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临床试验/NCT02064998
NCT02064998已完成不适用

Brief Alcohol Interventions With Mobile Phone Applications for University Students: Interventions Targeting Differing Risk Levels in Two Consecutive Randomized Controlled Trials

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 2,166 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,166
试验地点
2
主要终点
Change in estimated Blood Alcohol Concentration (eBAC)

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of three mobile phone applications, Promillekoll, PartyPlanner and TeleCoach among university student union members with problematic drinking. Two trials are conducted, one a three-armed randomized controlled study, and the second a two-armed randomized control study. Outcomes are measured in terms of changes in problematic alcohol use at follow up 6,12 and 18 weeks after baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and give feedback of estimated blood alcohol concentration levels. PartyPlanner also allows for planning an alcohol consumption event in advance and for later comparison of the plan with actual consumption. Study 1 compares these two apps with a control group. In Study 2, participants reporting alcohol consumption above the weekly recommended level are redirected to randomized assignment to an in-depth app, TeleCoach, which offers different exercises for reducing alcohol use. After 6 weeks the controls are offered the TeleCoach intervention for 6 weeks, and the first intervention group loses app access. In both studies, followup occurs 6, 12 and 18 weeks after baseline registration.

Hypotheses:

Study 1: 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 planning function in PartyPlanner will be associated with an increased decrease in alcohol consumption compared to only real-time use for Promillekoll.

Study 2: The proportion of participants with risky use above recommended levels will decline faster in the group that receives the intervention first, in comparison to controls.

详细描述

Objectives:

This is a composite study consisting of Study 1 and Study 2:

Study 1 evaluates the efficacy of two mobile phone applications, Promillekoll and PartyPlanner among university student union members at two or more universities in Sweden. The design is a three-armed randomized controlled trial, and outcomes are measured in terms of changes in problematic alcohol use at followup 6,12 and 18 weeks after baseline data collection. Both Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and feedback of estimated blood alcohol concentration (eBAC) levels. Both apps show the user when the estimated alcohol level is above 0.6%, a level that can lead to negative health consequences. PartyPlanner additionally provides the possibility of simulating and planning an alcohol consumption event in advance and later on comparing it with consumption at the actual event.

Study 2: At the 6 week followup participants reporting an alcohol consumption above the weekly recommended level in Sweden will be redirected into Study 2. They will be asked to stop using any prior app for alcohol use. Half the group will be randomized to the TeleCoach app intervention, which offers the user different exercises for reducing or abstaining from alcohol use, depending on the user's goal (reduction or abstinence). This group will have access to the app for 6 weeks. The other half of the participants will be randomized to a waitlist control group for 6 weeks. Six weeks into the study, the TeleCoach intervention group will lose access to the app, and the waitlist control group will be given access to the TeleCoach app for 6 weeks.

All participants (in both Study 1 and Study 2) will be followed up at 6, 12 and 18 weeks from initial baseline recruitment.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • membership in the included student unions

排除标准

  • 未提供

结局指标

主要结局

Change in estimated Blood Alcohol Concentration (eBAC)

时间窗: 6, 12 and 18 weeks

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

Alcohol Use Disorders Identification Test (AUDIT)

时间窗: 6, 12 and 18 weeks

Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).

次要结局

  • Quantity(6, 12 and 18 weeks)
  • Frequency(6, 12 and 18 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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