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Trial registered on ANZCTR


Registration number
ACTRN12618000146291
Ethics application status
Approved
Date submitted
7/12/2017
Date registered
31/01/2018
Date last updated
19/04/2022
Date data sharing statement initially provided
16/04/2021
Date results provided
19/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does nutrition counselling combined with an education and cooking program improve blood vessel function for patients with vascular disease?
Scientific title
Creating efficiencies while improving effectiveness: An evaluation of a student-led
nutrition service for delaying the progression of peripheral vascular disease.
Secondary ID [1] 293551 0
None
Universal Trial Number (UTN)
U1111-1206-2530
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral vascular disease 305766 0
Condition category
Condition code
Cardiovascular 304989 304989 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 304997 304997 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to usual care the intervention group will receive (1) a on-on-one nutritional assessment, (2) one-on-one education session, (3) one-on-one face-to-face review at 6 week, (4) fortnightly phone call or message review and (5) six fortnightly 3 hour small group cooking and education sessions, (6) one-on-one review and discharge session.

The face-to-face (~1-1.5hr) nutritional assessment at Flinders Medical Centre will include student dietitians collecting anthropometry measures (e.g. height, weight, waist circumference), clinical measures (e.g. blood pressure taken by an automated blood pressure machine, pain free walking distance, six minute walking distance), questionnaire on quality of life and a diet history under supervision by an Accredited Practising Dietitian (APD). Additional clinical measures include blood test collected by trained phlebotomist (testing lipid studies, white blood cell count and white blood cell differentials, hs-CRP, cortisol) and flow medicated dilation (collected by trained researcher).

A one-to-one face-to-face education session will be provided within one week from the date of the nutrition assessment. The face-to-face (~30min) education session will involve student dietitians supervised by an APD who will explain to patients the key nutrients that are beneficial to their condition and negotiate with the patient, realistic goals and strategies to include these nutrients in their diet. At the face-to-face 6 week review (~30mins), the patient and student dietitian (supervised by an APD) will review the existing goals and strategies to determine if new goals and strategies can be established or if new strategies are required to meet current goals. These sessions may occur at Flinders Medical Centre or at the participants place of residence.

The fortnightly phone call or text messages will provide encouragement through individualised reminders of the benefit of key nutrients and how consumption can be achieved. Research staff will manage this.

The 6 x3hour fortnightly face-to-face small group (~8-10 participants) cooking and education sessions are delivered by a dietetic students under the supervision of an APD over 12 weeks. Sessions are held at a local community centre. Each sessions provides a 30 minute interactive education session that discusses a key nutrient or nutritional skill each week through PowerPoint presentation and activities. The remaining time (~2hr) provides participants with hand-on interactive activities focused on cooking a main meal and dessert using key nutrients. These sessions focus on cooking skills, cooking methods, dietary fat, dietary fibre, dietary sodium, antioxidants, benefits of seasonal produce, energy balance, label reading and dietary supplements. Participants may then consume the meal together and also have a meal to take home.

The (1-1.5hr) review and discharge session at Flinders Medical Centre will incorporate the collection of the same anthropometry, clinical, quality of life and diet history measurements taken at baseline, a review of improvements made, any questions arising from service and strategies are discussed to make long term sustainable changes. A letter to the doctor will be provided to summarise the involvement in this study. A referral to a community dietitian will also be suggested if indicated by the final assessment. This is conducted by the student dietitians under APD supervision.

Peripheral vascular disease progression (e.g. changes in stenosis and ulcers), adverse outcomes (e.g. cardiovascular events, surgery, procedure, death) will be monitored through medical record audit that will collect information from discharge up to 24 months post-discharge. Medicare Benefits Scheme and Pharmaceutical Scheme History will be collected from Department of Human Services for the duration of the participant involvement in the study and 24 months post-discharge to determine cost-effectiveness.

Additionally at routine 6 and/or 12 month appointments up to 24 months post discharge, patients will be asked to fill in a quality of life questionnaire. Clinical markers routine collected at these appointments such as weight, height, blood pressure, waist circumference and blood results will also be recorded.

Attendance to all baseline, review, education and cooking sessions, review and discharge sessions will be recorded.
Intervention code [1] 299793 0
Lifestyle
Intervention code [2] 299949 0
Treatment: Other
Intervention code [3] 299950 0
Prevention
Comparator / control treatment
Participants randomised to the control group will undergo one face-to-face (~1-1.5hr) initial assessment at Flinders Medical Centre which will include student dietitians collecting anthropometry measures (e.g. height, weight, waist circumference), clinical measures (e.g. blood pressure taken by an automated blood pressure machine, pain free walking distance, six minute walking distance), questionnaire on quality of life and a diet history under supervision by an Accredited Practising Dietitian (APD). Additional clinical measures include blood test collected by trained phlebotomist (testing lipid studies, white blood cell count and white blood cell differentials, hs-CRP, cortisol) and flow medicated dilation (collected by trained researcher).

Control group will then receive usual care (general nutrition advice from Vascular Surgery Doctor and option of attending a 30 minute group seminar by a Clinical Dietitian working for Flinders Medical Centre).

At the end of the 12-weeks, a 1-1.5hr review and discharge session at Flinders Medical Centre that will incorporate the collection of the same anthropometry, clinical, quality of life and diet history measurements taken at baseline, any chances and concerns will be discussed. A letter to the doctor will be provided to summarise the involvement in this study. A referral to a community dietitian will also be suggested if indicated by the final assessment. This is conducted by the student dietitians under APD supervision.

Peripheral vascular disease progression (e.g. changes in stenosis and ulcers), adverse outcomes (e.g. cardiovascular events, surgery, procedure, death) will be monitored through medical record audit that will collect information from discharge up to 24 months post-discharge. Medicare Benefits Scheme and Pharmaceutical Scheme History will be collected from Department of Human Services for the duration of the participant involvement in the study and 24 months post-discharge to determine cost-effectiveness.

Additionally at routine 6 and/or 12 month appointments up to 24 months post discharge, patients will be asked to fill in a quality of life questionnaire. Clinical markers routine collected at these appointments such as weight, height, blood pressure, waist circumference and blood results will also be recorded.
Control group
Active

Outcomes
Primary outcome [1] 304157 0
Progression of peripheral arterial disease measured by changes in flow mediated dilation through ultrasound of the brachial artery following 5 minutes of occlusion, blood lipid levels, inflammatory markers (e.g. hs-CRP) and pain-free walking distance
Timepoint [1] 304157 0
Baseline and at the end of the 12 week intervention (primary timepoint)
Primary outcome [2] 304164 0
Quality of life measured by EQ5D-5L questionnaire, pain-free walking distance and six-minute walking distance
Timepoint [2] 304164 0
Baseline and at the end of the 12 week intervention (primary timepoint) Quality of life measured by EQ5D-5L questionnaire will also be collected at routine 6 or 12 month appointments for up to 24 months after the intervention for participants that consent to long term follow-up.
Primary outcome [3] 304167 0
Diet quality assessed using a 7-day diet history collected by the student dietitian and compared to the Australian Guide to Healthy Eating Recommendations.
Timepoint [3] 304167 0
Baseline, 6 weeks, 12 weeks (primary timepoint)
Secondary outcome [1] 341120 0
Nitric oxide activity measured by serum nitrate and nitrite levels
Timepoint [1] 341120 0
Baseline and at the end of the 12 week intervention
Secondary outcome [2] 341121 0
Adverse events (e.g. stenosis, amputation, revascularisation, myocardial infarction, stroke, TIA, ulcer development/deterioration, readmission, increased Rutherford score, death, increase ankle brachial index) recorded in medical records
Timepoint [2] 341121 0
Baseline, 6 weeks, 12 weeks, 12 months post intervention
Secondary outcome [3] 341122 0
Cost-effectiveness measured by MBS/PBS claims history
Timepoint [3] 341122 0
Baseline, 6 weeks and 12 weeks for all. Additional time points 12 months and 24 months post-intervention for participants that consent to follow up.
Secondary outcome [4] 341123 0
Progression of disease defined as changes in stenosis determined by ankle brachial index, x-rays or increased Rutherford score, after 1 year based on medical records
Timepoint [4] 341123 0
Baseline, 6 weeks and 12 weeks for all. 12 months post-intervention and up to 24 months post intervention for participants that consent to follow up.
Secondary outcome [5] 341614 0
Overall health measures by changes in BMI, waist circumference and weight
Timepoint [5] 341614 0
Baseline, 6 weeks and 12 weeks for all. 12 months post-intervention and up to 24 months post intervention for participants that consent to follow up.
Secondary outcome [6] 341616 0
Nutritional health measured by change diet quality (measured by 24hr and 7 day diet histories) and changes in blood vitamin (e.g. vitamin A, D, E, C, and mineral levels (e.g. iron, zinc, selenium)
Timepoint [6] 341616 0
Baseline, 12 weeks
Secondary outcome [7] 341617 0
Presence of high cortisol levels (e.g. >800 nmol/L) measured by blood cortisol level
Timepoint [7] 341617 0
Baseline, 12 weeks
Secondary outcome [8] 341618 0
Change in dietetic student knowledge and skills through the development of Dietitian Association of Australia competencies measured by a semi-structured interview and evaluation questionnaire (designed for the purposes of this study)
Timepoint [8] 341618 0
Within one week of the completion of their voluntary involvement

Eligibility
Key inclusion criteria
Peripheral arterial disease patients: Clinical history consistent with peripheral arterial disease

Dietetic students: enrolled in a dietetics program at Flinders University
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Peripheral arterial disease patients:
Undergone arterial intervention <1 month ago.
Deemed to be not competent of providing informed consent.
Unable to understand information provided in English.
Reside in a residential aged care facility.
Unable to physically cook.

Dietetics students: Unavailable to participate in the study

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)
Sealed opaque envelopes created by staff not involved in the research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation created by staff not involved in the research. Sequence was generated by stratifying patients according to periperal arterial disease stage and using permuted block randomisation.
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
Volunteer dietetics students who are supervised to provide the intervention (student nutrition service) are also participants of the research study which qualitatively assesses their experience in the service in relation to the development of skills and knowledge associated with the competencies they are required to gain at the end of their course of study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming an equivalent change to FMD and blood triglycerides as markers of PAD progression to Schiano and colleagues, 80% power, 0.05% alpha error to detect a clinically meaningful change in FMD of 2% and 50mg/dl in blood triglycerides in either direction, 25 per group is required. To account for attrition and mortality at 20%, 30 patients with PAD per group are required.

Primary analysis will be undertaken using ITT principles. Independent sample t-tests, Mann-Whitney U tests, Chi-square tests, related sample student t-tests, Wilcoxon and Sign tests across and within the two groups will be undertaken as appropriate. Statistical significance will be set at p=0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Covid.
Date of first participant enrolment
Anticipated
Actual
12/01/2018
Date of last participant enrolment
Anticipated
3/08/2018
Actual
22/02/2019
Date of last data collection
Anticipated
28/05/2021
Actual
31/12/2019
Sample size
Target
60
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9511 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 18253 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 298165 0
University
Name [1] 298165 0
Flinders University
Country [1] 298165 0
Australia
Primary sponsor type
Individual
Name
Professor Michelle Miller
Address
College of Nursing & Health Sciences
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country
Australia
Secondary sponsor category [1] 297264 0
None
Name [1] 297264 0
Address [1] 297264 0
Country [1] 297264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299180 0
Southern Adelaide Research and Ethics Committee
Ethics committee address [1] 299180 0
Ethics committee country [1] 299180 0
Australia
Date submitted for ethics approval [1] 299180 0
20/04/2017
Approval date [1] 299180 0
24/11/2017
Ethics approval number [1] 299180 0
83.17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79566 0
Prof Michelle Miller
Address 79566 0
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country 79566 0
Australia
Phone 79566 0
+61 8 8201 2421
Fax 79566 0
Email 79566 0
[email protected]
Contact person for public queries
Name 79567 0
Michelle Miller
Address 79567 0
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country 79567 0
Australia
Phone 79567 0
+61 8 8201 2421
Fax 79567 0
Email 79567 0
[email protected]
Contact person for scientific queries
Name 79568 0
Michelle Miller
Address 79568 0
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country 79568 0
Australia
Phone 79568 0
+61 8 8201 2421
Fax 79568 0
Email 79568 0
[email protected]

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?

No Supporting Document Provided



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.