Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04499456
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mediators and Moderators of a Web-based Intervention for Alcohol Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 685}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2020-07-31', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Typical alcohol use', 'timeFrame': '30 days', 'description': 'The number of typical drink units consumed'}, {'measure': 'Maximum alcohol use', 'timeFrame': '30 days', 'description': 'The number of maximum drink units consumed'}], 'secondaryOutcomes': [{'measure': 'Frequency of alcohol use', 'timeFrame': '30 days'}, {'measure': 'Total number of drink units', 'timeFrame': '30 days'}, {'measure': 'Number of consequences', 'timeFrame': '30 days', 'description': 'The number of consequences'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'Background: Alcohol use among college students causes health and social problems. However, even when available, many students do not access alcohol interventions. Web-based Personalized Normative Feedback (PNF) has been used to disseminate alcohol brief-interventions, and evidence supports PNF efficacy in reducing alcohol consumption among this population. On the other hand, studies on PNF mediators and moderators are scarce, limiting the knowledge on the mechanisms of change and conditions in which their effects occur. Objective: to evaluate whether normative perceptions mediate, and motivation to receive the intervention, moderates the effects of a web-based PNF intervention (Pesquisa Universitária sobre Bebidas - PUB 2.0) for alcohol use among Brazilian college students. Methods: Pragmatic randomized controlled trial among college students aged 18 and over and with follow-up assessments after 1, 3 and 6 months. Participants will be randomized into a Control group (assessment only) or to receive the updated version of the intervention (PUB 2.0). Outcomes are the typical number of drinks (primary outcome) and the total number of drinks consumed, drinking frequency, maximum number of drinks consumed and number of consequences (secondary outcomes). Statistical analyses will consider Structural Equation Models and significance level of 5%. This study will improve knowledge on how and in which conditions a web-based alcohol PNF effects occur, helping tailor future strategies to reduce the impact of alcohol problems among college students.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* College student\n* Alcohol use during the last year\n* Aged 18 or more years'}, 'identificationModule': {'nctId': 'NCT04499456', 'briefTitle': 'Mediators and Moderators of a Web-based Intervention for Alcohol Use', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Analysis of Mediators and Moderators of a Web-based Intervention for Alcohol Use Among College Students', 'orgStudyIdInfo': {'id': '2017/13831-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Waiting list control receiving the PNF after the last assessment', 'interventionNames': ['Other: Personalised Normative Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Single PNF', 'description': 'Receives PNF after the first assessment only', 'interventionNames': ['Other: Personalised Normative Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Boosted PNF', 'description': 'Receives PNF after every assessment', 'interventionNames': ['Other: Personalised Normative Feedback']}], 'interventions': [{'name': 'Personalised Normative Feedback', 'type': 'OTHER', 'description': 'The Personalised Normative Feedback provides information on 1) alcohol consumption (the number of drinks consumed, alcohol-pattern use, binge drinking); 2) normative comparisons; 3) alcohol-related consequences; 4) practical costs of alcohol consumption (money spent and calories consumed); 5) strategies to avoid or risks associated with alcohol use.', 'armGroupLabels': ['Boosted PNF', 'Control', 'Single PNF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023062', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'André Bedendo, PhD', 'role': 'CONTACT', 'email': 'andre.bedendo@unifesp.br', 'phone': '(011) 2149-0155'}], 'facility': 'Departamento de Psicobiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'André Bedendo', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}