- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 17176
- Karolinska Institutet, department of clinical neuroscience
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Untreated control group
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Experimental: Promillekoll
Smartphone app monitoring alcohol use with feedback.
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Smartphone app monitoring alcohol use with feedback.
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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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 weeks
|
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).
|
7 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne H Berman, PhD, Karolinska Institutet
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/1126-31/1
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