Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001257651p
Ethics application status
Submitted, not yet approved
Date submitted
1/10/2023
Date registered
5/12/2023
Date last updated
5/12/2023
Date data sharing statement initially provided
5/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Getting to the heart of healthy ageing: a behaviour change program targeting adherence to a healthy dietary pattern in postmenopausal women. The Wise & Well Study
Scientific title
Getting to the heart of healthy ageing: a behaviour change program targeting adherence to a healthy dietary pattern in postmenopausal women. The Wise & Well Study
Secondary ID [1] 310714 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 331646 0
Cardiovascular disease 331647 0
Falls and injurious fracture 331648 0
Condition category
Condition code
Neurological 328366 328366 0 0
Dementias
Cardiovascular 328367 328367 0 0
Coronary heart disease
Injuries and Accidents 328368 328368 0 0
Fractures
Diet and Nutrition 328861 328861 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this clinical trial is to evaluate a behaviour change program that provides (i) information on level of advanced structural vascular disease (AAC, the stimulus for change), (ii) its relationship with dementia, cardiovascular disease (CVD), and falls (the possible consequences), and (iii) the benefits of and guidelines to follow a Mediterranean diet (MedDiet), a dietary pattern linked to improved cognitive, cardiovascular, and musculoskeletal health outcomes. The program incorporates gold-standard behavioural change techniques.

Behaviour Change Program

Baseline.
Participants randomised into the “behaviour change program” will have their AAC determined from a lateral lumbar spine X-ray taken during a DXA scan. This will be performed during their baseline assessment period. Two weeks post the DXA scan, participants will individually meet with a Study Nurse who will provide a 30-minute consultation guided by motivational interviewing principles. These visits, using videos and handouts are based on those that we have developed and tested previously and have been created specifically for this study:
Video: An explanation of abdominal aortic calcification (AAC) and its link with dementia, CVD, falls and fracture risk. The video will encourage diet and physical activity changes to reduce the risk of these conditions.
Information on MedDiet, its importance and recommendations for goals focusing on the major components of the MedDiet to be achieved and maintained: Per day: i) 1-3 tablespoons extra virgin olive oil [substituting for other forms of fats such as butter and margarine], ii) Greater than or equal to 5 servings vegetables (including one serve of green leafy vegetables and one serve of cruciferous vegetables), iii) Greater than or equal to 2 servings fruit, iv) 3-6 servings grain foods (focusing on wholegrain cereals), v) up to 2 serves of plain yoghurt and cheese. Per week: i) Greater than or equal to 5 servings nuts, ii) Greater than or equal to 2 servings fish, and iii) Greater than or equal to 3 servings legumes.
AAC results: participants will then be provided with their AAC results. This will include a graphic image showing how much calcification is present. The Study Nurse will review and discuss the results with participants and answer any questions to enhance understanding of the results.
Hard copy booklet: participants will be provided with a hard copy MedDiet resource pack(created specifically for this study) providing written information describing the MedDiet including information on the important healthy components of the MedDiet, other components of the MedDiet, serving sizes, the recommended number of servings, tips for eating out, a checklist for self-monitoring of MedDiet adherence, a recipe book and physical activity guidelines.
Website: participants will be provided with access to a study website which will contain further resources such as recipes, podcasts, cooking demonstrations, and exercise videos.

3 months post-baseline.
Participants will have a 15-minute face-to-face consultation with the Study Nurse to provide feedback and reinforce the goals of the study.

Throughout the 12 month period, participants in the Behaviour Change Program will have access to the study website and their adherence to the MedDiet will be assessed monthly using a validated Mediterranean diet and culinary index (MediCul) questionnaire.
Intervention code [1] 327113 0
Lifestyle
Comparator / control treatment
“Standard care”
Participants allocated to standard care will be informed they will be provided with the behaviour change package at 12-months.
Control group
Active

Outcomes
Primary outcome [1] 336211 0
Adherence to a healthy dietary pattern (the MedDiet)
Timepoint [1] 336211 0
Monthly intervals post baseline up to and including 12 months post-baseline
Secondary outcome [1] 429213 0
Response speed to cognitive function tests
Timepoint [1] 429213 0
baseline, 3 months post-baseline and 12-months post baseline
Secondary outcome [2] 429214 0
Estimated 5-year CVD risk
Timepoint [2] 429214 0
Baseline and 12-months post baseline
Secondary outcome [3] 429215 0
Intake of olive oil
Timepoint [3] 429215 0
Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline
Secondary outcome [4] 429216 0
Intake of vegetables
Timepoint [4] 429216 0
Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline
Secondary outcome [5] 429217 0
Intake of fruit
Timepoint [5] 429217 0
Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline
Secondary outcome [6] 429218 0
Intake of whole grain foods
Timepoint [6] 429218 0
Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline
Secondary outcome [7] 429219 0
Intake of nuts
Timepoint [7] 429219 0
Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline
Secondary outcome [8] 429220 0
Intake of fish
Timepoint [8] 429220 0
Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline
Secondary outcome [9] 429221 0
Intake of legumes
Timepoint [9] 429221 0
Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline
Secondary outcome [10] 429222 0
Global cognition score
Timepoint [10] 429222 0
Baseline, 3 months post-baseline and 12-months post baseline
Secondary outcome [11] 429223 0
Attention
Timepoint [11] 429223 0
Baseline, 3 months post-baseline and 12-months post baseline
Secondary outcome [12] 429224 0
Working memory
Timepoint [12] 429224 0
Baseline, 3 months post-baseline and 12-months post baseline
Secondary outcome [13] 429225 0
Long term memory
Timepoint [13] 429225 0
Baseline, 3 months post-baseline and 12-months post baseline
Secondary outcome [14] 429226 0
Executive function
Timepoint [14] 429226 0
Baseline, 3 months post-baseline and 12-months post baseline
Secondary outcome [15] 429227 0
Plasma carotenoids, as a biomarker of fruit and vegetable intake
Timepoint [15] 429227 0
Baseline and 12-months post baseline
Secondary outcome [16] 429228 0
Plasma carotenoids and erythrocyte membrane fatty acids as a biomarker of MedDiet adherence. This will be assessed as a composite outcome.
Timepoint [16] 429228 0
Baseline and 12-months post baseline
Secondary outcome [17] 429229 0
Medication uptake and adherence. This will be assessed as a composite outcome.
Timepoint [17] 429229 0
Baseline and 12-months post baseline
Secondary outcome [18] 429230 0
Blood pressure
Timepoint [18] 429230 0
Baseline and 12-months post baseline
Secondary outcome [19] 429231 0
Fasting blood lipids
Timepoint [19] 429231 0
Baseline and 12-months post baseline
Secondary outcome [20] 429232 0
Fasting plasma glucose
Timepoint [20] 429232 0
Baseline and 12-months post baseline
Secondary outcome [21] 429233 0
Anthropometry including body mass index (BMI) and waist circumference
Timepoint [21] 429233 0
Baseline and 12-months post baseline
Secondary outcome [22] 429234 0
Body composition (fat mass, fat distribution, lean mass)
Timepoint [22] 429234 0
Baseline and 12-months post baseline
Secondary outcome [23] 429235 0
Physical activity
Timepoint [23] 429235 0
Baseline and 12-months post baseline
Secondary outcome [24] 429236 0
Muscle strength
Timepoint [24] 429236 0
Baseline, 3 months post-baseline and 12-months post baseline
Secondary outcome [25] 429602 0
HbA1C
Timepoint [25] 429602 0
Baseline and 12-months post baseline

Eligibility
Key inclusion criteria
Community dwelling postmenopausal older women
Minimum age
60 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals volunteering to participate in the study will be excluded according to the following criteria: (i) a confirmed dementia diagnosis, (ii) history of vascular disease or chest pain suggestive of angina pectoris, (iii) significant comorbidities such as end stage renal disease (glomerular filtration rate <30ml/min or dialysis), cancer requiring active surveillance or treatment, history of heart failure, (iv) BMI greater than or equal to 37 kg/m2 or BMI <18 kg/m2 or body weight >125 kg; (v) type 1 diabetes; (vi) systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg; (vii) use of anticoagulant therapy (Warfarin); (viii) diagnosis of osteoporosis within the previous 6-months or evidence of osteoporosis at the bone density testing visit; (ix) those unable or unwilling to follow the study protocol, (x) those without access or inability to use a computer/smart device; (xi) currently meeting the MedDiet recommendations for more than 4 of the important healthy components of a MedDiet: olive oil (1-3 Tbsp/day), vegetables (greater than or equal to 5 serves/day), fruit (greater than or equal to 2 serves/day), whole grain foods (3-6 serves/day), nuts (greater than or equal to 5 serves/week), fish (greater than or equal to 2 serves/week), legumes (greater than or equal to 3 serves/week), and discretionary foods (less than or equal to 3 serves/day).

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)
The study coordinator will contact the study investigator responsible for randomisation and intervention allocation to obtain the next available randomly generated intervention sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of allocation will be generated using STATA 17 (StataCorp) and the user-written module ‘ralloc’. Randomised blocks of size 4 will be created, so that the randomisation is balanced at the completion of assignment for each block. The randomisation will also be stratified according to the age group (above or below 70 years). Within each stratum, a sequential treatment code will be printed on paper in the order of treatment assignments.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 314929 0
Government body
Name [1] 314929 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 314929 0
Australia
Funding source category [2] 314933 0
University
Name [2] 314933 0
Edith Cowan University
Country [2] 314933 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup, Perth WA 6027
Country
Australia
Secondary sponsor category [1] 316934 0
None
Name [1] 316934 0
Address [1] 316934 0
Country [1] 316934 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313920 0
Edith Cowan University Human Ethics Committee
Ethics committee address [1] 313920 0
270 Joondalup Drive, Joondalup WA, 6027
Ethics committee country [1] 313920 0
Australia
Date submitted for ethics approval [1] 313920 0
24/07/2023
Approval date [1] 313920 0
Ethics approval number [1] 313920 0

Summary
Brief summary
Blood vessel disease is linked with risk of dementia, cardiovascular disease and falls. A large clinical trial will determine if a novel, low-cost, behaviour change program (knowledge of level of blood vessel disease, its links with risk of dementia, cardiovascular disease and falls, and the benefits of and how to follow a Mediterranean diet) will motivate an individual to make healthy lifestyle changes and will improve measures of risk for dementia, cardiovascular disease and falls. The study hypothesis is that adherence to the MedDiet will be improved after provision of the behaviour change program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129794 0
Dr Catherine Bondonno
Address 129794 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA 6027
Country 129794 0
Australia
Phone 129794 0
+61 8 63044601
Fax 129794 0
Email 129794 0
c.bondonno@ecu.edu.au
Contact person for public queries
Name 129795 0
Dr Catherine Bondonno
Address 129795 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA 6027
Country 129795 0
Australia
Phone 129795 0
+61 8 63044601
Fax 129795 0
Email 129795 0
c.bondonno@ecu.edu.au
Contact person for scientific queries
Name 129796 0
Dr Catherine Bondonno
Address 129796 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA 6027
Country 129796 0
Australia
Phone 129796 0
+61 8 63044601
Fax 129796 0
Email 129796 0
c.bondonno@ecu.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20549Study protocol  c.bondonno@ecu.edu.au Access to study protocol is by contacting CI Dr Ca... [More Details]



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.