Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-27 @ 12:47 AM
Study NCT ID:
NCT03704402
Status:
UNKNOWN
Last Update Posted:
2018-10-12
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063425', 'term': 'Binge Drinking'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binge drinking 4 or more times within the last month', 'timeFrame': 'january 2019', 'description': 'Reduction in the number of students that drink 5 or more drinks on the same occasion 4 or more times within the last month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Policy', 'Binge Drinking']}, 'descriptionModule': {'briefSummary': 'The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies in 30 high schools in 2017 on students binge drinking.', 'detailedDescription': "In August 2017, 13 high schools in Zealand and all of Funen's 11 high schools and 6 high schools in Ringkøbing introduced new mutual alcohol policy for alcohol on study trips, parties, cafes and other social events.\n\nThe background for the introduction of the alcohol policies was the aim of reducing alcohol intake among students and that alcohol should have a less dominant role. By setting the same framework, the alcohol policies aims at promoting community, responsibility and respect.\n\nThe aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies on students binge drinking.\n\nThe analysis is a natural experiment that compare binge drinking among students at schools after the introduction of the policy with binge drinking among students a schools that did not introduce the policy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consist of high school students participating in the Danish National Youth Study 2014 and the Danish National High School Study 2019', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High school student\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03704402', 'briefTitle': "Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment", 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': "Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment", 'orgStudyIdInfo': {'id': '15/4155'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'alcohol policy group', 'description': 'High schools that introduced the policy', 'interventionNames': ['Other: Alcohol policy']}, {'label': 'control group', 'description': 'High schools that did not introduce the policy'}], 'interventions': [{'name': 'Alcohol policy', 'type': 'OTHER', 'description': 'Introduction of new mutual alcohol policy', 'armGroupLabels': ['alcohol policy group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Veronica Pisinger', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Denmark University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}