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Clinical Trials/NCT04567121
NCT04567121RecruitingNot Applicable

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

Beijing Tsinghua Chang Gung Hospital1 site in 1 country60,000 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60,000
Locations
1
Primary Endpoint
incidence rate of new noncommunicable diseases

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
25 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intensive intervention group

Other

intensive life-style and care intervention

Intervention: Intensive intervention group (Behavioral)

Standard intervention group

Other

standard life-style and care intervention

Intervention: standard intervention group (Behavioral)

Outcomes

Primary Outcomes

incidence rate of new noncommunicable diseases

Time Frame: 2 year

incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension

incidence rate of major adverse cardiovascular events

Time Frame: 2 years

incidence rate of major adverse cardiovascular events, including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

incidence rate of all-cause mortality

Time Frame: 2 years

incidence rate of all-cause mortality in the population

Secondary Outcomes

  • Reduce the economic burden on health(2 years)
  • score of quality of life (SF-36 scale)(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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