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Trial registered on ANZCTR


Registration number
ACTRN12619001659190
Ethics application status
Approved
Date submitted
18/11/2019
Date registered
27/11/2019
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The ACTIVate Study: Optimising activity and diet compositions for dementia prevention
Scientific title
The ACTIVate Study: Optimising activity and diet compositions for dementia prevention
Secondary ID [1] 299841 0
NHMRC1171313
Universal Trial Number (UTN)
U1111-1243-8645
Trial acronym
ACTIVate
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Dementia 315239 0
Condition category
Condition code
Neurological 313546 313546 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants aged 60-70 years will be followed for 3 years to monitor changes in cognitive function. Data will be collected at baseline, 18 months and 36 months at sites in Adelaide and Newcastle. At baseline and 36month visits, participants will attend 3 sessions in Adelaide and 2 sessions in Newcastle.

At Session 1, Adelaide participants will arrive fasted for 12 hours from all food and beverages, excluding water and regular medication. Participants will provide informed consent and undergo anthropometric measures. A venous blood sample will be collected to measure BDNF, lipids and glucose in the Adelaide cohort. Saliva samples will be collected in both Adelaide and Newcastle to measure APOE genotype. Participants will then complete diet and lifestyle questionnaires and undergo 90 minutes of cognitive assessments. Participants will then be given an activity monitor to wear for 7 days. Between Session 1 and Session 2 participants will be contacted by phone to complete the Multimedia Activity Recall (MARCA) to validate activity monitor data.

At Session 2, participants will undergo an MRI brain scan to measure brain structure, connectivity and white matter hyper-intensities. EEG will then be recorded while participants complete a 60-minute executive function task-switching paradigm. Participants in Adelaide will then complete a 2-hour TMS-EEG protocol to measure brain plasticity and connectivity. Participants in Newcastle will undergo optical imaging to measure cerebral artery elasticity.

At Session 3 (Adelaide only) participants will complete another TMS-EEG session, identical to that administered in the Session 2.

Only Session 1 will take place at 18 months.
Intervention code [1] 316101 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321998 0
Cognitive function, measured using Addenbrooke's Cognitive Examination-III
Timepoint [1] 321998 0
Baseline, 18 months, and 36 months (primary endpoint)
Secondary outcome [1] 376956 0
Brain connectivity, measured using Transcranial Magnetic Stimulation (TMS)
Timepoint [1] 376956 0
Baseline and 36 months
Secondary outcome [2] 376957 0
Brain plasticity, measured using Transcranial Magnetic Stimulation (TMS)
Timepoint [2] 376957 0
Baseline and 36 months
Secondary outcome [3] 376958 0
Cerebral artery elasticity, measured using Pulse Diffuse Optical Tomography (Pulse-DOT)
Timepoint [3] 376958 0
Baseline and 36 months
Secondary outcome [4] 377131 0
Brain structure, measured using MRI
Timepoint [4] 377131 0
Baseline and 36 months
Secondary outcome [5] 377132 0
Brain connectivity, measured using MRI
Timepoint [5] 377132 0
Baseline and 36 months
Secondary outcome [6] 377133 0
White matter hyper-intensities. measured using MRI
Timepoint [6] 377133 0
Baseline and 36 months

Eligibility
Key inclusion criteria
Community-dwelling adults aged 60-70 years who are fluent in the English language and meet safety criteria for TMS and MRI
Minimum age
60 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Overall study exclusion criteria:
• Blindness, colour blindness or vision difficulties that cannot be corrected by glasses or contact lenses
• Major neurological or psychiatric diagnosis
• Known intellectual disability
• Major physical disability
• Previous head trauma resulting in a loss of consciousness of more than 5 minutes
• Current or previous alcohol or substance abuse or dependence
• Recreational drug use in the last 3 months
• Previous stroke or diagnosed transient ischemic attack
• Cancer treatment in the past 5 years
• Unable to undergo TMS or MRI assessments (detailed below), or unable to wear an EEG cap
• Scores below the mild cognitive impairment (MCI) cut-off on the Telephone Montreal Cognitive Assessment (T-MoCA) or a current diagnosis of dementia

TMS exclusion criteria:
• Current medications targeting the central nervous system (including anticonvulsants and antidepressants)
• History of epilepsy, convulsions or seizures
• History of severe head trauma followed by loss of consciousness
• Presence of metal in the brain or skull (excluding titanium) or a neurostimulator implant
• Cochlear implants
• Presence of pacemaker, intracardiac lines, implants or metals
• Presence of a medication infusion device
• History of surgical procedures to the spinal cord or any spinal or ventricular derivations

MRI exclusion criteria:
• Presence of a pacemaker
• Presence of metal implants, including aneurysm clips; brain shunt tubes; artificial heart valves; intravascular coils, filters or stents; vascular clips or wires; neurological implants (neurotransmitters or biostimulators); metal pins, plates, rods or screws
• Cochlear or other ear implants
• Presence of metal fragments or foreign objects in the eyes, skin or body, including; metallic fragments near the eyes or spinal cord;
• Any other form of implant (excluding dental fillings)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In our pilot study, multiple regression performed on ACE-III gave an R2 value of 0.14 when including covariates such as age and sex, but without compositional variables. When adding compositional variables, an R2 of 0.20 was obtained. We base our power calculation on these results, and assuming 7 parameters for the covariates and three compositional parameters representing the four-part composition (sleeping, sedentary time, light physical activity, and moderate-to-vigorous physical activity). We aim for 80% power and a significance level of 5%; however due to the multiple responses an adjusted significance level of 1% is used for each regression to account for multiple testing. Based on these assumptions, a total sample size of 236 is needed. This figure is further inflated to allow for 25% attrition over the 36-month period, and a 70% response rate at recruitment, resulting in a final sample size of 448 adults at study enrolment (224 per site).

