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High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools

Primary Purpose

Alcohol Drinking

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High schools High on Life
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Adolescence, Alcohol use, High school

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Enrolled in High school that participate in The Danish National Youth Study 2019
  • General High Schools

Exclusion Criteria:

  • non General High schools students
  • non participation in The Danish National Youth Study 2019

Sites / Locations

  • National Institute of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control group

Arm Description

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

Control high schools was asked to continue business as usual and promised to receive the intervention in the school year starting in 2020

Outcomes

Primary Outcome Measures

Mean number of binge drinking occasions within the last 30 days
30% lower number of binge drinking occasions within the last 30 days

Secondary Outcome Measures

Weekly alcohol consumption
Mean weekly alcohol consumption
Alcohol intake at last school party
Alcohol intake at last school party
Alcohol intake at the school during last school party
Alcohol intake at the school during last school party
Proportion that think alcohol play a too dominant part at the school
Proportion who think alcohol play a too dominant part at the school

Full Information

First Posted
March 29, 2019
Last Updated
September 28, 2021
Sponsor
University of Southern Denmark
Collaborators
Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT03906500
Brief Title
High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools
Official Title
High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Danish Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Adolescence, Alcohol use, High school

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
3682 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control high schools was asked to continue business as usual and promised to receive the intervention in the school year starting in 2020
Intervention Type
Behavioral
Intervention Name(s)
High schools High on Life
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean number of binge drinking occasions within the last 30 days
Description
30% lower number of binge drinking occasions within the last 30 days
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weekly alcohol consumption
Description
Mean weekly alcohol consumption
Time Frame
12 months
Title
Alcohol intake at last school party
Description
Alcohol intake at last school party
Time Frame
12 months
Title
Alcohol intake at the school during last school party
Description
Alcohol intake at the school during last school party
Time Frame
12 months
Title
Proportion that think alcohol play a too dominant part at the school
Description
Proportion who think alcohol play a too dominant part at the school
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Social inclusion
Description
Proportion of students who feel included in the social community at school, including students that do not drink or have a low alcohol intake
Time Frame
12 months
Title
Marihuana use
Description
proportion of students who have smoked marihuana
Time Frame
12 months
Title
Other drug use
Description
Proportion who have tried other drugs than marihuana
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrolled in High school that participate in The Danish National Youth Study 2019 General High Schools Exclusion Criteria: non General High schools students non participation in The Danish National Youth Study 2019
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Pisinger
Organizational Affiliation
the national institute of public health, Southern Denmark University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Public Health
City
Copenhagen
ZIP/Postal Code
1455
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33042935
Citation
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.
Results Reference
derived
PubMed Identifier
32764089
Citation
Pisinger 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.
Results Reference
derived

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High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools

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