Clinical trial NCT03262259: Evaluation of Global Smart Drinking Goals Initiative
Official title: Measurement and Evaluation of Global Smart Drinking Goals Initiative
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms
Lead sponsor: HBSA
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 36000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nine pairs of intervention and comparison cities followed over multiple years.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Institutionalized individuals

Primary outcomes:
measure: Health and social harms related to alcohol use
timeFrame: 1 year
Secondary outcomes:
measure: Heavy/binge drinking
timeFrame: 1 year
measure: Underage drinking
timeFrame: 1 year
measure: Perceived alcohol use and alcohol-related attitudes among family and friends
timeFrame: 1 year
measure: Alcohol expectancies
timeFrame: 1 year
measure: Awareness of alcohol policies
timeFrame: 1 year
measure: Perceived enforcement of alcohol policies
timeFrame: 1 year
measure: Awareness of chronic health risks associated with alcohol use
timeFrame: 1 year
measure: Awareness of alcohol health guidance labels and information
timeFrame: 1 year
measure: Consumption of no-alcohol and low-alcohol beer
timeFrame: 1 year
measure: Screening and brief intervention for heavy/binge drinking
timeFrame: 1 year
Other outcomes:
Locations:
city: Calverton
country: United States
facility: HBSA
state: Maryland
Study officials:
affiliation: HBSA
name: Ted Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: