Dietary Intervention to Improve Health of Cardiovascular Patients

Study Overview
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Brief Summary
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Voed je Beter is a randomized, multicenter, controlled trial to examine whether personalized guidance to increase adherence to the Dutch dietary guidelines, compared to usual care, improves health of cardiovascular patients who receive regular medical treatment.

Detailed Description
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Voed je Beter is a randomized, multicenter, controlled trial to examine whether a personalized intervention to increase adherence to the Dutch dietary guidelines, compared to usual clinical care, improves health of cardiovascular patients on top of medical treatment. Patients previously diagnosed with cardiovascular disease are randomized into two parallel groups: the intervention or the usual care group. The intervention consists of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines during a period of six months. The control group receives usual clinical care. At baseline, three months, six months, and 12 months measurements will be performed. Primary outcome data will be collected at 6 months. After 12 months, additional data will be collected to assess the prolonged effects of the intervention. The primary outcome of interest is the difference in SMART Risk Score between the intervention and usual care group from baseline till six months. Secondary outcomes are differences in SMART Risk Score at three months and twelve months; systolic blood pressure, diastolic blood pressure and cardiovascular parameters; diet quality, salt intake, vitamin levels in blood; body weight and waist circumference; renal function; quality of life; sleep; self-efficacy; mental health and medication use. In addition, an economic evaluation is carried out.

Official Title
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Dietary Intervention to Improve Health of Cardiovascular Patients

Conditions
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Cardiovascular Diseases, Heart Diseases, Vascular Diseases

Intervention / Treatment
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* Behavioral: Dietary counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A previously diagnosed cardiovascular disease, including acute coronary disease syndrome, angina pectoris, coronary revascularization, TIA, stroke, symptomatic aortic iliofemoral atherosclerosis, aortic aneurysm, intermittent claudication or peripheral revascularization. Over 18 years of age Exclusion Criteria: Uses medication for treatment of diabetes A known hereditary form of cardiovascular diseases Chronic kidney disease stage 4 or above (eGFR<30) Participation in another research study of which the outcomes may interfere with the current trial Not able to speak and understand the Dutch language Unable/unwilling to comply with the intervention Active treatment for cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention will consist of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines. | Behavioral: Dietary counselling<br>* Participants assigned to the intervention group will receive coaching from a dietitian to improve adherence to the Dutch dietary guidelines. Several behavioral change techniques will be used.<br>|
| No Intervention: Usual care group<br>The usual care group will not receive any special guidance regarding healthy nutrition, but will have access to their care team as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second manifestations of arterial disease (SMART) Risk Score | Estimate for 10-year risk for recurrent vascular events (range 0-100%), higher scores mean a worse outcome | baseline till six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second manifestations of arterial disease (SMART) Risk Score | Estimate for 10-year risk for recurrent vascular events (range 0-100%), higher scores mean a worse outcome | baseline till three months, baseline till twelve months | 
| Systolic and diastolic blood pressure | Blood pressure measurements following the recommendations for home blood pressure measurement by the European Society of Hypertension, meaning duplicate morning and evening measurements for 7 days. | baseline, three months, six months and twelve months | 
| Diabetic parameters | Insulin and glucose in mmol/L | baseline, three months, six months and twelve months | 
| Cardiovascular parameters | Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L | baseline, three months, six months and twelve months | 
| Inflammation marker | HsCRP mg/l | baseline, three months, six months and twelve months | 
| Diet quality assessed by the Dutch Helathy Diet Index 2015 score (Eetscore-FFQ) | Dutch Healthy Diet Index 2015 score (range 0-160 points, higher scores mean better outcome), assessed by a short Food Frequency Questionnaire. | baseline, three months, six months and twelve months | 
| Salt intake | 24-hour urinary sodium excretions. | baseline, six months | 
| Vitamin status | Serum vitamin B6, B12, folate and vitamin D. | baseline, six months | 
| Renal function | eGFR and albumin/creatinine ratio. | baseline, three months, six months and twelve months | 
| Anthropometrics - body weight | Body weight (in kilograms; weight and height will be combined to report BMI in kg/m^2) | baseline, three months, six months and twelve months | 
| Anthropometric - body height | Height (in meters; weight and height will be combined to report BMI in kg/m^2) | baseline, three months, six months and twelve months | 
| Anthropometrics -waist circumference | Waist circumference (in centimeters) | baseline, three months, six months and twelve months | 
| Self-reported quality of life | 36-Item Short Form Health Survey questionnaire, a high score defines a more favorable health state. | baseline, three months, six months and twelve months | 
| Self-efficacy assessed by the Dutch general self-efficacy scale | Dutch general self-efficacy scale (range 10-40), a higher scores mean a more positive self-efficacy | baseline, three months, six months and twelve months | 
| Mental status: self-rating happiness | Single-item on a 7-point Likert scale | baseline, three months, six months and twelve months | 
| Mental status: self rated health | Single- item on a 5-point scale | baseline, three months, six months and twelve months | 
| Mental status: dispositional optimism | Life Orientation Test-Revised (LOT-R) 10-item questionnaire. The LOT-R sum score that ranges from 0 to 24, with higher scores indicating greater optimism. | baseline, three months, six months and twelve months | 
| Mental status: anxiety and depression symptoms | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item depression module. The total score ranges from 0 to 27, with higher scores indicating higher severity of depressive symptoms | baseline, three months, six months and twelve months | 
| Mental status: depression symptoms | The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale with a score ranging from 0 to 21. Higher scores indicating higher severity of anxiety or depressive symptoms. | baseline, three months, six months and twelve months | 
| Evaluation from an economic perspective: quality of life | EuroQol- 5 Dimension questionnaire, the iMedical Consumption Questionnaire and the iProductivity Cost Questionnaire. | baseline, three months, six months and twelve months | 
| Evaluation from an economic perspective: productivity costs | The iProductivity Cost Questionnaire. | baseline, three months, six months and twelve months | 
| Evaluation from an economic perspective: medical consumption | The iMedical Consumption Questionnaire | baseline, three months, six months and twelve months | 
| Medication use | iMedical Consumption Questionnaire. | baseline, three months, six months and twelve months | 
| Sleep quality assessed by the Pittsburgh sleep quality index (PSQI) | The PSQI ranges from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. | baseline, three months, six months and twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Intervention study, nutrition, dietary guidelines, dietitian, cardiovascular diseases, tertiary prevention, SMART Risk Score