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Does nutrition counselling combined with a cooking program improve blood vessel function for patients with vascular disease?

Creating efficiencies while improving effectiveness: A pilot evaluation of a student-led nutrition service for delaying progression of peripheral vascular disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001347459
Enrollment
40
Registered
2016-09-27
Start date
2016-07-28
Completion date
2016-12-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with peripheral vascular disease are a nutritionally vulnerable group of patients and current management strategies for addressing nutritional health are sub-optimal. The importance of good nutritional health in achieving optimal clinical outcomes is well established. This project will therefore implement an established student-led model of nutritional care to manage the unique nutritional requirements of patients with peripheral vascular disease. Our evaluation of this model of care in other patient groups has demonstrated improved satisfaction and outcomes from a student, clinician and patient perspective. Transferring this model of care to those with peripheral vascular disease has the potential to have similar outcomes and we have designed this project to specifically identify improvements in cardiovascular health. The primary aim of this pilot RCT is to determine the feasibility of implementing a 12 week student-led nutrition service, for adults with PVD attending the Southern Adelaide Local Health Network (SALHN) Vascular Surgery Claudication Clinic and observe any clinically and statistically significant improvements in the cardiovascular health and quality of life of participants who receive individualised nutritional advice compared to usual care. 1. Study design: This intervention will be a Randomised Controlled Trial, where participants will be allocated to either an intervention (n=20) or control group (n=20). Participants in the control group will receive usual care, where patients typically receive general nutrition advice from Vascular Surgery Consultant or Registrar and the option of attending a 30 minute group seminar by a Dietitian. The study will be of 12 weeks duration.

Interventions

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 anthro

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.

Sponsors

Professor Michelle Miller
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Clinical history consistent with Intermittent Claudication as determined by ABPI

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026