ChiCTR-TRC-13003014已完成1 期
The effectiveness of Dietary Approaches to Stop Hypertension (DASH) counselling on cardiovascular risk among patients with newly diagnosed grade 1 hypertension: a randomised clinical trial
Health and Health Services Research Fund, Food and Health Bureau, Hong Kong1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in BP and CV risk
研究概览
简要总结
To compare the effects of counselling of the DASH diet by dieticians in addition to usual care given by physicians and usual care by physicians alone on lowering blood pressure (BP) and cardiovascular risk (CV) among stage I hypertensive patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 40 至 70（—）
- 性别
- All
入选标准
- •(1) aged between 40 to 70 years;
- •(2) newly diagnosed as having stage one hypertension (SBP 140-159 and/or 90-99 mmHg) as defined by the seventh report of the Joint National Committee based on the results of blood pressure readings in two separate clinic visits;
- •(3) currently not on any antihypertensive medications.
排除标准
- •Unwillingness or inability to modify current diet;
- •Alcoholic beverage intake > 14 drinks/week;
- •Use of food supplements that cannot be discontinued;
- •Current use of antihypertensive drugs or blood pressure-modifying medications that cannot be discontinued;
- •Cardiovascular disease event within the past 6 months;
- •Body mass index > 35 kg/m2;
- •Impaired fasting glucose or diabetes;
- •History of hypercalcemia or hyperkalemia;
- •Renal insufficiency;
- •Active malignancy or cancer therapy within the past 6 months;
- •Inflammatory bowel disease, malabsorption, hepatitis;
- •Other chronic disease thought to interfere with the effect of the diet or with participation;
- •Use of antacids containing magnesium or calcium, insulin, oral corticosteroids, lithium, unstable doses of psychotropics, bile acid sequestering resins, oral antiasthmatics, digitalis, or phenytoin;
- •Dyslipidemia (Total cholesterol > 6.2 mmol/l, Triglyceride > 2.3 mmol/l, LDL-cholesterol: > 4.0 mmol/l);
- •Poor compliance during screening.
研究组 & 干预措施
Two groups
Health Education
结局指标
主要结局
Change in BP and CV risk
次要结局
- BMI and lipid profiles
- Factors associated with non-optimisation of CV risk
研究者
研究点 (1)
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