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Completed

NCT Number: NCT01958398

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

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).

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska institutet, Department of Clinical Neuroscience

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Promillekoll

Behavioral

Smartphone app monitoring alcohol use with feedback.

PartyPlanner

Behavioral

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.

Primary outcomes

  1. Change in estimated Blood Alcohol Concentration (eBAC)

    Time frame: 7 weeks

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

Secondary outcomes

  1. AUDIT-C

    Time frame: 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.

  2. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: 7 weeks

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 9, 2013
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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