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Trial registered on ANZCTR
Registration number
ACTRN12616001323415
Ethics application status
Approved
Date submitted
28/10/2015
Date registered
22/09/2016
Date last updated
22/09/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
The MIDY pilot trial (Mobile Intervention for Drinking in Young people)
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Scientific title
Evaluation of a mobile phone-based intervention to reduce alcohol consumption and harms in young adults
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Secondary ID [1]
287740
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None
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Universal Trial Number (UTN)
U1111-1175-8749
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Trial acronym
MIDY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
High risk alcohol consumption
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Condition category
Condition code
Public Health
296845
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will be delivered on 6 drinking occasions (nights) over a 12 week period. The intervention will consist of hourly Ecological Momentary Assessments and feedback. While on a night out, participants will receive hourly reminders to complete a very brief questionnaire through an online survey accessed via the SMS message. The questionnaire will involve hourly reports of their alcohol consumption and spending, where they are, and their mood. They will then receive an individually tailored feedback message via SMS in response to these data, which aims to stop or slow down their drinking, or avoid harmful consequences of drinking. Participants will be sent a weekly reminder to register for any upcoming nights to do the trial, and adherence will be monitored through logs of completed questionnaires.
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Intervention code [1]
293137
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Behaviour
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Comparator / control treatment
The first control group will complete alcohol-related assessments while on a night out, but will not receive feedback SMS. A second control group will not have any contact during the study period.
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Control group
Active
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Outcomes
Primary outcome [1]
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The main outcome measure will be the self-reported peak number of drinks consumed in a single occasion on the subject's most recent heavy drinking event in the past 3 months. This question is assessed through the question: "Think back over the last 3 months and try to recall the single occasion during this time period that you had the most drinks (i.e. your biggest drinking session in the past three months)."
This question has been previously used as a measure of peak single occasion consumption (see: Dietze, P. M., Livingston, M., Callinan, S., & Room, R. (2014). The big night out: What happens on the most recent heavy drinking occasion among young Victorian risky drinkers?. Drug and alcohol review, 33(4), 346-353.)
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Assessment method [1]
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Timepoint [1]
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Immediately following the 12 week study period.
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Secondary outcome [1]
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Proportion of participants that experience any alcohol harm at follow-up compared to baseline (derived from GenACIS, VYADS questionnaires)
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Assessment method [1]
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Timepoint [1]
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Immediately following the 12 week study period
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Secondary outcome [2]
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Proportion reporting hazardous drinking (derived from WHO Alcohol Use Disorders Identification Test (AUDIT))
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Assessment method [2]
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Timepoint [2]
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Immediately following the 12 week study period
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Secondary outcome [3]
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Life satisfaction (Personal Wellbeing Index)
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Assessment method [3]
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Timepoint [3]
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Immediately following the 12 week study period
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Secondary outcome [4]
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Attitudes towards drinking (derived from GenACIS questionnaire)
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Assessment method [4]
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Timepoint [4]
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Immediately following the 12 week study period
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Secondary outcome [5]
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Proportion reporting use of tobacco over the study period (derived from GenACIS questionnaire)
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Assessment method [5]
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Timepoint [5]
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Immediately following the 12 week study period
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Secondary outcome [6]
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Proportion reporting use of illicit drugs over the study period (derived from GenACIS questionnaire)
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Assessment method [6]
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Timepoint [6]
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Immediately following the 12 week study period
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Secondary outcome [7]
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Proportion reporting non-medical use of pharmaceuticals over the study period (derived from GenACIS questionnaire)
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Assessment method [7]
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Timepoint [7]
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Immediately following the 12 week study period
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Eligibility
Key inclusion criteria
-Enrolled in the Young Adults Alcohol Study cohort study (which screened for age as being 18-25 years in 2012)
-Has a Smartphone
-Recent risky alcohol consumption (determined as consumed in excess of 10 Australian Standard Drinks (ASD) for males, and 7 ASD for females in a single session in previous 12 months).
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Minimum age
18
Years
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Maximum age
29
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
-Does not have smartphone
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
8/03/2016
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Date of last participant enrolment
Anticipated
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Actual
30/06/2016
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Date of last data collection
Anticipated
29/07/2016
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Actual
2/09/2016
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Sample size
Target
300
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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The Victorian Health Promotion Foundation (VicHealth)
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Address [1]
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15–31 Pelham St
Carlton, VIC 3053
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Gandel Philanthropy
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Address [2]
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Level 2, Office Tower One, Chadstone Place
1341 Dandenong Road
PO Box 204
Chadstone Vic 3148
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Country [2]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Burnet Institute
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Address
85 Commercial Rd
Melbourne VIC 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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26 Sports Walk Monash University Victoria 3800
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/09/2015
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Approval date [1]
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29/10/2015
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Ethics approval number [1]
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CF15/3600 - 2015001556
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Summary
Brief summary
Our proposal is to take brief interventions, proven to have a significant impact on young people's drinking, and apply them in the mobile realm during actual drinking occasions. The intervention will consist of hourly mobile assessment and feedback. While on a night out, participants will receive hourly reminders to complete a very brief questionnaire through an online survey accessed via the SMS message. The questionnaire will involve hourly reports of their alcohol consumption and spending, where they are, and their mood. They will then receive an individually tailored feedback message via SMS in response to these data, which aims to stop or slow down their drinking, or avoid harmful consequences of drinking. The intervention will be delivered on 6 drinking occasions (nights) over a 12 week period. This study aims to determine the impact of a tailored brief intervention delivered by mobile phone on young people's high-risk alcohol consumption. We will use a randomised controlled trial design to generate high quality evidence of the impact of this intervention on single occasion risky drinking among young people. This will be the world's first randomised controlled trial of a mobile delivered brief intervention to reduce alcohol consumption.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Megan Lim
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Address
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Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61385062403
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Megan Lim
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Address
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Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61385062403
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Megan Lim
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Address
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Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
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Country
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Australia
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Phone
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+61385062403
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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