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临床试验/NCT04499456
NCT04499456Unknown不适用

Analysis of Mediators and Moderators of a Web-based Intervention for Alcohol Use Among College Students

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 685 人开始时间: 2020年5月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
685
试验地点
2
主要终点
Typical alcohol use

研究概览

简要总结

Background: Alcohol use among college students causes health and social problems. However, even when available, many students do not access alcohol interventions. Web-based Personalized Normative Feedback (PNF) has been used to disseminate alcohol brief-interventions, and evidence supports PNF efficacy in reducing alcohol consumption among this population. On the other hand, studies on PNF mediators and moderators are scarce, limiting the knowledge on the mechanisms of change and conditions in which their effects occur. Objective: to evaluate whether normative perceptions mediate, and motivation to receive the intervention, moderates the effects of a web-based PNF intervention (Pesquisa Universitária sobre Bebidas - PUB 2.0) for alcohol use among Brazilian college students. Methods: Pragmatic randomized controlled trial among college students aged 18 and over and with follow-up assessments after 1, 3 and 6 months. Participants will be randomized into a Control group (assessment only) or to receive the updated version of the intervention (PUB 2.0). Outcomes are the typical number of drinks (primary outcome) and the total number of drinks consumed, drinking frequency, maximum number of drinks consumed and number of consequences (secondary outcomes). Statistical analyses will consider Structural Equation Models and significance level of 5%. This study will improve knowledge on how and in which conditions a web-based alcohol PNF effects occur, helping tailor future strategies to reduce the impact of alcohol problems among college students.

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 (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • College student
  • Alcohol use during the last year
  • Aged 18 or more years

排除标准

  • 未提供

结局指标

主要结局

Typical alcohol use

时间窗: 30 days

The number of typical drink units consumed

Maximum alcohol use

时间窗: 30 days

The number of maximum drink units consumed

次要结局

  • Frequency of alcohol use(30 days)
  • Total number of drink units(30 days)
  • Number of consequences(30 days)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

André Bedendo

Sponsor-Investigator

Federal University of São Paulo

研究点 (2)

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