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

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorPeking University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Precision Intervention GroupExperimental treatment 1 intervention
Group B: Standard Health Education GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 6 months
2

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.

Time frame
Baseline to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Peking University

Lead sponsor

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

Collaborator