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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
11/12/2018
Date data sharing statement initially provided
11/12/2018
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
Scientific title
Effectiveness of a Combined Web-Based and Ecological Momentary Intervention for Incoming First Year University Students: A three-armed Randomised Controlled Trial
Secondary ID [1] 293520 0
Nil
Universal Trial Number (UTN)
U1111-1206-1464
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 305706 0
Condition category
Condition code
Public Health 304923 304923 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299753 0
Prevention
Intervention code [2] 299754 0
Lifestyle
Comparator / control treatment
No-intervention control.
Control group
Active

Outcomes
Primary outcome [1] 304120 0
Alcohol use
Timepoint [1] 304120 0
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.
Secondary outcome [1] 341030 0
Alcohol related consequences as measured by the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ).
Timepoint [1] 341030 0
The B-YAACQ will be measured at baseline, 3 months, 9 months, 15 months, 21 months.

Eligibility
Key inclusion criteria
Must be a full time first year student residing at a residential college.
Minimum age
17 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We will also exclude participants who do not finish the first survey.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed (randomized by computer software).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9409 0
New Zealand
State/province [1] 9409 0
Otago

Funding & Sponsors
Funding source category [1] 298133 0
Government body
Name [1] 298133 0
Health Research Council of New Zealand
Address [1] 298133 0
Level 3, 110 Stanley St, Grafton, Auckland 1010, New Zealand
Country [1] 298133 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Department of Psychology
Address
University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 297215 0
None
Name [1] 297215 0
Address [1] 297215 0
Country [1] 297215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299153 0
University of Otago Ethics Committee
Ethics committee address [1] 299153 0
University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
Ethics committee country [1] 299153 0
New Zealand
Date submitted for ethics approval [1] 299153 0
25/11/2013
Approval date [1] 299153 0
09/01/2014
Ethics approval number [1] 299153 0
13/267

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79474 0
Mr Benjamin Riordan
Address 79474 0
Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
Country 79474 0
New Zealand
Phone 79474 0
+64 273540840
Fax 79474 0
Email 79474 0
riobe135@student.otago.ac.nz
Contact person for public queries
Name 79475 0
Dr Damian Scarf
Address 79475 0
Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
Country 79475 0
New Zealand
Phone 79475 0
+64 3 479 7636
Fax 79475 0
Email 79475 0
damian@psy.otago.ac.nz
Contact person for scientific queries
Name 79476 0
Dr Damian Scarf
Address 79476 0
Department of Psychology, University of Otago, 275 Leith Walk, Dunedin 9016 NZ
Country 79476 0
New Zealand
Phone 79476 0
+64 3 479 7636
Fax 79476 0
Email 79476 0
damian@psy.otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Attachments/websites
Type [1] 687 0
Study protocol
URL/details/comments [1] 687 0
https://www.researchprotocols.org/2018/5/e10164/
Attachment [1] 687 0
Summary results
Not applicable