ANZCTR - Registration

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 information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12620000978965

Ethics application status

Approved

Date submitted

15/07/2020

Date registered

30/09/2020

Date last updated

2/08/2022

Date data sharing statement initially provided

30/09/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating the effect of diet and exercise lifestyle interventions on cognitive performance and dementia risk in older people.

Scientific title

Investigating the effect of Mediterranean diet and exercise on cognitive performance and dementia risk in independently living older Australians: the MedWalk randomised controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1255-2911

Trial acronym

MedWalk

Linked study record

ACTRN12614001133628 - This study (the LIILAC trial) was used as the pilot study for the current trial

Health condition

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

cognitive decline

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This will be a 1-year trial will consist of 180 participants, aged 60 to 90, who will be recruited from at least 28 facility sites through agreements with Independent Living providers or other community groups in Vic and SA via advertisements and information sessions held at these sites. Residents in these communities live independently, undertaking all of their own activities of daily living (such as cooking, shopping and cleaning). Participants will be randomised to one of two conditions:

Group 1: MedWalk Intervention - Diet and exercise change intervention
Group 2 : Control - No requirement to change diet or exercise / social engagement

1. MedWalk Intervention:

The intervention combines dietary modification with a supervised progressive walking program and is underpinned by established psychosocial behavioural change techniques (embedded within dietary modification and walking program).
Participants will be supported by a study dietitian for the first year in a tapering visit regime. During these visits MI-CBT, as outlined below, will be employed by the dietitian. The ‘intense support’ phase will last 8 weeks, in which each participant will have fortnightly, face-to-face, 60-minute consultations with a dietitian. Further the dietitian will be available to answer questions via email and phone during this time. These visits will occur 2 weeks, 4 weeks, 6 weeks and 8 weeks after the baseline session. The ‘continued support’ phase will follow the first 8 weeks and consist of monthly visits for 4 months and then quarterly visits until the end of year 1. These visits will be similar to the fortnightly visits, whereby MI-CBT will be used to provide support and empower participants to continue the intervention. These visits are expected to take up to 60 minutes. During the continued support phase, the dietitian will be available via email and phone to answer questions during business hours. The monthly visits will occur at weeks 12, 16, 20 and 26 (6 months). Quarterly visits will occur at week 39 and week 52 (12 months).
Walking exercise intervention will take place in parallel with the dietary intervention. Supervised group walking sessions, involving all participants at a site, will take place weekly for the first 6 months, and then reduce to monthly sessions for the following 6 months. Supervised walking sessions will be ceased after 1 year.

1.1 MedWalk - Mediterranean dietary component:

The dietary intervention is based on the PREDIMED dietary guidelines, modified for Australian use investigators. Abundant use of EVOO for cooking and dressing vegetables and salad; 2 or more daily serves of both vegetables and fresh fruits and dried fruit as snacks; 3 or more weekly servings of the following: legumes; fish and seafood (at least 1 serving of oily fish); nuts or seeds; daily consumption of Greek yoghurt, low-fat cheese (feta, ricotta, hard cheese) and milk; ad libitum consumption of wholegrains; select white meats over red and processed meat; cook 2 or more times a week with tomato, garlic and onion; eliminate or limit the consumption of sweetened soft drinks; for alcohol consumers, choose red wine and consume no more than 2 standard drinks per day.
The assistant dietitian will provide detailed instructions on following a MedDiet together with meal planning and recipes and utilise MI-CBT to assist with dietary behaviour change and manage ambivalence toward change. This level of education and support initially, is vital to allow participants to fully comprehend the dietary pattern and how it differs from the Australian diet. As extra-virgin olive oil (EVOO) is an essential component of the MedDiet, Cobram Estate will donate EVOO for MedWalk.
Adherence to the dietary component of this study will be evaluated using attendance by attendance at dietician information session, the MEDAS dietary screening tool.

1.2 MedWalk - Walking component

The assistant exercise scientist will prescribe an individualised, structured, progressive home-based walking program together with a handout and stretching routine. Participants will be asked to walk for at least 30 min on 5-days per week (150 min in total, consistent with the current national physical activity guidelines); working up from 10-30 min sessions performed 2-3 days per week. Each session will include a 5-minute warm-up and cool-down period of walking slowly. The objective is to increase fitness as measured by distance covered during the 6-minute walk test. Consistent with the American College of Sports Medicine guidelines, training intensity will commence at a low-moderate intensity (a rating of 2-3 on the Modified Borg Category-Ratio Scale (Borg CR10)) and will be progressively increased.
Walking groups will be organised at each IL facility, and will consist of all the participants (13) at that facility. The weekly trainer-led group sessions provide the opportunity for each participant’s walking program to be progressed to maintain desired intensity. Training intensity will be modified through a reduction in rest intervals, increasing walking speed and number of steps per walk, or per week, and/or through the prescription of hill walking or interval walk training. All participants in the MedWalk intervention group will be provided with a wrist-worn activity tracker for motivational purposes.
Adherence to the walking exercise component will be assessed via attendance at group walking sessions and the International Physical Activity Questionnaire modified for the elderly (IPAQ-E). Additionally, change in free-living ambulatory physical activity and sedentary behaviour will be assessed via accelerometry.

