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临床试验/NCT01958398
NCT01958398已完成不适用

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

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 4,408 人开始时间: 2013年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4,408
试验地点
2
主要终点
Change in estimated Blood Alcohol Concentration (eBAC)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Control

No Intervention

Untreated control group

Promillekoll

Experimental

Smartphone app monitoring alcohol use with feedback.

干预措施: Promillekoll (Behavioral)

PartyPlanner

Experimental

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.

干预措施: PartyPlanner (Behavioral)

结局指标

主要结局

Change in estimated Blood Alcohol Concentration (eBAC)

时间窗: 7 weeks

Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.

次要结局

  • AUDIT-C(7 weeks)
  • Alcohol Use Disorders Identification Test (AUDIT)(7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne H Berman

Associate Professor

Karolinska Institutet

研究点 (2)

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