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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lifestyle Intervention, Non Communicable Diseases

Intervention / Treatment
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* Behavioral: Intensive intervention group
* Behavioral: standard intervention group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intensive intervention group<br>intensive life-style and care intervention | Behavioral: Intensive intervention group<br>* 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.<br>|
| Other: Standard intervention group<br>standard life-style and care intervention | Behavioral: standard intervention group<br>* Conduct general health education without active management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of new noncommunicable diseases | incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension | 2 year | 
| 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 | 
| incidence rate of all-cause mortality | incidence rate of all-cause mortality in the population | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of quality of life (SF-36 scale) | the improvement of quality of life | 2 years | 
| Reduce the economic burden on health | survey of health economic burden, calculate medical expenses | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet Technology, lifestyle intervention, Non Communicable Diseases