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Trial registered on ANZCTR
Registration number
ACTRN12618000015246
Ethics application status
Approved
Date submitted
3/12/2017
Date registered
11/01/2018
Date last updated
17/01/2022
Date data sharing statement initially provided
11/12/2018
Date results information initially provided
25/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of a Combined Web-Based and Ecological Momentary Intervention for Incoming First Year University Students
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Scientific title
Effectiveness of a Combined Web-Based and Ecological Momentary Intervention for Incoming First Year University Students: A three-armed Randomised Controlled Trial
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Secondary ID [1]
293520
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Nil
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Universal Trial Number (UTN)
U1111-1206-1464
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol use
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Condition category
Condition code
Public Health
304923
304923
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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
Participants will be randomised into one of three conditions after completing the initial survey before Orientation Week: 1. an active control group, 2. A Web-Based feedback Intervention (WBI) only condition, 3. A WBI and Ecological Momentary Intervention (EMI) condition.
The WBI only and the WBI + EMI condition will receive the WBI at baseline. The WBI will combine aspects of social norms, provide information on Alcohol Use Disorder Identification Test (AUDIT) score, Blood Alcohol Content, risk of alcohol-related consequences, long-term consequences, and protective behavioural strategies. The intervention will be automatically generated by the system and delivered after participants' initial survey and include sections of text with feedback about their drinking. The online intervention will take approximately 5-10 minutes to complete and is to be completed by participants prior to Orientation Week.
The WBI and EMI condition will be sent intervention text messages twice a day (at 1pm and 7pm) on the Tuesday, Thursday, Friday, and Saturday of Orientation Week. The 1pm messages will remind participants of a protective behavioural strategy presented in the online intervention. The 7pm messages will contain a social consequence of alcohol use. These participants will also receive fortnightly EMI messages during the first semester. These messages will be sent on a Wednesday reminding participants of the drinking norms (tailored to gender).
All conditions will be asked to respond to 2 Orientation Week messages and 14 fortnightly text messages during the academic year asking them to report their drinking from the past 3 days (e.g., 'How many standard drinks did you consume Thurs, Fri, Sat? Please Text Back (TB) like this 5, 0, 1).
All participants will also fill out a questionnaire at the start and end of the semester (baseline, 3 months, 9 months, 15 months, and 21 months) asking them to report the number of alcohol related consequences they experienced over the past 3 months (Brief Young Adult Alcohol Consequences Questionnaire [B-YAACQ]), drinks consumed during a typical week in the past month, and the AUDIT.
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Intervention code [1]
299753
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Prevention
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Intervention code [2]
299754
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Lifestyle
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Comparator / control treatment
No-intervention control.
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Control group
Active
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Outcomes
Primary outcome [1]
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Alcohol use
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Assessment method [1]
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Timepoint [1]
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Measured at baseline, 3 months (primary timepoint), 9 months, 15 months, 21 month. Assessment will use a modified version of timeline followback asking participants to report their drinking during a typical week.
During Orientation Week and fortnightly during their first academic year, participants will be sent messages asking them to report their drinking from the past 3 days.
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Secondary outcome [1]
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Alcohol related consequences as measured by the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ).
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Assessment method [1]
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Timepoint [1]
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The B-YAACQ will be measured at baseline, 3 months, 9 months, 15 months, 21 months.
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Eligibility
Key inclusion criteria
Must be a full time first year student residing at a residential college.
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Minimum age
17
Years
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Maximum age
25
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
We will also exclude participants who do not finish the first survey.
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Study design
Purpose of the study
Prevention
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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)
Allocation is concealed (randomized by computer software).
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer software.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We intend to use Multi-Level Modelling to test for differences between conditions over time.
