Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT05403957
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2022-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cluster RCT on TID
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2881}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2022-05-30', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TID beliefs', 'timeFrame': 'Immediately after the main intervention', 'description': "1. Tobacco industry's philanthropy is to care about community well-being.\n2. Tobacco industry does everything possible to make children smoke.\n3. Tobacco industry deceives the public for commercial gain.\n4. Tobacco industry uses many tactics to resist tobacco control regulations.\n\nAll the statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5 or 5-1, as appropriate, with higher scores indicating stronger TID beliefs."}, {'measure': 'Alternative smoking product (ASP)-related knowledge', 'timeFrame': 'Immediately after the main intervention', 'description': 'Electronic cigarettes (ECs) and heated tobacco products (HTPs) are less harmful than cigarettes.\n\nThe statement has 5 options from strongly disagree to strongly agree. The options were scored as 5-1, with higher scores indicating better knowledge.'}, {'measure': 'Risk perceptions of ASPs', 'timeFrame': 'Immediately after the main intervention', 'description': '1. Do you think trying a few puffs of ECs will harm your health?\n2. Do you think trying a few puffs of HTPs will harm your health?\n\nBoth statements have 11 options from not harmful at all to very harmful. The options were scored as 0-10, with higher scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'Acceptability of ASPs', 'timeFrame': 'Immediately after the main intervention', 'description': '1. Do you think it is acceptable for primary school students to try a few puffs of ECs?\n2. Do you think it is acceptable for primary school students to try a few puffs of HTPs?\n\nBoth statements have 11 options from very unacceptable to very acceptable. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'General views on the tobacco industry', 'timeFrame': 'Immediately after the main intervention', 'description': 'What do you think of the tobacco industry?\n\nThe statement has 11 options from very bad to very good. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.'}], 'secondaryOutcomes': [{'measure': 'Susceptibility to use ASPs', 'timeFrame': 'Immediately after the main intervention', 'description': '1. If your good friend passes you an EC, will you use it?\n2. Do you think you will use EC within the next 12 months?\n3. If your good friend passes you an HTP, will you use it?\n4. Do you think you will use HTP within the next 12 months?\n\nAll the statements have 5 options from definitely yes to definitely not. Responses were dichotomised as a binary outcome, students who chose "definitely not" for both items were deemed not susceptible to a specific smoking product and otherwise susceptible.'}, {'measure': 'TID beliefs', 'timeFrame': 'One month after the main intervention', 'description': '1. Tobacco industry conceals the harms of smoking products for commercial gain.\n2. Tobacco industry deceives the public for commercial gain.\n3. Tobacco industry uses many tactics to resist tobacco control regulations.\n\nAll the statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5, with higher scores indicating stronger TID beliefs.'}, {'measure': 'ASP-related knowledge', 'timeFrame': 'One month after the main intervention', 'description': '1. ECs and HTPs are less harmful than cigarettes.\n2. HTPs contain many carcinogens.\n\nBoth statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5 or 5-1, as appropriate, with higher scores indicating better knowledge.'}, {'measure': 'Risk perceptions of ASPs', 'timeFrame': 'One month after the main intervention', 'description': '1. Do you think trying a few puffs of ECs will harm your health?\n2. Do you think trying a few puffs of HTPs will harm your health?\n\nBoth statements have 11 options from not harmful at all to very harmful. The options were scored as 0-10, with higher scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'Acceptability of ASPs', 'timeFrame': 'One month after the main intervention', 'description': '1. Do you think it is acceptable for primary school students to try a few puffs of ECs?\n2. Do you think it is acceptable for primary school students to try a few puffs of HTPs?\n\nBoth statements have 11 options from very unacceptable to very acceptable. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'General views on the tobacco industry', 'timeFrame': 'One month after the main intervention', 'description': 'What do you think of the tobacco industry?\n\nThe statement has 11 options from very bad to very good. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'Susceptibility to use ASPs', 'timeFrame': 'One month after the main intervention', 'description': '1. If your good friend passes you an EC, will you use it?\n2. Do you think you will use EC within the next 12 months?\n3. If your good friend passes you an HTP, will you use it?\n4. Do you think you will use HTP within the next 12 months?\n\nAll the statements have 5 options from definitely yes to definitely not. Responses were dichotomised as a binary outcome, students who chose "definitely not" for both items were deemed not susceptible to a specific smoking product and otherwise susceptible.'}, {'measure': 'TID beliefs', 'timeFrame': 'Three months after the main intervention', 'description': '1. Tobacco industry uses many tactics to resist tobacco control regulations.