Evaluation of Global Smart Drinking Goals Initiative

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

— GSDG  

Official title:

Measurement and Evaluation of Global Smart Drinking Goals Initiative

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03262259
• Other study ID #: 0881
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: HBSA
• Contact: Mallie J Paschall, Ph.D.
• Phone: 5108835753
• Email: paschall[@]prev.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• At least 12 years old

• Parental consent is be required if under 18 years old

Exclusion Criteria:

• Institutionalized individuals

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	HBSA	Calverton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
HBSA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	Heavy/binge drinking	Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)	1 year
Secondary	Underage drinking	Self-reported alcohol use	1 year
Secondary	Perceived alcohol use and alcohol-related attitudes among family and friends	Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use	1 year
Secondary	Alcohol expectancies	Expectations regarding positive and negative consequences of alcohol use	1 year
Secondary	Awareness of alcohol policies	Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving	1 year
Secondary	Perceived enforcement of alcohol policies	Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.	1 year
Secondary	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)	1 year
Secondary	Awareness of alcohol health guidance labels and information	Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere	1 year
Secondary	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	1 year
Secondary	Screening and brief intervention for heavy/binge drinking	Self-reported frequency and impacts, archival medical record data	1 year