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Recruiting NCT04567121

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

No phase Interventional Lifestyle Intervention Non Communicable Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intensive intervention group, standard intervention group.
Who it may be relevant to
Registry conditions: Lifestyle Intervention, Non Communicable Diseases. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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.
  • Behavioral standard intervention group
    Conduct general health education without active management

Primary outcome measures

  • incidence rate of new noncommunicable diseases [Time frame: 2 year]
  • incidence rate of major adverse cardiovascular events [Time frame: 2 years]
  • incidence rate of all-cause mortality [Time frame: 2 years]
Secondary outcome measures (2)
  • score of quality of life (SF-36 scale) [Time frame: 2 years]
  • Reduce the economic burden on health [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

China · 1 center
  • Beijing Tsinghua Changgung Hospital — Beijing

Identifiers

NCT: NCT04567121 · 20281-0-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