Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000909628
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
23/08/2023
Date last updated
23/08/2023
Date data sharing statement initially provided
23/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A one year follow-up study of the MedWalk South Australian participants to assess maintenance of lifestyle changes and selected health measures.
Scientific title
A 12-month follow-up to determine maintenance of lifestyle change and selected clinical outcomes in the South Australian MedWalk study participants.
Secondary ID [1] 310225 0
Nil known
Universal Trial Number (UTN)
U1111-1295-9169
Trial acronym
Linked study record
This is a follow-up study of the MedWalk Study (ANZCTR12620000978965 )

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 330913 0
Condition category
Condition code
Mental Health 327697 327697 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 327698 327698 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is observational.
This research project is a follow-up study of the MedWalk study. We will compare data collected for this research project with that collected in MedWalk, to determine long-term changes between visits in MedWalk and the follow-up study 12 months later. This is essential to answer the aims of this project.
Aim 1: To compare lifestyle measures (Mediterranean diet adherence and moderate to vigorous physical activity level) across MedWalk trial timepoints to one year since completing the MedWalk trial
Aim 2: To compare markers of cognitive function at trial timepoints to one year since completing the MedWalk trial
Aim 3: To compare anthropometry, blood pressue and pusle wave velocity between trial timepoints to one year since completing the MedWalk trial
Aim 4: To investigate changes in quality of life and mood one year since completing the MedWalk trial
Aim 5: To collect blood samples for future analysis of lipids, carotenoids and F2-isoprostanes one year since completing the MedWalk trial

This study will be conducted as a once-off 12-month follow-up visit. The visits will take place within a 2-week window 12 months after the participants' 12 month visit from MedWalk (Note: MedWalk was originally going to include a 24-month visit, but was shorted to 12 months due to the COVID-19 pandemic. The follow-up visits will occur roughly when the planned 24 month visits would have occured).

Only participants who have completed at least part of their 12 month visit for MedWalk will be invited to complete the follow-up. Withdrawals from MedWalk will not be invited.

The follow-up study will have two levels of involvement. Level 1 is for the participants to complete the MedWalk questionnaire battery and a 4-day weighed food record only. Level 2 will include the above, and a 2-hour fasted clinic visit for other assessments. The commitment for participants completing Level 1 will be approximately 2 hours, including 1 hour to complete the questionnaires and 1 hour to complete the 4-day weighed food record at home. Participants completing Level 2 will involve a 4-hour commitment, including the above as well as attending a 2-hour clinic visit for physical measures and a fasting blood test.
Intervention code [1] 326618 0
Not applicable
Comparator / control treatment
No control group, Data collected as part of this study will be compared to that collected during the MedWalk study, which will involve splitting the cohort into the original groups (Intervention and Control groups from MedWalk, ACTRN12620000978965). If data are compared in this way, we will compare results from the three MedWalk visits (Baseline, 6 months and 12 months) with the follow-up study, as a 24-month time point, Groups will be compared as well as the whole cohort for changes in outcomes across time.
Control group
Historical

Outcomes
Primary outcome [1] 335501 0
Mediterranean diet compliance.
Assessed using 4-day weighed food records (WFR)
Timepoint [1] 335501 0
12 months after MedWalk trial completion
Primary outcome [2] 335502 0
Change in moderate to vigorous physical activity level.
Assessed using International Physical Activity Questionnaire for the elderly (IPAQ-E)
Timepoint [2] 335502 0
12 months after MedWalk trial completion
Primary outcome [3] 335785 0
Mediterranean Adherence Score (MEDAS)
Assessed using the 14-point Mediterranean diet adherence questionnaire
Timepoint [3] 335785 0
12 months after MedWalk trial completion
Secondary outcome [1] 424809 0
Body mass index

Weight assessed in minimal clothing using digital scales, height assessed barefoot or in socks using wall-mounted stadiometre.
Timepoint [1] 424809 0
12 months after MedWalk trial completion
Secondary outcome [2] 424810 0
Waist to hip ratio

Waist circumference measured over skin, hip circumference measured over clothing, according to ISAK standards.
Timepoint [2] 424810 0
12 months after MedWalk trial completion
Secondary outcome [3] 424811 0
Quality of life
Assessed using the Assessment of Quality of Life (AQol)
Timepoint [3] 424811 0
12 months after MedWalk trial completion
Secondary outcome [4] 424812 0
Fasting lipid levels (total cholesterol, HDL cholestrol, LDL cholesterol and triglycerides)
Assessed by fasting blood test (8 hour fast). We plan to take blood samples via venepuncture from participants.
Timepoint [4] 424812 0
12 months after MedWalk trial completion
Secondary outcome [5] 425267 0
Cognitive function (composite outcome)
Assessed using cognitive testing battery completed via CANTAB Connect on an electronic tablet. This includes spacial working memory, reaction time and speed of processing, with Paired Associated Learning as the primary measure.
Timepoint [5] 425267 0
12 months after MedWalk trial completion
Secondary outcome [6] 425270 0
Change in diastolic blood pressure
Taken in the supine position using a Syphmacor system
Timepoint [6] 425270 0
12 months after MedWalk trial completion
Secondary outcome [7] 425273 0
Change in systolic blood pressure
Taken in the supine position using a Syphmacor system
Timepoint [7] 425273 0
12 months after MedWalk trial completion
Secondary outcome [8] 425274 0
Mood

Assessed using the Profile of Mood States questionnaire
Timepoint [8] 425274 0
12 months after MedWalk trial completion
Secondary outcome [9] 425275 0
Depression Anxiety Stress Scale (DASS-21)
Timepoint [9] 425275 0
12 months after MedWalk trial completion
Secondary outcome [10] 425623 0
General Health Questionnaires (GHQ)
Timepoint [10] 425623 0
12 months after MedWalk trial completion
Secondary outcome [11] 425624 0
Pittsburg Sleep Quality Index
Timepoint [11] 425624 0
12 months after MedWalk trial completion
Secondary outcome [12] 425625 0
Flourishing Index
Timepoint [12] 425625 0
12 months after MedWalk trial completion

Eligibility
Key inclusion criteria
Aged 61-91 years
Completed at least part of their MedWalk 12 month visit (South Australian cohort).
Willing and able to complete the follow-up study.
Minimum age
61 Years
Maximum age
91 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Death or severe disability that has occured between completion of the MedWalk study and the follow-up study commencement.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data collected in this follow-up study will be compared to the 3 timepoints from MedWalk (0, 6 and 12 months). Using a linear mixed effects model with AR-1 heterogenous repeated covariance type, and fixed effects for group, time and group*time interactions, we will compare differences between the MedDiet and HabDiet groups, as well as change in the whole sample across time, and within group change.. Model 2 will include covariants, determined based on significant differences between groups at baseline, as well as gender, age, BMI and retirement facility. Missing data will be treated with maximum-likelihood estimation. Similar tests will be performed for the secondary outcomes using appropriate transformations if necessary.

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
4/09/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
15/07/2024
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314387 0
University
Name [1] 314387 0
University of South Australia
Country [1] 314387 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, University of South Australia, 5001 SA, Australia
Country
Australia
Secondary sponsor category [1] 316505 0
None
Name [1] 316505 0
Address [1] 316505 0
Country [1] 316505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313481 0
University of South Australia Human Research Ethics Committee (UniSA HREC)
Ethics committee address [1] 313481 0
UniSA HREC
GPO Box 2471, University of South Australia, 5001 SA
Ethics committee country [1] 313481 0
Australia
Date submitted for ethics approval [1] 313481 0
29/06/2023
Approval date [1] 313481 0
27/07/2023
Ethics approval number [1] 313481 0
205665

Summary
Brief summary
Research trials have demonstrated the short-term benefits of the Mediterranean diet (MedDiet), showing improvements to cholesterol levels, blood pressure and antioxidant levels in the body. Evidence is quite strong that people who follow a MedDiet have improved cardiovascular health, and now we are trying to find out if it might also protect us against dementia and cognitive decline.

During 2021 and 2022 we completed a 12-month long study called MedWalk with 74 older Australians. We asked half of them to try the MedDiet, while the other half stayed on their usual diet. Those following the MedDiet were also asked to be active, aiming for 30 minutes of physical activity per day. We were interested in their cognitive function, but also their mental health and wellbeing, their cardiovascular health, fitness and their frailty.

While 12 months will tell us about some short-term changes, it is not really long enough to see changes in long-term cognition or dementia diagnoses. So this follow-up study will ask those same 74 people to come in and have some measures taken, to see if they have kept on following the MedDiet, kept up the physical activity, and to see if there is any benefits to their cogntive health 24 months since starting the MedWalk trial (12 months since their final MedWalk visit).

We are hoping to see that our participants have maintained some aspects of the MedDiet and their physical activity levels from the study, and we may perhaps see that the control group have also adopted some of these changes since finishing the trial. If we see benefits to cognitive health or in some of the other outcomes, this will be strong promotion for older Australians to adopt a more Mediterranean lifestyle through diet and physical activity.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 128318 0
A/Prof Karen Murphy
Address 128318 0
GPO Box 2471
Adelaide SA 5001
MedWalk Study
A/Prof Karen Murphy
UniSA Clinical and Health Sciences
City East Campus
IPC CEA-17
Country 128318 0
Australia
Phone 128318 0
+61 0883021033
Fax 128318 0
Email 128318 0
karen.murphy@unisa.edu.au
Contact person for public queries
Name 128319 0
Dr Courtney Davis
Address 128319 0
GPO Box 2471
Adelaide SA 5001
MedWalk Study
Dr Courtney Davis
UniSA Clinical and Health Sciences
City East Campus
IPC CEA-17
Country 128319 0
Australia
Phone 128319 0
+61 0883021417
Fax 128319 0
Email 128319 0
courtney.davis@unisa.edu.au
Contact person for scientific queries
Name 128320 0
Dr Courtney Davis
Address 128320 0
GPO Box 2471
Adelaide SA 5001
MedWalk Study
Dr Courtney Davis
UniSA Clinical and Health Sciences
City East Campus
IPC CEA-17
Country 128320 0
Australia
Phone 128320 0
+61 0883021417
Fax 128320 0
Email 128320 0
courtney.davis@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?
We will aim to make publicly available all data pertaining to the primary and secondary outcomes. Personal and/or identifying data will not be shared.
When will data be available (start and end dates)?
It is anticipated data will be available when the main outcomes are published, estimated around Nov 2024. There will be no end date.
Available to whom?
Data will be availble to other researchers who make a reasonable request to the chief investigator.
Available for what types of analyses?
Data will be available for any suitable analysis, e.g meta-analysis, or combined with similar datasets for larger-scale investigations.
How or where can data be obtained?
We expect that the data will be available through the future journal platform who will publish the main outcome paper. If data is needed prior to this, it can be requested from the principle investigator (Karen Murphy, karen.murphy@unisa.edu.au).


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.