Dietary Intervention to Improve Health of Cardiovascular Patients

Cardiovascular Diseases Clinical Trial

Official title:

Dietary Intervention to Improve Health of Cardiovascular Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071092
• Other study ID #: NL73021.091.20
• Status: Completed
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: February 5, 2024

Study information

• Verified date: February 2024
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Johanna M. Geleijnse, PhD	Wageningen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Gelderse Vallei Hospital, Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

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