Hypertension
Conditions
Keywords
Hypertension Prevention, Hypertension Risk Prediction, Digital Health, WeChat Mini-Program, Lifestyle Intervention, Community-Based Intervention, Precision Prevention, Cluster Randomized Trial
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.
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.
Interventions
BEHAVIORALHypertension 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.
BEHAVIORALStandard 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.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diastolic Blood Pressure From Baseline | 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 | 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. |
Countries
China
Outcome results
None listed