Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases(NCD)
Primary Purpose
Lifestyle Intervention, Non Communicable Diseases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive intervention group
standard intervention group
Sponsored by
About this trial
This is an interventional health services research trial for Lifestyle Intervention focused on measuring Internet Technology, lifestyle intervention, Non Communicable Diseases
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
Sites / Locations
- Beijing Tsinghua Changgung HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intensive intervention group
Standard intervention group
Arm Description
intensive life-style and care intervention
standard life-style and care intervention
Outcomes
Primary Outcome Measures
incidence rate of new noncommunicable diseases
incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension
incidence rate of major adverse cardiovascular events
incidence rate of major adverse cardiovascular events, including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
incidence rate of all-cause mortality
incidence rate of all-cause mortality in the population
Secondary Outcome Measures
score of quality of life (SF-36 scale)
the improvement of quality of life
Reduce the economic burden on health
survey of health economic burden, calculate medical expenses
Full Information
NCT ID
NCT04567121
First Posted
September 7, 2020
Last Updated
March 16, 2022
Sponsor
Beijing Tsinghua Chang Gung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04567121
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2070 (Anticipated)
Study Completion Date
December 1, 2070 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle Intervention, Non Communicable Diseases
Keywords
Internet Technology, lifestyle intervention, Non Communicable Diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive intervention group
Arm Type
Other
Arm Description
intensive life-style and care intervention
Arm Title
Standard intervention group
Arm Type
Other
Arm Description
standard life-style and care intervention
Intervention Type
Behavioral
Intervention Name(s)
Intensive intervention group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standard intervention group
Intervention Description
Conduct general health education without active management
Primary Outcome Measure Information:
Title
incidence rate of new noncommunicable diseases
Description
incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension
Time Frame
2 year
Title
incidence rate of major adverse cardiovascular events
Description
incidence rate of major adverse cardiovascular events, including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Time Frame
2 years
Title
incidence rate of all-cause mortality
Description
incidence rate of all-cause mortality in the population
Time Frame
2 years
Secondary Outcome Measure Information:
Title
score of quality of life (SF-36 scale)
Description
the improvement of quality of life
Time Frame
2 years
Title
Reduce the economic burden on health
Description
survey of health economic burden, calculate medical expenses
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianzhong xiao, PHD
Phone
+8613683685711
Email
xiaojzh858@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianzhong xiao, PHD
Organizational Affiliation
Beijing Tsinghua Changgeng Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
Beijing, BJ 10
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaoxiang liu, MD
Phone
+8613718898419
Email
lzxa01684@btch.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases(NCD)
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