Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000242921
Ethics application status
Approved
Date submitted
24/02/2011
Date registered
4/03/2011
Date last updated
20/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study on the modification of drinking and safety behaviour through the use of participant designed, self generated text messages via mobile phones delivered at times scheduled by the participant
Scientific title
In people aged 18 or over, do self-designed and self-scheduled text messages delivered via a web application to their phones prompt safer drinking practices while they are out socialising with friends?
Secondary ID [1] 253533 0
Nil
Universal Trial Number (UTN)
Trial acronym
SPILL IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unintended negative consequences due to alcohol intoxication or impairment 261097 0
Excessive drinking to intoxication 261179 0
Condition category
Condition code
Public Health 259229 259229 0 0
Health promotion/education
Injuries and Accidents 259334 259334 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have 6 month access to a web site which allows them to generate text for their own messages. Participants will also determine when the messages will be sent to their mobile phone. The frequency of use of the web site and messaging is at the participants own discretion. They are the most qualified to determine when they will need a prompt to consider their safety and drinking behaviour. The control group will have 3 months access to the web site messaging. This is a feasibility study. The researchers do not wish to lead the participants regarding message content or frequency. The web site will provide instructions on how to use the messaging but no suggestions for message content. At the end of three months, both the intervention and control groups will have access to the intervention. This is to assess longevity of use and engagement with the web site.
Intervention code [1] 257961 0
Behaviour
Intervention code [2] 264164 0
Prevention
Comparator / control treatment
Control treatment is 3 months access to a web site which has a community chat page and instructions on how to use the pending messaging option. This is the same web site that the intervention group will access but the message function will be hidden from the Control group. At the end of 3 months the control group will be given access to the message component.
Control group
Active

Outcomes
Primary outcome [1] 262063 0
Reduction in unintended negative consequences as measured by Young Adult Alcohol Problem Severity Test
Timepoint [1] 262063 0
3 months & 6 months
Secondary outcome [1] 273076 0
Reduction in number of drinks consumed during a drinking session as measured by AUDIT-C
Timepoint [1] 273076 0
3 months & 6 months

Eligibility
Key inclusion criteria
Participants must be within the age limits defined below and own a mobile phone.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No mobile phone or outside the specified age limit

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)
Participants will access the web site and be provided with study information, click to agree to participate, fill in demographic data, drinking (AUDIT-C) and consequences (YAAPST) questions. They will then be computer assigned to a intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3166 0
New Zealand
State/province [1] 3166 0
Auckland

Funding & Sponsors
Funding source category [1] 258486 0
Self funded/Unfunded
Name [1] 258486 0
Country [1] 258486 0
New Zealand
Primary sponsor type
Individual
Name
Karen Renner
Address
General Practice & Primary Health Care
School of Population Health
University of Auckland
261 Morrin Rd,
Tamaki Campus,
Glen Innes, Auckland 1072
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257627 0
None
Name [1] 257627 0
Address [1] 257627 0
Country [1] 257627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260462 0
Central Ethics Committee
Ethics committee address [1] 260462 0
Ethics Committees
Health and Disability Services Policy
Population Health Directorate
Ministry of Health
PO Box 5013
Wellington 6011
Ethics committee country [1] 260462 0
New Zealand
Date submitted for ethics approval [1] 260462 0
01/02/2011
Approval date [1] 260462 0
01/03/2011
Ethics approval number [1] 260462 0
CEN/11/03/010

Summary
Brief summary
SPILL IT is a small study which aims to assess whether young drinkers (aged 18-34) would use a web site which helps them to get reminders on their mobile phones to keep safe while drinking. To ensure the safety messages are relevant, the young drinkers will write their own message and set the date and time when the message is sent to their phone. The reason for this is that plans to keep safe during drinking are forgotten when they have had a few drinks and are interacting with friends. A text message to their phone, while they are drinking, may remind them of their plans and therefore stop them getting hurt.
Trial website
www.spillitnz.co.nz
Trial related presentations / publications
Harm Reduction Text Messages Delivered During Alcohol Drinking: Feasibility Study Protocol Karen Adell Renner; Natalie Walker; Varsha Parag; Ross McCormick. JMIR Research Protocols 23.5.2012
Public notes

Contacts
Principal investigator
Name 32162 0
Address 32162 0
Country 32162 0
Phone 32162 0
Fax 32162 0
Email 32162 0
Contact person for public queries
Name 15409 0
Karen Renner
Address 15409 0
General Practice & Primary Health,
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
Country 15409 0
New Zealand
Phone 15409 0
+(64) 9 923 9170
Fax 15409 0
Email 15409 0
k.renner@auckland.ac.nz
Contact person for scientific queries
Name 6337 0
Natalie Walker
Address 6337 0
Clinical Trials Research Unit
School of Population Health
University of Auckland

Private Bag 92019
Auckland 1142
Country 6337 0
New Zealand
Phone 6337 0
+(64) 9 373 7599 x 89884
Fax 6337 0
Email 6337 0
n.walker@ctru.auckland.ac.nz

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
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