Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- 24-hour urine sodium excretion
研究概览
简要总结
Sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. Dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for CVD-related mortality. From recent national survey, Thai people had consumed more than 9.1 g of salt per day, which was nearly two times above WHO reference level. Dietary salt reduction was unsuccessful because of lacking awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. To create awareness in the community, we should be educated, managed the environmental for salt reduction, and used salt meter to detect sodium content in daily food. This study aimed to compare the efficacy of intervention; education, reformulation, environmental change and used salt meter compared with standard treatment alone in terms of salt intake reduction and blood pressure.
详细描述
A randomized-controlled trial was conducted in adult 18-70 years old with hypertensive patients (SBP>130 mmHg) in Uthaithani. Participants were randomized to intervention groups (education, reformulation, environmental change and used salt meter) and control group (standard education and treatment). Trial was followed up for 12 weeks. The primary objective was change in 24-hour urinary sodium excretion between groups and secondary objectives was change in systolic and diastolic blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-70 years of age with hypertension
- •Systolic blood pressure > 130 mmHg
- •Provided informed consent to participate in the study
排除标准
- •Participants with end stage kidney disease
- •History of adjust antihypertensive agents or diuretic within 2 weeks before enrollment
- •Pregnant or breastfeeding women
- •Adjustment of any antihypertensive agents during study period
- •Participants with salt supplement
结局指标
主要结局
24-hour urine sodium excretion
时间窗: 12 weeks
Compare the change of 24-hour urine sodium excretion between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment
次要结局
- blood pressure(4, 8 12 weeks)