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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

Tracking Information
First Submitted Date  ICMJE October 6, 2013
First Posted Date  ICMJE October 9, 2013
Last Update Posted Date April 30, 2019
Study Start Date  ICMJE February 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
  • 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).
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
Official Title  ICMJE Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Problematic Alcohol Use
Intervention  ICMJE
  • Behavioral: Promillekoll
    Smartphone app monitoring alcohol use with feedback.
  • 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.
Study Arms  ICMJE
  • Experimental: Promillekoll
    Smartphone app monitoring alcohol use with feedback.
    Intervention: Behavioral: Promillekoll
  • 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.
    Intervention: Behavioral: PartyPlanner
  • No Intervention: Control
    Untreated control group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2013)
4408
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01958398
Other Study ID Numbers  ICMJE 2012/1126-31/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne H Berman, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne H Berman, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP