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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lifestyle Intervention; Non Communicable Diseases
• Intervention / Treatment: Behavioral: Intensive intervention group; Behavioral: standard intervention group

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 Type: Interventional
• Enrollment (Anticipated): 60000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jianzhong xiao, PHD; Phone Number: +8613683685711; Email: xiaojzh858@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, Beijing, BJ 10
      • Recruiting
      • Beijing Tsinghua Changgung Hospital
      • Contact: zhaoxiang liu, MD; Phone Number: +8613718898419; Email: lzxa01684@btch.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Study Director: jianzhong xiao, PHD, Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 1, 2070
• Study Completion (Anticipated): December 1, 2070

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: lifestyle intervention; Non Communicable Diseases; Internet Technology
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 20281-0-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No