Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,376
- 试验地点
- 1
- 主要终点
- Systolic/diastolic blood pressure (mmHg)
研究概览
简要总结
This protocol aims to implement, using a stepped wedge trial design, a population-level intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban area of Tumbes.
We hypothesize that participants aged 18 years and over from villages receiving a salt substitute will have lower blood pressure compared to control villages.
详细描述
Several randomized clinical trials and meta-analysis have reported that reduction of sodium intake decreases blood pressure. Also, the increase of potassium ingestion in minimal doses has been found in systematic reviews to produce a small reduction in blood pressure levels.
The proposed intervention is a community-wide mass-strategy in which direct delivery of a salt substitute to households is accompanied by wide social marketing campaigns, both before and during the intervention period. With this experimental stepped wedge trial design, we will estimate the impact of a reduced-sodium salt substitution program on blood pressure at the population level.
We propose the following specific aims:
Specific Aim 1: To implement and assess the impact of an intervention using a salt substitute on blood pressure at the population level using a stepped wedge trial design.
Specific Aim 2: To determine costs and efficacy of this implementation strategy using cost-effectiveness analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females aged 18 years and over from the randomly selected villages.
- •Capable of understanding study procedures and providing informed consent.
- •Full-time resident in the area.
排除标准
- •Self-reported history of chronic kidney disease or heart disease.
- •Refusal to participate.
结局指标
主要结局
Systolic/diastolic blood pressure (mmHg)
时间窗: Three years
We will assess changes in systolic and diastolic blood pressure over time. Periodic assessments will be carried out to obtain clinical measurements. Every five months, a new evaluation will be performed in all participant villages (intervention and control). Systolic and diastolic blood pressure will be measured in triplicate using standard procedures and automated and validated devices. These periodic assessments will be taken at each household to guarantee contact with each family member enrolled in this study.
次要结局
- Progression to hypertension(Three years)
研究者
Jaime Miranda
Research Professor
Universidad Peruana Cayetano Heredia