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Trial registered on ANZCTR


Registration number
ACTRN12614000938606
Ethics application status
Approved
Date submitted
26/08/2014
Date registered
2/09/2014
Date last updated
2/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutrition and Lifestyle Modifications to an Internet-based Treatment for Alcohol Misuse - Pilot Study
Scientific title
For drinkers with alcohol misuse issues will the combination of a weekly 'Healthy Living' newsletter and an online alcohol treatment reduce their consumption of alcohol?
Secondary ID [1] 285169 0
None
Universal Trial Number (UTN)
U1111-1160-9180
Trial acronym
NALMITAM - PS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol misuse 292763 0
Diet and Nutrition 292925 0
Mental Health 292926 0
Condition category
Condition code
Public Health 293052 293052 0 0
Other public health
Diet and Nutrition 293211 293211 0 0
Other diet and nutrition disorders
Mental Health 293212 293212 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Interested participants will visit www.ontrack.org.au and register online. Participants then complete the online alcohol program at their own pace.

Participants will be asked to log into OnTrack at least once a week for three months. OnTrack provides the core alcohol program, focusing on practical skills, such as mindfulness and goal-setting. OnTrack uses elements of motivational interviewing where participants are encouraged to think about the reasons for changing their drinking behaviour. There is no focus on nutrition or physical activity.

2. The "OnTrack to Cutting Down and Feeling Good" pdf newsletters are emailed to participants once a week for 6 weeks and contain advice and ideas designed to help participants become healthier. The focus of the intervention is on addressing diet and healthy living by asking participants to increase their physical activity (specifically walking behaviour) and to increase their intake of fruit and vegetables and healthy meals.

After three months participants will be interviewed over the phone regarding their experience of using the On Track alcohol program and the Nutrition Support intervention. Adherence to the intervention will be monitored through these phone interviews.
Intervention code [1] 290021 0
Lifestyle
Intervention code [2] 290154 0
Behaviour
Comparator / control treatment
No control treatment in this Pilot Study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293020 0
Alcohol consumption, measured with the Timeline Followback method.
Timepoint [1] 293020 0
Baseline, 12 weeks
Secondary outcome [1] 310166 0
Physical Activity, measured with the International Physical Activity Questionnaire (IPAQ).
Timepoint [1] 310166 0
Baseline, 12 weeks
Secondary outcome [2] 310167 0
Diet, measured with the Diet Quality Tool (DQT).
Timepoint [2] 310167 0
Baseline, 12 weeks

Eligibility
Key inclusion criteria
Participants must report a weekly alcohol consumption over the previous month of >14 standard drinks/week for both men and women.

Participants must have sufficient English to complete treatment and assessments without translation and be able and willing to access the internet and email or text messages.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not have not used injected drugs in the previous month or report daily use of an illicit substance. They can not have a self-reported history of a psychosis lasting > 2 days or a diagnosis of Bipolar Disorder. They must not be acutely suicidal.

People under the age of 18 have been excluded from this research as child and adolescent treatment requires different clinical considerations and approaches than adult.



People in existing dependent or unequal relationships with any member of the research team will not be recruited into the study to avoid any potential coercion or breaches of confidentiality. Any people in such relationships who express interest in the research will be referred to other appropriate sources for treatment.

As is the case for adolescents, it is recommended by the NHMRC that pregnant women abstain from alcohol use for the duration of their pregnancy. As this project does not specifically promote or require abstinence as a treatment goal, this treatment could directly conflict with this advice. Additionally, the risks involved in treatment failure are too high to be acceptable. Any pregnant women referred to the project will be referred for appropriate face-to-face treatment that can provide the high level of monitoring and support that is required by this group. People who are highly dependent on medical care may have conditions that are exacerbated by alcohol use and therefore require an abstinence goal. As for adolescents and pregnant women, these people will be referred to other appropriate treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested participants will visit www.ontrack.org.au and register online. They will receive a screening telephone call where they are provided information about the research. If eligible they will be sent a link to an online survey which includes participant consent section.

Baseline data will be obtained from participants through telephone interview online questions regarding drinking behaviour, physical activity, and diet.

Participants then complete the online alcohol program at their own pace. These Pilot Study participants will also receive emailed Healthy Living intervention information in the form of “OnTrack to Cutting Down and Feeling Good” emailed newsletters.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable to this Pilot Study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To investigate the effects of the conditions on alcohol consumption across two time points (i.e., baseline, 3 months post-baseline), SPSS Mixed Models will be utilised. Mixed models ANOVAs allow analyses to address missing data without making data substitutions. Data on screening, refusals and dropout to be coded and reported, and the key analyses use intention-to-treat.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
Date of last participant enrolment
Anticipated
1/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289780 0
Self funded/Unfunded
Name [1] 289780 0
Hugh Dickson
Country [1] 289780 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Australia
Country
Australia
Secondary sponsor category [1] 288470 0
None
Name [1] 288470 0
Address [1] 288470 0
Country [1] 288470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291510 0
Human Research Ethics Committee of Queensland University of Technology
Ethics committee address [1] 291510 0
Research Ethics Officer
Office of Research
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Ethics committee country [1] 291510 0
Australia
Date submitted for ethics approval [1] 291510 0
Approval date [1] 291510 0
06/11/2013
Ethics approval number [1] 291510 0
1300000407

Summary
Brief summary
The current project aims to conduct a Pilot Study, to obtain qualitative and quantitative data on the impact of a combined treatment, comprising an existing online alcohol support program – OnTrack (www.ontrack.org.au), together with emails and newsletters focusing on nutrition and healthy lifestyle "OnTrack to Cutting Down and Feeling Good" emailed newsletters.

Approximately fifteen male and female participants, aged over 18 years and drinking more than 14 standard drinks per week will be recruited in to the OnTrack online alcohol program. They will be assessed on their drinking behaviour, physical activity, and diet at the start of the Pilot Study and then again after participating in OnTrack Alcohol and receiving the emailed "OnTrack to Cutting Down and Feeling Good" newsletters. The participants will also be questioned by phone interview about their experiences using OnTrack Alcohol and the "OnTrack to Cutting Down and Feeling Good" emailed newsletters.
Trial website
www.ontrack.org.au
Trial related presentations / publications
Public notes
Attachments [1] 164 164 0 0
/AnzctrAttachments/366910-ISSUE 1 (Healthy Living Participants).pdf

Contacts
Principal investigator
Name 50698 0
Mr Hugh Dickson
Address 50698 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Australia
Country 50698 0
Australia
Phone 50698 0
+61 7 3138 6143
Fax 50698 0
Email 50698 0
[email protected]
Contact person for public queries
Name 50699 0
David Kavanagh
Address 50699 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Australia
Country 50699 0
Australia
Phone 50699 0
+61 7 3138 6143
Fax 50699 0
Email 50699 0
[email protected]
Contact person for scientific queries
Name 50700 0
David Kavanagh
Address 50700 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Australia
Country 50700 0
Australia
Phone 50700 0
+61 7 3138 6143
Fax 50700 0
Email 50700 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

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