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Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial

2019年4月28日 更新者:Anne H Berman、Karolinska Institutet

Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll and PartyPlanner among university government members at two universities in Stockholm, Sweden. The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and giving feedback of estimated blood alcohol concentration levels. Both apps inform and warn the user when the estimated alcohol level is above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally provides the possibility of simulating and planning an alcohol consumption event in advance and later on comparing it with the real time registration at the event.

Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the app assigned to them gathered after 7 weeks.

The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce their alcohol use to a larger extent than the control group at follow-up compared to the baseline level. 2. The addition of the possibility to plan events beforehand (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time use (Promillekoll).

研究概览

详细说明

Background Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students.

Methods Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks.

研究类型

介入性

注册 (实际的)

4408

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Stockholm、瑞典、17176
        • Karolinska Institutet, department of clinical neuroscience

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Access to a smartphone running iOS or Android OS.
  • AUDIT >7 for men or AUDIT >5 for women.

Exclusion Criteria:

  • AUDIT <8 (men) or <6 (women)
  • No access to a smartphone running iOS or Android OS.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:控制
未处理的对照组
实验性的:Promillekoll
Smartphone app monitoring alcohol use with feedback.
Smartphone app monitoring alcohol use with feedback.
实验性的:PartyPlanner
Smartphone-adapted web based app for simulating an event with alcohol consumption in advance, real time monitoring alcohol use with feedback during the event and the possibility to compare these two.
Smartphone-adapted web based app for simulating an event with alcohol consumption in advance, real time monitoring alcohol use with feedback during the event and the possibility to compare these two.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in estimated Blood Alcohol Concentration (eBAC)
大体时间:7 weeks
Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.
7 weeks

次要结果测量

结果测量
措施说明
大体时间
AUDIT-C
大体时间:7 weeks
The change in score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
7 weeks
Alcohol Use Disorders Identification Test (AUDIT)
大体时间:7 weeks
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
7 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Anne H Berman, PhD、Karolinska Institutet

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年2月1日

初级完成 (实际的)

2013年5月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2013年10月6日

首先提交符合 QC 标准的

2013年10月8日

首次发布 (估计)

2013年10月9日

研究记录更新

最后更新发布 (实际的)

2019年4月30日

上次提交的符合 QC 标准的更新

2019年4月28日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2012/1126-31/1

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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