A Cluster-Randomized Trial of a Hypertension Risk Model-Based Precision Intervention in High-Risk Adults in Shunyi District
14 de septiembre de 2026 actualizado por: Peking University
A Multicenter, Parallel-Group, Community Cluster-Randomized Controlled Trial of a Hypertension Risk Model-Based Precision Intervention for Adults at High Risk of Hypertension in Shunyi District, Beijing, China
This community cluster-randomized controlled trial aims to evaluate the effectiveness of a hypertension risk model-based precision intervention among adults at high risk of developing hypertension in Shunyi District, Beijing, China.
Four community clusters are included in the trial and are allocated in a 1:1 ratio to either a precision intervention group or a control group, with two community clusters in each group.
Eligible participants are adults aged 35 to 65 years who are identified as having a predicted hypertension risk greater than 20%, have not been diagnosed with hypertension, and are not taking antihypertensive medications.
Participants in the intervention clusters receive individualized health management delivered through a WeChat mini-program and community healthcare providers, including personalized health education, behavioral goal setting and follow-up, blood pressure monitoring guidance, and health management tools.
Participants in the control clusters receive standard, non-personalized health education and usual community health services.
The primary outcomes are changes in systolic and diastolic blood pressure.
Secondary outcomes include hypertension-related status, incidence of new-onset hypertension, changes in anthropometric measures, and hypertension-related knowledge and beliefs.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
This is a multicenter, parallel-group, community cluster-randomized controlled trial conducted in Shunyi District, Beijing, China. The trial includes four community clusters: Shuangxing South Community, Jianxin North Community, Houfengbo Village, and Hebei Village. The community cluster is the unit of randomization. The four clusters are allocated in a 1:1 ratio, with two clusters assigned to the precision intervention group (Shuangxing South Community and Houfengbo Village) and two clusters assigned to the control group (Jianxin North Community and Hebei Village). Individual participants are not separately randomized; eligible participants receive the intervention assigned to their community cluster.
Eligible residents are screened using a WeChat-based hypertension risk assessment program. Adults aged 35 to 65 years with a predicted hypertension risk greater than 20%, without a current diagnosis of hypertension and without current use of antihypertensive medication, are eligible for enrollment if all other eligibility criteria are met.
Participants in intervention clusters receive a hypertension risk model-based precision health management intervention. Following baseline risk assessment, community healthcare providers conduct an initial face-to-face or online visit within 5 to 15 days and develop an individualized health management plan. Follow-up is conducted at months 1, 3, and 6. Each follow-up focuses on the control or improvement of individual hypertension-related risk factors and lasts at least 15 minutes. The intervention also includes personalized health education, behavioral goal setting and tracking, health management tools, guidance on regular blood pressure monitoring, and referral to a hypertension specialist when clinically indicated.
Participants in control clusters receive standard health education materials, general non-personalized health information, routine quarterly health education, and usual community healthcare services.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
500
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Feng Sun, PhD
- Número de teléfono: +8613811155891
- Correo electrónico: sunfeng@bjmu.edu.cn
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 101300
- Reclutamiento
- Shunyi District Center for Disease Control and Prevention, Beijing
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Contacto:
- Abiden Kapar, MM
- Número de teléfono: +8617690831880
- Correo electrónico: abiden@sina.com
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Contacto:
- Zhiqiang Feng, BD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
Aged 35 to 65 years. Permanent resident of Shunyi District, Beijing, China. Identified as being at high risk of developing hypertension through the Hypertension Risk Assessment WeChat mini-program, with a predicted hypertension risk greater than 20%.
No current diagnosis of hypertension, with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, and not currently taking antihypertensive medication.
Willing to participate in the study and able to provide written informed consent.
Owns a smartphone and is able to use basic WeChat functions.
Exclusion Criteria:
Previously diagnosed hypertension or current use of antihypertensive medications.
History of serious cardiovascular or cerebrovascular disease, such as myocardial infarction or stroke.
Severe hepatic or renal dysfunction, malignant tumor, serious psychiatric disorder, or other serious disease.
Planning to move out of Shunyi District within the next 9 months. Currently participating in another similar intervention study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Precision Intervention Group
Participants residing in community clusters assigned to the intervention group receive a hypertension risk model-based precision intervention delivered through a WeChat mini-program and community physicians.
Following baseline risk assessment, participants receive an initial face-to-face or online visit within 5 to 15 days.
Follow-up is conducted at months 1, 3, and 6, with each follow-up session lasting at least 15 minutes.
The intervention includes individualized health education, behavioral goal setting and tracking, health management tools, blood pressure monitoring guidance, and referral to a hypertension specialist when clinically indicated.
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A multicomponent precision health management intervention based on individual hypertension risk assessment.
The intervention combines a WeChat-based hypertension risk assessment and management program with community physician follow-up.
Participants receive personalized health education based on individual risk factors; behavioral goal setting and tracking for modifiable risk factors such as weight control, salt intake, and physical activity; health management tools such as salt-restriction spoons and oil-control containers; guidance on regular blood pressure monitoring; and referral to a hypertension specialist when clinically indicated.
Follow-up is conducted at 1, 3, and 6 months.
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Comparador activo: Standard Health Education Group
Participants residing in community clusters assigned to the control group receive standard health education materials, general non-personalized health information, routine health education provided by community health service centers once every three months, and usual community healthcare services.
Participants may seek routine medical consultation according to standard community healthcare procedures.
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Participants receive standard non-personalized hypertension prevention and healthy lifestyle education through written educational materials, general health information, and routine health education sessions conducted once every three months at community health service centers.
Participants continue to receive usual community healthcare services and may seek routine medical consultation according to standard community healthcare procedures.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Diastolic Blood Pressure From Baseline
Periodo de tiempo: Baseline to 6 months
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Change in mean diastolic blood pressure, measured in mmHg, from baseline to the prespecified follow-up time point.
Blood pressure is measured using an upper-arm electronic blood pressure monitor after the participant has rested in a seated position for at least 5 minutes.
Two measurements are obtained 1 to 2 minutes apart, and the mean of the two measurements is used.
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Baseline to 6 months
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Change in Systolic Blood Pressure From Baseline
Periodo de tiempo: Baseline to 6 months
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Change in mean systolic blood pressure, measured in mmHg, from baseline to the prespecified follow-up time point.
Blood pressure is measured using an upper-arm electronic blood pressure monitor after the participant has rested in a seated position for at least 5 minutes.
Two measurements are obtained 1 to 2 minutes apart, and the mean of the two measurements is used.
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Baseline to 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
1 de abril de 2026
Finalización primaria (Estimado)
Finalización primaria
31 de diciembre de 2026
Finalización del estudio (Estimado)
Finalización del estudio
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
1 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
4 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- SYHTN-RCT-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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