Compositional data analysis will be used to determine cross-sectional and longitudinal associations between physical activity compositions and cognitive outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 28477 0
5000 - Adelaide
Recruitment postcode(s) [2] 28482 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 28483 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 304300 0
Government body
Name [1] 304300 0
National Health and Medical Research Institute
Address [1] 304300 0
414 La Trobe St, Melbourne VIC 3000
Country [1] 304300 0
Australia
Primary sponsor type
Individual
Name
Dr Ashleigh Smith
Address
University of South Australia,
108 North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 304545 0
None
Name [1] 304545 0
Address [1] 304545 0
Country [1] 304545 0
Other collaborator category [1] 281037 0
Individual
Name [1] 281037 0
Professor Frini Karayanidis
Address [1] 281037 0
University of Newcastle,
University Drive, Callaghan, NSW 2308
Country [1] 281037 0
Australia
Other collaborator category [2] 281038 0
Individual
Name [2] 281038 0
Professor Michael Breakspear
Address [2] 281038 0
University of Newcastle,
University Drive, Callaghan, NSW 2308
Country [2] 281038 0
Australia
Other collaborator category [3] 281039 0
Individual
Name [3] 281039 0
Dr Kate Laver
Address [3] 281039 0
Flinders Medical Centre,
Rehabilitation and Palliative Care,
Flinders Drive, Bedford Park SA 5042
Country [3] 281039 0
Australia
Other collaborator category [4] 281040 0
Individual
Name [4] 281040 0
Professor Timothy Olds
Address [4] 281040 0
University of South Australia,
108 North Terrace, Adelaide SA 5000
Country [4] 281040 0
Australia
Other collaborator category [5] 281041 0
Individual
Name [5] 281041 0
Dr Mitchell Goldsworthy
Address [5] 281041 0
University of Adelaide,
North Terrace, Adelaide SA 5000
Country [5] 281041 0
Australia
Other collaborator category [6] 281042 0
Individual
Name [6] 281042 0
Dr Dorothea Dumuid
Address [6] 281042 0
University of South Australia,
108 North Terrace, Adelaide SA 5000
Country [6] 281042 0
Australia
Other collaborator category [7] 281043 0
Individual
Name [7] 281043 0
Professor Michael Ridding
Address [7] 281043 0
University of South Australia,
108 North Terrace, Adelaide SA 5000
Country [7] 281043 0
Australia
Other collaborator category [8] 281044 0
Individual
Name [8] 281044 0
Professor Monica Fabiani
Address [8] 281044 0
University of Illinois,
603 East Daniel St, Champaign IL 61801
Country [8] 281044 0
United States of America
Other collaborator category [9] 281045 0
Individual
Name [9] 281045 0
Associate Professor Jill Dorrian
Address [9] 281045 0
University of South Australia,
St Bernards Road, Magill SA 5072
Country [9] 281045 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304754 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 304754 0
University of South Australia,
Adelaide SA 5000
Ethics committee country [1] 304754 0
Australia
Date submitted for ethics approval [1] 304754 0
24/09/2019
Approval date [1] 304754 0
31/10/2019
Ethics approval number [1] 304754 0
202639

Summary
Brief summary
The ACTIVate Study is a joint project between the University of South Australia, the University of Newcastle, the University of Adelaide, Flinders University and the University of Illinois. Our aim is to investigate the effect of different lifestyle patterns on brain function in older adults. Specifically, we're interested in activity and diet compositions, and how these might influence our risk of developing dementia. Four hundred and fifty participants will be recruited in Adelaide and Newcastle and followed over 3 years to monitor changes in lifestyle factors, brain structure and function, and overall health. From the information we collect we will develop a tool that will enable older adults to tailor their ‘best day’ of activity and diet compositions to reduce dementia risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98094 0
Dr Ashleigh Smith
Address 98094 0
University of South Australia,
108 North Terrace, Adelaide SA 5000
Country 98094 0
Australia
Phone 98094 0
+61 883021734
Fax 98094 0
Email 98094 0
ashleigh.smith@unisa.edu.au
Contact person for public queries
Name 98095 0
Dr Ashleigh Smith
Address 98095 0
University of South Australia,
108 North Terrace, Adelaide SA 5000
Country 98095 0
Australia
Phone 98095 0
+61 883021734
Fax 98095 0
Email 98095 0
ashleigh.smith@unisa.edu.au
Contact person for scientific queries
Name 98096 0
Dr Ashleigh Smith
Address 98096 0
University of South Australia,
108 North Terrace, Adelaide SA 5000
Country 98096 0
Australia
Phone 98096 0
+61 883021734
Fax 98096 0
Email 98096 0
ashleigh.smith@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data will be made publicly available for all outcome measures
When will data be available (start and end dates)?
It is estimated that data will be available upon completion of the project in 2025. No end date to data availability is determined.
Available to whom?
Data will be available by Open Access to anyone who wishes to use it
Available for what types of analyses?
Data can be used for any purpose
How or where can data be obtained?
Data will be accessible via the University of South Australia's Data Access Portal. A link will be provided when data has been uploaded.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 5738 0
Study protocol
Citation [1] 5738 0
Link [1] 5738 0
Email [1] 5738 0
Other [1] 5738 0
The ACTIVate Study Protocol will be made available when published
Attachment [1] 5738 0
Summary results
No Results