Household Salt Substitution for Hypertension Prevention and Control: The HOME-Salt Trial (HOME-Salt)
Household-Oriented Salt Substitution for CoMprehensive Hypertension PrEvention and Control: A Cluster-Randomized, Double-Blind Controlled Trial (HOME-Salt Trial)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xianghui Zhang, PhD
- 전화번호: +8618999335467
- 이메일: zxh818@shzu.edu.cn
연구 장소
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Xinjiang
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Shihezi, Xinjiang, 중국, 832000
- Shihezi City People's Hospital
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연락하다:
- Qiang Zhang, Master
- 전화번호: +8613899513431
- 이메일: zhqiang120@126.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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.
Exclusion Criteria:
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Low-Sodium Salt Group
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Low-sodium salt containing approximately 75% sodium chloride and 25% potassium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period. |
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활성 비교기: Regular Salt Group
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Regular salt containing approximately 99.8% sodium chloride. It will replace the household's usual cooking and table salt throughout the 12-month intervention period. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants With Failure of Hypertension Prevention or Control
기간: From randomization to Month 12
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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. |
From randomization to Month 12
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12
기간: Month 12
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Month 12
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Change in Systolic Blood Pressure Among Participants With Hypertension
기간: Baseline to Month 12
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Baseline to Month 12
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Change in Diastolic Blood Pressure Among Participants With Hypertension
기간: Baseline to Month 12
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Baseline to Month 12
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Proportion of Participants With Hypertension Who Have Controlled Mean Blood Pressure During Follow-up
기간: Months 3, 6, and 12
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Months 3, 6, and 12
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Incidence of Hypertension Among Participants Without Hypertension at Baseline
기간: From randomization to Month 12
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From randomization to Month 12
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Change in Systolic Blood Pressure Among Participants Without Hypertension at Baseline
기간: Baseline to Month 12
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Baseline to Month 12
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Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline
기간: Baseline to Month 12
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Baseline to Month 12
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Proportion of Households With Successful Hypertension Prevention and Control
기간: From randomization to Month 12
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From randomization to Month 12
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HOME-SALT-2026-01
- KYLL-2026-61 (기타 식별자: Shihezi City People's Hospital Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Deidentified individual participant data underlying the results reported in publications from this trial may be shared with qualified researchers upon reasonable request and approval by the study investigators. Data sharing will be subject to applicable ethical, privacy, and institutional requirements.
IPD 공유 기간
Beginning 12 months after publication of the primary study results and available for 5 years
IPD 공유 액세스 기준
Deidentified individual participant data and supporting information may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and, where applicable, relevant institutional or ethics committees. Data will be shared only for scientifically appropriate purposes and subject to an appropriate data use agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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