NCT03906500

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,682

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

March 29, 2019

Last Update Submit

September 28, 2021

Conditions

Keywords

AdolescenceAlcohol useHigh school

Outcome Measures

Primary Outcomes (1)

  • Mean number of binge drinking occasions within the last 30 days

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

    12 months

Secondary Outcomes (4)

  • Weekly alcohol consumption

    12 months

  • Alcohol intake at last school party

    12 months

  • Alcohol intake at the school during last school party

    12 months

  • Proportion that think alcohol play a too dominant part at the school

    12 months

Other Outcomes (3)

  • Social inclusion

    12 months

  • Marihuana use

    12 months

  • Other drug use

    12 months

Study Arms (2)

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

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

Interventions

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

Intervention

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Public Health

Copenhagen, 1455, Denmark

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Veronica Pisinger

    the national institute of public health, Southern Denmark University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistent

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 8, 2019

Study Start

April 1, 2019

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations