HypertensionNCT07804420
A Cluster-Randomized Trial of a Hypertension Risk Model-Based Precision Intervention in High-Risk Adults in Shunyi District
A study testing Hypertension Risk Model-Based Precision Intervention and Standard Health Education in people with Hypertension, run by Peking University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Hypertension Risk Model-Based Precision Intervention and Standard Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shunyi District Center for Disease Control and Prevention, Beijing
Beijing, Beijing Municipality, 101300
Abiden Kapar, MM, +8617690831880, abiden@sina.com
Zhiqiang Feng, BD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Hypertension Risk Model-Based Precision Intervention, Standard Health Education
- Keywords
- Hypertension Prevention, Hypertension Risk Prediction, Digital Health, WeChat Mini-Program, Lifestyle Intervention, Community-Based Intervention, Precision Prevention, Cluster Randomized Trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension Risk Model-Based Precision InterventionBehavioural
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.
Standard Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Precision Intervention Group | Experimental | 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. Receives: Behavioral: Hypertension Risk Model-Based Precision Intervention |
| Standard Health Education Group | Active comparator | 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. Receives: Behavioral: Standard Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diastolic Blood Pressure From Baseline
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.
Measured: Baseline to 6 months
Change in Systolic Blood Pressure From Baseline
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group, community cluster-randomized design. Four community clusters in Shunyi District, Beijing, China are randomized 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). The community cluster is the unit of randomization. Individual participants are not separately randomized; eligible participants receive the intervention assigned to their community cluster.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Shunyi District Center for Disease Control and Prevention (Beijing Shunyi District Health Supervision Institute)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804420
- Sponsor's protocol ID
- SYHTN-RCT-2026-01
- Status last verified
- Apr 2026
- First submitted
- 1 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07804420
- Acronym / sponsor ID
- SYHTN-RCT-2026-01
- Conditions
- Hypertension
- Keywords
- Hypertension Prevention, Hypertension Risk Prediction, Digital Health, WeChat Mini-Program, Lifestyle Intervention, Community-Based Intervention, Precision Prevention, Cluster Randomized Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Beijing Shunyi District Center for Disease Control and Prevention (Beijing Shunyi District Health Supervision Institute)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel-group, community cluster-randomized design. Four community clusters in Shunyi District, Beijing, China are randomized 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). The community cluster is the unit of randomization. Individual participants are not separately randomized; eligible participants receive the intervention assigned to their community cluster.
| Arm | Type | Receives |
|---|---|---|
| Precision Intervention Group | Experimental | Behavioral: Hypertension Risk Model-Based Precision InterventionParticipants 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. |
| Standard Health Education Group | Active comparator | Behavioral: Standard Health EducationParticipants 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertension Risk Model-Based Precision InterventionA 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. | Behavioural | Precision Intervention Group |
| Standard Health EducationParticipants 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. | Behavioural | Standard Health Education Group |
Primary outcome
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.
Change in Systolic Blood Pressure From Baseline
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertension Risk Model-Based Precision Intervention and Standard Health Education in people with Hypertension, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Sun, PhD (+8613811155891, sunfeng@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diastolic Blood Pressure From Baseline (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.