NCT05071092

Dietary Intervention to Improve Health of Cardiovascular Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Wageningen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-28
• Primary completion: 2024-02-05
• Completion: 2024-02-05
• First posted: 2021-10-07
• Last updated: 2025-04-11

Locations

1 site across 1 country: Netherlands