1.3 MedWalk – Behaviour change counselling using Motivational Interviewing – Cognitive Behavioural Therapy (MI-CBT)

MI uses a combination of relational and technical micro-skills (e.g., open questions, affirmations and reflective listening) to explore and action plan around an individual’s barriers to change. MI is an effective approach to promote physical activity (PA) and diet change. CBT includes action-orientated treatments (e.g. behavioural counselling, goal-orientated therapy, cognitive behaviour therapy) to build maintenance skills. Our team has recently demonstrated that integrated MI-CBT can increase physical activity in older insufficiently active secondary care patients. The intervention will be underpinned with a theoretical framework (self-determination theory; SDT) which identifies progression by clients towards autonomous (self-directed) behaviours. This will be evaluated at each stage of the intervention delivery and receipt. The MI component will be delivered by research assistants trained in MI by one of the MI trained chief investigators or a member of the MI Network of Trainers (MINT) to a level of proficiency according to the Motivational Interviewing Treatment Integrity guidelines. To achieve change in diet and exercise behaviour, staff will use open questions, affirmations, reflective listening skills to build social support; identify change barriers and goals; develop flexible goal setting; action planning; managing relapse; building maintenance strategies and processes for self-monitoring. This will be conducted by trained researchers, and done in a non-judgemental, collaborative and compassionate manner guided by the participant.

The format of the intervention will be a 12-session psycho-educational approach underpinned by the four processes (engaging, focusing, evoking, planning) and relational (spirit) and technical (Open ended questions, Affirmations, Reflective listening and Summarising; OARS) components of MI. The approach develops autonomy, evoking their perceived resources and abilities, and developing collaboration. Specific applications for the use of MI in PA and diet modification will form the basis of the training and subsequent MI delivery as well as adaptations required for the use of MI in individual and group settings.

Along with the CB aspects, the intervention includes relapse prevention to support long-term behaviour change and contingency management. The relapse prevention components include, a) identifying high risk situations for relapse, b) flexible rather than rigid PA and diet change goals, and c) strategies for dealing with setbacks. Each session will be clearly manualised for content and style of delivery and will include psycho-educational, emotional and applied skills for managing barriers.
Sessions will also explore the participants’ attitudes, motives and values toward PA and diet and how behaviours can be congruent to these three components. The proposed programme will be based on successful MI interventions to promote PA to adolescent populations and the 12 aspects of the intervention will be: 1) Getting to know each other: ice breaker and team activities (focussed around activity and healthy nutrition), 2) psycho-education: the background to PA and diet, group activities and knowledge exchange (elicit-provide-elicit; MI-based strategy), 3) Exploring attitudes and values toward change (PA and diet), 4) Understanding motives and reasons for PA and health nutrition, 5) Getting to know your options: How to take responsibility for your health in your environment, 6) Identifying and managing your barriers to change, 7) Identifying and managing risks of setbacks in yourself and others, 8) Identifying and managing flexible approaches to being more active and eating well, 9) Developing cognitive skills: recognising thoughts and emotions, 10) Developing cognitive skills: helpful thoughts and emotions, 11) Developing cognitive skills: Staying on track, 12) Where next and action planning
MI-CBT will not be delivered as separate sessions, but will be incorporated into the dietitian visits and exercise sessions.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Comparator / control treatment

Control condition (no requirement to change diet and exercise; social engagement group):

Participants in facilities randomised into the control condition will not be asked to change their usual diet and exercise habits. The habitual lifestyle group will receive similar attention as the MedWalk group through equivalent testing sessions and during social gathering group sessions. Each session will last approximately 2 hours and will be scheduled at the same frequency as the dietitian visits,

Control group sessions will conducted by the researchers in a group setting at each site, These sessions can include organised activities such as: talks (non diet/health related), movie afternoons, bingo sessions, afternoon/morning tea (bring a plate to share), games days, etc. (a total of 11 visits). Participants will receive 5 x $30 shopping vouchers that will be distributed to participants across the control group sessions.

