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

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ClinicalTrials.gov Identifier: NCT01958398
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Problematic Alcohol Use Behavioral: Promillekoll Behavioral: PartyPlanner Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Promillekoll
Smartphone app monitoring alcohol use with feedback.
Behavioral: Promillekoll
Smartphone app monitoring alcohol use with feedback.

Experimental: 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.
Behavioral: 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.

No Intervention: Control
Untreated control group



Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958398


Locations
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Sweden
Karolinska institutet, Department of Clinical Neuroscience
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Anne H Berman, PhD Karolinska Institutet

Additional Information:
Publications of Results:
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Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01958398     History of Changes
Other Study ID Numbers: 2012/1126-31/1
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

Keywords provided by Anne H Berman, Karolinska Institutet:
Randomized Controlled Trial
Alcohol
Internet
Mobile phone
Screening
Brief intervention

Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs