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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Vascular Diseases
• Intervention / Treatment: Behavioral: Dietary counselling

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: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna M. Geleijnse, PhD; Phone Number: +31317482574; Email: marianne.geleijnse@wur.nl
• Study Contact Backup: Name: Ilse Evers, MSc; Email: ilse.evers@wur.nl

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	baseline till six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	baseline, three months, six months and twelve months
Diabetic parameters	Insulin and glucose in mmol/L	baseline, three months, six months and twelve months
Cardiovascular parameters	Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mmol/L	baseline, three months, six months and twelve months
Inflammation marker	HsCRP mg/l	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.	baseline, three months, six months and twelve months
Salt intake	24-hour urinary sodium excretions.	baseline, six months
Vitamin status	Serum vitamin B6, B12, folate and vitamin D.	baseline, six months
Renal function	eGFR and albumin/creatinine ratio.	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.	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	baseline, three months, six months and twelve months
Mental status: self-rating happiness	Single-item on a 7-point Likert scale	baseline, three months, six months and twelve months
Mental status: self rated health	Single- item on a 5-point scale	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.	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	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.	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.	baseline, three months, six months and twelve months
Evaluation from an economic perspective: productivity costs	The iProductivity Cost Questionnaire.	baseline, three months, six months and twelve months
Evaluation from an economic perspective: medical consumption	The iMedical Consumption Questionnaire	baseline, three months, six months and twelve months
Medication use	iMedical Consumption Questionnaire.	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.	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)	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)	baseline, three months, six months and twelve months
Anthropometrics -waist circumference	Waist circumference (in centimeters)	baseline, three months, six months and twelve months

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Rijnstate Hospital; Gelderse Vallei Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: nutrition; cardiovascular diseases; RCT; dietitian; Intervention study; dietary guidelines; tertiary prevention; SMART Risk Score
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases
• Other Study ID 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