Cardiovascular DiseasesNCT05071092
Dietary Intervention to Improve Health of Cardiovascular Patients
A study testing Dietary counselling in people with Cardiovascular Diseases and Heart Diseases, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Vascular Diseases
- What is being tested?
- Dietary counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 May 2021to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Johanna M. Geleijnse, PhD
Wageningen, Gelderland, 6708 PD
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Vascular Diseases
- Being tested
- Dietary counselling
- Keywords
- Intervention study, RCT, nutrition, dietary guidelines, dietitian, cardiovascular diseases, tertiary prevention, SMART Risk Score
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary counsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention will consist of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines. Receives: Behavioral: Dietary counselling |
| Usual care group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline till six months
Secondary outcomes (24)
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
Measured: 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.
Measured: baseline, three months, six months and twelve months
Diabetic parameters
Insulin and glucose in mmol/L
Measured: baseline, three months, six months and twelve months
Cardiovascular parameters
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L
Measured: baseline, three months, six months and twelve months
Inflammation marker
HsCRP mg/l
Measured: 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.
Measured: baseline, three months, six months and twelve months
Salt intake
24-hour urinary sodium excretions.
Measured: baseline, six months
Vitamin status
Serum vitamin B6, B12, folate and vitamin D.
Measured: baseline, six months
Renal function
eGFR and albumin/creatinine ratio.
Measured: 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)
Measured: 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)
Measured: baseline, three months, six months and twelve months
Anthropometrics -waist circumference
Waist circumference (in centimeters)
Measured: 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.
Measured: 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
Measured: baseline, three months, six months and twelve months
Mental status: self-rating happiness
Single-item on a 7-point Likert scale
Measured: baseline, three months, six months and twelve months
Mental status: self rated health
Single- item on a 5-point scale
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline, three months, six months and twelve months
Evaluation from an economic perspective: productivity costs
The iProductivity Cost Questionnaire.
Measured: baseline, three months, six months and twelve months
Evaluation from an economic perspective: medical consumption
The iMedical Consumption Questionnaire
Measured: baseline, three months, six months and twelve months
Medication use
iMedical Consumption Questionnaire.
Measured: 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.
Measured: baseline, three months, six months and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start28 May 2021
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Rijnstate Hospital
- Responsible party
- Principal investigator, Renate Winkels, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071092
- Sponsor's protocol ID
- NL73021.091.20
- Status last verified
- Apr 2025
- First submitted
- 27 Aug 2021
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Damme I, van Veldhuisen ER, Verkaar AJCF, Bemelmans RHH, Hovens MMC, Visseren FLJ, Koopal C, Winkels RM, Geleijnse JM. The effects of 6 months dietary counseling on diet quality and cardiovascular risk profile in patients with cardiovascular disease: A randomized controlled trial. Clin Nutr. 2025 Feb;45:101-110. doi: 10.1016/j.clnu.2024.12.020. Epub 2024 Dec 26.
PubMed 39798221
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention to Improve Health of Cardiovascular Patients
- ClinicalTrials.gov ID
- NCT05071092
- Acronym / sponsor ID
- NL73021.091.20
- Conditions
- Cardiovascular Diseases, Heart Diseases, Vascular Diseases
- Keywords
- Intervention study, RCT, nutrition, dietary guidelines, dietitian, cardiovascular diseases, tertiary prevention, SMART Risk Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Rijnstate Hospital
- Study start
- 28 May 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Dietary counsellingThe intervention will consist of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines. |
| Usual care group | No intervention | –The usual care group will not receive any special guidance regarding healthy nutrition, but will have access to their care team as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary counsellingParticipants 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. | Behavioural | Intervention group |
Primary outcome
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
24 secondary outcomes
Second manifestations of arterial disease (SMART) Risk Score
Time frame: baseline till three months, baseline till twelve months
Systolic and diastolic blood pressure
Time frame: baseline, three months, six months and twelve months
Diabetic parameters
Time frame: baseline, three months, six months and twelve months
Cardiovascular parameters
Time frame: baseline, three months, six months and twelve months
Inflammation marker
Time frame: baseline, three months, six months and twelve months
Diet quality assessed by the Dutch Helathy Diet Index 2015 score (Eetscore-FFQ)
Time frame: baseline, three months, six months and twelve months
Salt intake
Time frame: baseline, six months
Vitamin status
Time frame: baseline, six months
Renal function
Time frame: baseline, three months, six months and twelve months
Anthropometrics - body weight
Time frame: baseline, three months, six months and twelve months
Anthropometric - body height
Time frame: baseline, three months, six months and twelve months
Anthropometrics -waist circumference
Time frame: baseline, three months, six months and twelve months
Self-reported quality of life
Time frame: baseline, three months, six months and twelve months
Self-efficacy assessed by the Dutch general self-efficacy scale
Time frame: baseline, three months, six months and twelve months
Mental status: self-rating happiness
Time frame: baseline, three months, six months and twelve months
Mental status: self rated health
Time frame: baseline, three months, six months and twelve months
Mental status: dispositional optimism
Time frame: baseline, three months, six months and twelve months
Mental status: anxiety and depression symptoms
Time frame: baseline, three months, six months and twelve months
Mental status: depression symptoms
Time frame: baseline, three months, six months and twelve months
Evaluation from an economic perspective: quality of life
Time frame: baseline, three months, six months and twelve months
Evaluation from an economic perspective: productivity costs
Time frame: baseline, three months, six months and twelve months
Evaluation from an economic perspective: medical consumption
Time frame: baseline, three months, six months and twelve months
Medication use
Time frame: baseline, three months, six months and twelve months
Sleep quality assessed by the Pittsburgh sleep quality index (PSQI)
Time frame: baseline, three months, six months and twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 39798221van Damme I, van Veldhuisen ER, Verkaar AJCF, Bemelmans RHH, Hovens MMC, Visseren FLJ, Koopal C, Winkels RM, Geleijnse JM. The effects of 6 months dietary counseling on diet quality and cardiovascular risk profile in patients with cardiovascular disease: A randomized controlled trial. Clin Nutr. 2025 Feb;45:101-110. doi: 10.1016/j.clnu.2024.12.020. Epub 2024 Dec 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary counselling in people with Cardiovascular Diseases and Heart Diseases, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Second manifestations of arterial disease (SMART) Risk Score (time frame: baseline till six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.