Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
1 other identifier
interventional
4,408
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 6, 2013
CompletedFirst Posted
Study publicly available on registry
October 9, 2013
CompletedApril 30, 2019
April 1, 2019
3 months
October 6, 2013
April 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in estimated Blood Alcohol Concentration (eBAC)
Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.
7 weeks
Secondary Outcomes (2)
AUDIT-C
7 weeks
Alcohol Use Disorders Identification Test (AUDIT)
7 weeks
Study Arms (3)
Promillekoll
EXPERIMENTALSmartphone app monitoring alcohol use with feedback.
PartyPlanner
EXPERIMENTALSmartphone-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.
Control
NO INTERVENTIONUntreated control group
Interventions
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.
Eligibility Criteria
You may qualify if:
- Access to a smartphone running iOS or Android OS.
- AUDIT \>7 for men or AUDIT \>5 for women.
You may not qualify if:
- AUDIT \<8 (men) or \<6 (women)
- No access to a smartphone running iOS or Android OS.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska institutet, Department of Clinical Neuroscience
Stockholm, 17176, Sweden
Related Publications (1)
Gajecki M, Berman AH, Sinadinovic K, Rosendahl I, Andersson C. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study. Addict Sci Clin Pract. 2014 Jul 2;9(1):11. doi: 10.1186/1940-0640-9-11.
PMID: 24985342RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Anne H Berman, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 6, 2013
First Posted
October 9, 2013
Study Start
February 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 30, 2019
Record last verified: 2019-04