Clinical trial NCT04567121: Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases（NCD）
Official title: Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases（NCD）-a Randomized, Controlled Trial in Communities Following Up for 50 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lifestyle Intervention
Non Communicable Diseases
Keywords: Internet Technology
lifestyle intervention
Non Communicable Diseases
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 60000
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to control risk factors of non communicable diseases by life style and care intervention based on internet technology, looking forward to improve cardiovascular and cerebrovascular complications, diabetes and all-cause death.

Detailed description: Cardiovascular and cerebrovascular diseases, diabetes, chronic obstructive pulmonary disease and malignant tumors are the main chronic diseases, which have been the most important cause of human death, consuming most health resources. In China, patients with cardiovascular and cerebrovascular diseases account for more than 40% of all causes of death. After half a century of research, we have a thorough understanding of risk factors of cardiovascular disease, including genetics, aging, ethnicity, physical activity decreases, unbalanced nutrition and calorie intake, smoking, obesity, hypertension, dyslipidemia, and glucose abnormalities, etc. Many factors can be corrected through health education, indicating that the occurrence of chronic diseases can be prevented through lifestyle changes and the control of risk factors.

This project collects risk factors of cardiovascular disease and establishes a real and reliable health database by conducting a cross-sectional survey of chronic diseases among residents of Tian Tong Yuan District (there are hundreds of thousands of people).On this basis, community health management network was established with internet technology. Meanwhile, prospective, open, community randomized and controlled lifestyle intervention studies were carried out. Intervention was conducted on risk factors of cardiovascular and cerebrovascular diseases, such as smoking, obesity, hypertension, lipid metabolism disorder, and hyperglycemia. For patients with chronic diseases, lifestyle intervention and health education should be carried out to improve the diagnosis rate and control rate. The project focuses on the impact of lifestyle interventions and health education on risk factor control, cardiovascular and cerebrovascular complications, diabetes and all-cause death.

Eligibility criteria: Inclusion Criteria:

* Men and women older than 25 years of age with two or more risk factors as follows, BMI≥24 or BMI≤18.5 kg/m2, smoking, active exercise less than 30 minutes every day, blood pressure higher than 130/85 mmHg, dyslipidemia, fasting glucose higher than 6.1mmol/l, fatty liver.
* Patients with hypertension, diabetes and ASCVD

Exclusion Criteria:

* Patients had not signed the consent form
* Patients with severe heart failure, hepatic failure, renal failure and malignant tumor.
* Patients planing pregnancy

Primary outcomes:
measure: incidence rate of new noncommunicable diseases
timeFrame: 2 year
measure: incidence rate of major adverse cardiovascular events
timeFrame: 2 years
measure: incidence rate of all-cause mortality
timeFrame: 2 years
Secondary outcomes:
measure: score of quality of life (SF-36 scale)
timeFrame: 2 years
measure: Reduce the economic burden on health
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: jianzhong xiao, PHD
role: STUDY_DIRECTOR
References: