Dietary Intervention to Improve Health of Cardiovascular Patients
- Conditions
- Cardiovascular DiseasesHeart DiseasesVascular Diseases
- Interventions
- Behavioral: Dietary counselling
- Registration Number
- NCT05071092
- Lead Sponsor
- Wageningen University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Dietary counselling The intervention will consist of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines.
- Primary Outcome Measures
Name Time Method Second manifestations of arterial disease (SMART) Risk Score baseline till six months Estimate for 10-year risk for recurrent vascular events (range 0-100%), higher scores mean a worse outcome
- Secondary Outcome Measures
Name Time Method Inflammation marker baseline, three months, six months and twelve months HsCRP mg/l
Anthropometrics - body weight baseline, three months, six months and twelve months Body weight (in kilograms; weight and height will be combined to report BMI in kg/m\^2)
Evaluation from an economic perspective: productivity costs baseline, three months, six months and twelve months The iProductivity Cost Questionnaire.
Cardiovascular parameters baseline, three months, six months and twelve months Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L
Anthropometrics -waist circumference baseline, three months, six months and twelve months Waist circumference (in centimeters)
Self-reported quality of life baseline, three months, six months and twelve months 36-Item Short Form Health Survey questionnaire, a high score defines a more favorable health state.
Mental status: depression symptoms baseline, three months, six months and twelve months 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.
Second manifestations of arterial disease (SMART) Risk Score baseline till three months, baseline till twelve months Estimate for 10-year risk for recurrent vascular events (range 0-100%), higher scores mean a worse outcome
Systolic and diastolic blood pressure baseline, three months, six months and twelve months 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.
Diabetic parameters baseline, three months, six months and twelve months Insulin and glucose in mmol/L
Diet quality assessed by the Dutch Helathy Diet Index 2015 score (Eetscore-FFQ) baseline, three months, six months and twelve months Dutch Healthy Diet Index 2015 score (range 0-160 points, higher scores mean better outcome), assessed by a short Food Frequency Questionnaire.
Renal function baseline, three months, six months and twelve months eGFR and albumin/creatinine ratio.
Self-efficacy assessed by the Dutch general self-efficacy scale baseline, three months, six months and twelve months Dutch general self-efficacy scale (range 10-40), a higher scores mean a more positive self-efficacy
Mental status: self-rating happiness baseline, three months, six months and twelve months Single-item on a 7-point Likert scale
Mental status: dispositional optimism baseline, three months, six months and twelve months 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.
Salt intake baseline, six months 24-hour urinary sodium excretions.
Vitamin status baseline, six months Serum vitamin B6, B12, folate and vitamin D.
Anthropometric - body height baseline, three months, six months and twelve months Height (in meters; weight and height will be combined to report BMI in kg/m\^2)
Mental status: self rated health baseline, three months, six months and twelve months Single- item on a 5-point scale
Evaluation from an economic perspective: medical consumption baseline, three months, six months and twelve months The iMedical Consumption Questionnaire
Sleep quality assessed by the Pittsburgh sleep quality index (PSQI) baseline, three months, six months and twelve months 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.
Evaluation from an economic perspective: quality of life baseline, three months, six months and twelve months EuroQol- 5 Dimension questionnaire, the iMedical Consumption Questionnaire and the iProductivity Cost Questionnaire.
Mental status: anxiety and depression symptoms baseline, three months, six months and twelve months 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
Medication use baseline, three months, six months and twelve months iMedical Consumption Questionnaire.
Trial Locations
- Locations (1)
Johanna M. Geleijnse, PhD
🇳🇱Wageningen, Gelderland, Netherlands