Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000021370
Ethics application status
Approved
Date submitted
2/01/2017
Date registered
9/01/2017
Date last updated
9/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Combining a web-based intervention (WBI) and Ecological Momentary Intervention (EMI) to curb alcohol consumption in university students: A randomized control trial.
Scientific title
Combining a web-based intervention (WBI) and Ecological Momentary Intervention (EMI) to curb alcohol consumption in university students: A randomized control trial.
Secondary ID [1] 290788 0
Nil
Universal Trial Number (UTN)
U1111-1191-0811
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 301419 0
Condition category
Condition code
Public Health 301149 301149 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a computer delivered intervention prior to Orientation Week. The computer delivered intervention will combine aspects of social norms, provide information on AUDIT score, BAC, risk of alcohol-related consequences, long-term consequences, and protective behavioural strategies. The intervention will be 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.

Following the online aspect, participants will be assigned to one of 4 conditions outlined below, All conditions will be asked to respond to 2 Orientation Week messages and 7 fortnightly text messages asking them to report their drinking from the past 3 days (e.g., 'How many standard drinks did you consume Thurs, Fri, Sat? Please TB like this 5, 0, 1).:

1. Orientation Week Ecological Momentary Assessment (EMA) and Academic Year EMA: Participants in this condition will only receive messages asking them to report their alcohol use during Orientation Week and fortnightly throughout the academic year.

2. Orientation Week Ecological Momentary Intervention (EMI) and Academic Year EMA: Participants 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 messages during Orientation Week and fortnightly throughout the year asking them to report their drinking from the past 3 days.

3. Orientation Week EMA and Academic Year EMI: Participants in this condition will receive intervention text messages fortnightly during the first semester. These messages will be sent on a Wednesday reminding participants of the drinking norms (tailored to gender). These participants will also receive messages during Orientation Week and fortnightly throughout the year asking them to report their drinking from the past 3 days.

4. Orientation Week EMI and Academic Year EMI: Participants will receive both the Orientation Week and Academic Year EMIs described above. These participants will also receive messages during Orientation Week and fortnightly throughout the year asking them to report their drinking from the past 3 days.

All participants will also fill out a questionnaire at the start and end of the semester (baseline and 3 months) asking them to report the number of alcohol related consequences they experienced over the past 3 months (B-YAACQ) as well as alcohol use over the last week and the AUDIT.
Intervention code [1] 296702 0
Prevention
Intervention code [2] 296767 0
Lifestyle
Comparator / control treatment
No-intervention control (Ecological momentary assessment (EMA) only condition).
Control group
Active

Outcomes
Primary outcome [1] 300561 0
Alcohol use
Timepoint [1] 300561 0
Measured at baseline, during Orientation Week, and fortnightly throughout first semester of the academic year. Baseline assessment will use a modified version of timeline followback asking participants to report their drinking during a typical week. During Orientation Week and the academic year, participants will be sent messages asking them to report their drinking from the past 3 days.
Secondary outcome [1] 330313 0
Alcohol related consequences as measured by the Brief Young Adult Alcohol Consequences Questionnaire.
Timepoint [1] 330313 0
Baseline and after first semester (approximately 3 months after baseline).

Eligibility
Key inclusion criteria
Must be a full time first year student residing at a residential college.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students who do not live at a residential college.

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 not concealed.
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
Repeated measures ANOVA and planned comparisons.

The total sample size [n = 300] should have sufficient power, even when taking potential drop-out into account. The design is well powered for detecting group differences of 6.5 standard drinks during O’Week and 2 standard drinks/week during the academic year.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/02/2017
Actual
Date of last participant enrolment
Anticipated
28/02/2017
Actual
Date of last data collection
Anticipated
31/10/2017
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 8521 0
New Zealand
State/province [1] 8521 0

Funding & Sponsors
Funding source category [1] 295214 0
University
Name [1] 295214 0
University of Otago
Country [1] 295214 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Department of Psychology
Address
PO Box 56, Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 294042 0
None
Name [1] 294042 0
Address [1] 294042 0
Country [1] 294042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296560 0
University of Otago
Ethics committee address [1] 296560 0
Ethics committee country [1] 296560 0
New Zealand
Date submitted for ethics approval [1] 296560 0
01/11/2016
Approval date [1] 296560 0
09/11/2016
Ethics approval number [1] 296560 0
13/267

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1340 1340 0 0
/AnzctrAttachments/372058-Ethics approval.pdf

Contacts
Principal investigator
Name 71290 0
Mr Benjamin C. Riordan
Address 71290 0
University of Otago, Department of Psychology
PO Box 56, Dunedin, 9054
Country 71290 0
New Zealand
Phone 71290 0
+64-3-479-9427
Fax 71290 0
Email 71290 0
[email protected]
Contact person for public queries
Name 71291 0
Benjamin C. Riordan
Address 71291 0
University of Otago, Department of Psychology
PO Box 56, Dunedin, 9054
Country 71291 0
New Zealand
Phone 71291 0
+64-3-479-9427
Fax 71291 0
Email 71291 0
[email protected]
Contact person for scientific queries
Name 71292 0
Benjamin C. Riordan
Address 71292 0
University of Otago, Department of Psychology
PO Box 56, Dunedin, 9054
Country 71292 0
New Zealand
Phone 71292 0
+64-3-479-9427
Fax 71292 0
Email 71292 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.