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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xianghui Zhang, PhD
- Número de teléfono: +8618999335467
- Correo electrónico: zxh818@shzu.edu.cn
Ubicaciones de estudio
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Xinjiang
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Shihezi, Xinjiang, Porcelana, 832000
- Shihezi City People's Hospital
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Contacto:
- Qiang Zhang, Master
- Número de teléfono: +8613899513431
- Correo electrónico: zhqiang120@126.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants With Failure of Hypertension Prevention or Control
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12
Periodo de tiempo: Month 12
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Month 12
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Change in Systolic Blood Pressure Among Participants With Hypertension
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From randomization to Month 12
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From randomization to Month 12
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HOME-SALT-2026-01
- KYLL-2026-61 (Otro identificador: Shihezi City People's Hospital Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Beginning 12 months after publication of the primary study results and available for 5 years
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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