Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-27 @ 3:20 PM
Study NCT ID:
NCT03342768
Status:
COMPLETED
Last Update Posted:
2018-09-12
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An RCT of a Smartphone-based TID Programme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TID beliefs in parents', 'timeFrame': '1 month', 'description': 'Parents will report their opinions towards 4 sentences: 1) Tobacco companies are a respectable industry; 2) the tobacco industry does everything it can to get young people to smoke; 2) the tobacco industry use many tactics to resist tobacco control regulations; 4) the tobacco industry deceived the public for financial interests. All the 4 questions have 5 options from definitely yes to definitely no. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry. A sum of scores from the 4 questions will be deemed a measurement of TID beliefs.'}, {'measure': 'TID beliefs in children', 'timeFrame': '1 month', 'description': 'Students will report their opinions towards 4 sentences: 1) Tobacco companies are a respectable industry; 2) the tobacco industry does everything it can to get young people to smoke; 2) the tobacco industry use many tactics to resist tobacco control regulations; 4) the tobacco industry deceived the public for financial interests. All the 4 questions have 5 options from definitely yes to definitely no. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry. A sum of scores from the 4 questions will be deemed a measurement of TID beliefs.'}], 'secondaryOutcomes': [{'measure': 'Tobacco related communication reported by parents', 'timeFrame': '1 month', 'description': 'Parents will report whether they said the following to children in the past 30 days: 1) harm of smoking 2) harm of secondhand smoking 3) criticise smoking behaviour 4) approve tobacco control measures. Each of the messages will be analyse as a binary outcome.'}, {'measure': 'Sugar sweetened beverage (SSB) related communication reported by parents', 'timeFrame': '1 month', 'description': "Parents will report whether they said the following to children in the past 30 days: 1) harm of SSB 2) certain kind of drinks contain sugar 3) don't drink or drink less SSB. Each of the messages will be analyse as a binary outcome."}, {'measure': 'Tobacco related communication reported by children', 'timeFrame': '1 month', 'description': 'Students will report whether they heard the following from parents in the past 30 days: 1) harm of smoking 2) harm of secondhand smoking 3) criticize smoking behaviour 4) approve tobacco control measures. Each of the messages will be analyse as a binary outcome.'}, {'measure': 'SSB related communication reported by children', 'timeFrame': '1 month', 'description': "Students will report whether they heard the following from parents in the past 30 days: 1) harm of SSB 2) certain kind of drinks contain sugar 3) don't drink or drink less SSB. Each of the messages will be analyse as a binary outcome."}, {'measure': 'Intention to smoke in children', 'timeFrame': '1 month', 'description': 'Two questions will be used to assess this outcome: 1) do you think you will smoke in the next 12 months? 2) If one of your good friends offers you a cigarette, will you smoke it? Response options are definitely not/probably not/probably yes/definitely yes. Those choosing options other than "definitely not" for either of the questions will be deemed having intention to smoke; the other students will be deemed having no intention to smoke.'}, {'measure': 'Home exposure to secondhand smoke in children reported by children', 'timeFrame': '1 month', 'description': 'One question will be asked: 1) On how many of the past 7 days did someone smoke near you at home? (Options 0 day/1/2/3/4/5/6/7). The responses will dichotomised into a binary indicator of secondhand smoke exposure (no/any) and analysed as an outcome.'}, {'measure': 'Home exposure to secondhand smoke in children reported by parents', 'timeFrame': '1 month', 'description': 'One question will be asked: 1) On how many of the past 7 days did someone smoke near your children at home? (Options 0 day/1/2/3/4/5/6/7). The responses will dichotomised into a binary indicator of secondhand smoke exposure (no/any) and analysed as an outcome.'}, {'measure': "Parents' support for tobacco control", 'timeFrame': '1 month', 'description': "Parents will report their opinions towards 4 sentences: 1) government should adopt plain packaging; 2) government should impose stronger regulation on tobacco; 3) government should strengthen the prevention of the harm of tobacco. The options were strongly support/support/neutral/oppose/strongly oppose. The options will be recoded into 4-0, with higher scores indicating stronger support for tobacco control. A sum of scores from the 4 questions will be deemed a measurement of parents' support for tobacco control."}, {'measure': 'Negative attitude towards smoking in parents', 'timeFrame': '1 month', 'description': 'Parents will be asked "your attitude towards smoking is" with options of very positive/positive/neutral/negative/very negative. The options will be dichotomised as very negative vs others (negative/neutral/positive/very positive) for analysis.'}, {'measure': 'Negative attitude towards smoking in children', 'timeFrame': '1 month', 'description': 'Children will be asked "your attitude towards smoking is" with options of very positive/positive/neutral/negative/very negative. The options will be dichotomised as very negative vs others (negative/neutral/positive/very positive) for analysis.'}, {'measure': 'Past 7-day consumption of SSB and water in children reported by children', 'timeFrame': '1 month', 'description': 'Children will be asked "On how many of the past 7 days did you drink SSBs?" and "On how many of the past 7 days did you drink water?" For both questions, the options were 0/1/2/3/4/5/6/7 days. These two variables will be analysed as both binary (No (0 day) vs any (1/2/3/4/5/6/7 days)) and continuous variables.'}, {'measure': 'Past 7-day consumption of SSB and water in children reported by parents', 'timeFrame': '1 month', 'description': 'Parents will be asked "On how many of the past 7 days did you drink SSBs?" and "On how many of the past 7 days did you drink water?" For both questions, the options were 0/1/2/3/4/5/6/7 days. These two variables will be analysed as both binary (No (0 day) vs any (1/2/3/4/5/6/7 days)) and continuous variables.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Industry Denormalisation Beliefs', 'Tobacco-related Communications']}, 'descriptionModule': {'briefSummary': "The study aims to test the effect a smartphone-based intervention on primary school students and their parents' attitudes towards tobacco industry and their tobacco-related communications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents and children should all understand Chinese.\n* Parents should have a smartphone and use WhatsApp (a smartphone-based app)\n\nExclusion Criteria:\n\n* n/a'}, 'identificationModule': {'nctId': 'NCT03342768', 'briefTitle': 'An RCT of a Smartphone-based TID Programme', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Smartphone Messaging Programme for Tobacco Industry Denormalisation - a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'coshdrama'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TID', 'description': 'Messages will be sent 1-2 times per week containing information that aims to denormalise the tobacco industry.', 'interventionNames': ['Other: Smartphone-based messages']}, {'type': 'OTHER', 'label': 'Sugar sweetened beverages', 'description': 'Messages will be sent 1-2 times per week containing information on the adverse health effects of sugar sweetened beverages.', 'interventionNames': ['Other: Smartphone-based messages']}], 'interventions': [{'name': 'Smartphone-based messages', 'type': 'OTHER', 'description': "For the TID arm, the messages' contents include the tobacco industry's (TI's) anti-smoking campaigns that made smoking more grown-up and more appealing to youth; the TI's role in smoking in movies; etc.\n\nFor the sugar sweetened beverage (SSB) arm, the messages' contents include the disease conditions linked to SSBs, and the interference of sugar industry in scientific research.", 'armGroupLabels': ['Sugar sweetened beverages', 'TID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Local primary schools', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Sai Yin Ho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator and associate professor', 'investigatorFullName': 'Dr. Daniel Sai-Yin Ho', 'investigatorAffiliation': 'The University of Hong Kong'}}}}