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Evaluation of Global Smart Drinking Goals Initiative (GSDG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03262259
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
HBSA

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms Behavioral: GSDG multi-component intervention Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Nine pairs of intervention and comparison cities followed over multiple years.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Measurement and Evaluation of Global Smart Drinking Goals Initiative
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GSDG Intervention
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.
 Behavioral: GSDG multi-component intervention
Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.
No Intervention: Comparison
Comparison cities receiving no evidence-based interventions.


Outcome Measures
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Primary Outcome Measures :
  1. Health and social harms related to alcohol use [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Heavy/binge drinking [ Time Frame: 1 year ]
    Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)

  2. Underage drinking [ Time Frame: 1 year ]
    Self-reported alcohol use

  3. Perceived alcohol use and alcohol-related attitudes among family and friends [ Time Frame: 1 year ]
    Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use

  4. Alcohol expectancies [ Time Frame: 1 year ]
    Expectations regarding positive and negative consequences of alcohol use

  5. Awareness of alcohol policies [ Time Frame: 1 year ]
    Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving

  6. Perceived enforcement of alcohol policies [ Time Frame: 1 year ]
    Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.

  7. Awareness of chronic health risks associated with alcohol use [ Time Frame: 1 year ]
    Self-reported knowledge of possible chronic health-related consequences of alcohol use (e.g., liver cirrhosis, coronary heart disease)

  8. Awareness of alcohol health guidance labels and information [ Time Frame: 1 year ]
    Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere

  9. Consumption of no-alcohol and low-alcohol beer [ Time Frame: 1 year ]
    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

  10. Screening and brief intervention for heavy/binge drinking [ Time Frame: 1 year ]
    Self-reported frequency and impacts, archival medical record data


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 12 years old
  • Parental consent is be required if under 18 years old

Exclusion Criteria:

  • Institutionalized individuals
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262259


Contacts
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Contact: Mallie J Paschall, Ph.D. 5108835753 paschall@prev.org
Contact: Ted Miller, Ph.D. 301-593-7471 miller@pire.org

Locations
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United States, Maryland
HBSA Recruiting
Calverton, Maryland, United States, 20705
Contact: Ted Miller, Ph.D.    301-593-7471    miller@pire.org   
Sponsors and Collaborators
HBSA
Investigators
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Principal Investigator: Ted Miller, Ph.D. HBSA
More Information
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Responsible Party: HBSA
ClinicalTrials.gov Identifier: NCT03262259    
Other Study ID Numbers: 0881
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.
Supporting Materials: Study Protocol
Time Frame: Data will become available upon completion of the study for an indefinite period.
Access Criteria: Not yet available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Binge Drinking
Underage Drinking
Alcohol-Related Disorders
Substance-Related Disorders
 Chemically-Induced Disorders
Alcohol Drinking
Drinking Behavior
Mental Disorders