<!-- Alternate content for non-supporting browsers --> <h2>upgrade</h2> <h3>your browser</h3>
Home
Login
Contact us
Feedback
Register Trial
Trial Search
Latest News
FAQ
About Us
Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082281
ACTR Number:
ACTRN12608000104358
Trial Status:
Registered
Date Submitted:
25/02/2008
Date Registered:
25/02/2008
Page 1
Public title:
THRIVE (Tertiary Health Research Intervention Via Email)
Update:
Reason:
ANZCTR registration title:
For undergraduate university students drinking at harmful and hazardous levels, how effective is 10 minutes of web-based motivational assessment and personalised feedback compared to screening alone in reducing frequency and quantity of alcohol consumption?
Update:
Reason:
Secondary ID:
UTN:
Update:
Reason:
Trial acronym:
THRIVE
Update:
Page 2
Health condition(s) or problem(s) studied:
Alcohol Consumption
Alcohol-Related Harm
Tobacco Use
Condition category:
Condition code:
Public Health
Health promotion/education
Public Health
Health promotion/education
Page 3
Description of intervention(s) / exposure:
10 minutes of web-based motivational assessment and personalised feedback on alcohol consumption versus screening only control followed up at one and six months.
Update:
Reason:
Intervention code 1:
Early detection / Screening
Intervention code 2:
Prevention
Intervention code 3:
Behaviour
Comparator / control treatment:
Web-based assessment of drinking only
Update:
Reason:
Control group:
Active
Update:
Reason:
Page 4
Primary outcome 1:
Frequency of drinking
Timepoint:
At 1 and 6 months after randomization
Primary outcome 2:
Drinks per typical occasion
Timepoint:
At 1 and 6 months after randomization
Primary outcome 3:
Overall volume of alcohol consumed
Timepoint:
At 1 and 6 months after randomization
Secondary outcome 1:
Frequency of heavy episodes
Timepoint:
At 6 months after randomization
Secondary outcome 2:
Number of personal problems
Timepoint:
At 1 and 6 months after randomization
Secondary outcome 3:
Number of academic problem behaviours
Timepoint:
At 1 and 6 months after randomization
Secondary outcome 4:
Subjective views of intervention effects
Timepoint:
At 6 months after randomization
Secondary outcome 5:
Intervention effect on health seeking behaviour
Timepoint:
At 6 months after randomization
Page 5
Key inclusion criteria:
Inclusion criteria: full-time enrolment at Curtin University of Technololgy, internal study mode at Bentley campus, recent hazardous drinking: scoring 8+ on the Alcohol Use Disorders Identification Test (AUDIT) and drinking more than 4/6 (females/males) standard drinks on one or more occasions in previous 4 weeks. (Hazardous drinking status assessed via web-based screening questionnaire.)
Update:
Reason:
Minimum Age:
17
Years
Update:
Reason:
Maximum Age:
25
Years
Update:
Reason:
Gender:
Both males and females
Update:
Reason:
Healthy volunteers?
Yes
Update:
Reason:
Key exclusion criteria:
Not recent hazardous drinking: scoring 7 or below on the AUDIT and/or not drinking more than 4/6 (females/males) standard drinks on one or more occasions in previous 4 weeks.
Update:
Reason:
Page 6
Study type:
Interventional
Update:
Reason:
Purpose of the study:
Prevention
Update:
Allocation to intervention:
Randomised controlled trial
Update:
Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Participants randomly selected from university enrolment database, sent postal and email invitations to complete baseline survey. Those screening positive for hazardous drinking via computer algorithms within the baseline survey were then automatically allocated to intervention or control group via computerised randomisation. Contacted by letter and email at 1 and 6 months to complete follow ups via web-based interface. In accordance with ethics approval, participants were not informed that the study was a RCT.
Update:
Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Sequence generation conducted by programmer not involved in implementation of the trial on site (therefore not in contact with study participants) by using a randomisation table created by computer software. Sequence applied automatically by computer algorithms during completion of the baseline survey.
Update:
Reason:
Masking / blinding:
Blinded (masking used)
Update:
Reason:
Who is/are masked/blinded:
Update:
Reason:
Assignment:
Parallel
Update:
Reason:
Other design features (specify):
Update:
Reason:
Type of endpoint(s):
Efficacy
Update:
Reason:
Update:
Reason:
Update:
Reason:
Update:
Reason:
Update:
Reason:
Page 7
Phase
Not Applicable
Update:
Reason:
Anticipated or actual date of first participant enrolement:
5/03/2007
Update:
Reason:
Target sample size:
13000
Update:
Reason:
Recruitment status:
Closed: follow-up complete
Update:
Reason:
Page 8
Funding source:
Government funding body e.g. Australian Research Council
Name:
Healthway (Western Australian Health Promotion Foundation)
Address:
Level 3, 46 Parliament Place West Perth WA 6005
Country:
Australia
Primary sponsor:
University
Update:
Reason:
Name:
Western Australian Centre for Health Promotion Research, Curtin University of Technology
Update:
Reason:
Address:
Kent Street Bentley WA 6102
Update:
Reason:
Country:
Australia
Update:
Reason:
Secondary sponsor:
None
Name:
Address:
Country:
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
Curtin University Human Research Ethics Committee
Address:
Office of Research and Development Curtin University of Technology GPO Box U1987 Perth WA 6845
Country:
Australia
Date of approval:
26/01/2006
HREC Number:
189/2005
Countries of recruitment:
Australia
Postcode:
6102
Brief summary:
This study sought to determine the efficacy of universal web-based screening and provision of motivational feedback to reduce hazardous drinking among a university undergraduate student population.
Update:
Reason:
Trial website:
Update:
Presentations / publication list:
Update:
Page 10
Contact person for public queries
Name:
Professor Peter Howat
Update:
Reason:
Address:
Centre for Behavioural Research in Cancer Control
Curtin University
GPO Box U1987
Perth WA 6845
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 8 92661719
Update:
Reason:
Fax:
Update:
Reason:
Email:
p.howat@curtin.edu.au
Update:
Reason:
Contact person for scientific queries
Name:
Dr Kypros Kypri
Update:
Reason:
Address:
School of Medicine and Public Health
Level 3
David Maddison Clinical Sciences Building
University of Newcastle
King & Watt Streets
Newcastle NSW 2300
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 2 4913 8231
Update:
Reason:
Fax:
Update:
Reason:
Email:
kypros.kypri@newcastle.edu.au
Update:
Reason:
Contact person responsible for updating information
Name:
Update:
Reason:
Address:
Update:
Reason:
Country:
Update:
Reason:
Tel:
Update:
Reason:
Fax:
Update:
Reason:
Email:
Update:
Reason:
