Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001347459
Ethics application status
Approved
Date submitted
27/07/2016
Date registered
27/09/2016
Date last updated
27/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does nutrition counselling combined with a cooking program improve blood vessel function for patients with vascular disease?
Scientific title
Creating efficiencies while improving effectiveness: A pilot evaluation of a student-led nutrition service for delaying progression of peripheral vascular disease
Secondary ID [1] 289776 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral vascular disease 299658 0
Condition category
Condition code
Diet and Nutrition 299604 299604 0 0
Other diet and nutrition disorders
Cardiovascular 299613 299613 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention arm will attend a student led nutrition service. The nutrition care process will be delivered in four stages, (1) an initial assessment (for both intervention and control), (2) an individualised 30 minute education session (intervention only), (3) a cooking skills and education program delivered via six sessions over 12 weeks (intervention only), and (4) review and discharge (for both intervention and control).

The assessment will incorporate anthropometry (e.g. height, weight, waist circumference) and a diet history. Students will report their findings at a team meeting and then an individualised education session that focusses on realistic dietary modification to improve diet quality consistent with established evidence for preventing progression of PVD will occur.

A cooking skills and education program will be delivered by a dietetic student under the supervision of an Accredited Practicing Dietitian, using a small group format (6-10 participants per group) fortnightly over 12 weeks with hands-on interactive sessions focussed on cooking skills, cooking methods, dietary fat and fibre, dietary sodium, antioxidants and the benefits of seasonal produce, energy balance and label reading, and dietary supplements. Each session will be 2-3 hours duration and will consist of an education session followed by a hands-on cooking session and will finish with participants gathering to eat what has been cooked during the session,
Attendance will be recorded for all cooking sessions, baseline and post-intervention clinic visits.
The cooking skills and education program will be evaluated post-program for changes in cooking skills, knowledge and confidence

The review and discharge session will incorporate a review of improvements made, any questions arising from the cooking skills and education program will be addressed and strategies discussed to make changes long term and sustainable. The assessment, individualised education session and review/discharge session will be supervised by an academic Accredited Practising Dietitian of Flinders University who will progressively reduce their input as student competence increases. The cooking skills program will be supervised by an Accredited Practising Dietitian employed by SPROUT cooking school.
Follow up
Peripheral vascular disease progressions will be monitor in all participants through a medical record audit. Any data on hospital admissions, revascularisation procedures and other related examinations and procedures (e.g. blood tests and angiogram results) will be extracted from medical records.

1. Laboratory assessment.
Fasting blood samples will be collected by a trained phlebotomist. Samples will be analysed for High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), triglycerides, total cholesterol, C-reactive protein, absolute neutrophils and lymphocytes. LDL-C concentrations will be calculated using the Friedewald equation.
2. Other assessment (e.g. radiological).
Blood pressure (systolic and diastolic blood pressure) measurements will be taken using a sphygmomanometer. Flow mediated dilation tests will be conducted using a sphygmomanometer and ultrasound equipment. Both measurements and tests will be conducted by a trained researcher.
3. Monitoring adverse effects (e.g. emotional, psychological and physical):
Staff will be required to undergo full immunisation screening and criminal history check to ensure no risk is placed to this vulnerable population group. Staff and participants will undergo an induction, consisting of occupational health and safety training prior to the cooking and nutrition classes at Sprout cooking school. As there is no pharmacological drug being tested in this research study, there are negligible chances of any adverse effect. Any harm to a participant should be reported to a member of the research team immediately.
Intervention code [1] 295431 0
Lifestyle
Intervention code [2] 295449 0
Treatment: Other
Intervention code [3] 295450 0
Prevention
Comparator / control treatment
Participants randomised to the control group will undergo the initial assessment and the review and discharge as per the intervention group. Apart from this, controls will receive standard/usual care which is an optional 30 minute group education session with a dietitian covering healthy eating for CVD and the provision of a list of available community-based cooking programs.
Control group
Active

Outcomes
Primary outcome [1] 299076 0
Change in flow-mediated dilatation which will be measured via ultrasound of the brachial artery following 5 minutes of occlusion.
Timepoint [1] 299076 0
12 weeks
Primary outcome [2] 299077 0
Diet quality will be assessed using a 7-day diet history collected by the student dietitian. Dietary intake will be compared to the Australian Guide to Healthy Eating recommendations.
Timepoint [2] 299077 0
12 weeks
Secondary outcome [1] 326075 0
blood pressure will be measured using an electronic blood pressure monitor.
Timepoint [1] 326075 0
12 weeks
Secondary outcome [2] 326076 0
change in body weight will be assessed by weighing the patient using a stand-on electronic scales in light clothing.
Timepoint [2] 326076 0
12 weeks
Secondary outcome [3] 326077 0
Adverse events. Potential adverse events from the intervention include injuries sustained during the cooking program such as burns and cuts. These will be assessed using self-report from the participant and records kept in a diary by the research staff conducting the cooking program.
Timepoint [3] 326077 0
12 weeks
Secondary outcome [4] 327961 0
Plasma Lipid Levels via venapuncture by a trained phlebotomist and analysed by the local pathology service.
Timepoint [4] 327961 0
Baseline and 12 weeks
Secondary outcome [5] 327962 0
C-reactive protein, Absolute neutrophils and lymphocyte count will be measured via venapuncture by a trained phlebotomist and analysed by the local pathology service to assess the inflammatory status of the participant
Timepoint [5] 327962 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
Clinical history consistent with Intermittent Claudication as determined by ABPI
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lower limb ischaemic rest pain
2. Clinical evidence of tissue loss e.g. ulcers
3. Undergone arterial intervention in the proceeding 12 months
4. Incompetent to provide own consent e.g. dementia, confusion, delirium

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome of FMD, a sample size of 130 (66 per group) is estimated based on our own pilot data, previous literature and clinical experience that an absolute change of 2% in FMD is clinically meaningful. We aim to recruit 30% of the estimated sample size for this pilot feasibility study, n=40 (20 per group). Primary analysis for this study will be undertaken using intention-to-treat principles. Independent samples t-tests, Mann-Whitney U tests and Chi-square tests across the two groups will be undertaken as appropriate. Statistical significance will be set at p= 0.05. Feasibility outcomes will be reported as frequency (%) and qualitatively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/07/2016
Date of last participant enrolment
Anticipated
30/12/2016
Actual
Date of last data collection
Anticipated
30/01/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6270 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 6271 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 13804 0
5042 - Bedford Park
Recruitment postcode(s) [2] 13806 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 294155 0
University
Name [1] 294155 0
Flinders University
Country [1] 294155 0
Australia
Primary sponsor type
Individual
Name
Professor Michelle Miller
Address
Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country
Australia
Secondary sponsor category [1] 292986 0
Individual
Name [1] 292986 0
Prof Ian Spark
Address [1] 292986 0
Dept Vascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park
SA
5042
Country [1] 292986 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295564 0
Southern Adelaide Research and Ethics Commitee
Ethics committee address [1] 295564 0
Ethics committee country [1] 295564 0
Australia
Date submitted for ethics approval [1] 295564 0
01/06/2016
Approval date [1] 295564 0
26/07/2016
Ethics approval number [1] 295564 0

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

Contacts
Principal investigator
Name 67782 0
Prof Michelle Miller
Address 67782 0
Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country 67782 0
Australia
Phone 67782 0
61 409870065
Fax 67782 0
61 8 82046406
Email 67782 0
michelle.miller@flinders.edu.au
Contact person for public queries
Name 67783 0
michelle Miller
Address 67783 0
Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country 67783 0
Australia
Phone 67783 0
61 409870065
Fax 67783 0
61 8 82046406
Email 67783 0
michelle.muller@flinders.edu.au
Contact person for scientific queries
Name 67784 0
Michelle Miller
Address 67784 0
Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide
SA
5001
Country 67784 0
Australia
Phone 67784 0
61 409870065
Fax 67784 0
61 8 82046406
Email 67784 0
michelle.miller@flinders.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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