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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 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] 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
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] 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
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] 306365 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Primary outcome [2] 329213 0
Composite total fruit and vegetable intake (in g/d) estimated using food frequency questionnaire data
Timepoint [2] 329213 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] 348356 0
Smoking status (current/ex-smoker/never smoked; duration in months/years; and amount smoked) assessed using questionnaire designed for the study
Timepoint [7] 348356 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [8] 348357 0
Health-related habits including alcohol intake assessed using a demographic and lifestyle questionnaire specifically designed for this study
Timepoint [8] 348357 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [9] 348358 0
Health-related habits including sitting time assessed using a Demographic and lifestyle questionnaire specifically designed for this study
Timepoint [9] 348358 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [10] 348359 0
Health-related habits including social activities, assessed using the SF36 questionnaire
Timepoint [10] 348359 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [11] 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 [11] 348360 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [12] 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 [12] 348371 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [13] 348372 0
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] 348372 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [14] 348373 0
Non-fasting serum glucose and HbA1c using a fully automated analyser (Architect ci8200/c16000 Analyser).
Change made prior to enrolment commencement.
Timepoint [14] 348373 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [15] 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 [15] 348374 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [16] 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 [16] 348377 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [17] 348378 0
Medication and health-care use, including medical procedures / further risk factor testing assessed using a questionnaire specifically designed for this study
Timepoint [17] 348378 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [18] 348379 0
Visits to health care professionals assessed using a questionnaire specifically designed for this study
Timepoint [18] 348379 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [19] 348380 0
Drug prescriptions assessed using a questionnaire specifically designed for this study
Timepoint [19] 348380 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [20] 348709 0
Medication use assessed using a medication record form
Timepoint [20] 348709 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [21] 379652 0
Total vegetable intake assessed using food frequency questionnaire data
Timepoint [21] 379652 0
Randomized controlled trial: assessed at baseline and 12 weeks Observational study: assessed at 2 years
Secondary outcome [22] 379653 0
Total fruit intake assessed using food frequency questionnaire data
Timepoint [22] 379653 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 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)
WA

Funding & Sponsors
Funding source category [1] 299826 0
University
Name [1] 299826 0
Edith Cowan University
Country [1] 299826 0
Australia
Funding source category [2] 302813 0
University
Name [2] 302813 0
Deakin University
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] 310928 0
None
Name [1] 310928 0
Address [1] 310928 0
Country [1] 310928 0

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
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
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
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
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6782Study protocol  jonathan.hodgson@ecu.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseModification of diet, exercise and lifestyle (MODEL) study: A randomised controlled trial protocol.2020https://dx.doi.org/10.1136/bmjopen-2019-036366
N.B. These documents automatically identified may not have been verified by the study sponsor.