Control group

Active

Outcomes

Primary outcome [1]

Cognitive performance as assessed by:
- Errors on the Paired Associates Learning task (PAL) of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Timepoint [1]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [1]

Cognitive performance as assessed by the Spatial Working Memory (SWM) test of the CANTAB

Timepoint [1]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [2]

Cognitive performance assessed by the Spatial Working Memory test of the
Swinburne University Computerised Cognitive Assessment Battery (SUCCAB)

Timepoint [2]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [3]

Adherence to MedDiet as assessed by the Mediterranean Diet Adherence Screener (MEDAS)

Timepoint [3]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [4]

Diet and dietary change as assessed by:
- Easy Diet Diary (FoodWorks V10, Xyris Pty Ltd)

Timepoint [4]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [5]

Functional exercise performance as assessed by
- The Six Minute Walk Test

Timepoint [5]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [6]

Physical activity as measured by:
- Accelerometery recordings using Actigraph accelerometers (model GT3X-BT; ActiGraph, USA)

Timepoint [6]

Over 8 continuous days prior to Baseline, 6month and 12 months assessment points

Secondary outcome [7]

Blood biomarkers as assessed by:
o Apolipoprotein E (APOE)
o High-sensitivity C-reactive protein (hs-CRP)
o Homocysteine
o F2-isoprostanes
o Brain-derived neurotrophic factor (BDNF)
o Haemoglobin A1c (HbA1c)
o Glucose
o Lipid profile
* Triglycerides
* Total Cholesterol
* Low-density lipoproteins (LDL)
* High-density lipoprotein (HDL)
o Liver function tests
o Calcium
o Phosphate
o Urea
o Uric Acid
o Electrolytes
o Creatinine
o Nutrient markers including:
* erythrocyte fatty acid profile
* Vitamin B6
* Vitamin B12
* Vitamin C
* Red cell folate
* Carotenoids

Timepoint [7]

Baseline and 12 months after intervention commencement

Secondary outcome [8]

Depression, anxiety and stress as assessed by the Depression Anxiety Stress Scales (DASS)

Timepoint [8]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [9]

Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [9]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [10]

Quality of life as assessed by the Flourishing Index

Timepoint [10]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [11]

Peripheral (brachial) blood pressures
- assessed using the SphygmoCor XCEL device

Timepoint [11]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [12]

Social engagement. as assessed by:
- the Berkman-Syme Social Network Index (BSSNI)

Timepoint [12]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [13]

Effectiveness of MedWalk and fidelity to the protocol (MI-CBT) as assessed by:
- Client Evaluation of Motivational Interviewing (CEMI)

Timepoint [13]

Baseline, 6 months and 12 months after intervention commencement

Secondary outcome [14]

Health care costs as assessed using:
* Vic and SA State Health Department data of hospital
admissions, emergency department attendances
* Medicare Benefits Schedule (MBS) data
* Pharmaceutical Benefits Scheme (PBS)

Timepoint [14]

Baseline and 24 months after intervention commencement

Secondary outcome [15]

Cognitive performance as assessed by the Motor Screening Task (MOT) test of the CANTAB

Timepoint [15]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [16]

Cognitive performance as assessed by the Reaction Time test of the CANTAB

Timepoint [16]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [17]

Cognitive performance as assessed by the Rapid Visual Information Processing (RVP) test of the CANTAB

Timepoint [17]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [18]

Cognitive performance assessed by the Simple Reaction Time test of the SUCCAB

Timepoint [18]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [19]

Cognitive performance assessed by the Choice Reaction Time test of the SUCCAB

Timepoint [19]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [20]

Mood as assessed by Profile of Mood States (POMS)

Timepoint [20]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [21]

Psychiatric disorders as assessed by the General Health Questionnaire (GHQ)

Timepoint [21]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [22]

Faecal microbiome and biomarkers - exploratory

Timepoint [22]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [23]

Adherence to MedDiet as assessed by attendance at diet education sessions

Timepoint [23]

Assessed at each education session - fortnightly for the first 8 weeks, monthly for the next 4 months, then quarterly for the remainder of the first year.