The total sample size [n = 800] should have sufficient power, even when taking potential drop-out into account. The design is well powered for detecting group differences of 3.5 standard drinks during O’Week and 2 standard drinks/week during the academic year.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2018
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Actual
2/02/2018
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Date of last participant enrolment
Anticipated
17/02/2019
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Actual
18/02/2019
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Date of last data collection
Anticipated
1/11/2021
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Actual
1/11/2021
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Sample size
Target
800
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Accrual to date
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Final
746
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
298133
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
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Level 3, 110 Stanley St, Grafton, Auckland 1010, New Zealand
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Otago, Department of Psychology
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Address
University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
297215
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Address [1]
297215
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Country [1]
297215
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299153
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University of Otago Ethics Committee
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Ethics committee address [1]
299153
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University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
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Ethics committee country [1]
299153
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New Zealand
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Date submitted for ethics approval [1]
299153
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25/11/2013
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Approval date [1]
299153
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09/01/2014
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Ethics approval number [1]
299153
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13/267
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Summary
Brief summary
Young adults have the highest alcohol consumption of any age group. Within this high risk age group, university students stand out, consuming more alcohol than their non-university attending peers. As a result, university students not only have a higher incidence of alcohol use disorders, but also report a higher incidence of harm resulting from alcohol. A number of factors have been implicated in this increase in alcohol use at university, however, new research suggests that drinking during certain events (e.g., Orientation Week) may have a flow on effect and influence the number of drinks students consume throughout the year.
The primary aim of the research project is to reduce overall alcohol consumption by university students (i.e., alcohol consumed during the academic year) by using a combination of web-based intervention (WBI) and EMI. We hypothesize that a brief WBI and EMI will reduce the amount of alcohol use throughout both Orientation Week and throughout the year (relative to a control group or a WBI only condition).
Participants will be randomly assigned at baseline to either a control condition, WBI only condition, or a WBI + EMI condition. The WBI only and the WBI + EMI condition will receive the WBI at baseline. The WBI will combine aspects of social norms, provide information on Alcohol Use Disorder Identification Test (AUDIT) score, Blood Alcohol Content, risk of alcohol-related consequences, long-term consequences, and protective behavioural strategies. The intervention will be automatically generated by the system and delivered after participants' initial survey and include sections of text with feedback about their drinking. The online intervention will take approximately 5-10 minutes to complete and is to be completed by participants prior to Orientation Week.
The WBI and EMI condition will also be sent intervention text messages twice a day (at 1pm and 7pm) on the Tuesday, Thursday, Friday, and Saturday of Orientation Week. The 1pm messages will remind participants of a protective behavioural strategy presented in the online intervention. The 7pm messages will contain a social consequence of alcohol use. These participants will also receive fortnightly EMI messages during the first semester. These messages will be sent on a Wednesday reminding participants of the drinking norms (tailored to gender).
All conditions will be asked to respond to 2 Orientation Week messages and 14 fortnightly text messages during the academic year asking them to report their drinking from the past 3 days (e.g., 'How many standard drinks did you consume Thurs, Fri, Sat? Please Text Back (TB) like this 5, 0, 1).
All participants will also fill out a questionnaire at the start and end of the semester (baseline, 3 months, 9 months, 15 months, and 21 months) asking them to report their drinking and alcohol-related consequences.
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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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Mr Benjamin Riordan
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Address
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Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
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Country
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New Zealand
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Phone
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+64 273540840
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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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Dr Damian Scarf
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Address
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Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
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Country
79475
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New Zealand
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Phone
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+64 3 479 7636
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Fax
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Email
79475
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[email protected]
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Contact person for scientific queries
Name
79476
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Dr Damian Scarf
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Address
79476
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Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
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Country
79476
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New Zealand
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Phone
79476
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+64 3 479 7636
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Fax
79476
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Email
79476
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
687
Study protocol
https://www.researchprotocols.org/2018/5/e10164/
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
374104-(Uploaded-14-01-2022-06-39-37)-Basic results summary.docx
Plain language summary
No
There were no significant differences between the ...
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No additional documents have been identified.
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