Alcohol PolicyNCT03704402
Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment
An observational study of Alcohol Policy and Binge Drinking, run by University of Southern Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Policy, Binge Drinking
- What is being tested?
- Alcohol policy
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- High school student
Who cannot join
- -
About this study
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.
Read the 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.
- Conditions
- Alcohol Policy, Binge Drinking
- Being tested
- Alcohol policy
- Medical subject headings
- Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol policyOther
Introduction of new mutual alcohol policy
| Study group | Role | What they receive |
|---|---|---|
| alcohol policy group | High schools that introduced the policy Receives: Other: Alcohol policy | |
| control group | High schools that did not introduce the policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: january 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Jan 2014
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol PolicyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronica Pisinger, Principal investigator, Southern Denmark University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704402
- Sponsor's protocol ID
- 15/4155
- Status last verified
- Oct 2018
- First submitted
- 10 Aug 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High School Alcohol Policies on Students' Binge Drinking- a Natural Experiment
- ClinicalTrials.gov ID
- NCT03704402
- Acronym / sponsor ID
- 15/4155
- Conditions
- Alcohol Policy, Binge Drinking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcohol policy group | – | Other: Alcohol policyHigh schools that introduced the policy |
| control group | – | –High schools that did not introduce the policy |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- High school student
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol policyIntroduction of new mutual alcohol policy | Other | alcohol policy group |
Primary outcome
Binge drinking 4 or more times within the last month
Time frame: january 2019
Reduction in the number of students that drink 5 or more drinks on the same occasion 4 or more times within the last month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Pisinger principal investigator
Southern Denmark University
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Policy and Binge Drinking, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge drinking 4 or more times within the last month (time frame: january 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.