Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases（NCD）

Non Communicable Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567121
• Other study ID #: 20281-0-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2070

Study information

• Verified date: March 2022
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: jianzhong xiao, PHD
• Phone: +8613683685711
• Email: xiaojzh858[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60000
• Est. completion date: December 1, 2070
• Est. primary completion date: January 1, 2070
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lifestyle Intervention
• Non Communicable Diseases
• Noncommunicable Diseases

Intervention

Behavioral:
• Intensive intervention group
Establish a team of chronic disease prevention managers (5 people), with each educator responsible for the intervention of 200 people. For sub-health population and chronic disease patients, there would be conducted health education interview twice, 4 calls, online communication 50 times once a year, controlling risk factors and making treatment plan.
• standard intervention group
Conduct general health education without active management

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of new noncommunicable diseases	incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension	2 year
Primary	incidence rate of major adverse cardiovascular events	incidence rate of major adverse cardiovascular events, including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death	2 years
Primary	incidence rate of all-cause mortality	incidence rate of all-cause mortality in the population	2 years
Secondary	score of quality of life (SF-36 scale)	the improvement of quality of life	2 years
Secondary	Reduce the economic burden on health	survey of health economic burden, calculate medical expenses	2 years