<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262259</url>
  </required_header>
  <id_info>
    <org_study_id>0881</org_study_id>
    <nct_id>NCT03262259</nct_id>
  </id_info>
  <brief_title>Evaluation of Global Smart Drinking Goals Initiative</brief_title>
  <acronym>GSDG</acronym>
  <official_title>Measurement and Evaluation of Global Smart Drinking Goals Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HBSA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HBSA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate effects of a multi-component, population-level intervention on&#xD;
      alcohol use and related harms in six intervention cities relative to six matched comparison&#xD;
      cities. Intervention components include screening and brief interventions by health&#xD;
      providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage&#xD;
      drinking laws), and novel or partially tested interventions that warrant further evaluation.&#xD;
      Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle&#xD;
      crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate effects of a multi-component, population-level intervention on&#xD;
      alcohol use and related harms in six intervention cities relative to six matched comparison&#xD;
      cities. The trial is expected to expand to nine intervention and nine comparison cities in&#xD;
      2018. Intervention components include screening and brief interventions by health providers,&#xD;
      other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking&#xD;
      laws), and novel or partially tested interventions that warrant further evaluation. Key&#xD;
      outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle&#xD;
      crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.&#xD;
&#xD;
      Multiple years of pre- and post-intervention survey data will be collected from&#xD;
      cross-sectional samples of adults and youth in each city to assess intervention effects on&#xD;
      harmful alcohol use. Multiple years of archival data will also be collected from each city to&#xD;
      assess intervention effects on alcohol-related harms such as motor vehicle crashes and&#xD;
      fatalities, violence and unintentional injuries. Multi-level analyses will be conducted with&#xD;
      data for the total sample of 18 cities and for each pair of cities to determine whether the&#xD;
      overall goal of reducing harmful alcohol use by at least 10% is achieved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Nine pairs of intervention and comparison cities followed over multiple years.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health and social harms related to alcohol use</measure>
    <time_frame>1 year</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heavy/binge drinking</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Underage drinking</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived alcohol use and alcohol-related attitudes among family and friends</measure>
    <time_frame>1 year</time_frame>
    <description>Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol expectancies</measure>
    <time_frame>1 year</time_frame>
    <description>Expectations regarding positive and negative consequences of alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness of alcohol policies</measure>
    <time_frame>1 year</time_frame>
    <description>Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived enforcement of alcohol policies</measure>
    <time_frame>1 year</time_frame>
    <description>Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness of chronic health risks associated with alcohol use</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported knowledge of possible chronic health-related consequences of alcohol use (e.g., liver cirrhosis, coronary heart disease)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness of alcohol health guidance labels and information</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of no-alcohol and low-alcohol beer</measure>
    <time_frame>1 year</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screening and brief intervention for heavy/binge drinking</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported frequency and impacts, archival medical record data</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36000</enrollment>
  <condition>Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms</condition>
  <arm_group>
    <arm_group_label>GSDG Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Comparison cities receiving no evidence-based interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GSDG multi-component intervention</intervention_name>
    <description>Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.</description>
    <arm_group_label>GSDG Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 12 years old&#xD;
&#xD;
          -  Parental consent is be required if under 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Institutionalized individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ted Miller, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>HBSA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mallie J Paschall, Ph.D.</last_name>
    <phone>5108835753</phone>
    <email>paschall@prev.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ted Miller, Ph.D.</last_name>
    <phone>301-593-7471</phone>
    <email>miller@pire.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HBSA</name>
      <address>
        <city>Calverton</city>
        <state>Maryland</state>
        <zip>20705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ted Miller, Ph.D.</last_name>
      <phone>301-593-7471</phone>
      <email>miller@pire.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Binge Drinking</mesh_term>
    <mesh_term>Underage Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will become available upon completion of the study for an indefinite period.</ipd_time_frame>
    <ipd_access_criteria>Not yet available.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262259
org study id: 0881
nct id: NCT03262259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.

      Multiple 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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Nine pairs of intervention and comparison cities followed over multiple years.
primary purpose: Prevention
masking: None (Open Label)
measure: Health and social harms related to alcohol use
time frame: 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
measure: Heavy/binge drinking
time frame: 1 year
description: Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)
measure: Underage drinking
time frame: 1 year
description: Self-reported alcohol use
measure: Perceived alcohol use and alcohol-related attitudes among family and friends
time frame: 1 year
description: Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use
measure: Alcohol expectancies
time frame: 1 year
description: Expectations regarding positive and negative consequences of alcohol use
measure: Awareness of alcohol policies
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 1 year
description: Self-reported frequency and impacts, archival medical record data
arm group label: GSDG Intervention
arm group type: Experimental
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.
arm group label: Comparison
arm group type: No Intervention
description: Comparison cities receiving no evidence-based interventions.
intervention type: Behavioral
intervention name: GSDG multi-component intervention
description: Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.
arm group label: GSDG Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ted Miller, Ph.D.
role: Principal Investigator
affiliation: HBSA
last name: Mallie J Paschall, Ph.D.
phone: 5108835753
email: paschall@prev.org
last name: Ted Miller, Ph.D.
phone: 301-593-7471
email: miller@pire.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Binge Drinking
mesh term: Underage Drinking
sharing ipd: Yes
ipd description: De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.
ipd info type: Study Protocol
ipd time frame: Data will become available upon completion of the study for an indefinite period.
ipd access criteria: Not yet available.