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

Not Applicable

Recruiting

• Conditions: Lifestyle Intervention; Non Communicable Diseases
• Interventions: Behavioral: Intensive intervention group; Behavioral: standard intervention group

• Registration Number: NCT04567121
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31
• Primary Completion: 2070-01-01
• Study Completion: 2070-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60000

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive intervention group	Intensive intervention group	intensive life-style and care intervention
Standard intervention group	standard intervention group	standard life-style and care intervention

Primary Outcome Measures

Name	Time	Method
incidence rate of new noncommunicable diseases	2 year	incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension
incidence rate of major adverse cardiovascular events	2 years	incidence rate of major adverse cardiovascular events, including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
incidence rate of all-cause mortality	2 years	incidence rate of all-cause mortality in the population

Secondary Outcome Measures

Name	Time	Method
Reduce the economic burden on health	2 years	survey of health economic burden, calculate medical expenses
score of quality of life (SF-36 scale)	2 years	the improvement of quality of life

Trial Locations

Locations (1)

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China