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A Cluster-Randomized Trial of a Hypertension Risk Model-Based Precision Intervention in High-Risk Adults in Shunyi District

14 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

500

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 101300
        • Recrutement
        • Shunyi District Center for Disease Control and Prevention, Beijing
        • Contact:
          • Abiden Kapar, MM
          • Numéro de téléphone: +8617690831880
          • E-mail: abiden@sina.com
        • Contact:
          • Zhiqiang Feng, BD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Hypertension Risk Model-Based Precision Intervention
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.
Comparateur actif: 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.
Comportemental: Standard Health Education
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Diastolic Blood Pressure From Baseline
Délai: Baseline to 6 months
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.
Baseline to 6 months
Change in Systolic Blood Pressure From Baseline
Délai: Baseline to 6 months
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.
Baseline to 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking University

Collaborateurs

Beijing Shunyi District Center for Disease Control and Prevention (Beijing Shunyi District Health Supervision Institute)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

1 septembre 2026

Première soumission répondant aux critères de contrôle qualité

1 septembre 2026

Première publication (Réel)

4 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SYHTN-RCT-2026-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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