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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Xianghui Zhang, PhD
- Numéro de téléphone: +8618999335467
- E-mail: zxh818@shzu.edu.cn
Lieux d'étude
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Xinjiang
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Shihezi, Xinjiang, Chine, 832000
- Shihezi City People's Hospital
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Contact:
- Qiang Zhang, Master
- Numéro de téléphone: +8613899513431
- E-mail: zhqiang120@126.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of Participants With Failure of Hypertension Prevention or Control
Délai: 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. |
From randomization to Month 12
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Proportion of Participants With Hypertension Who Have Controlled Blood Pressure at Month 12
Délai: Month 12
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Month 12
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Change in Systolic Blood Pressure Among Participants With Hypertension
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline to Month 12
|
Baseline to Month 12
|
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Change in Diastolic Blood Pressure Among Participants Without Hypertension at Baseline
Délai: Baseline to Month 12
|
Baseline to Month 12
|
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Proportion of Households With Successful Hypertension Prevention and Control
Délai: From randomization to Month 12
|
From randomization to Month 12
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HOME-SALT-2026-01
- KYLL-2026-61 (Autre identifiant: Shihezi City People's Hospital Ethics Committee)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage IPD
Beginning 12 months after publication of the primary study results and available for 5 years
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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