Youth Smokers: a Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '202111159206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMA+ group', 'description': 'EMA assessment + EMA-based cessation counselling', 'interventionNames': ['Behavioral: EMA assessment', 'Behavioral: EMA-based cessation counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EMA group', 'description': 'EMA assessment only + Usual peer counselling', 'interventionNames': ['Behavioral: EMA assessment', 'Behavioral: Usual peer counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Usual peer counselling', 'interventionNames': ['Behavioral: Usual peer counselling']}], 'interventions': [{'name': 'EMA assessment', 'type': 'BEHAVIORAL', 'description': 'Subjects will be asked to complete 3 waves of ecological momentary assessment (EMA) about smoking cues and smoking consumption via mobile phone at the first, second and third month after baseline (total 6 weeks)', 'armGroupLabels': ['EMA group', 'EMA+ group']}, {'name': 'EMA-based cessation counselling', 'type': 'BEHAVIORAL', 'description': "Subjects will receive tailored peer counselling based on the participants' EMA responses at 1-month and 3-month telephone follow-ups.", 'armGroupLabels': ['EMA+ group']}, {'name': 'Usual peer counselling', 'type': 'BEHAVIORAL', 'description': 'Subjects will receive peer counselling through telephone during follow-ups (usual care), in which the counsellor will apply the 5As model and motivational interviewing techniques.', 'armGroupLabels': ['Control', 'EMA group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'HKU Youth Quitline', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Tzu Tsun Luk, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Tzu Tsun Luk', 'investigatorAffiliation': 'The University of Hong Kong'}}}}