HealthyRHearts: The effect of personalised nutrition counselling via telehealth on cholesterol in rural adult populations.

Not Applicable

• Conditions: Heart disease; Cardiovascular - Coronary heart disease; Cardiovascular - Hypertension; Cardiovascular - Normal development and function of the cardiovascular system; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12621001495819
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-03
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

A person is eligible for inclusion if they are assessed at moderate to high risk of cardiovascular disease, as assessed by their GP and the CVD risk calculator/Guidelines for the management of Absolute cardiovascular disease risk.
A person may be eligible for inclusion if they have no known Coronary Artery Disease (CAD), or they are judged by their GP to be currently stable with a CAD diagnosis and free of clinical events for at least 6 months.

Exclusion Criteria

People are not eligible for the study if:
•Their GP considers them to be ineligible due to the complexity of their condition or is aware of a circumstance that would impact on their ability to participate in the study.
•They are pregnant or planning to become pregnant.
•They have a medical condition that affects dietary intake, e.g., Conditions with swallowing difficulties, or restrictive exclusion diets.
•They are newly diagnosed with diabetes (< 3 months).
•They are unable to participate in telehealth dietary consultations due to disability or medical condition.
•They have been hospitalised or revascularized in the preceding 6 months.
•They have not been on a stable statin dose for the preceding 3 months.
•They do not have access to an email address or to the internet.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total serum cholesterol, collected and analysed by accredited pathology services[ Baseline, 3, 6 and 12 (primary outcome) months after randomisation. ];Serum low density lipoprotein (LDL) cholesterol, collected and analysed at accredited pathology services.[ Baseline, 3, 6 and 12 months (primary outcome) after randomisation];Serum triglycerides, collected and analysed at accredited pathology services.[ Baseline, 3, 6 and 12 (primary outcome) months after randomisation ]

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure. This will be measured by the General Practitioner, or their appropriate staff, at their service in accordance with their usual routine, and using practices and equipment consistent with their usual care. Values used are those documented in their case files.[ Baseline and at 12 months after randomisation.];Percentage of energy from dietary intake attributed to energy-dense, nutrient poor foods. This is measured by the Australian Eating Survey - Heart version.[ Baseline, and at 3, 6 and 12 months after randomisation];Self-reported weight [ Baseline, and at 3, 6 and 12 months after randomisation];Quality of life, as assessed by the PROMIS Global Health Scale (v1.2, 13th April, 2018) [ Baseline, and at 3, 6 and 12 months after randomisation];Self-reported waist circumference[ Baseline, and at 3, 6 and 12 months after randomisation]