Dietary Intervention to Improve Health of Cardiovascular Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Wageningen University
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Second manifestations of arterial disease (SMART) Risk Score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Renate Winkels
Renate Winkels
Wageningen University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Second manifestations of arterial disease (SMART) Risk Score
Time Frame: baseline till six months
Estimate for 10-year risk for recurrent vascular events (range 0-100%), higher scores mean a worse outcome
Secondary Outcomes
- Inflammation marker(baseline, three months, six months and twelve months)
- Anthropometrics - body weight(baseline, three months, six months and twelve months)
- Evaluation from an economic perspective: productivity costs(baseline, three months, six months and twelve months)
- Cardiovascular parameters(baseline, three months, six months and twelve months)
- Anthropometrics -waist circumference(baseline, three months, six months and twelve months)
- Self-reported quality of life(baseline, three months, six months and twelve months)
- Mental status: depression symptoms(baseline, three months, six months and twelve months)
- Second manifestations of arterial disease (SMART) Risk Score(baseline till three months, baseline till twelve months)
- Systolic and diastolic blood pressure(baseline, three months, six months and twelve months)
- Diabetic parameters(baseline, three months, six months and twelve months)
- Diet quality assessed by the Dutch Helathy Diet Index 2015 score (Eetscore-FFQ)(baseline, three months, six months and twelve months)
- Renal function(baseline, three months, six months and twelve months)
- Self-efficacy assessed by the Dutch general self-efficacy scale(baseline, three months, six months and twelve months)
- Mental status: self-rating happiness(baseline, three months, six months and twelve months)
- Mental status: dispositional optimism(baseline, three months, six months and twelve months)
- Salt intake(baseline, six months)
- Vitamin status(baseline, six months)
- Anthropometric - body height(baseline, three months, six months and twelve months)
- Mental status: self rated health(baseline, three months, six months and twelve months)
- Evaluation from an economic perspective: medical consumption(baseline, three months, six months and twelve months)
- Sleep quality assessed by the Pittsburgh sleep quality index (PSQI)(baseline, three months, six months and twelve months)
- Evaluation from an economic perspective: quality of life(baseline, three months, six months and twelve months)
- Mental status: anxiety and depression symptoms(baseline, three months, six months and twelve months)
- Medication use(baseline, three months, six months and twelve months)