Binge Drinking Clinical Trial
Official title:
Brief Alcohol Interventions With Mobile Phone Applications for University Students: Interventions Targeting Differing Risk Levels in Two Consecutive Randomized Controlled Trials
The purpose of this study is to evaluate the efficacy of three mobile phone applications,
Promillekoll, PartyPlanner and TeleCoach among university student union members with
problematic drinking. Two trials are conducted, one a three-armed randomized controlled
study, and the second a two-armed randomized control study. Outcomes are measured in terms
of changes in problematic alcohol use at follow up 6,12 and 18 weeks after baseline data
gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of
alcohol consumption and give feedback of estimated blood alcohol concentration levels.
PartyPlanner also allows for planning an alcohol consumption event in advance and for later
comparison of the plan with actual consumption. Study 1 compares these two apps with a
control group. In Study 2, participants reporting alcohol consumption above the weekly
recommended level are redirected to randomized assignment to an in-depth app, TeleCoach,
which offers different exercises for reducing alcohol use. After 6 weeks the controls are
offered the TeleCoach intervention for 6 weeks, and the first intervention group loses app
access. In both studies, followup occurs 6, 12 and 18 weeks after baseline registration.
Hypotheses:
Study 1: 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 planning function in PartyPlanner will be associated with an
increased decrease in alcohol consumption compared to only real-time use for Promillekoll.
Study 2: The proportion of participants with risky use above recommended levels will decline
faster in the group that receives the intervention first, in comparison to controls.
Objectives:
This is a composite study consisting of Study 1 and Study 2:
Study 1 evaluates the efficacy of two mobile phone applications, Promillekoll and
PartyPlanner among university student union members at two or more universities in Sweden.
The design is a three-armed randomized controlled trial, and outcomes are measured in terms
of changes in problematic alcohol use at followup 6,12 and 18 weeks after baseline data
collection. Both Promillekoll and PartyPlanner apps feature real time registration of
alcohol consumption and feedback of estimated blood alcohol concentration (eBAC) levels.
Both apps show the user when the estimated alcohol level is above 0.6%, a level that can
lead to negative health consequences. PartyPlanner additionally provides the possibility of
simulating and planning an alcohol consumption event in advance and later on comparing it
with consumption at the actual event.
Study 2: At the 6 week followup participants reporting an alcohol consumption above the
weekly recommended level in Sweden will be redirected into Study 2. They will be asked to
stop using any prior app for alcohol use. Half the group will be randomized to the TeleCoach
app intervention, which offers the user different exercises for reducing or abstaining from
alcohol use, depending on the user's goal (reduction or abstinence). This group will have
access to the app for 6 weeks. The other half of the participants will be randomized to a
waitlist control group for 6 weeks. Six weeks into the study, the TeleCoach intervention
group will lose access to the app, and the waitlist control group will be given access to
the TeleCoach app for 6 weeks.
All participants (in both Study 1 and Study 2) will be followed up at 6, 12 and 18 weeks
from initial baseline recruitment.
Method: Study 1:Participants with problematic alcohol use (AUDIT >7 for men and >5 for
women), having access to a smartphone running either the Android or the iOs operating
systems, are randomized into one of three groups: 1. Access to Promillekoll, 2. Access to
PartyPlanner and 3. Waitlist control group (gains access to both apps week 12). Alcohol use
outcomes are collected 6,12 and 18 weeks after recruitment to the study.
Study 2: At week 6 of Study 1, participants with risky weekly consumption, i.e. over 9 and
14 Swedish standard glasses (Swedish standard glass = 12 g of alcohol) for women and men
respectively are randomized into one of two groups: 1. Access to TeleCoach for 6 weeks,
followed by 6 weeks without the app. 2. Six weeks as waitlist controls followed by 6 weeks
of access to TeleCoach. Alcohol use outcomes are collected 6 and 12 weeks after entering
Study 2 (equivalent to 12 and 18 weeks after initial recruitment to Study 1).
Students without problematic drinking and/or appropriate smartphones also participate in
followups, in order to control for the regression to the mean phenomenon. All students who
complete all baseline and followup questionnaires participate in a lottery with the chance
of winning one of three computer tablets.
Hypotheses:
Study 1: 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 planning function in PartyPlanner will be associated with an
increased decrease in alcohol consumption compared to only real-time use for Promillekoll.
Study 2: The proportion of participants with risky use above recommended levels will decline
faster in the group that receives the intervention first, in comparison to controls.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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