Household-Oriented Salt Substitution for CoMprehensive Hypertension PrEvention and Control: A Cluster-Randomized, Double-Blind Controlled Trial (HOME-Salt Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Failure of Hypertension Prevention or Control
研究概览
简要总结
Hypertension is a major risk factor for cardiovascular disease. Excess sodium intake and insufficient potassium intake contribute to elevated blood pressure, while replacing regular salt with a potassium-enriched salt substitute may help lower blood pressure. Because cooking salt is commonly shared within households, a household-based salt substitution strategy may provide benefits not only for people with hypertension but also for family members who have not yet developed hypertension.
The HOME-Salt Trial is a cluster-randomized, double-blind controlled trial designed to evaluate the effects of household salt substitution on hypertension prevention and control. Eligible households will include at least one adult with diagnosed hypertension and at least one adult without hypertension at baseline. Households will be randomly assigned in a 1:1 ratio to receive either a low-sodium salt substitute or regular salt for 12 months.
Approximately 400 households, including at least 800 adults, will be enrolled. Participants, field staff, and outcome assessors will be unaware of treatment assignment. Follow-up assessments will be conducted at 3, 6, and 12 months. The study will evaluate whether household use of low-sodium salt improves blood pressure control among adults with hypertension and reduces the development of hypertension among adults without hypertension at baseline. Blood pressure, medication use, sodium and potassium intake indicators, safety outcomes, and other health-related measures will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Household-level criteria:
- •The household includes at least one adult aged 18 years or older with diagnosed hypertension.
- •The household includes at least one adult aged 18 years or older without hypertension at baseline.
- •Household members primarily share cooking and meals. All adult household members intended to be included in study evaluations provide written informed consent.
- •Participant-level criteria: Aged 18 years or older. Long-term resident of the study area with no plan to move away during the following 12 months.
- •Consumes most meals at home. Provides written informed consent.
排除标准
- •Household-level criteria:
- •The household is currently using low-sodium salt or another potassium-containing salt substitute on a long-term basis.
- •Any household member who routinely shares meals has a contraindication to potassium-enriched salt or is at increased risk of hyperkalemia, including chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m², a history of dialysis, or a history of hyperkalemia.
- •Any household member who routinely shares meals is pregnant. Any household member who routinely shares meals has hyperthyroidism.
- •Participant-level criteria: Currently participating in another interventional study that may affect blood pressure, sodium or potassium intake, or study outcomes.
- •Serious cardiovascular or cerebrovascular disease, severe liver disease, malignant tumor, severe mental illness, cognitive impairment, or another condition considered unsuitable for study participation.
- •Unable to complete follow-up visits, standardized blood pressure measurements, or required data collection.
- •Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.
研究组 & 干预措施
Low-Sodium Salt Group
干预措施: Low-Sodium Salt Substitute (Dietary Supplement)
Regular Salt Group
干预措施: Regular Salt (Dietary Supplement)
结局指标
主要结局
Proportion of Participants With Failure of Hypertension Prevention or Control
时间窗: From randomization to Month 12
A participant-level composite outcome. For participants with hypertension at baseline, failure of hypertension control is defined as a mean systolic blood pressure (SBP) ≥140 mmHg and/or mean diastolic blood pressure (DBP) ≥90 mmHg based on three standardized office blood pressure measurements at Month 12. For participants without hypertension at baseline, failure of hypertension prevention is defined as incident hypertension during follow-up, including a mean SBP ≥140 mmHg and/or mean DBP ≥90 mmHg based on three standardized office measurements, a new diagnosis of hypertension, or initiation of antihypertensive medication.
次要结局
- Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12(Month 12)
- Change in Systolic Blood Pressure Among Participants With Hypertension(Baseline to Month 12)
- Change in Diastolic Blood Pressure Among Participants With Hypertension(Baseline to Month 12)
- Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up(Months 3, 6, and 12)
- Incidence of Hypertension Among Participants Without Hypertension at Baseline(From randomization to Month 12)
- Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline(Baseline to Month 12)
- Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline(Baseline to Month 12)
- Proportion of Households With Successful Hypertension Prevention and Control(From randomization to Month 12)
研究者
Xianghui Zhang
Associate Professor
Shihezi University