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

Problematic Alcohol Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958398
• Other study ID #: 2012/1126-31/1
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: April 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4408
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Problematic Alcohol Use

Intervention

Behavioral:
• Promillekoll
Smartphone app monitoring alcohol use with feedback.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska institutet, Department of Clinical Neuroscience	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & 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;9:11. doi: 10.1186/1940-0640-9-11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUDIT-C	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
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).	7 weeks

External Links

•   Berman's research group profile