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Trial registered on ANZCTR


Registration number
ACTRN12616001171404
Ethics application status
Approved
Date submitted
7/07/2016
Date registered
26/08/2016
Date last updated
26/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition and Lifestyle Modifications to an Internet-based Treatment for Alcohol Misuse
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] 287184 0
None
Universal Trial Number (UTN)
U1111-1172-7434
Trial acronym
NALMITAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Misuse 295753 0
Condition category
Condition code
Public Health 296031 296031 0 0
Other public health
Diet and Nutrition 296032 296032 0 0
Other diet and nutrition disorders
Mental Health 296033 296033 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study aims to evaluate the efficacy of adding a nutrition and healthy lifestyle component to an existing online alcohol treatment program for people who are drinking alcohol at harmful levels.

This study is a randomised controlled trial with 3 comparison treatments, each with approximately 50 participants, who will be followed up for 6 months.

The 3 treatments that will be compared are:
1. OnTrack Participants (OTP) – The Ontrack Alcohol program includes the following components: a step by step guide, a personal diary for recording drinking + mood, graphs, interactive tools, summary pages - and the following modules: Making Plans, First Steps, Closing a Risky Track, Taking Care in Risky Situations, Developing a Close Relationship, Building a New Life. These modules take approximately 90 minutes to complete.

2. OnTrack plus Newsletter Support (OTNS) – This group consists of OnTrack participants, who are also receiving an additional six emailed newsletters about their use of the OnTrack program. Newsletters are emailed to participants on a weekly basis, beginning in week 2. Participants will be asked to respond to these emails. If there is no response this is followed up with email and phone call if necessary to check that the newsletters are being received. The option to stop these follow up emails will be given to the participants.

3. OnTrack plus Healthy Living (OTHL) -– This group consists of OnTrack participants, who are also receiving an additional six emailed newsletters about their use of the OnTrack program and information and ideas aimed at being healthy. Specifically, this entails suggestions and advice aimed at encouraging healthier eating and more walking activities. Newsletters are emailed to participants on a weekly basis, beginning in week 2.
Participants will be asked to respond to these emails. If there is no response this is followed up with email and phone call if necessary to check that the newsletters are being received. The option to stop these follow up emails will be given to the participants.

Following recruitment, participants are randomly assigned to the OnTrack treatment (OTP) condition, the OnTrack plus Newsletter Support (OTNS) treatment, or the OnTrack Healthy Living (OTHL) condition.

Participants in all three groups are encouraged to access the site as often as they want and to work through the program at their own pace. Participants can come back to the program and work through the activities as many times as they like.

Participants in all three groups are sent automated reminder emails if they haven't logged onto the Ontrack program in 14 days. The database allows Ontrack administrators to assess the number of times people have logged in, the duration of their use of the program and the number of pages visited.

Duration of intervention period for all groups is 3 months. Primary assessments will occur at Baseline, 3, and 6 months.

Primary predictions are that: (1) OTHL interventions will have superior alcohol outcomes at 3 and 6 months, compared with OTP and OTNS, and (2) OTHL will elicit greater client satisfaction and completion rate than OTP and OTNS.
Intervention code [1] 292460 0
Lifestyle
Intervention code [2] 295531 0
Behaviour
Intervention code [3] 295532 0
Treatment: Other
Comparator / control treatment
The control treatment consists of the participants attending the OnTrack online alcohol treatment program without receiving any newletters (OTP condition),
Control group
Active

Outcomes
Primary outcome [1] 295701 0
Alcohol consumption, measured with the Timeline Followback method
Timepoint [1] 295701 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [1] 316271 0
Physical Activity, measured with the International Physical Activity Questionnaire (IPAQ).
Timepoint [1] 316271 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [2] 316272 0
Diet, measured with the Diet Quality Tool (DQT).
Timepoint [2] 316272 0
Baseline, 12 weeks, 24 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
Use of injected drugs in the previous month or report daily use of an illicit substance. Self-reported history of a psychosis lasting > 2 days or a diagnosis of Bipolar Disorder. 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
Randomised controlled 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.

Following recruitment, participants are randomly assigned to the OnTrack treatment (OTP) condition, the OnTrack plus Newsletter Support (OTNS) treatment, or the OnTrack Healthy Living (OTHL) condition.

Method of allocation concealment is through the use of sealed envelopes which are opened after a person has become eligible for participation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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, 6 months), 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.

Using G*Power version 3.1.9.2. for a Time x Condition interaction, 3 groups, alpha = .05, power = .80. Original sample size of 150 (50 per group) assumed corr of 0.50 resulted in small effect size of f=0.116.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/10/2015
Date of last participant enrolment
Anticipated
28/02/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 10041 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 291747 0
University
Name [1] 291747 0
Queensland University of Technology
Country [1] 291747 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] 290417 0
None
Name [1] 290417 0
Address [1] 290417 0
Country [1] 290417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293266 0
Human Research Ethics Committee of Queensland University of Technology
Ethics committee address [1] 293266 0
Research Ethics Officer
Office of Research
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Ethics committee country [1] 293266 0
Australia
Date submitted for ethics approval [1] 293266 0
02/06/2015
Approval date [1] 293266 0
17/09/2015
Ethics approval number [1] 293266 0
1500000409

Summary
Brief summary
The current project aims to assess 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.

Approximately150 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 randomised into three groups and assessed on their drinking behaviour, physical activity, and diet at the start of the study and then again after participating in OnTrack Alcohol and receiving the emailed "OnTrack to Cutting Down and Feeling Good" newsletters.
Trial website
www.ontrack.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59178 0
Mr Hugh Dickson
Address 59178 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059 Australia
Country 59178 0
Australia
Phone 59178 0
+61 7 3138 6143
Fax 59178 0
Email 59178 0
[email protected]
Contact person for public queries
Name 59179 0
David Kavanagh
Address 59179 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059 Australia
Country 59179 0
Australia
Phone 59179 0
+61 7 3138 6143
Fax 59179 0
Email 59179 0
[email protected]
Contact person for scientific queries
Name 59180 0
David Kavanagh
Address 59180 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059 Australia
Country 59180 0
Australia
Phone 59180 0
+61 7 3138 6143
Fax 59180 0
Email 59180 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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