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Completed

NCT Number: NCT05071092

Dietary Intervention to Improve Health of Cardiovascular Patients

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.

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Key information

Conditions

Cardiovascular Diseases Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johanna M. Geleijnse, PhD

Wageningen, Gelderland, 6708 PD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary counselling

Behavioral

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.

Primary outcomes

  1. 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

  1. Second manifestations of arterial disease (SMART) Risk Score

    Time frame: 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

  2. Systolic and diastolic blood pressure

    Time frame: 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.

  3. Diabetic parameters

    Time frame: baseline, three months, six months and twelve months

    Insulin and glucose in mmol/L

  4. Cardiovascular parameters

    Time frame: baseline, three months, six months and twelve months

    Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L

  5. Inflammation marker

    Time frame: baseline, three months, six months and twelve months

    HsCRP mg/l

  6. Diet quality assessed by the Dutch Helathy Diet Index 2015 score (Eetscore-FFQ)

    Time frame: 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.

  7. Salt intake

    Time frame: baseline, six months

    24-hour urinary sodium excretions.

  8. Vitamin status

    Time frame: baseline, six months

    Serum vitamin B6, B12, folate and vitamin D.

  9. Renal function

    Time frame: baseline, three months, six months and twelve months

    eGFR and albumin/creatinine ratio.

  10. Anthropometrics - body weight

    Time frame: 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)

  11. Anthropometric - body height

    Time frame: baseline, three months, six months and twelve months

    Height (in meters; weight and height will be combined to report BMI in kg/m^2)

  12. Anthropometrics -waist circumference

    Time frame: baseline, three months, six months and twelve months

    Waist circumference (in centimeters)

  13. Self-reported quality of life

    Time frame: baseline, three months, six months and twelve months

    36-Item Short Form Health Survey questionnaire, a high score defines a more favorable health state.

  14. Self-efficacy assessed by the Dutch general self-efficacy scale

    Time frame: 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

  15. Mental status: self-rating happiness

    Time frame: baseline, three months, six months and twelve months

    Single-item on a 7-point Likert scale

  16. Mental status: self rated health

    Time frame: baseline, three months, six months and twelve months

    Single- item on a 5-point scale

  17. Mental status: dispositional optimism

    Time frame: 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.

  18. Mental status: anxiety and depression symptoms

    Time frame: 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

  19. Mental status: depression symptoms

    Time frame: 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.

  20. Evaluation from an economic perspective: quality of life

    Time frame: baseline, three months, six months and twelve months

    EuroQol- 5 Dimension questionnaire, the iMedical Consumption Questionnaire and the iProductivity Cost Questionnaire.

  21. Evaluation from an economic perspective: productivity costs

    Time frame: baseline, three months, six months and twelve months

    The iProductivity Cost Questionnaire.

  22. Evaluation from an economic perspective: medical consumption

    Time frame: baseline, three months, six months and twelve months

    The iMedical Consumption Questionnaire

  23. Medication use

    Time frame: baseline, three months, six months and twelve months

    iMedical Consumption Questionnaire.

  24. Sleep quality assessed by the Pittsburgh sleep quality index (PSQI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Gelderse Vallei Hospital
  • Rijnstate Hospital

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2021
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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