Intervention study investigating the effect of a dietary intervention geared towards improved adherence to the Dutch dietary guidelines on the 10-year risk for recurrent vascular events (SMART risk score) in patients with cardiovascular diseases compared with usual care.

Intervention study investigating the effect of a dietary intervention geared towards improved adherence to the Dutch dietary guidelines on the 10-year risk for recurrent vascular events (SMART risk score) in patients with cardiovascular diseases compared with usual care. - Dutch dietary guidelines for patients with cardiovascular diseases.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49536

Enrollment

144

Registered

2020-12-15

Start date

2021-05-28

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Cardiovascular diseases

Interventions

The intervention group will receive personalized guidance from a dietician to improve adherence to the Dutch dietary guidelines, the control group will receive usual care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Be categorised in the highest risk category of the guideline for cardiovascular risk management 2019 (Tjin-A-Ton, J., & Vrolijk, M., 2019). This includes patients with: o Previously diagnosed cardiovascular disease, including acute coronary disease syndrome, angina, coronary revascularization, TIA or stroke, symptomatic aortic iliofemoral atherosclerosis, aortic aneurysm, intermittent claudication or peripheral revascularization. - Aged 18 year or older.

Exclusion criteria

Exclusion criteria: - Uses medication (e.g. metformine, sulfonylureumderivate, insulin or DPP4-inhibitors/GLP1-agonists) for treatment of diabetes - a known hereditary form of cardiovascular diseases (e.g. Familial hypercholesterolaemia) - chronic kidney disease in stage 4 or above (meaning an eGFR

Design outcomes

Primary

Measure	Time frame
The change in Smart Risk Score from baseline until 6 months will be the primary outcome of this study. The SMART Risk Score estimates the 10-year risk for recurrent vascular events in patients with manifest cardiovascular disease based on the following modifiable parameters: systolic blood pressure, creatinine, hsCRP and cholesterol.	—

Secondary

Measure	Time frame
Secondary study variables are the difference in biomedical cardiovascular outcomes, nutritional status, and mental and physical wellbeing between intervention and control group from baseline to 6 months. Cardiovascular outcomes include systolic and diastolic blood pressure, biomarkers such as hba1c, cholesterol, triglycerides, eGFR, insulin and glucose and inflammation markers. In addition, we measure urine to be able to determine salt and protein. Body weight and waist circumference are further outcomes of the study. Nutritional status is measured by the DHD15 index, which requires participants to complete a habitual diet questionnaire. Furthermore, a number of biomarkers for nutrition are used. Mental and physical fitness is measured with questionnaires about quality of life, self-efficacy, mental status, and physical activity. In addition, data on health care use is requested and hospitalization, development of comorbidities and mortality from the patient files will be assessed.	—

Measure

Time frame

Secondary study variables are the difference in biomedical cardiovascular outcomes, nutritional status, and mental and physical wellbeing between intervention and control group from baseline to 6 months. Cardiovascular outcomes include systolic and diastolic blood pressure, biomarkers such as hba1c, cholesterol, triglycerides, eGFR, insulin and glucose and inflammation markers. In addition, we measure urine to be able to determine salt and protein. Body weight and waist circumference are further outcomes of the study. Nutritional status is measured by the DHD15 index, which requires participants to complete a habitual diet questionnaire. Furthermore, a number of biomarkers for nutrition are used. Mental and physical fitness is measured with questionnaires about quality of life, self-efficacy, mental status, and physical activity. In addition, data on health care use is requested and hospitalization, development of comorbidities and mortality from the patient files will be assessed.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)