Effect of High School Alcohol Policies on Students' Binge... | NCT03704402

Studies
Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment

NCT03704402

Sponsor

University of Southern Denmark

Status

Unknown status

Last Update Posted

Oct 12, 2018Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Alcohol Policy
Binge Drinking

Interventions

Alcohol policy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Apr 30, 2019Estimated

Completion Date

Apr 30, 2019Estimated

First Submitted Date

Aug 10, 2018

First Submission Date that Met QC Criteria

Oct 11, 2018

First Posted Date

Oct 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2018

Last Update Posted Date

Oct 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies in 30 high schools in 2017 on students binge drinking.

Detailed Description

In August 2017, 13 high schools in Zealand and all of Funen's 11 high schools and 6 high schools in Ringkøbing introduced new mutual alcohol policy for alcohol on study trips, parties, cafes and other social events.

The background for the introduction of the alcohol policies was the aim of reducing alcohol intake among students and that alcohol should have a less dominant role. By setting the same framework, the alcohol policies aims at promoting community, responsibility and respect.

The aim of the project is to evaluate the effects of the introduction of new mutual alcohol policies on students binge drinking.

The analysis is a natural experiment that compare binge drinking among students at schools after the introduction of the policy with binge drinking among students a schools that did not introduce the policy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
alcohol policy group		High schools that introduced the policy	Other: Alcohol policy
control group		High schools that did not introduce the policy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alcohol policy	Other	Introduction of new mutual alcohol policy	alcohol policy group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Binge drinking 4 or more times within the last month	Reduction in the number of students that drink 5 or more drinks on the same occasion 4 or more times within the last month	january 2019

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High school student

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

The study population consist of high school students participating in the Danish National Youth Study 2014 and the Danish National High School Study 2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veronica Pisinger	Southern Denmark University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063425	Binge Drinking

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D000428	Alcohol Drinking

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000431	Ethanol

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided