Dietary Intervention to Improve Health of Cardiovascular Patients

April 8, 2025 updated by: Renate Winkels, Wageningen University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6708 PD
        • Johanna M. Geleijnse, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
The intervention will consist of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines.
Behavioral: Dietary counselling
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.
No Intervention: Usual care group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline till six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline till three months, baseline till twelve months
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.
baseline, three months, six months and twelve months
Diabetic parameters
Time Frame: baseline, three months, six months and twelve months
Insulin and glucose in mmol/L
baseline, three months, six months and twelve months
Cardiovascular parameters
Time Frame: baseline, three months, six months and twelve months
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L
baseline, three months, six months and twelve months
Inflammation marker
Time Frame: baseline, three months, six months and twelve months
HsCRP mg/l
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
Dutch Healthy Diet Index 2015 score (range 0-160 points, higher scores mean better outcome), assessed by a short Food Frequency Questionnaire.
baseline, three months, six months and twelve months
Salt intake
Time Frame: baseline, six months
24-hour urinary sodium excretions.
baseline, six months
Vitamin status
Time Frame: baseline, six months
Serum vitamin B6, B12, folate and vitamin D.
baseline, six months
Renal function
Time Frame: baseline, three months, six months and twelve months
eGFR and albumin/creatinine ratio.
baseline, three months, six months and twelve months
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.
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
Dutch general self-efficacy scale (range 10-40), a higher scores mean a more positive self-efficacy
baseline, three months, six months and twelve months
Mental status: self-rating happiness
Time Frame: baseline, three months, six months and twelve months
Single-item on a 7-point Likert scale
baseline, three months, six months and twelve months
Mental status: self rated health
Time Frame: baseline, three months, six months and twelve months
Single- item on a 5-point scale
baseline, three months, six months and twelve months
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.
baseline, three months, six months and twelve months
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
baseline, three months, six months and twelve months
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.
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
EuroQol- 5 Dimension questionnaire, the iMedical Consumption Questionnaire and the iProductivity Cost Questionnaire.
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
The iProductivity Cost Questionnaire.
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
The iMedical Consumption Questionnaire
baseline, three months, six months and twelve months
Medication use
Time Frame: baseline, three months, six months and twelve months
iMedical Consumption Questionnaire.
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
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.
baseline, three months, six months and twelve months
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)
baseline, three months, six months and twelve months
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)
baseline, three months, six months and twelve months
Anthropometrics -waist circumference
Time Frame: baseline, three months, six months and twelve months
Waist circumference (in centimeters)
baseline, three months, six months and twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wageningen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rijnstate Hospital
Gelderse Vallei Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL73021.091.20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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