Secondary outcome [24]

Central (aortic) blood pressures
- assessed using the SphygmoCor XCEL device

Timepoint [24]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [25]

Augmented pulse pressure
- assessed using the SphygmoCor XCEL device

Timepoint [25]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [26]

Pulse wave velocity measure of arterial stiffness
- assessed using the SphygmoCor XCEL device

Timepoint [26]

Baseline, 6month and 12 months after intervention commencement

Secondary outcome [27]

Differential Quality-adjusted life years (QALY)
- assessed by combining the AQoL with time - gain/loss over the trial and modelled out to 10 years

Timepoint [27]

24 months after intervention commencement

Eligibility

Key inclusion criteria

• Live in independent living supported accommodation
• Fluent in written and spoken English
• Able to walk independently and free from major physical conditions that would prevent regular walking
• Willing to provide blood and stool samples throughout the testing phases
• Willing to participate in all scheduled assessments
• Willing to participate in regular engagement sessions

Minimum age

60 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Have been diagnosed with dementia (e.g. Alzheimer’s disease) or other forms of cognitive impairment.
• Have a history of stroke or any other conditions that affect your brain function
• Participate (on average) in more than 150 min of moderate-to-vigorous leisure time physical activity per week AND already eat a mostly Mediterranean style diet
• Have a diagnosed allergy or intolerance of food groups (e.g. olive oil/nuts/seafood) that would prevent you from eating a Mediterranean style diet

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer by a disinterested third party

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

There will be a total of 28 independent living sites, 14 in Victoria and 14 in South Australia. Each of these independent living sites will be designated as either control or MedWalk intervention sites. Within each site, a sample of approximately 13 people will be recruited to participate in the study. The sites will be cluster randomised within states and within living site organisations (if they have more than one site in a state)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Determination of Sample Size:

In this cluster-randomised controlled trial we need to determine the number of Independent Living (IL) facilities (i.e. clusters) to be included in the study and the number of people to recruit at each. The latter is determined on practical grounds with 13 people regarded as a feasible average number of participants to recruit at each facility. Based on our LIILAC pilot study results a moderate effect size is indicated (d=.5, F Hedges=.25) using the SUCCAB SWM performance measure. A similar effect size is expected for errors on the CANTAB-PAL, when comparing the intervention and control group over time, with 3.6% of the variation attributable to differences between facilities as found in the LILAC study. In this power analysis, a repeated measures MANOVA analysis allowed for multiple outcome measures with 5 assessments for all participants. In addition, an adjustment was made for the cluster sampling, taking into account the average number of people recruited at each facility and the percentage of between cluster (facility) variation (Kish, 1965). Assuming a significance level of 5%, power of 80% and an attrition rate of 30% (expect <30% based on LIILAC, MedLey and proposed MI-CBT approach) it was determined that the sample size would equal 364 participants with 13 participants per facility for each of 28 facilities. Ideally there will be 14 facilities in both Victoria and South Australia, with groups randomly assigned to matched facilities in each state.

However, due to extensive COVID related delays over a number of years this number is no longer feasible as a result of associated financial and time reasons. Therefore, the adjusted target of 180 participants has been implemented as this has been estimated to be the highest achievable target within these unavoidable financial and temporal limitations

Statistical Analyses

The baseline characteristics of the intervention and control group participants will be compared using chi-squared and independent sample t-tests as appropriate. The study hypothesis will be addressed using a 3-level hierarchical linear model (HLM) analysis with HLM7 software, assuming a Poisson distribution for the total number of PAL errors. The three levels are, time, participant and independent/ retirement living facility. With this ITT analysis we will test for significant differences between the intervention and control groups over time. This analysis uses all available information from participants. Incomplete data will not be discarded and missing data not replaced with estimated values or observations carried forward. Instead, maximum-likelihood estimation will be applied with available data. Where there are significant group-X-time interactions, planned contrasts will compare changes from baseline under each intervention. Similar tests will be performed for the secondary hypotheses, using appropriate transformations if necessary. This analysis will allow us to control for any baseline group differences, for demographic characteristics (e.g. age and social interaction), any IL facility characteristics (e.g. city), and to test for moderation effects in terms of these participant and IL facility characteristics over time.
The level of significance will be at a = 0.05, with Bonferroni adjustments for multiple comparisons.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/02/2021

Actual

7/04/2021

Date of last participant enrolment

Anticipated

30/09/2022

Actual

Date of last data collection

Anticipated

30/09/2023

Actual

Sample size

Target

180

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

SA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra,
ACT 2601

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Cobram Estate (In kind donation of Premium Extra Virgin Olive Oil)

Address [2]

Unit 14, 75 Lorimer Street
Southbank
Victoria 3006

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Nutricia Research Foundation

Address [3]

Uppsalastr. 12
3584CT Utrecht
The Netherlands

Country [3]

Netherlands

Primary sponsor type

University

Name

Swinburne University of Technology

Address

Centre for Human Psychopharmacology
John St
Hawthorn
Victoria 3122

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of South Australia

Address [1]

GPO Box 2471
Adelaide
SA 5001

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Murdoch University

Address [1]

