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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625001109493
Ethics application status
Approved
Date submitted
5/09/2025
Date registered
10/10/2025
Date last updated
10/10/2025
Date data sharing statement initially provided
10/10/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of physical activity coaching for rural older adults
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Scientific title
Effectiveness of physical activity coaching for rural older adults: a randomised controlled trial
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Secondary ID [1]
315263
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Physical inactivity
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Quality of life
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Social isolation
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Condition category
Condition code
Public Health
335016
335016
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0
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Health service research
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Mental Health
335017
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants in the intervention group will receive a structured telephone-based physical activity coaching program (Healthy4U for older adults) incorporating motivational interviewing (MI) and cognitive behaviour therapy (CBT) strategies.
Materials: Allied health professionals will distribute recruitment fliers, and participants complete the PAR-Q+ safety screening prior to enrolment.
Procedures/activities: The program focuses on helping participants identify meaningful physical activity goals, enhance self-efficacy, problem-solve around barriers, and develop strategies for maintaining activity. Sessions 1–3 emphasise motivational interviewing for initiating behaviour change, while sessions 4–5 integrate MI-CBT to support maintenance.
Who delivers it: Coaching is delivered by a registered healthcare practitioner (AHPRA accredited) with specific training in MI-CBT. Practitioners receive supervision from experienced clinicians who have delivered previous Healthy4U trials.
Mode of delivery: All coaching is conducted by telephone, one-to-one with participants.
Frequency and duration: Each participant receives five coaching sessions of ~15–20 minutes:
- Four sessions over a six-week period
- One booster session at week 11 post-baseline.
Attendance rates will be measured using an attendance checklist.
Setting: Participants are older adults living in rural/regional Victoria. Sessions are conducted remotely from Bendigo Health.
Dose/intensity: Total intervention dose is approximately 75–100 minutes of coaching over three months.
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Intervention code [1]
331871
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Behaviour
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Intervention code [2]
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Lifestyle
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Comparator / control treatment
Comparator: Control group participants receive a single “check-in” phone call at week three (no coaching content). After trial completion, they are offered three optional coaching calls over 12 weeks.
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Control group
Active
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Outcomes
Primary outcome [1]
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Physical activity (minutes per day of moderate-to-vigorous physical activity)
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Assessment method [1]
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Self-reported using the International Physical Activity Questionnaire – Short Form (IPAQ-SF)
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Timepoint [1]
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Outcome measures will be completed at baseline (pre-intervention), 3 months and 6 months (primary timepoint) post-baseline.
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Secondary outcome [1]
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Self-efficacy for physical activity
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Assessment method [1]
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Physical Activity Self-Efficacy Scale (Sallis et al.)
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Timepoint [1]
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Outcome measures will be completed at baseline (pre-intervention), 3 months and 6 months (primary timepoint) post-baseline.
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Secondary outcome [2]
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Quality of life (physical and mental health components)
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Assessment method [2]
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Medical Outcomes Study Short Form 12 Health Survey (SF-12)
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Timepoint [2]
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Outcome measures will be completed at baseline (pre-intervention), 3 months and 6 months post-baseline.
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Secondary outcome [3]
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Body mass index (BMI)
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Assessment method [3]
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Weight and height self-reported by participants (kg/m²)
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Timepoint [3]
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Outcome measures will be completed at baseline (pre-intervention), 3 months and 6 months post-baseline.
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Secondary outcome [4]
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Loneliness
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Assessment method [4]
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UCLA Loneliness Scale – 3 item short version
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Timepoint [4]
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Outcome measures will be completed at baseline (pre-intervention), 3 months and 6 months post-baseline.
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Secondary outcome [5]
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Social isolation
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Assessment method [5]
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6-Item Social Isolation Scale
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Timepoint [5]
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Outcome measures will be completed at baseline (pre-intervention), 3 months and 6 months post-baseline.
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Secondary outcome [6]
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Mental wellbeing
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Assessment method [6]
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Short Warwick–Edinburgh Mental Wellbeing Scale (SWEMWBS)
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Timepoint [6]
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Outcome measures will be completed at baseline (pre-intervention), 3 months and 6 months post-baseline.
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Secondary outcome [7]
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Barriers and enablers for participating in the coaching sessions
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Assessment method [7]
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Qualitative interviews. Format: Semi-structured interviews using a study-specific guide (piloted prior to use). Questions focus on participants’ experiences, acceptability and perceived impacts of the intervention and trial procedures. Who conducts them: A trained member of the research team (e.g., research officer/CI) who is not involved in participants’ clinical care to minimise perceived coercion. Mode & duration: Conducted via telephone or secure videoconference (or in-person if preferred and feasible); approximately 20–40 minutes per interview. Audio-recording: With written/verbal consent, interviews are audio-recorded and professionally transcribed verbatim. Transcripts are de-identified; recordings are deleted after accuracy checks. Data management (brief): De-identified transcripts stored on a secure institutional server accessible only to the study team and retained per institutional policy. Participants may decline to answer any question or withdraw at any time without affecting their care.
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Timepoint [7]
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After study completion - 6 months
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Eligibility
Key inclusion criteria
Aged 65 years or older; or 50 years and older for Aboriginal and Torres Strait Islander peoples, or individuals with a disability (as per Community Allied Health Services eligibility)
Reside in a rural or regional postcode in Victoria
Insufficiently physically active, defined as engaging in less than 150 minutes of moderate-to-vigorous physical activity per week (self-reported)
Have access to a telephone
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Deafness or significant hearing impairment
Neurological disorder causing disability
Active, serious mental illness (e.g., psychosis)
Learning disability or dementia
Registered blind
Inability to mobilise independently
Advanced cancer
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sequentially numbered, sealed opaque envelopes prepared by research staff not involved in randomisation schedule development or statistical analysis.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence with permuted blocks of variable size will be used to allocate participants in a 1:1 ratio to intervention or control groups.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Analyses will follow the intention-to-treat principle. A series of 3 × 2 mixed-model ANOVAs will be conducted to compare differences in primary and secondary outcomes between groups across time points (baseline, 12 weeks, and 6 months).
For participants with missing data at 12 weeks or 6 months, a last-observation-carried-forward approach will be applied. Sensitivity analyses using multiple imputation methods will be undertaken to assess robustness of results.
Exploratory qualitative data from semi-structured interviews (intervention group subsample) will be analysed thematically using NVivo software to identify barriers, facilitators, and acceptability of the program.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
27/10/2025
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Actual
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Date of last participant enrolment
Anticipated
30/04/2026
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Actual
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Date of last data collection
Anticipated
30/11/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Bendigo Health
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Bendigo Health Care Group
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
322358
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Country [1]
322358
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318390
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Bendigo Health Human Research Ethics Committee
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Ethics committee address [1]
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https://www.bendigohealth.org.au/Ethicsandresearchgovernance/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
318390
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16/06/2025
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Approval date [1]
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04/09/2025
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Ethics approval number [1]
318390
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LRSSA /119510/BH-2025-490691(v1)
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Summary
Brief summary
This randomised controlled trial will evaluate the effectiveness of a structured telephone-based physical activity coaching program for insufficiently active older adults living in rural and regional Victoria. Participants will be referred by allied health professionals and randomised to either receive five coaching sessions incorporating motivational interviewing and cognitive behaviour therapy or to a control group receiving a brief check-in call. The primary outcome is change in physical activity at 12 weeks, assessed using the International Physical Activity Questionnaire – Short Form. Secondary outcomes include self-efficacy, quality of life, mental wellbeing, loneliness, social isolation, body mass index, waist circumference, and smoking status. The findings will inform the feasibility and scalability of telephone-based coaching as a preventive health strategy for rural populations.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Stephen Barrett
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Address
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Bendigo Health, 100 Barnard St. Bendigo, VIC, 3550
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Country
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Australia
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Phone
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+61 419599708
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Stephen Barrett
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Address
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Bendigo Health, 100 Barnard St. Bendigo, VIC, 3550
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Country
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Australia
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Phone
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+61 419599708
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Stephen Barrett
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Address
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Bendigo Health, 100 Barnard St. Bendigo, VIC, 3550
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Country
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Australia
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Phone
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+61 419599708
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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
No additional documents have been identified.
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