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Evaluation of Global Smart Drinking Goals Initiative (GSDG)

Primary Purpose

Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GSDG multi-component intervention
Sponsored by
HBSA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Institutionalized individuals

Sites / Locations

  • HBSARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GSDG Intervention

Comparison

Arm 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.

Comparison cities receiving no evidence-based interventions.

Outcomes

Primary Outcome Measures

Health and social harms related to alcohol use
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

Heavy/binge drinking
Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)
Underage drinking
Self-reported alcohol use
Perceived alcohol use and alcohol-related attitudes among family and friends
Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use
Alcohol expectancies
Expectations regarding positive and negative consequences of alcohol use
Awareness of alcohol policies
Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving
Perceived enforcement of alcohol policies
Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.
Awareness of chronic health risks associated with alcohol use
Self-reported knowledge of possible chronic health-related consequences of alcohol use (e.g., liver cirrhosis, coronary heart disease)
Awareness of alcohol health guidance labels and information
Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere
Consumption of no-alcohol and low-alcohol beer
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
Screening and brief intervention for heavy/binge drinking
Self-reported frequency and impacts, archival medical record data

Full Information

First Posted
August 21, 2017
Last Updated
March 16, 2022
Sponsor
HBSA
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1. Study Identification

Unique Protocol Identification Number
NCT03262259
Brief Title
Evaluation of Global Smart Drinking Goals Initiative
Acronym
GSDG
Official Title
Measurement and Evaluation of Global Smart Drinking Goals Initiative
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HBSA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Nine pairs of intervention and comparison cities followed over multiple years.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GSDG Intervention
Arm Type
Experimental
Arm 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 Title
Comparison
Arm Type
No Intervention
Arm Description
Comparison cities receiving no evidence-based interventions.
Intervention Type
Behavioral
Intervention Name(s)
GSDG multi-component intervention
Intervention Description
Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.
Primary Outcome Measure Information:
Title
Health and social harms related to alcohol use
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Heavy/binge drinking
Description
Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)
Time Frame
1 year
Title
Underage drinking
Description
Self-reported alcohol use
Time Frame
1 year
Title
Perceived alcohol use and alcohol-related attitudes among family and friends
Description
Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use
Time Frame
1 year
Title
Alcohol expectancies
Description
Expectations regarding positive and negative consequences of alcohol use
Time Frame
1 year
Title
Awareness of alcohol policies
Description
Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving
Time Frame
1 year
Title
Perceived enforcement of alcohol policies
Description
Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.
Time Frame
1 year
Title
Awareness of chronic health risks associated with alcohol use
Description
Self-reported knowledge of possible chronic health-related consequences of alcohol use (e.g., liver cirrhosis, coronary heart disease)
Time Frame
1 year
Title
Awareness of alcohol health guidance labels and information
Description
Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere
Time Frame
1 year
Title
Consumption of no-alcohol and low-alcohol beer
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
Time Frame
1 year
Title
Screening and brief intervention for heavy/binge drinking
Description
Self-reported frequency and impacts, archival medical record data
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 12 years old Parental consent is be required if under 18 years old Exclusion Criteria: Institutionalized individuals
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mallie J Paschall, Ph.D.
Phone
5108835753
Email
paschall@prev.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ted Miller, Ph.D.
Phone
301-593-7471
Email
miller@pire.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Miller, Ph.D.
Organizational Affiliation
HBSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
HBSA
City
Calverton
State/Province
Maryland
ZIP/Postal Code
20705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ted Miller, Ph.D.
Phone
301-593-7471
Email
miller@pire.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.
IPD Sharing Time Frame
Data will become available upon completion of the study for an indefinite period.
IPD Sharing Access Criteria
Not yet available.

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Evaluation of Global Smart Drinking Goals Initiative

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