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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

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)
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?
Secondary ID: 
UTN:
Trial acronym: THRIVE

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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.
Intervention code 1:Early detection / Screening 
Intervention code 2:Prevention 
Intervention code 3:Behaviour 
Comparator / control treatment: Web-based assessment of drinking only
Control group: Active

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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 

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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.)
Minimum Age: 17 Years
Maximum Age: 25 Years
Gender: Both males and females
Healthy volunteers? Yes
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.

Page 6
Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
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.
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.
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded:
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

Page 7
Phase Not Applicable
Anticipated or actual start date: 5/03/2007
Target sample size: 13000
Recruitment status: Closed: follow-up complete

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
Name: Western Australian Centre for Health Promotion Research, Curtin University of Technology
Address: Kent Street Bentley WA 6102
Country: Australia
Secondary sponsor:None 
Name: 
Address: 
Country: 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
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.
Trial website:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Professor Peter Howat
Address: Centre for Behavioural Research in Cancer Control
Curtin University
GPO Box U1987
Perth WA 6845
Country: Australia
Tel: +61 8 92661719
Fax:
Email: p.howat@curtin.edu.au

Contact person for scientific queries
Name: Dr Kypros Kypri
Address: School of Medicine and Public Health
Level 3
David Maddison Clinical Sciences Building
University of Newcastle
King & Watt Streets
Newcastle NSW 2300
Country: Australia
Tel: +61 2 4913 8231
Fax:
Email: kypros.kypri@newcastle.edu.au

Contact person responsible for updating information
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Address:
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