Clinical trial NCT06387875: Cohort in Qianwan New District, Ningbo
Official title: Prevention and Control of Chronic Noncommunicable Diseases in Natural Population in Qianwan New District, Ningbo
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Stroke
Non-Communicable Chronic Diseases
Keywords: cohort
natural population
Non-communicable Chronic Disease
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Ningbo Hangzhou Bay Hospital
First posted: 2024-04-29
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Relying on the manufacturing factories gathered around Hangzhou Bay Hospital, a relatively stable cohort of participants was provided. According to the entry criteria, eligible subjects were selected to be included in the Hangzhou Bay natural population cohort.

Brief summary: Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span.

Detailed description: 1. Through baseline survey (cross-sectional survey) and prospective cohort design, the health status information and biological samples of residents in Hangzhou Bay Hospital were collected, and the physical, psychological and social adaptability information was collected through questionnaires and other forms, basic tests and omics measurements were carried out based on the collected samples to build a multi-dimensional data platform.
2. Develop a disease risk prediction model based on big data platform, conduct high-risk population screening and establish risk assessment files; In view of the common health problems in the study population, the key factors and effects of health status were analyzed comprehensively, and the corresponding mathematical model was established to form the prediction of health status. Finally to establish the stratified standard of population health status and provide effective health guidance.

   Questionnaire survey on epidemiology: The Hangzhou Bay Natural Population Cohort Questionnaire was designed according to the principles and requirements of cohort study. All respondents who entered the cohort will sign informed consent, receive face-to-face interview with uniformly trained investigators, and the questionnaire will be reviewed by quality control personnel for quality control.

   Physical examination: The examination contents include height, weight, blood pressure, waist circumference, hip circumference, hearing, vision, medical history and surgery, inbody composition, chest film, electrocardiogram, B-ultrasound, non-invasive arteriosclerosis examination, vascular endothelial ultrasound and other imaging examinations.

   Clinical biochemical test: 5-10 ml of blood, 20 ml of urine and 5 g of feces were collected (if necessary) according to the chronic non-communicable disease spectrum and clinical test requirements in Qianwan New District of Ningbo; The blood samples and urine were tested for biochemistry, liver and kidney function, blood lipids and electrolytes according to clinical testing requirements, as well as multi-omics indicators as needed.
3. Prospective study data: Follow-up of the cohort population (disease occurrence, death, migration, etc.) was conducted through annual active follow-up (telephone, interview, etc.) and passive follow-up, including data of all-cause death, incidence of any kind of diseases.

Eligibility criteria: Inclusion Criteria:

* 1) Local permanent residents aged 18 and above (including residents with household registration, or residents without household registration but with a permanent job);
* 2) No serious physical disability, can communicate normally;
* 3) Participate voluntarily and sign informed consent.

Exclusion Criteria:

* 1) Temporary resident and floating population;
* 2) There are serious health conditions unable to participate in the survey;
* 3) Those who are unwilling to accept the follow-up inspection of the project.

Primary outcomes:
measure: death
timeFrame: 4 years
measure: incidence of cardio-cerebrovascular diseases
timeFrame: 4 years
measure: incidence of other non-communicable chronic diseases
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Ningbo Hangzhou Bay Hospital
name: Jun Pu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: