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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

9/08/2023

Date data sharing statement initially provided

17/05/2019

Date results information initially provided

9/08/2023

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

Secondary ID [1]

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

Musculoskeletal disorders

Gastrointestinal function

Cognition

Wellbeing

Physical function

Mental health

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Cardiovascular

Normal development and function of the cardiovascular system

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Mental Health

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
A 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 more than half of all men and women (60 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 be randomised (1:1) to either have knowledge of their AAC provided to them at baseline, approximately 2 weeks after their baseline assessments (intervention group) or have knowledge of their AAC provided at the end (week 12) of the RCT (the wait-listed control group). All participants will receive standardised diet and lifestyle advice provided in a booklet approximately 2 weeks after their baseline assessments, and a video (via email). At baseline the intervention group will also be given access to a video that explains their AAC result. The same video will be provided to the wait-listed control group at the at the end (week 12) of the RCT together with their AAC scan result. All clinical assessments will be performed at baseline and 12 weeks. When participants receive their AAC result, this will also be sent to the participant’s GP together with a GP’s information sheet describing AAC. Participants will be encouraged to discuss their results with their GP. In addition to the email with the video links and booklet, participants will receive a call from a study investigator (on the same day wherever possible), who will briefly explain the AAC scan results (invervention group at baseline and wait-listed control group at 12 weeks) and reinforce the lifestyle advice provided in the booklet and video. Both the booklet and video have been designed and produced specifically for this study. The day and time of the phone call will be booked at the time of the participant’s baseline visit.
During the phone call the study investigator will reinforce three goals to be achieved within 12 weeks: i) The first of these will be to increase fresh fruit intake and increase vegetable intake; 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). The impact on a variety of other dietary and lifestyle factors and measures related to health status will also be assessed.

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 primary 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]

Treatment: Other

Intervention code [2]

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]

Serum circulating concentrations of carotenoids. Individual carotenoids including alpha-carotene, beta-carotene, lycopene, lutein and beta-cryptoxanthin/zeaxanthin. The primary outcome is total carotenoids.

Timepoint [1]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Primary outcome [2]

Composite total fruit and vegetable intake (in g/d) estimated using food frequency questionnaire data

Timepoint [2]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years.

Secondary outcome [1]

Physical activity and inactivity assessed using CHAMPS, a physical activity questionnaire

Timepoint [1]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [2]

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]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [3]

Body composition including: Body fat mass and percentage using dual energy x-ray absorptiometry (DXA).

Timepoint [3]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [4]

Body composition including visceral adiposity using dual energy x-ray absorptiometry (DXA).

Timepoint [4]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [5]

Body composition including lean mass assessed using dual energy x-ray absorptiometry (DXA).

Timepoint [5]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [6]

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]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [7]

Smoking status (current/ex-smoker/never smoked; duration in months/years; and amount smoked) assessed using questionnaire designed for the study

Timepoint [7]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [8]

Health-related habits including alcohol intake assessed using a demographic and lifestyle questionnaire specifically designed for this study

Timepoint [8]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [9]

Health-related habits including sitting time assessed using a Demographic and lifestyle questionnaire specifically designed for this study

Timepoint [9]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [10]

Health-related habits including social activities, assessed using the SF36 questionnaire

Timepoint [10]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [11]

Gastrointestinal function, including bowel habits and stool consistency assessed using a Bowel health questionnaire, Bristol stool chart and 24h faecal samples collection

Timepoint [11]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [12]

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 [12]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [13]

Lipid and lipoprotein profile: Standard biochemical analyses of non-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.

Timepoint [13]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [14]

Non-fasting serum glucose and HbA1c using a fully automated analyser (Architect ci8200/c16000 Analyser).
Change made prior to enrolment commencement.

Timepoint [14]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [15]

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 [15]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [16]

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 [16]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [17]

Medication and health-care use, including medical procedures / further risk factor testing assessed using a questionnaire specifically designed for this study

Timepoint [17]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [18]

Visits to health care professionals assessed using a questionnaire specifically designed for this study

Timepoint [18]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [19]

Drug prescriptions assessed using a questionnaire specifically designed for this study

Timepoint [19]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [20]

Medication use assessed using a medication record form

Timepoint [20]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [21]

Total vegetable intake assessed using food frequency questionnaire data

Timepoint [21]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Secondary outcome [22]

Total fruit intake assessed using food frequency questionnaire data

Timepoint [22]

Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years

Eligibility

Key inclusion criteria

Ambulant men and women aged 60 to 80 years

Minimum age

60 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Poor image quality of the DXA scans resulting in an inability to assess the AAC;
Those unable or unwilling to follow the study protocol. This will include some individuals who do not have email and or are not able to get access to a computer to complete questionnaires.

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 (1:1) using a computer generated randomisation list using blocks of size 4.

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

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Other reasons/comments

Other reasons

This was due to COVID-related delays and protocol changes that resulted in exhaustion of funding prior to reaching the n=300 target.

Date of first participant enrolment

Anticipated

24/09/2020

Actual

25/09/2020

Date of last participant enrolment

Anticipated

14/10/2022

Actual

9/02/2022

Date of last data collection

Anticipated

28/06/2024

Actual

21/06/2022

Sample size

Target

300

Accrual to date

Final

240

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

270 Joondalup Dr, Joondalup WA 6027

Country [1]

Australia

Funding source category [2]

University

Name [2]

Deakin University

Address [2]

221 Burwood Hwy, Burwood VIC 3125

Country [2]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Dr, Joondalup WA 6027

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Edith Cowan University (ECU) Human Research Ethics Committee (HREC)

Ethics committee address [1]

270 Joondalup Dr, Joondalup WA 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/04/2018

Approval date [1]

15/06/2018

Ethics approval number [1]

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 a 12week randomized controlled trial including men and women 60 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

Prof Jonathan Hodgson

Address

Edith Cowan University, Level 4, Medical Research Foundation Building, Rear of 50 Murray Street, Perth, WA 6000

Country

Australia

Phone

+61 (0)8 9224 0267

Fax

jonathan.hodgson@ecu.edu.au

Contact person for public queries

Name

Prof Jonathan Hodgson

Address

Edith Cowan University, Level 4, Medical Research Foundation Building, Rear of 50 Murray Street, Perth, WA 6000

Country

Australia

Phone

+61 (0)8 9224 0267

Fax

jonathan.hodgson@ecu.edu.au

Contact person for scientific queries

Name

Prof Jonathan Hodgson

Address

Edith Cowan University, Level 4, Medical Research Foundation Building, Rear of 50 Murray Street, Perth, WA 6000

Country

Australia

Phone

+61 (0)8 9224 0267

Fax

jonathan.hodgson@ecu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We do not have ethics approval for this.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6782	Study protocol			jonathan.hodgson@ecu.edu.au

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Data analysis is continuing

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Modification of diet, exercise and lifestyle (MODEL) study: A randomised controlled trial protocol.	2020	https://dx.doi.org/10.1136/bmjopen-2019-036366

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically