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

Primary Purpose

Problematic Alcohol Use

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Promillekoll
PartyPlanner
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problematic Alcohol Use focused on measuring Randomized Controlled Trial, Alcohol, Internet, Mobile phone, Screening, Brief intervention

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska institutet, Department of Clinical Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Promillekoll

PartyPlanner

Control

Arm Description

Smartphone app monitoring alcohol use with feedback.

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.

Untreated control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).

Full Information

First Posted
October 6, 2013
Last Updated
April 28, 2019
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01958398
Brief Title
Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
Official Title
Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problematic Alcohol Use
Keywords
Randomized Controlled Trial, Alcohol, Internet, Mobile phone, Screening, Brief intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
4408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Promillekoll
Arm Type
Experimental
Arm Description
Smartphone app monitoring alcohol use with feedback.
Arm Title
PartyPlanner
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Untreated control group
Intervention Type
Behavioral
Intervention Name(s)
Promillekoll
Intervention Description
Smartphone app monitoring alcohol use with feedback.
Intervention Type
Behavioral
Intervention Name(s)
PartyPlanner
Intervention Description
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 Outcome Measure Information:
Title
Change in estimated Blood Alcohol Concentration (eBAC)
Description
Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
AUDIT-C
Description
The change in score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
Time Frame
7 weeks
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska institutet, Department of Clinical Neuroscience
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24985342
Citation
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.
Results Reference
result
Links:
URL
http://ki.se/people/anberm
Description
Berman's research group profile

Learn more about this trial

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

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