Alcohol DrinkingNCT03906500
High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools
A study testing High schools High on Life in people with Alcohol Drinking, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- High schools High on Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,682 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2019to 30 Aug 2021
- Phase
- Interventional
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in High school that participate in The Danish National Youth Study 2019
- General High Schools
Who cannot join
- non General High schools students
- non participation in The Danish National Youth Study 2019
Trial locations and contacts
1 site in 1 country.
About this study
High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group. Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.
Read the detailed description
High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: based on sample size calculations investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group.
Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.
- Conditions
- Alcohol Drinking
- Being tested
- High schools High on Life
- Keywords
- Adolescence, Alcohol use, High school
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High schools High on LifeBehavioural
The intervention consist of three main components.
Environmental factors of the school environment
The component targeting the high school environment consisted of two separate elements:
- Revision of school alcohol policy
- Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee.
Student component
The Student components consisted of three main elements:
- Online education for the student committees organizing events where alcohol is sold and the student introduction committee
- Pocket movie campaign competition
- Social norms campaign
Parent component
The parent component consisted of three separate elements:
- Parent Information Meeting
- Parent Information Folder
- Parent Information Website
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consist of three main components.
School environmental component
The component targeting the high school environment consisted of two separate elements:
* Revision of school alcohol policy
* Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee.
Student components
The Student components consisted of three main elements:
* Web-based education for the student committees organizing events where alcohol is sold and the student introduction committee
* Pocket movie campaign
* Social norms campaign
Parent components
The parent component consisted of three separate elements:
* Parent Information Meeting
* Parent Information Folder
* Parent Information Website Receives: Behavioral: High schools High on Life |
| control group | No intervention | Control high schools was asked to continue business as usual and promised to receive the intervention in the school year starting in 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of binge drinking occasions within the last 30 days
30% lower number of binge drinking occasions within the last 30 days
Measured: 12 months
Secondary outcomes (4)
Weekly alcohol consumption
Mean weekly alcohol consumption
Measured: 12 months
Alcohol intake at last school party
Alcohol intake at last school party
Measured: 12 months
Alcohol intake at the school during last school party
Alcohol intake at the school during last school party
Measured: 12 months
Proportion that think alcohol play a too dominant part at the school
Proportion who think alcohol play a too dominant part at the school
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Apr 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Why it stopped: Due to the corona-crisis, we asses that it is not possible to carry out the effect-measurement as planned. The lockdown has strongly affected the young people's social life and alcohol use that could hide possible effects of the intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group.
- Masking
- None (open label)
- Enrolment
- 3,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Veronica Pisinger, University of Southern Denmark
- Investigators
- Veronica Pisinger, Principal investigator, the national institute of public health, Southern Denmark University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906500
- Sponsor's protocol ID
- 15/4155_2
- Status last verified
- Sep 2021
- First submitted
- 29 Mar 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pisinger VSC, Hoffmann SH, Palsson L, Dalum P, Gronbaek MK, Tolstrup JS, Thygesen LC, Krolner RF. 'High schools High on life': Development of an Intervention to Reduce Excessive Drinking in Danish High Schools. Front Public Health. 2020 Sep 15;8:435. doi: 10.3389/fpubh.2020.00435. eCollection 2020.
PubMed 33042935Pisinger VSC, Hoffmann S, Rosing JA, Gronbaek M, Tolstrup JS, Thygesen L, Krolner R. Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools. BMJ Open. 2020 Aug 6;10(8):e038857. doi: 10.1136/bmjopen-2020-038857.
PubMed 32764089
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools
- ClinicalTrials.gov ID
- NCT03906500
- Acronym / sponsor ID
- 15/4155_2
- Conditions
- Alcohol Drinking
- Keywords
- Adolescence, Alcohol use, High school
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the corona-crisis, we asses that it is not possible to carry out the effect-measurement as planned. The lockdown has strongly affected the young people's social life and alcohol use that could hide possible effects of the intervention.
- Enrolment
- 3,682 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 8 Apr 2019 (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.
High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group. Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.
Detailed description
High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: based on sample size calculations investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group.
Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: High schools High on LifeThe intervention consist of three main components. School environmental component The component targeting the high school environment consisted of two separate elements: * Revision of school alcohol policy * Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee. Student components The Student components consisted of three main elements: * Web-based education for the student committees organizing events where alcohol is sold and the student introduction committee * Pocket movie campaign * Social norms campaign Parent components The parent component consisted of three separate elements: * Parent Information Meeting * Parent Information Folder * Parent Information Website |
| control group | No intervention | –Control high schools was asked to continue business as usual and promised to receive the intervention in the school year starting in 2020 |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Enrolled in High school that participate in The Danish National Youth Study 2019
- General High Schools
Key exclusion criteria (2 listed)
- non General High schools students
- non participation in The Danish National Youth Study 2019
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 |
|---|---|---|
| High schools High on LifeThe intervention consist of three main components. Environmental factors of the school environment The component targeting the high school environment consisted of two separate elements: * Revision of school alcohol policy * Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee. Student component The Student components consisted of three main elements: * Online education for the student committees organizing events where alcohol is sold and the student introduction committee * Pocket movie campaign competition * Social norms campaign Parent component The parent component consisted of three separate elements: * Parent Information Meeting * Parent Information Folder * Parent Information Website | Behavioural | Intervention |
Primary outcome
Mean number of binge drinking occasions within the last 30 days
Time frame: 12 months
30% lower number of binge drinking occasions within the last 30 days
4 secondary outcomes
Weekly alcohol consumption
Time frame: 12 months
Alcohol intake at last school party
Time frame: 12 months
Alcohol intake at the school during last school party
Time frame: 12 months
Proportion that think alcohol play a too dominant part at the school
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Due to the corona-crisis, we asses that it is not possible to carry out the effect-measurement as planned. The lockdown has strongly affected the young people's social life and alcohol use that could hide possible effects of the intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 33042935Pisinger VSC, Hoffmann SH, Palsson L, Dalum P, Gronbaek MK, Tolstrup JS, Thygesen LC, Krolner RF. 'High schools High on life': Development of an Intervention to Reduce Excessive Drinking in Danish High Schools. Front Public Health. 2020 Sep 15;8:435. doi: 10.3389/fpubh.2020.00435. eCollection 2020.
- Derived from this study: PubMed 32764089Pisinger VSC, Hoffmann S, Rosing JA, Gronbaek M, Tolstrup JS, Thygesen L, Krolner R. Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools. BMJ Open. 2020 Aug 6;10(8):e038857. doi: 10.1136/bmjopen-2020-038857.
- Individual participant dataSharing planned: No
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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
the national institute of public health, Southern Denmark University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High schools High on Life in people with Alcohol Drinking, run by University of Southern Denmark at 1 site in 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Due to the corona-crisis, we asses that it is not possible to carry out the effect-measurement as planned. The lockdown has strongly affected the young people's social life and alcohol use that could hide possible effects of the intervention.). 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?
Mean number of binge drinking occasions within the last 30 days (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906500, which also lists 2 linked publications.
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 6 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.