Dietary Intervention to Improve Health of Cardiovascular Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Second manifestations of arterial disease (SMART) Risk Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Second manifestations of arterial disease (SMART) Risk Score
时间窗: baseline till six months
Estimate for 10-year risk for recurrent vascular events (range 0-100%), higher scores mean a worse outcome
次要结局
- Inflammation marker(baseline, three months, six months and twelve months)
- Anthropometrics - body weight(baseline, three months, six months and twelve months)
- Evaluation from an economic perspective: productivity costs(baseline, three months, six months and twelve months)
- Cardiovascular parameters(baseline, three months, six months and twelve months)
- Anthropometrics -waist circumference(baseline, three months, six months and twelve months)
- Self-reported quality of life(baseline, three months, six months and twelve months)
- Mental status: depression symptoms(baseline, three months, six months and twelve months)
- 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)
- Diet quality assessed by the Dutch Helathy Diet Index 2015 score (Eetscore-FFQ)(baseline, three months, six months and twelve months)
- Renal function(baseline, three months, six months and twelve months)
- Self-efficacy assessed by the Dutch general self-efficacy scale(baseline, three months, six months and twelve months)
- Mental status: self-rating happiness(baseline, three months, six months and twelve months)
- Mental status: dispositional optimism(baseline, three months, six months and twelve months)
- Salt intake(baseline, six months)
- Vitamin status(baseline, six months)
- Anthropometric - body height(baseline, three months, six months and twelve months)
- Mental status: self rated health(baseline, three months, six months and twelve months)
- Evaluation from an economic perspective: medical consumption(baseline, three months, six months and twelve months)
- Sleep quality assessed by the Pittsburgh sleep quality index (PSQI)(baseline, three months, six months and twelve months)
- Evaluation from an economic perspective: quality of life(baseline, three months, six months and twelve months)
- Mental status: anxiety and depression symptoms(baseline, three months, six months and twelve months)
- Medication use(baseline, three months, six months and twelve months)
研究者
Renate Winkels
Renate Winkels
Wageningen University