ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Dementia

Cardiovascular disease

Falls and injurious fracture

Condition category

Condition code

Neurological

Dementias

Cardiovascular

Coronary heart disease

Injuries and Accidents

Fractures

Diet and Nutrition

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]

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]

Adherence to a healthy dietary pattern (the MedDiet)

Timepoint [1]

Monthly intervals post baseline up to and including 12 months post-baseline

Secondary outcome [1]

Response speed to cognitive function tests

Timepoint [1]

baseline, 3 months post-baseline and 12-months post baseline

Secondary outcome [2]

Estimated 5-year CVD risk

Timepoint [2]

Baseline and 12-months post baseline

Secondary outcome [3]

Intake of olive oil

Timepoint [3]

Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline

Secondary outcome [4]

Intake of vegetables

Timepoint [4]

Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline

Secondary outcome [5]

Intake of fruit

Timepoint [5]

Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline

Secondary outcome [6]

Intake of whole grain foods

Timepoint [6]

Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline

Secondary outcome [7]

Intake of nuts

Timepoint [7]

Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline

Secondary outcome [8]

Intake of fish

Timepoint [8]

Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline

Secondary outcome [9]

Intake of legumes

Timepoint [9]

Baseline and at monthly intervals post-baseline up to and including 12 months post-baseline

Secondary outcome [10]

Global cognition score

Timepoint [10]

Baseline, 3 months post-baseline and 12-months post baseline

Secondary outcome [11]

Attention

Timepoint [11]

Baseline, 3 months post-baseline and 12-months post baseline

Secondary outcome [12]

Working memory

Timepoint [12]

Baseline, 3 months post-baseline and 12-months post baseline

Secondary outcome [13]

Long term memory

Timepoint [13]

Baseline, 3 months post-baseline and 12-months post baseline

Secondary outcome [14]

Executive function

Timepoint [14]

Baseline, 3 months post-baseline and 12-months post baseline

Secondary outcome [15]

Plasma carotenoids, as a biomarker of fruit and vegetable intake

Timepoint [15]

Baseline and 12-months post baseline

Secondary outcome [16]

Plasma carotenoids and erythrocyte membrane fatty acids as a biomarker of MedDiet adherence. This will be assessed as a composite outcome.

Timepoint [16]

Baseline and 12-months post baseline

Secondary outcome [17]

Medication uptake and adherence. This will be assessed as a composite outcome.

Timepoint [17]

Baseline and 12-months post baseline

Secondary outcome [18]

Blood pressure

Timepoint [18]

Baseline and 12-months post baseline

Secondary outcome [19]

Fasting blood lipids

Timepoint [19]

Baseline and 12-months post baseline

Secondary outcome [20]

Fasting plasma glucose

Timepoint [20]

Baseline and 12-months post baseline

Secondary outcome [21]

Anthropometry including body mass index (BMI) and waist circumference

Timepoint [21]

Baseline and 12-months post baseline

Secondary outcome [22]

Body composition (fat mass, fat distribution, lean mass)

Timepoint [22]

Baseline and 12-months post baseline

Secondary outcome [23]

Physical activity

Timepoint [23]

Baseline and 12-months post baseline

Secondary outcome [24]

Muscle strength

Timepoint [24]

Baseline, 3 months post-baseline and 12-months post baseline

Secondary outcome [25]

HbA1C

Timepoint [25]

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)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF)

Address [1]

Department of Health and Aged CareGPO Box 9848Canberra ACT 2601Australia

Country [1]

Australia

Funding source category [2]

University

Name [2]

Edith Cowan University

Address [2]

270 Joondalup Drive, Joondalup, Perth, WA6027

Country [2]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Drive, Joondalup, Perth WA 6027

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Edith Cowan University Human Ethics Committee

Ethics committee address [1]

270 Joondalup Drive, Joondalup WA, 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/07/2023

Approval date [1]

Ethics approval number [1]

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

Dr Catherine Bondonno

Address

Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA 6027

Country

Australia

Phone

+61 8 63044601

Fax

[email protected]

Contact person for public queries

Name

Catherine Bondonno

Address

Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA 6027

Country

Australia

Phone

+61 8 63044601

Fax

[email protected]

Contact person for scientific queries

Name

Catherine Bondonno

Address

Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA 6027

Country

Australia

Phone

+61 8 63044601

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

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20549	Study protocol			[email protected]	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.

Trial Review

Documents added manually

Documents added automatically