Dietary Intervention to Improve Health of Cardiovascular Patients

NCT05071092 | Completed DMC

• 1 other identifier: NL73021.091.20
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Heart Diseases; Vascular Diseases

Keywords

Intervention study; RCT; nutrition; dietary guidelines; dietitian; cardiovascular diseases; tertiary prevention; SMART Risk Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Second manifestations of arterial disease (SMART) Risk Score

  baseline till three months, baseline till twelve months

• Systolic and diastolic blood pressure

  baseline, three months, six months and twelve months

• Diabetic parameters

  baseline, three months, six months and twelve months

• Cardiovascular parameters

  baseline, three months, six months and twelve months

• Inflammation marker

  baseline, three months, six months and twelve months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention will consist of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines.

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Gelderse Vallei Hospital: collaborator
• Rijnstate Hospital: collaborator

Study Sites (1)

Johanna M. Geleijnse, PhD

Wageningen, Gelderland, 6708 PD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39798221 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The nature of the intervention does not allow for blinding of the participants or researchers. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Renate Winkels

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: October 7, 2021
• Study Start: May 28, 2021
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

NL (1)