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

NCT07804420 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-09-04

No results posted yet for this study

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

Interventions

BEHAVIORAL

Hypertension 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.

BEHAVIORAL

Standard 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 & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804420 on ClinicalTrials.gov