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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

7/06/2021

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]

NHMRC1171313

Universal Trial Number (UTN)

U1111-1243-8645

Trial acronym

ACTIVate

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Condition category

Condition code

Neurological

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Cognitive function, measured using Addenbrooke's Cognitive Examination-III

Timepoint [1]

Baseline, 18 months, and 36 months (primary endpoint)

Secondary outcome [1]

Brain connectivity, measured using Transcranial Magnetic Stimulation (TMS)

Timepoint [1]

Baseline and 36 months

Secondary outcome [2]

Brain plasticity, measured using Transcranial Magnetic Stimulation (TMS)

Timepoint [2]

Baseline and 36 months

Secondary outcome [3]

Cerebral artery elasticity, measured using Pulse Diffuse Optical Tomography (Pulse-DOT)

Timepoint [3]

Baseline and 36 months

Secondary outcome [4]

Brain structure, measured using MRI

Timepoint [4]

Baseline and 36 months

Secondary outcome [5]

Brain connectivity, measured using MRI

Timepoint [5]

Baseline and 36 months

Secondary outcome [6]

White matter hyper-intensities. measured using MRI

Timepoint [6]

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

Sex

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

Recruiting

Date of first participant enrolment

Anticipated

3/02/2020

Actual

29/07/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/07/2024

Actual

Sample size

Target

448

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,SA

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

2305 - New Lambton Heights

Recruitment postcode(s) [3]

2308 - Newcastle University

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Institute

Address [1]

414 La Trobe St, Melbourne VIC 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Professor Frini Karayanidis

Address [1]

University of Newcastle,
University Drive, Callaghan, NSW 2308

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Professor Michael Breakspear

Address [2]

University of Newcastle,
University Drive, Callaghan, NSW 2308

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Kate Laver

Address [3]

Flinders Medical Centre,
Rehabilitation and Palliative Care,
Flinders Drive, Bedford Park SA 5042

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Professor Timothy Olds

Address [4]

University of South Australia,
108 North Terrace, Adelaide SA 5000

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Dr Mitchell Goldsworthy

Address [5]

University of Adelaide,
North Terrace, Adelaide SA 5000

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Dr Dorothea Dumuid

Address [6]

University of South Australia,
108 North Terrace, Adelaide SA 5000

Country [6]

Australia

Other collaborator category [7]

Individual

Name [7]

Professor Michael Ridding

Address [7]

University of South Australia,
108 North Terrace, Adelaide SA 5000

Country [7]

Australia

Other collaborator category [8]

Individual

Name [8]

Professor Monica Fabiani

Address [8]

University of Illinois,
603 East Daniel St, Champaign IL 61801

Country [8]

United States of America

Other collaborator category [9]

Individual

Name [9]

Associate Professor Jill Dorrian

Address [9]

University of South Australia,
St Bernards Road, Magill SA 5072

Country [9]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

University of South Australia, 
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/09/2019

Approval date [1]

31/10/2019

Ethics approval number [1]

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

Dr Ashleigh Smith

Address

University of South Australia,
108 North Terrace, Adelaide SA 5000

Country

Australia

Phone

+61 883021734

Fax

[email protected]

Contact person for public queries

Name

Ashleigh Smith

Address

University of South Australia,
108 North Terrace, Adelaide SA 5000

Country

Australia

Phone

+61 883021734

Fax

[email protected]

Contact person for scientific queries

Name

Ashleigh Smith

Address

University of South Australia,
108 North Terrace, Adelaide SA 5000

Country

Australia

Phone

+61 883021734

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5738	Study protocol				The ACTIVate Study Protocol will be made available... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Characterising activity and diet compositions for dementia prevention: Protocol for the ACTIVate prospective longitudinal cohort study.	2022	https://dx.doi.org/10.1136/bmjopen-2020-047888
Embase	Cross-sectional associations between 24-hour time-use composition, grey matter volume and cognitive function in healthy older adults.	2024	https://dx.doi.org/10.1186/s12966-023-01557-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically