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Trial registered on ANZCTR


Registration number
ACTRN12620000978965
Ethics application status
Approved
Date submitted
15/07/2020
Date registered
30/09/2020
Date last updated
30/09/2020
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] 301771 0
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 318236 0
Condition category
Condition code
Mental Health 316248 316248 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a 2-year trial will consist of 364 participants, aged 60 to 90, who will be recruited from at least 28 facility sites through agreements with Independent Living providers 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] 318065 0
Lifestyle
Intervention code [2] 318066 0
Behaviour
Intervention code [3] 318069 0
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] 324433 0
Cognitive performance as assessed by:
- Errors on the Paired Associates Learning task (PAL) of the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [1] 324433 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement.
Secondary outcome [1] 384631 0
Cognitive performance as assessed by the Spatial Working Memory (SWM) test of the CANTAB
Timepoint [1] 384631 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement.
Secondary outcome [2] 384633 0
Cognitive performance assessed by the Spatial Working Memory test of the
Swinburne University Computerised Cognitive Assessment Battery (SUCCAB)
Timepoint [2] 384633 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement

Secondary outcome [3] 384638 0
Adherence to MedDiet as assessed by the Mediterranean Diet Adherence Screener (MEDAS)
Timepoint [3] 384638 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [4] 384639 0
Diet and dietary change as assessed by:
- Easy Diet Diary (FoodWorks V10, Xyris Pty Ltd)
Timepoint [4] 384639 0
Baseline, 12 months and 24 months after intervention commencement
Secondary outcome [5] 384647 0
Functional exercise performance as assessed by
- The Six Minute Walk Test
Timepoint [5] 384647 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [6] 384648 0
Physical activity as measured by:
- Accelerometery recordings using Actigraph accelerometers (model GT3X-BT; ActiGraph, USA)
Timepoint [6] 384648 0
Over 8 continuous days prior to the Baseline, 12 month and 24 month assessments points.
Secondary outcome [7] 384650 0
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] 384650 0
Baseline, 12 months and 24 months after intervention commencement
Secondary outcome [8] 384651 0
Depression, anxiety and stress as assessed by the Depression Anxiety Stress Scales (DASS)
Timepoint [8] 384651 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [9] 384652 0
Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [9] 384652 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [10] 384656 0
Quality of life as assessed by the Flourishing Index
Timepoint [10] 384656 0
Baseline, 12 months and 24 months after intervention commencement
Secondary outcome [11] 384674 0
Peripheral (brachial) blood pressures
- assessed using the SphygmoCor XCEL device
Timepoint [11] 384674 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [12] 384675 0
Social engagement. as assessed by:
- the Berkman-Syme Social Network Index (BSSNI)
Timepoint [12] 384675 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [13] 384676 0
Effectiveness of MedWalk and fidelity to the protocol (MI-CBT) as assessed by:
- Client Evaluation of Motivational Interviewing (CEMI)
Timepoint [13] 384676 0
Baseline, 6 months and 12 months after intervention commencement
Secondary outcome [14] 384677 0
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] 384677 0
Baseline and 24 months after intervention commencement
Secondary outcome [15] 385450 0
Cognitive performance as assessed by the Motor Screening Task (MOT) test of the CANTAB
Timepoint [15] 385450 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [16] 385451 0
Cognitive performance as assessed by the Reaction Time test of the CANTAB
Timepoint [16] 385451 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [17] 385452 0
Cognitive performance as assessed by the Rapid Visual Information Processing (RVP) test of the CANTAB
Timepoint [17] 385452 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [18] 385453 0
Cognitive performance assessed by the Simple Reaction Time test of the SUCCAB
Timepoint [18] 385453 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [19] 385454 0
Cognitive performance assessed by the Choice Reaction Time test of the SUCCAB
Timepoint [19] 385454 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [20] 385455 0
Mood as assessed by Profile of Mood States (POMS)
Timepoint [20] 385455 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [21] 385480 0
Psychiatric disorders as assessed by the General Health Questionnaire (GHQ)
Timepoint [21] 385480 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [22] 385481 0
Faecal microbiome and biomarkers - exploratory
Timepoint [22] 385481 0
Baseline, 12 months and 24 months after intervention commencement
Secondary outcome [23] 385487 0
Adherence to MedDiet as assessed by attendance at diet education sessions
Timepoint [23] 385487 0
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] 385616 0
Central (aortic) blood pressures
- assessed using the SphygmoCor XCEL device
Timepoint [24] 385616 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [25] 385617 0
Augmented pulse pressure
- assessed using the SphygmoCor XCEL device
Timepoint [25] 385617 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [26] 385618 0
Pulse wave velocity measure of arterial stiffness
- assessed using the SphygmoCor XCEL device
Timepoint [26] 385618 0
Baseline, 6 months, 12 months, 18 months and 24 months after intervention commencement
Secondary outcome [27] 385619 0
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] 385619 0
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
Gender
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.

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
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)
SA,VIC

Funding & Sponsors
Funding source category [1] 306202 0
Government body
Name [1] 306202 0
National Health and Medical Research Council (NHMRC)
Address [1] 306202 0
GPO Box 1421
Canberra,
ACT 2601
Country [1] 306202 0
Australia
Funding source category [2] 306216 0
Commercial sector/Industry
Name [2] 306216 0
Cobram Estate (In kind donation of Premium Extra Virgin Olive Oil)
Address [2] 306216 0
Unit 14, 75 Lorimer Street
Southbank
Victoria 3006
Country [2] 306216 0
Australia
Funding source category [3] 306219 0
Charities/Societies/Foundations
Name [3] 306219 0
Nutricia Research Foundation
Address [3] 306219 0
Uppsalastr. 12
3584CT Utrecht
The Netherlands
Country [3] 306219 0
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] 306676 0
University
Name [1] 306676 0
University of South Australia
Address [1] 306676 0
GPO Box 2471
Adelaide
SA 5001
Country [1] 306676 0
Australia
Other collaborator category [1] 281388 0
University
Name [1] 281388 0
Murdoch University
Address [1] 281388 0
90 South Street
Murdoch
WA 6150
Country [1] 281388 0
Australia
Other collaborator category [2] 281389 0
University
Name [2] 281389 0
La Trobe University
Address [2] 281389 0
Corner Plenty Road and Kingsbury Drive
Bundoora
VIC 3086
Country [2] 281389 0
Australia
Other collaborator category [3] 281390 0
University
Name [3] 281390 0
Deakin University
Address [3] 281390 0
Locked Bag 20000
Geelong
VIC 3220
Country [3] 281390 0
Australia
Other collaborator category [4] 281391 0
University
Name [4] 281391 0
University of East Anglia
Address [4] 281391 0
Norwich Research Park
Norwich, Norfolk,
NR4 7TJ, UK
Country [4] 281391 0
Australia
Other collaborator category [5] 281392 0
University
Name [5] 281392 0
Sheffield Hallam University
Address [5] 281392 0
Howard Street,
Sheffield
S1 1WB UK
Country [5] 281392 0
United Kingdom
Other collaborator category [6] 281393 0
Commercial sector/Industry
Name [6] 281393 0
Ryman Healthcare
Address [6] 281393 0
Ryman Healthcare
PO Box 33119
Melbourne
Victoria 3004
Country [6] 281393 0
Australia
Other collaborator category [7] 281394 0
Charities/Societies/Foundations
Name [7] 281394 0
Catholic Homes Villa Maria
Address [7] 281394 0
PO Box 134
East Melbourne
VIC 8002
Country [7] 281394 0
Australia
Other collaborator category [8] 281395 0
Commercial sector/Industry
Name [8] 281395 0
Australian Unity Ltd
Address [8] 281395 0
114 Albert Road
South Melbourne
Victoria 3205
Country [8] 281395 0
Australia
Other collaborator category [9] 281396 0
University
Name [9] 281396 0
University College Cork
Address [9] 281396 0
College Road
Cork
T12 K8AF Ireland
Country [9] 281396 0
Ireland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306414 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 306414 0
Swinburne University of Technology,
PO Box 218
Hawthorn
VIC 3122.
Ethics committee country [1] 306414 0
Australia
Date submitted for ethics approval [1] 306414 0
15/01/2020
Approval date [1] 306414 0
14/02/2020
Ethics approval number [1] 306414 0
20201600-3559
Ethics committee name [2] 306427 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 306427 0
Mawson Lakes Blvd,
Mawson Lakes
SA 5095
Ethics committee country [2] 306427 0
Australia
Date submitted for ethics approval [2] 306427 0
12/06/2020
Approval date [2] 306427 0
16/06/2020
Ethics approval number [2] 306427 0
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 103790 0
Prof Andrew Pipingas
Address 103790 0
Swinburne University of Technology
Centre for Human Psychopharmacology
H24
PO Box 218, Hawthorn
Victoria 3122 Australia
Country 103790 0
Australia
Phone 103790 0
+61 3 9214 5215
Fax 103790 0
Email 103790 0
apipingas@swin.edu.au
Contact person for public queries
Name 103791 0
Dr Greg Kennedy
Address 103791 0
Swinburne University of Technology
Centre for Human Psychopharmacology
H24
PO Box 218, Hawthorn
Victoria 3122 Australia
Country 103791 0
Australia
Phone 103791 0
+61 3 9214 8168
Fax 103791 0
Email 103791 0
gikennedy@swin.edu.au
Contact person for scientific queries
Name 103792 0
Dr Greg Kennedy
Address 103792 0
Swinburne University of Technology
Centre for Human Psychopharmacology
H24
PO Box 218, Hawthorn
Victoria 3122 Australia
Country 103792 0
Australia
Phone 103792 0
+61 3 9214 8168
Fax 103792 0
Email 103792 0
gikennedy@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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 other documents available
Summary results
No Results