90 South Street
Murdoch
WA 6150

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

La Trobe University

Address [2]

Corner Plenty Road and Kingsbury Drive
Bundoora
VIC 3086

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Deakin University

Address [3]

Locked Bag 20000
Geelong
VIC 3220

Country [3]

Australia

Other collaborator category [4]

University

Name [4]

University of East Anglia

Address [4]

Norwich Research Park
Norwich, Norfolk,
NR4 7TJ, UK

Country [4]

Australia

Other collaborator category [5]

University

Name [5]

Sheffield Hallam University

Address [5]

Howard Street,
Sheffield
S1 1WB UK

Country [5]

United Kingdom

Other collaborator category [6]

Commercial sector/Industry

Name [6]

Ryman Healthcare

Address [6]

Ryman Healthcare
PO Box 33119
Melbourne
Victoria 3004

Country [6]

Australia

Other collaborator category [7]

Charities/Societies/Foundations

Name [7]

Catholic Homes Villa Maria

Address [7]

PO Box 134
East Melbourne
VIC 8002

Country [7]

Australia

Other collaborator category [8]

Commercial sector/Industry

Name [8]

Australian Unity Ltd

Address [8]

114 Albert Road
South Melbourne
Victoria 3205

Country [8]

Australia

Other collaborator category [9]

University

Name [9]

University College Cork

Address [9]

College Road
Cork
T12 K8AF Ireland

Country [9]

Ireland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne University Human Research Ethics Committee (SUHREC)

Ethics committee address [1]

Swinburne University of Technology,
PO Box 218
Hawthorn
VIC 3122.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/01/2020

Approval date [1]

14/02/2020

Ethics approval number [1]

20201600-3559

Ethics committee name [2]

University of South Australia Human Research Ethics Committee

Ethics committee address [2]

Mawson Lakes Blvd,
Mawson Lakes
SA 5095

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

12/06/2020

Approval date [2]

16/06/2020

Ethics approval number [2]

202844

Summary

Brief summary

The study aims to determine if a combination of following a Mediterranean style of diet and walking-based exercise, slows the decline in brain function (cognition) that is commonly associated with older age.

A study we recently conducted is the only clinical trial to investigate the effect of a combined Mediterranean diet and exercise lifestyle intervention on cognition in older people. This small (pilot) study showed improved memory and thinking in a sub-group of older participants adhering to a combination of Mediterranean diet and daily walking for 6 months. We are now extending the pilot trial, into a 2-year, definitive clinical trial involving over 364 participants, across 28 sites in Victoria and South Australia. Translating this knowledge into a lifestyle program for behaviour change for the prevention of dementia could be physically, socially and economically significant.

This study will investigate the effects of diet and exercise on memory, attention and other mental functions. We will also investigate: mood, stress, fitness and wellbeing. While memory and other brain functions have been shown to normally decline over the lifespan, poorer diet and lack of exercise has been linked with a faster decline in brain functions. This research is aimed at investigating the effectiveness of a combined Mediterranean diet and walking intervention (MedWalk), on cognitive decline in an older population, living independently without cognitive impairment. The study will examine participants’ memory and attention, heart and artery health, mood and wellbeing, and biological markers in blood and faeces following a 24-month lifestyle intervention.

Trial website

www.medwalk.com.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Andrew Pipingas

Address

Swinburne University of Technology
Centre for Human Psychopharmacology
H24
PO Box 218, Hawthorn
Victoria 3122 Australia

Country

Australia

Phone

+61 3 9214 5215

Fax

[email protected]

Contact person for public queries

Name

Dr Greg Kennedy

Address

Swinburne University of Technology
Centre for Human Psychopharmacology
H24
PO Box 218, Hawthorn
Victoria 3122 Australia

Country

Australia

Phone

+61 3 9214 8168

Fax

[email protected]

Contact person for scientific queries

Name

Dr Greg Kennedy

Address

Swinburne University of Technology
Centre for Human Psychopharmacology
H24
PO Box 218, Hawthorn
Victoria 3122 Australia

Country

Australia

Phone

+61 3 9214 8168

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

It is expected that the results of this trial will be disseminated via peer-reviewed publications and at academic conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identified raw data will be uploaded to an appropriate repository

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

Source	Title	Year of Publication	DOI
Embase	A Mediterranean Diet and Walking Intervention to Reduce Cognitive Decline and Dementia Risk in Independently Living Older Australians: The MedWalk Randomized Controlled Trial Experimental Protocol, Including COVID-19 Related Modifications and Baseline Characteristics.	2023	https://dx.doi.org/10.3233/JAD-230641

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

Trial Review

Documents added manually

Documents added automatically