Trial Review

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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)
Scientific title
Evaluation of a mobile phone-based intervention to reduce alcohol consumption and harms in young adults
Secondary ID [1] 287740 0
None
Universal Trial Number (UTN)
U1111-1175-8749
Trial acronym
MIDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High risk alcohol consumption 296603 0
Condition category
Condition code
Public Health 296845 296845 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 293137 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 296455 0
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.)
Timepoint [1] 296455 0
Immediately following the 12 week study period.
Secondary outcome [1] 322694 0
Proportion of participants that experience any alcohol harm at follow-up compared to baseline (derived from GenACIS, VYADS questionnaires)
Timepoint [1] 322694 0
Immediately following the 12 week study period
Secondary outcome [2] 322696 0
Proportion reporting hazardous drinking (derived from WHO Alcohol Use Disorders Identification Test (AUDIT))
Timepoint [2] 322696 0
Immediately following the 12 week study period
Secondary outcome [3] 322698 0
Life satisfaction (Personal Wellbeing Index)
Timepoint [3] 322698 0
Immediately following the 12 week study period
Secondary outcome [4] 327786 0
Attitudes towards drinking (derived from GenACIS questionnaire)
Timepoint [4] 327786 0
Immediately following the 12 week study period
Secondary outcome [5] 327787 0
Proportion reporting use of tobacco over the study period (derived from GenACIS questionnaire)
Timepoint [5] 327787 0
Immediately following the 12 week study period
Secondary outcome [6] 327788 0
Proportion reporting use of illicit drugs over the study period (derived from GenACIS questionnaire)
Timepoint [6] 327788 0
Immediately following the 12 week study period
Secondary outcome [7] 327789 0
Proportion reporting non-medical use of pharmaceuticals over the study period (derived from GenACIS questionnaire)
Timepoint [7] 327789 0
Immediately following the 12 week study period

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).
Minimum age
18 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Does not have smartphone

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/03/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
29/07/2016
Actual
2/09/2016
Sample size
Target
300
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292284 0
Government body
Name [1] 292284 0
The Victorian Health Promotion Foundation (VicHealth)
Country [1] 292284 0
Australia
Funding source category [2] 293315 0
Charities/Societies/Foundations
Name [2] 293315 0
Gandel Philanthropy
Country [2] 293315 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Burnet Institute
Address
85 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 292129 0
None
Name [1] 292129 0
Address [1] 292129 0
Country [1] 292129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293757 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 293757 0
26 Sports Walk
Monash University
Victoria 3800
Ethics committee country [1] 293757 0
Australia
Date submitted for ethics approval [1] 293757 0
24/09/2015
Approval date [1] 293757 0
29/10/2015
Ethics approval number [1] 293757 0
CF15/3600 - 2015001556

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61194 0
Dr Megan Lim
Address 61194 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 61194 0
Australia
Phone 61194 0
+61385062403
Fax 61194 0
Email 61194 0
[email protected]
Contact person for public queries
Name 61195 0
Dr Megan Lim
Address 61195 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 61195 0
Australia
Phone 61195 0
+61385062403
Fax 61195 0
Email 61195 0
[email protected]
Contact person for scientific queries
Name 61196 0
Dr Megan Lim
Address 61196 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 61196 0
Australia
Phone 61196 0
+61385062403
Fax 61196 0
Email 61196 0
[email protected]

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

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