Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-04 @ 5:09 PM
Study NCT ID:
NCT03262259
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Global Smart Drinking Goals Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063425', 'term': 'Binge Drinking'}, {'id': 'D000066608', 'term': 'Underage 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'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Nine pairs of intervention and comparison cities followed over multiple years.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health and social harms related to alcohol use', 'timeFrame': '1 year', 'description': 'Self-reported problems related to alcohol use (e.g., drinking and driving, injury, unwanted sex, vandalism, property crime); alcohol-related motor vehicle crashes and fatalities'}], 'secondaryOutcomes': [{'measure': 'Heavy/binge drinking', 'timeFrame': '1 year', 'description': 'Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)'}, {'measure': 'Underage drinking', 'timeFrame': '1 year', 'description': 'Self-reported alcohol use'}, {'measure': 'Perceived alcohol use and alcohol-related attitudes among family and friends', 'timeFrame': '1 year', 'description': 'Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use'}, {'measure': 'Alcohol expectancies', 'timeFrame': '1 year', 'description': 'Expectations regarding positive and negative consequences of alcohol use'}, {'measure': 'Awareness of alcohol policies', 'timeFrame': '1 year', 'description': 'Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving'}, {'measure': 'Perceived enforcement of alcohol policies', 'timeFrame': '1 year', 'description': 'Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.'}, {'measure': 'Awareness of chronic health risks associated with alcohol use', 'timeFrame': '1 year', 'description': 'Self-reported knowledge of possible chronic health-related consequences of alcohol use (e.g., liver cirrhosis, coronary heart disease)'}, {'measure': 'Awareness of alcohol health guidance labels and information', 'timeFrame': '1 year', 'description': 'Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere'}, {'measure': 'Consumption of no-alcohol and low-alcohol beer', 'timeFrame': '1 year', 'description': 'Self-reported consumption (quantity and frequency) of no-alcohol and low-alcohol beer, no-alcohol and low-alcohol beer sales, underage use of no-alcohol and low-alcohol beer'}, {'measure': 'Screening and brief intervention for heavy/binge drinking', 'timeFrame': '1 year', 'description': 'Self-reported frequency and impacts, archival medical record data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms']}, 'descriptionModule': {'briefSummary': 'This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.', 'detailedDescription': 'This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. The trial is expected to expand to nine intervention and nine comparison cities in 2018. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.\n\nMultiple years of pre- and post-intervention survey data will be collected from cross-sectional samples of adults and youth in each city to assess intervention effects on harmful alcohol use. Multiple years of archival data will also be collected from each city to assess intervention effects on alcohol-related harms such as motor vehicle crashes and fatalities, violence and unintentional injuries. Multi-level analyses will be conducted with data for the total sample of 18 cities and for each pair of cities to determine whether the overall goal of reducing harmful alcohol use by at least 10% is achieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 12 years old\n* Parental consent is be required if under 18 years old\n\nExclusion Criteria:\n\n* Institutionalized individuals'}, 'identificationModule': {'nctId': 'NCT03262259', 'acronym': 'GSDG', 'briefTitle': 'Evaluation of Global Smart Drinking Goals Initiative', 'organization': {'class': 'OTHER', 'fullName': 'HBSA'}, 'officialTitle': 'Measurement and Evaluation of Global Smart Drinking Goals Initiative', 'orgStudyIdInfo': {'id': '0881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSDG Intervention', 'description': 'Cities receiving a multi-component intervention, including screening and brief intervention, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation.', 'interventionNames': ['Behavioral: GSDG multi-component intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison', 'description': 'Comparison cities receiving no evidence-based interventions.'}], 'interventions': [{'name': 'GSDG multi-component intervention', 'type': 'BEHAVIORAL', 'description': 'Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.', 'armGroupLabels': ['GSDG Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20705', 'city': 'Calverton', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ted Miller, Ph.D.', 'role': 'CONTACT', 'email': 'miller@pire.org', 'phone': '301-593-7471'}], 'facility': 'HBSA', 'geoPoint': {'lat': 39.05761, 'lon': -76.93581}}], 'centralContacts': [{'name': 'Mary V Gordon', 'role': 'CONTACT', 'email': 'gordon@pire.org', 'phone': '3017552752'}, {'name': 'Ted Miller, Ph.D.', 'role': 'CONTACT', 'email': 'miller@pire.org', 'phone': '301-593-7471'}], 'overallOfficials': [{'name': 'Ted Miller, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HBSA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will become available upon completion of the study for an indefinite period.', 'ipdSharing': 'YES', 'description': 'De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.', 'accessCriteria': 'Not yet available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HBSA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}