CClinicalTrials.gg
RecruitingNCT03262259GSDGUpdated Sep 3, 2025

Evaluation of Global Smart Drinking Goals Initiative

An interventional study of GSDG multi-component intervention in Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms, sponsored by HBSA. Recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by HBSA · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
36,000
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Institutionalized individuals
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36,000 participants (estimated)

Study arms

  • 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

  • No intervention
    Comparison

    Comparison cities receiving no evidence-based interventions.

Interventions

  • BehavioralGSDG 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. Heavy/binge drinking

    Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)

    Time frame: 1 year

  2. Underage drinking

    Self-reported alcohol use

    Time frame: 1 year

  3. Perceived alcohol use and alcohol-related attitudes among family and friends

    Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use

    Time frame: 1 year

  4. Alcohol expectancies

    Expectations regarding positive and negative consequences of alcohol use

    Time frame: 1 year

  5. Awareness of alcohol policies

    Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving

    Time frame: 1 year

  6. Perceived enforcement of alcohol policies

    Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.

    Time frame: 1 year

  7. 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)

    Time frame: 1 year

  8. Awareness of alcohol health guidance labels and information

    Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere

    Time frame: 1 year

  9. 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

    Time frame: 1 year

  10. Screening and brief intervention for heavy/binge drinking

    Self-reported frequency and impacts, archival medical record data

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • HBSA
    Calverton, Maryland 20705, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03262259
Lead sponsor
HBSA
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Sep 1, 2017
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 3, 2025

Study contacts

Mary V Gordon
Contact
gordon@pire.org
3017552752
Ted Miller, Ph.D.
Contact
miller@pire.org
301-593-7471
Ted Miller, Ph.D.
principal investigator · HBSA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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