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一项测试“High schools High on life”干预措施减少丹麦高中过度饮酒效果的整群随机对照试验研究方案。

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.

机构信息

National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark

National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.

出版信息

BMJ Open. 2020 Aug 6;10(8):e038857. doi: 10.1136/bmjopen-2020-038857.

DOI:10.1136/bmjopen-2020-038857
PMID:32764089
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7412607/
Abstract

INTRODUCTION

This paper describes the evaluation design of the 'High schools High on life' intervention; a school-based intervention to reduce excessive drinking among high school students in Denmark. The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol.

METHODS AND DESIGN

The study will employ a cluster randomised controlled study design and will include a random sample of 16 high schools randomly allocated 1:1 to either intervention or control group. Target group: first year high school students. Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019. Delivery of intervention: April 2019 to March 2020. Follow-up survey: April to May 2020.

PRIMARY OUTCOME MEASURE

30% reduction in mean number of binge-drinking episodes (five or more alcoholic drinks on one occasion) within the last 30 days.

SECONDARY OUTCOME MEASURES

proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, proportion of students who agree to be able to have fun at a party without drinking and the proportion of students who think alcohol plays a too dominant part at the school. Implementation will be monitored through process evaluation.

ETHICS AND DISSEMINATION

The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr. 19021957). The study is registered at the Research an Innovation Office at University of Southern Denmark (ref: 10.314) allowing collection of personal data. Results will be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT03906500.

摘要

简介

本文介绍了“High schools High on life”干预措施的评估设计;这是一项在丹麦针对高中生过度饮酒问题的基于学校的干预措施。该干预措施包括学校环境组成部分,以限制学生在学校接触酒精;学校教育组成部分,改变一年级学生对酒精的社会规范;以及家长组成部分,解决家长对酒精的知识和态度。

方法与设计

该研究将采用集群随机对照研究设计,包括随机抽取的 16 所高中,随机分为干预组和对照组各 1:1。目标群体:一年级高中生。时间线:基线调查:2019 年 1 月至 3 月,作为 2019 年丹麦全国青年研究的一部分进行收集。干预措施实施:2019 年 4 月至 2020 年 3 月。随访调查:2020 年 4 月至 5 月。

主要结局指标

过去 30 天内 binge-drinking (一次性饮酒五杯或以上)的平均次数减少 30%。

次要结局指标

饮酒学生的比例、平均每周酒精摄入量、上一次学校派对时的饮酒量、上一次学校派对时在学校的饮酒量、同意在派对上不饮酒也能玩得开心的学生比例以及认为酒精在学校中扮演了过于主导角色的学生比例。实施情况将通过过程评估进行监测。

伦理与传播

丹麦首都大区科学伦理委员会已宣布该试验无需通知(jnr. 19021957)。该研究已在南丹麦大学创新办公室注册(编号:10.314),允许收集个人数据。研究结果将发表在同行评议的期刊上。

试验注册号

NCT03906500。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4187/7412607/2f3421161bc8/bmjopen-2020-038857f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4187/7412607/987f3b6aa416/bmjopen-2020-038857f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4187/7412607/95978925f1da/bmjopen-2020-038857f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4187/7412607/2f3421161bc8/bmjopen-2020-038857f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4187/7412607/987f3b6aa416/bmjopen-2020-038857f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4187/7412607/95978925f1da/bmjopen-2020-038857f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4187/7412607/2f3421161bc8/bmjopen-2020-038857f03.jpg

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