A Cluster-Randomized Trial of a Hypertension Risk Model-Based Precision Intervention in High-Risk Adults in Shunyi District
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Feng Sun, PhD
- Phone Number: +8613811155891
- Email: sunfeng@bjmu.edu.cn
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 101300
- Recruiting
- Shunyi District Center for Disease Control and Prevention, Beijing
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Contact:
- Abiden Kapar, MM
- Phone Number: +8617690831880
- Email: abiden@sina.com
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Contact:
- Zhiqiang Feng, BD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
Active Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline
Time Frame: 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.
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Baseline to 6 months
|
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Change in Systolic Blood Pressure From Baseline
Time Frame: 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.
|
Baseline to 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYHTN-RCT-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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