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Trial registered on ANZCTR


Registration number
ACTRN12618001087246
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
28/06/2018
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of knowledge of vascular disease on Modification Of Diet, Exercise and Lifestyle: The MODEL study
Scientific title
Impact of knowledge of structural vascular disease on modification of diet, exercise and lifestyle in men and women aged over 50 years
Secondary ID [1] 295237 0
None
Universal Trial Number (UTN)
Trial acronym
MODEL (Modification Of Diet, Exercise and Lifestyle)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 308399 0
Musculoskeletal disorders 308400 0
Gastrointestinal function 308401 0
Cognition 308402 0
Wellbeing 308403 0
Physical function 308404 0
Mental health 308507 0
Condition category
Condition code
Diet and Nutrition 307392 307392 0 0
Other diet and nutrition disorders
Cardiovascular 307393 307393 0 0
Normal development and function of the cardiovascular system
Musculoskeletal 307394 307394 0 0
Normal musculoskeletal and cartilage development and function
Oral and Gastrointestinal 307395 307395 0 0
Normal oral and gastrointestinal development and function
Mental Health 307479 307479 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be both interventional and observational. Participants will be recruited to an 12-week randomized controlled trial. All participants will then be followed out to 2 years in an observational study.

1. The randomised controlled trial
An 12-week randomized controlled design trial in men and women will be performed. All participants will have a lateral spine image captured using dual-energy x-ray absorptiometry (DXA), and the presence and severity of abdominal aortic calcification (AAC) assessed from the lateral spine image. It is anticipated that approximately half of all men and women (50 to 80 years old) recruited to the study will have evidence of calcification in the abdominal aorta: this indicates presence of advanced vascular disease. Therefore, an AAC assessment provides participants with knowledge of presence and severity of advanced vascular disease. Participants will then be randomly assigned (2:1) to the intervention or control group using a computer generated randomization list. Participants will be stratified according to age category (above or below 65 years) and gender. The intervention group will be provided with knowledge of their AAC at baseline. The results of AAC assessment will be communicated to those in the intervention group at baseline. Participants will be informed of the result of their AAC assessment using standardized messages administered face to face by the trial coordinator. The control group will not be provided with knowledge of their AAC score until the end of the trial period (12-weeks). All participants will receive usual care standard dietary and lifestyle advice, with focus on improving F&V intake, other aspects of their diet and increasing physical activity. A study investigator, trained regarding the need for impartiality and consistency in counselling, will conduct a 30 minute private counselling session.
They will work with each participant to set up three clear, specific and achievable goals to be achieved within 12 weeks: i) The first of these will be to increase fresh fruit intake by at least 1 serve/d (150 g/d) and increase vegetable intake by at least 1 serve/d (75 g/d); ii) The second goal will be to improve other aspects of their diet including reducing the intake of salt, alcohol, processed meats, and increasing the intake of whole grains, seeds, nuts and healthy oils such as olive oil; and (iii) The third goal will be to increase physical activity and reduce inactivity (sitting time). This design of the trial will allow assessment of the effect of providing knowledge of advanced structural vascular disease on primary and secondary outcomes.
The primary aim of the randomised controlled trial is to determine if providing knowledge of advanced structural vascular disease can lead to a short-term (12 weeks) increase in fruit and vegetable intake, compared to control (no knowledge of AAC). We will also explore the impact on a variety of other dietary and lifestyle factors and measures related to health status.

2. The observational study (2 years)
The observational study will follow all participants recruited to the 12 week randomised controlled trial out to 2 years. All participants will be provided with the results of their assessment of AAC by 12 weeks (end of the randomised controlled trial phase of the study). All participants will also have received counselling and information on how to improve their diet and lifestyle, including how to increase fruit and vegetable intake, improve other aspects of diet and increase physical activity. This advice will provided at baseline and re-enforced again at 12 weeks.
The aim of the observational study is to investigate whether the knowledge of the presence of advanced vascular disease is associated with higher fruit and vegetable intake. We will also assess other dietary and lifestyle factors and measures related to health status.
Intervention code [1] 301572 0
Treatment: Other
Intervention code [2] 301602 0
Lifestyle
Comparator / control treatment
For the randomised controlled trial, the 'control' is no knowledge of personal advanced vascular disease. This is compared with the 'intervention' of knowledge of personal advanced vascular disease.

For the observational study, we will compare those with presence of advanced vascular disease to those without evidence of advanced vascular disease assessed using abdominal aortic calcification (AAC).
Control group
Active

Outcomes
Primary outcome [1] 306365 0
Fruit and vegetable intake assessed using a food frequency questionnaire.
Timepoint [1] 306365 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [1] 348264 0
Physical activity and inactivity assessed using CHAMPS, a physical activity questionnaire
Timepoint [1] 348264 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [2] 348347 0
Anthropometry including: body weight / height / Body Mass Index (BMI).
Body weight will be measured using digital scales to the nearest 0.1 kg with participants wearing lightweight clothes and not wearing shoes. Height will be measured using a wall-mounted stadiometer to the nearest 0.1 cm while participants are not wearing socks or shoes. BMI (kg/m2) will then be calculated as weight in kg, divided by height in meters squared.
Timepoint [2] 348347 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [3] 348348 0
Body composition including: Body fat mass and percentage using dual energy x-ray absorptiometry (DXA).
Timepoint [3] 348348 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [4] 348351 0
Body composition including visceral adiposity using dual energy x-ray absorptiometry (DXA).
Timepoint [4] 348351 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [5] 348352 0
Body composition including lean mass assessed using dual energy x-ray absorptiometry (DXA).
Timepoint [5] 348352 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [6] 348353 0
Physical function assessed using Grip strength. Grip strength of the dominant hand will be recorded as the highest of three attempts using a handheld dynamometer (Hand Grip Dynamometer; TEC).
Timepoint [6] 348353 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [7] 348354 0
Physical function assessed using TUG (Timed Up and Go)
Time up-and-go (TUG): Mobility functioning will be measured by TUG test, which requires participants to be timed while getting up from a chair, walking 3 m, turning, returning to the chair, and sitting down again.
Timepoint [7] 348354 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [8] 348355 0
Physical function assessed using Gait speed.
Gait speed requires participants to be timed while walking 6-m. Timer starts with first foot fall and stops when first foot completely crossed the 6-m end line.
Timepoint [8] 348355 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [9] 348356 0
Smoking status (current/ex-smoker/never smoked; duration in months/years; and amount smoked) assessed using questionnaire designed for the study
Timepoint [9] 348356 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [10] 348357 0
Health-related habits including alcohol intake assessed using a demographic and lifestyle questionnaire specifically designed for this study
Timepoint [10] 348357 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [11] 348358 0
Health-related habits including sitting time assessed using a Demographic and lifestyle questionnaire specifically designed for this study
Timepoint [11] 348358 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [12] 348359 0
Health-related habits including social activities, assessed using the SF36 questionnaire
Timepoint [12] 348359 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [13] 348360 0
Gastrointestinal function, including bowel habits and stool consistency assessed using a Bowel health questionnaire, Bristol stool chart and 24h faecal samples collection
Timepoint [13] 348360 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [14] 348361 0
Gastrointestinal function, including oral microbiome from saliva test assessed using mass-spectrometry and biomarkers of oral bacterial metabolism assessed using mass-spectrometry.
Timepoint [14] 348361 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [15] 348363 0
Gastrointestinal function, including biomarkers of gut bacterial metabolism assessed in blood, and/or urine samples assessed using mass-spectrometry
Timepoint [15] 348363 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [16] 348371 0
Blood pressure: Office/clinic BP will be assessed using the CARESCAPETM, Dinamap v100 Vital Signs Monitor (GE Healthcare, Buckinghamshire, UK. After subjects had rested for 5 min in a supine position, BP measurements will be assessed on five occasions at 1 min intervals, the first measurement will be discarded and the mean of the second, third, fourth and fifth measurements will be calculated
Timepoint [16] 348371 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [17] 348372 0
Lipid and lipoprotein profile: Standard biochemical analyses of fasting serum total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (TG), and LDL-cholesterol (LDL-C) will be performed in the PathWest laboratory at Royal Perth Hospital, Western Australia. TC, HDL-C and TG will be measured using an enzymatic colorimetric test with a fully automated analyser (Architect ci8200/c16000 Analyser). LDL-C concentrations will be calculated using the Friedewald formula. Plasma carotentoids will be measured using HPLC.
Timepoint [17] 348372 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [18] 348373 0
Glucose, insulin and HbA1c. Serum glucose will be measured at each visit using a fully automated analyser (Architect ci8200/c16000 Analyser) to assess presence of diabetes. HOMA (homeostatic model assessment) will be calculated to quantify insulin resistance and ß-cell function.
Timepoint [18] 348373 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [19] 348374 0
Estimated glomerular filtration rate (eGFR) will be measured to assess kidney function. It will be performed by measuring serum creatinine concentrations using an enzymatic colorimetric test with a fully automated analyser (Architect ci8200/c16000 Analyser).
Timepoint [19] 348374 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [20] 348376 0
Arterial stiffness will be assessed by PWA (pulse wave analysis) using the Sphygmocor Xcel device.
Timepoint [20] 348376 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [21] 348377 0
Abdominal aortic calcification (AAC) scan: DXA (dual energy x-ray absorptiometry) scanning will be performed at Gairdner Bone Densitometry Unit, Sir Charles Gairdner Hospital, using the latest fan beam technology (Hologic Horizon A densitometer). Participants will have a lateral spine image captured to allow for assessment of AAC.
Timepoint [21] 348377 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [22] 348378 0
Medication and health-care use, including medical procedures / further risk factor testing assessed using a questionnaire specifically designed for this study
Timepoint [22] 348378 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [23] 348379 0
Visits to health care professionals assessed using a questionnaire specifically designed for this study
Timepoint [23] 348379 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [24] 348380 0
Drug prescriptions assessed using a questionnaire specifically designed for this study
Timepoint [24] 348380 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [25] 348709 0
Medication use assessed using a medication record form
Timepoint [25] 348709 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Eligibility
Key inclusion criteria
Ambulant men and women aged 50 to 80 years
Minimum age
50 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with BMI >37 kg/m2 or BMI <18 kg/m2 or body weight >125kg;
Individuals with type 1 diabetes
Individuals with type 2 diabetes for more than 10y since diagnosis
Individuals with a history of CVD including ischemic heart disease, cerebrovascular disease, cardiomyopathy, peripheral arterial disease
Individuals who have had prior coronary artery calcification or coronary angiograms and those already undergoing intensive management of their CVD
Participants with abnormal Electrocardiography (ECG): ECG will be performed to investigate whether participants have any abnormal heart condition that would prevent them from increasing their level of physical activity (one of the recommendations in the intervention of this study). ECG will be analysed by a medical professional. Participants with abnormal ECG will be encouraged to share their results with their general practitioner (GP) and will be excluded from the study
Systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg
Use of anticoagulant (Warfarin)
Those with clinically unstable health status or significant comorbidities such as end stage renal disease (eGFR < 45ml/min/1.73m2), cancer or heart failure (grade 1, 2, 3)
Those unable or unwilling to follow the study protocol
Those whom in the investigators opinion should be excluded

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 investigator who will determine if a subject is eligible for inclusion in the trial will not be aware of which group the participant should be allocated to. This will be done by the holder of the allocation schedule (the study biostatistician).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to the intervention or control group (2:1) using a computer generated randomisation list using blocks of size 3. Subjects will be stratified according to age category (above or below 65 years) and gender.
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
At completion of the parallel-design randomized controlled trial, all participants will be followed out to 2 years in an observational study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
1. The randomized controlled trial
The primary analysis will be intent-to-treat analysis. The population will be defined as participants who were randomized for which there are complete baseline measurements. At baseline, characteristics of participants in the intervention and control groups will be compared by using the independent-samples t-test on transformed data when appropriate and the chi-square test for categorical variables. Baseline and 12 week values for outcome measures, and between-group differences will be presented as least-squares means and 95% CIs. Outcomes will be analysed by using general linear models to examine differences between intervention (knowledge of AAC) and control in post intervention values (12 weeks) for each outcome, unadjusted and after adjustment for baseline values, used as covariates. Outcomes with multiple measurements will use mixed models to determine the effect of intervention (knowledge of AAC) compared with the control.

2. The observational study
At baseline, characteristics of participants with and without advanced structural vascular disease (AAC>0 versus AAC=0) will be compared by using the independent-samples t-test on transformed data when appropriate and the chi-square test for categorical variables. The effect of the knowledge of presence of advanced structural vascular disease (AAC>0) compared with AAC=0, on primary and major secondary outcomes will be assessed by using general linear models to examine differences between AAC>0 and AAC=0 after adjustment for baseline values, used as covariates. In addition, models will adjust for treatment code (intervention or control), and other potential confounding factors.

3. Other analyses
Cross-sectional analysis of baseline data:
Pearson’s correlation coefficient or Spearman’s rank correlation will be used to explore the degree and direction of association between variables at baseline. The relationships of baseline variables with other baseline measures will be explored using analysis of covariance or binary logistic regression, with adjustment of potential confounders.

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)
WA,VIC

Funding & Sponsors
Funding source category [1] 299826 0
University
Name [1] 299826 0
Edith Cowan University
Address [1] 299826 0
270 Joondalup Dr, Joondalup WA 6027
Country [1] 299826 0
Australia
Funding source category [2] 302813 0
University
Name [2] 302813 0
Deakin University
Address [2] 302813 0
221 Burwood Hwy, Burwood VIC 3125
Country [2] 302813 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 299181 0
University
Name [1] 299181 0
Deakin University
Address [1] 299181 0
221 Burwood Hwy, Burwood VIC 3125
Country [1] 299181 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300705 0
Edith Cowan University (ECU) Human Research Ethics Committee (HREC)
Ethics committee address [1] 300705 0
270 Joondalup Dr, Joondalup WA 6027
Ethics committee country [1] 300705 0
Australia
Date submitted for ethics approval [1] 300705 0
16/04/2018
Approval date [1] 300705 0
15/06/2018
Ethics approval number [1] 300705 0
20513

Summary
Brief summary
Cardiovascular diseases (CVD) are the leading causes of death in the world. Globally, over 30% of all deaths are attributable to CVD, with the majority of these attributable to either ischemic heart disease (heart attack) or cerebrovascular disease (stroke). In Australia ~29% of all deaths have an underlying cause of CVD. Suboptimal lifestyle behaviours are the leading causes of CVD globally, and most CVD-related events could be prevented or substantially delayed by improving diet, increasing physical activity and stopping smoking. There is a strong rationale to focus on primary prevention targeting lifestyle behaviour change.
Early intervention can arrest chronic disease and prevent adverse outcomes. Intervention guided by new non-invasive measures of advanced structural vascular disease are revolutionising CVD risk management. Structural vascular disease measurements, assessed using vascular calcium scores substantially improve estimation of future CVD risk. The most commonly used measure clinically is coronary artery calcium (CAC) scoring. The main disadvantage of this test is that it is not recommended for routine, repeated assessment because of the radiation dose involved. Its cost also limits repeated measurement. We have developed a test to assess abdominal aortic calcification (AAC) that is rapid, inexpensive and ultra-low radiation, and thus can be used for population-based screening in almost any individual. It can also be repeated at regular intervals to follow disease progression. AAC is closely related to coronary artery calcium (CAC) and atherosclerosis at other vascular beds, and strongly predicts CVD events, CVD deaths and deaths from all-causes.
We will conduct an 8 week randomized controlled trial including men and women 50 to 80 years old. Participants will then be followed up out to 12 months in an observational study. Our overarching aim is to determine if providing individuals with knowledge of their structural vascular disease together with brief nutrition and lifestyle education might lead to short-term (12 weeks) and longer-term (2 years) benefits on diet and lifestyle, and other health-related measures. We expect that an individual’s knowledge of AAC will result in increased fruit and vegetable intake (primary outcome), improved diet and improvement in other measures related health status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84542 0
Prof Jonathan Hodgson
Address 84542 0
Edith Cowan University, Level 4, Medical Research Foundation Building, Rear of 50 Murray Street, Perth, WA 6000
Country 84542 0
Australia
Phone 84542 0
+61 (0)8 9224 0267
Fax 84542 0
Email 84542 0
jonathan.hodgson@ecu.edu.au
Contact person for public queries
Name 84543 0
Prof Jonathan Hodgson
Address 84543 0
Edith Cowan University, Level 4, Medical Research Foundation Building, Rear of 50 Murray Street, Perth, WA 6000
Country 84543 0
Australia
Phone 84543 0
+61 (0)8 9224 0267
Fax 84543 0
Email 84543 0
jonathan.hodgson@ecu.edu.au
Contact person for scientific queries
Name 84544 0
Prof Jonathan Hodgson
Address 84544 0
Edith Cowan University, Level 4, Medical Research Foundation Building, Rear of 50 Murray Street, Perth, WA 6000
Country 84544 0
Australia
Phone 84544 0
+61 (0)8 9224 0267
Fax 84544 0
Email 84544 0
jonathan.hodgson@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
We do not have ethics approval for this.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
No Results