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Trial registered on ANZCTR


Registration number
ACTRN12617001509358p
Ethics application status
Not yet submitted
Date submitted
18/10/2017
Date registered
26/10/2017
Date last updated
26/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile phone Intervention for Drinking in Young people (MIDY)
Scientific title
Impact of a mobile-phone based intervention on single-occasion mean peak alcohol consumption among young adults in Australia: a randomised controlled trial
Secondary ID [1] 293159 0
None
Universal Trial Number (UTN)
U1111-1203-9457
Trial acronym
MIDY
Linked study record
MIDY pilot trial: ACTRN12616001323415

Health condition
Health condition(s) or problem(s) studied:
High risk alcohol consumption 305138 0
Condition category
Condition code
Public Health 304459 304459 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered by SMS on drinking occasions on Friday and Saturday nights over a 6-week period. The intervention will consist of hourly Ecological Momentary Assessments (repeated, real-time behavioural surveys) and tailored feedback.

Participants will be sent an SMS at 6pm every Friday and Saturday night during the trial period, with a link to an online survey. This will ask about their plans for the evening and, if they are going out, details about what they plan to do.

If they plan to go out, participants will then receive hourly SMS reminders (7pm to 3am) to complete a very brief online questionnaire. 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 next day they will be sent a follow-up message with a link to another short survey to confirm details of the night, including total drinks consumed.

Every Monday, they will receive an SMS-linked survey asking them to report on the highest number of alcoholic drinks consumed in a single occasion in the past week (peak number of drinks), and the night of the week it was consumed.
Intervention code [1] 299409 0
Behaviour
Comparator / control treatment
There are two control groups.

The first control group will complete the same alcohol-related assessments as the intervention group (i.e. the same SMS-linked questionnaires), but will not receive any feedback SMS.

The second will be an attention control group, in which participants will be sent SMS-linked surveys on the same schedule as the other two groups, but not related to alcohol. The surveys will instead address their social environment, social media use, and other non-alcohol related behaviour. They will not receive any feedback SMS.
Control group
Active

Outcomes
Primary outcome [1] 303703 0
The main outcome is change in the mean peak number of drinks consumed in a single night, over the six week intervention period. This will be compared between the intervention group and the attention control group.

This outcome will be assessed during the SMS-linked questionnaires sent every Monday to all participants. This asks them to report on the highest number of alcoholic drinks consumed in a single occasion in the past week (peak number of drinks), and the night of the week it was consumed.
Timepoint [1] 303703 0
Immediately following the 6-week study period.
Secondary outcome [1] 339905 0
Frequency and quantity of alcohol consumption in the past 12 months (Measured using the Graduated Frequency questionnaire; Greenfield, 2000). This measure involves six questions asking about the frequency of consumption of different quantities of standard drinks. The outcome is a composite of these questions.
Timepoint [1] 339905 0
Immediately following the 6-week study period.
Secondary outcome [2] 339906 0
Peak consumption in a single event during the past 12 months,
In the six-week questionnaire, the participant will be asked to name the most alcoholic drinks they have had on any one occasion in the last 12 months.
Timepoint [2] 339906 0
Immediately following the 6-week study period.
Secondary outcome [3] 339907 0
Proportion of participants that experience any alcohol harm at follow-up compared to baseline (derived from GenACIS, VYADS questionnaires)
Timepoint [3] 339907 0
Immediately following the 6-week study period.
Secondary outcome [4] 339908 0
Knowledge of the impacts of drinking on health (derived from GenACIS)
Timepoint [4] 339908 0
Immediately following the 6-week study period.
Secondary outcome [5] 339909 0
Proportion reporting hazardous drinking (derived from WHO Alcohol Use Disorders Identification Test, AUDIT)
Timepoint [5] 339909 0
Immediately following the 6-week study period.
Secondary outcome [6] 339910 0
Proportion reporting use of tobacco (derived from GenACIS)
Timepoint [6] 339910 0
Immediately following the 6-week study period.
Secondary outcome [7] 339911 0
Life satisfaction (Personal Wellbeing Index)
Timepoint [7] 339911 0
Immediately following the 6-week study period.
Secondary outcome [8] 339912 0
Acceptability and usability of the intervention
This will be assessed using 5 point Likert scales asking participants to rate a series of individual statements pertaining to their experience of undertaking the intervention (e.g. ‘The assessments were easy to complete’). Additional process evaluation measures, such as participant levels of response, refusal, and timeliness of response, will also be explored to assess feasibility and acceptability.
Timepoint [8] 339912 0
Immediately following the 6-week study period.
Secondary outcome [9] 340063 0
Attitudes towards the impacts of drinking on health (derived from GenACIS)
Timepoint [9] 340063 0
Immediately following the 6-week study period.
Secondary outcome [10] 340064 0
Proportion reporting use of illicit drugs (derived from GenACIS)
Timepoint [10] 340064 0
Immediately following the 6-week study period.
Secondary outcome [11] 340065 0
Proportion reporting non-medical use of pharmaceuticals (derived from GenACIS)
Timepoint [11] 340065 0
Immediately following the 6-week study period.

Eligibility
Key inclusion criteria
• Australian residents
• Aged 18-25 years
• Report drinking at least 8 (female) or 11 (male) standard drinks in a single session at least once in the previous year at screening
• Possess a mobile phone with internet access
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None additional

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)
The person who determines eligibility, obtains verbal consent and administers the baseline questionnaire (over the phone) does not know what group the participant will be allocated to. After the baseline phone survey is complete, central randomisation takes place by computer. The participant is then sent SMS messages providing more information about the study including information about the group they have been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Randomisation will take place for each participant after they provided verbal consent and completed the baseline telephone survey.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Three-arm controlled trial. The attention control group will be the comparator for the primary outcome. The second control group is included to determine whether alcohol-related assessments alone (without tailored messaging) could impact on alcohol consumption and related-harms.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2018
Actual
Date of last participant enrolment
Anticipated
28/02/2018
Actual
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297786 0
Government body
Name [1] 297786 0
National Health and Medical Research Council (NHMRC)
Country [1] 297786 0
Australia
Funding source category [2] 297790 0
Charities/Societies/Foundations
Name [2] 297790 0
The Victorian Health Promotion Foundation (VicHealth)
Country [2] 297790 0
Australia
Funding source category [3] 297791 0
Charities/Societies/Foundations
Name [3] 297791 0
Gandel Philanthropy
Country [3] 297791 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Burnet Institute
Address
85 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 296829 0
None
Name [1] 296829 0
Address [1] 296829 0
Country [1] 296829 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298845 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 298845 0
Ethics committee country [1] 298845 0
Date submitted for ethics approval [1] 298845 0
01/12/2017
Approval date [1] 298845 0
Ethics approval number [1] 298845 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78422 0
Dr Megan Lim
Address 78422 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 78422 0
Australia
Phone 78422 0
+61385062403
Fax 78422 0
Email 78422 0
lim@burnet.edu.au
Contact person for public queries
Name 78423 0
Megan Lim
Address 78423 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 78423 0
Australia
Phone 78423 0
+61385062403
Fax 78423 0
Email 78423 0
lim@burnet.edu.au
Contact person for scientific queries
Name 78424 0
Megan Lim
Address 78424 0
Burnet Institute
85 Commercial Rd
Melbourne VIC 3004
Country 78424 0
Australia
Phone 78424 0
+61385062403
Fax 78424 0
Email 78424 0
lim@burnet.edu.au

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.