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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
124
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.
Johanna M. Geleijnse, PhD
Wageningen, Gelderland, Netherlands
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
Time frame: baseline till six months
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
Time frame: 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.
Time frame: baseline, three months, six months and twelve months
Diabetic parameters
Insulin and glucose in mmol/L
Time frame: baseline, three months, six months and twelve months
Cardiovascular parameters
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L
Time frame: baseline, three months, six months and twelve months
Inflammation marker
HsCRP mg/l
Time frame: 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.
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Time frame: baseline, three months, six months and twelve months
Salt intake
24-hour urinary sodium excretions.
Time frame: baseline, six months
Vitamin status
Serum vitamin B6, B12, folate and vitamin D.
Time frame: baseline, six months
Renal function
eGFR and albumin/creatinine ratio.
Time frame: 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)
Time frame: 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)
Time frame: baseline, three months, six months and twelve months
Anthropometrics -waist circumference
Waist circumference (in centimeters)
Time frame: 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.
Time frame: 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
Time frame: baseline, three months, six months and twelve months
Mental status: self-rating happiness
Single-item on a 7-point Likert scale
Time frame: baseline, three months, six months and twelve months
Mental status: self rated health
Single- item on a 5-point scale
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline, three months, six months and twelve months
Evaluation from an economic perspective: productivity costs
The iProductivity Cost Questionnaire.
Time frame: baseline, three months, six months and twelve months
Evaluation from an economic perspective: medical consumption
The iMedical Consumption Questionnaire
Time frame: baseline, three months, six months and twelve months
Medication use
iMedical Consumption Questionnaire.
Time frame: 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.
Time frame: baseline, three months, six months and twelve months