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

NCT07804420 | Recruiting

• 1 other identifier: SYHTN-RCT-2026-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension

Keywords

Hypertension Prevention; Hypertension Risk Prediction; Digital Health; WeChat Mini-Program; Lifestyle Intervention; Community-Based Intervention; Precision Prevention; Cluster Randomized Trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to 6 months

Study Arms (2)

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.

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.

Behavioral: Standard Health Education

Interventions

Hypertension Risk Model-Based Precision Intervention BEHAVIORAL

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.

Precision Intervention Group

Standard Health Education BEHAVIORAL

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.

Standard Health Education Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Beijing Shunyi District Center for Disease Control and Prevention (Beijing Shunyi District Health Supervision Institute): collaborator

Study Sites (1)

Shunyi District Center for Disease Control and Prevention, Beijing

Beijing, Beijing Municipality, 101300, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Feng Sun, PhD

CONTACT

+8613811155891; sunfeng@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)