\n2. Tobacco industry struggles to build a corporate image to improve tobacco products sales.\n\nBoth statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5, with higher scores indicating stronger TID beliefs.'}, {'measure': 'ASP-related Knowledge', 'timeFrame': 'Three months after the main intervention', 'description': '1. HTPs contain many carcinogens.\n2. ECs are less harmful than cigarettes.\n3. Secondhand aerosols of ECs and HTPs are less harmful.\n\nAll the statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5 or 5-1, as appropriate, with higher scores indicating better knowledge.'}, {'measure': 'Risk perceptions of ASPs', 'timeFrame': 'Three months after the main intervention', 'description': '1. Do you think trying a few puffs of ECs will harm your health?\n2. Do you think trying a few puffs of HTPs will harm your health?\n\nBoth statements have 11 options from not harmful at all to very harmful. The options were scored as 0-10, with higher scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'Acceptability of ASPs', 'timeFrame': 'Three months after the main intervention', 'description': '1. Do you think it is acceptable for primary school students to try a few puffs of ECs?\n2. Do you think it is acceptable for primary school students to try a few puffs of HTPs?\n\nBoth statements have 11 options from very unacceptable to very acceptable. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'General views on the tobacco industry', 'timeFrame': 'Three months after the main intervention', 'description': 'What do you think of the tobacco industry?\n\nThe statement has 11 options from very bad to very good. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.'}, {'measure': 'Susceptibility to use ASPs', 'timeFrame': 'Three months after the main intervention', 'description': '1. If your good friend passes you an EC, will you use it?\n2. Do you think you will use EC within the next 12 months?\n3. If your good friend passes you an HTP, will you use it?\n4. Do you think you will use HTP within the next 12 months?\n\nAll the statements have 5 options from definitely yes to definitely not. Responses were dichotomised as a binary outcome, students who chose "definitely not" for both items were deemed not susceptible to a specific smoking product and otherwise susceptible.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Industry', 'Denormalisation']}, 'descriptionModule': {'briefSummary': 'The brief intervention comprised the main intervention (tobacco industry denormalisation \\[TID\\] video, TID worksheet and sugar-sweetened beverages \\[SSB\\] worksheet) and booster intervention (worksheets where key contents in the main intervention reappeared).\n\nThe worksheets in the main intervention were printed in colour and contained eight pictures and eight texts which described the pictures. Students needed to match the pictures and texts. The booster worksheets contained the previous eight coloured pictures for the TID and SSB worksheet groups or six coloured screenshots from the TID video. Students needed to complete the six true or false questions based on the pictures provided.\n\nAssessments were conducted immediately (T1), two weeks (T2), one month (T3) and three months (T4) after the main intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parents' consent to their children's participation;\n* Parents and children could understand Chinese.\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT05403957', 'briefTitle': 'A Cluster RCT on TID', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Cluster Randomised Controlled Trial on Tobacco Industry Denormalisation', 'orgStudyIdInfo': {'id': 'TIDvideo202021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TID video', 'interventionNames': ['Other: TID video']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TID worksheet', 'interventionNames': ['Other: TID worksheet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SSB worksheet', 'interventionNames': ['Other: SSB worksheet']}], 'interventions': [{'name': 'TID video', 'type': 'OTHER', 'description': "Main intervention: A video introducing the tobacco industry's marketing tactics to attract children and adolescents to smoke and their manipulation of tobacco control policy formation.\n\nBooster intervention: 6 screenshots from the video and 6 true or false questions.", 'armGroupLabels': ['TID video']}, {'name': 'TID worksheet', 'type': 'OTHER', 'description': "Main intervention: A worksheet using pictures and texts to introduce the tobacco industry's marketing tactics to attract children and adolescents to smoke and their manipulation of tobacco control policy formation.\n\nBooster intervention: 8 pictures from the TID worksheet in the main intervention and 6 true or false questions.", 'armGroupLabels': ['TID worksheet']}, {'name': 'SSB worksheet', 'type': 'OTHER', 'description': "Main intervention: A worksheet using pictures and texts to introduce the beverage industry's marketing tactics to attract children and adolescents to drink SSBs and the health risks of SSBs.\n\nBooster intervention: 8 pictures from the SSB worksheet in the main intervention and 6 true or false questions.", 'armGroupLabels': ['SSB worksheet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Local primary schools', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'SAI YIN HO', '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': 'Principle investigator and associate professor', 'investigatorFullName': 'Dr. Daniel Sai-Yin Ho', 'investigatorAffiliation': 'The University of Hong Kong'}}}}