NCT05528068

Effect of Lifestyle Intervention Among Patients With Hypertension or High-normal Blood Pressure

Effect of Lifestyle Intervention Based on Continuous Physiological Monitoring Among Patients With Hypertension or High-normal Blood Pressure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 424 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hypertension is a major risk factor for cardiovascular disease and cardiovascular events. Healthy lifestyle factors are widely recommended for hypertension prevention and control, and cardiorespiratory fitness is a strong and independent predictor of the progression of hypertension. Increased cardiorespiratory fitness through lifestyle modifications is associated with lower mortality in hypertensive or high-normal blood pressure individuals. The aim of the study is to evaluate the effects of supervised lifestyle intervention that include diet and exercise and base on intelligent application and continuous physiological monitoring on improvement of cardiopulmonary fitness, blood pressure and other health outcomes among participants with hypertension or high-normal blood pressure.

Conditions

• Hypertension
• High-normal Blood Pressure

Interventions

Type	Name	Description
BEHAVIORAL	supervised lifestyle intervention	Participants will receive personalized dietary and exercise prescription according to the assessment of nutritional status, physical fitness and physiological-biochemical indexes. The participants will use the digital application for the first 3 months with supervised lifestyle intervention. Wearable devices, such as ambulatory blood pressure monitoring, dynamic electrocardio scanner and smart watch, will be worn to provide continuous physiological monitoring for safety. And then, participants will use the application by self-management for the next 6 months. All participants are given questionnaires, nutritional, physical fitness and physiological-biochemical assessment at baseline, 3 months, 6 months and 9 months.
BEHAVIORAL	healthy lifestyle education	Participants will receive standard care and healthy lifestyle education for hypertension prevention and control. Wearable devices, such as ambulatory blood pressure monitoring, dynamic electrocardio scanner and smart watch, will be worn to provide continuous physiological monitoring for safety. Participants will use the application by self-management for 9 months. All participants are given questionnaires, nutritional, physical fitness and physiological-biochemical assessment at baseline, 3 months, 6 months and 9 months.

Timeline

• Start date: 2022-07-27
• Primary completion: 2023-04-27
• Completion: 2023-10-27
• First posted: 2022-09-06
• Last updated: 2022-09-06

Locations

1 site across 1 country: China