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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000146291
Enrollment
42
Registered
2018-01-31
Start date
2018-01-12
Completion date
2019-02-22
Last updated
2022-04-25

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 arterial disease are at risk of poor nutritional health. Poor nutritional health can affect the patients’ ability to have ideal clinical outcomes. This project will implement a randomized controlled trial providing a 12-week student nutrition service (consisting of nutrition counselling and 6 fortnightly education and cooking classes) for adults with peripheral arterial disease who attend the Southern Adelaide Local Health Network Vascular Surgery Outpatient Clinic (at Marion GP Plus and Flinders Medical Centre). Through comparing the results of those who are given the intervention with those who are provided with the usual care, the project will enable researchers to observe if this service is associated with any significant improvements in patient's cardiovascular health, nutritional health and quality of life. It will also help researchers to understand if the service can be provided free of charge to patients at an acceptable cost to the government.

Interventions

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. h

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.

Sponsors

Professor Michelle Miller
Lead SponsorIndividual

Study design

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

Eligibility

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

Inclusion criteria

Peripheral arterial disease patients: Clinical history consistent with peripheral arterial disease Dietetic students: enrolled in a dietetics program at Flinders University

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026