Clinical trial NCT05071092: Dietary Intervention to Improve Health of Cardiovascular Patients
Official title: Dietary Intervention to Improve Health of Cardiovascular Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Keywords: Intervention study
RCT
nutrition
dietary guidelines
dietitian
cardiovascular diseases
tertiary prevention
SMART Risk Score
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Gelderse Vallei Hospital
name: Rijnstate Hospital
First posted: 2021-10-07
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Second manifestations of arterial disease (SMART) Risk Score
timeFrame: baseline till six months
Secondary outcomes:
measure: Second manifestations of arterial disease (SMART) Risk Score
timeFrame: baseline till three months, baseline till twelve months
measure: Systolic and diastolic blood pressure
timeFrame: baseline, three months, six months and twelve months
measure: Diabetic parameters
timeFrame: baseline, three months, six months and twelve months
measure: Cardiovascular parameters
timeFrame: baseline, three months, six months and twelve months
measure: Inflammation marker
timeFrame: baseline, three months, six months and twelve months
measure: Diet quality assessed by the Dutch Helathy Diet Index 2015 score (Eetscore-FFQ)
timeFrame: baseline, three months, six months and twelve months
measure: Salt intake
timeFrame: baseline, six months
measure: Vitamin status
timeFrame: baseline, six months
measure: Renal function
timeFrame: baseline, three months, six months and twelve months
measure: Anthropometrics - body weight
timeFrame: baseline, three months, six months and twelve months
measure: Anthropometric - body height
timeFrame: baseline, three months, six months and twelve months
measure: Anthropometrics -waist circumference
timeFrame: baseline, three months, six months and twelve months
measure: Self-reported quality of life
timeFrame: baseline, three months, six months and twelve months
measure: Self-efficacy assessed by the Dutch general self-efficacy scale
timeFrame: baseline, three months, six months and twelve months
measure: Mental status: self-rating happiness
timeFrame: baseline, three months, six months and twelve months
measure: Mental status: self rated health
timeFrame: baseline, three months, six months and twelve months
measure: Mental status: dispositional optimism
timeFrame: baseline, three months, six months and twelve months
measure: Mental status: anxiety and depression symptoms
timeFrame: baseline, three months, six months and twelve months
measure: Mental status: depression symptoms
timeFrame: baseline, three months, six months and twelve months
measure: Evaluation from an economic perspective: quality of life
timeFrame: baseline, three months, six months and twelve months
measure: Evaluation from an economic perspective: productivity costs
timeFrame: baseline, three months, six months and twelve months
measure: Evaluation from an economic perspective: medical consumption
timeFrame: baseline, three months, six months and twelve months
measure: Medication use
timeFrame: baseline, three months, six months and twelve months
measure: Sleep quality assessed by the Pittsburgh sleep quality index (PSQI)
timeFrame: baseline, three months, six months and twelve months
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Johanna M. Geleijnse, PhD
state: Gelderland
Study officials:
References: