- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03288805
Cohort Study in South China
May 3, 2022 updated by: Min Xia
Prospective Cohort Study of Chronic Diseases in South China
Healthy Chinese residents from South China will be recruited and followed up for at least 4 years to evaluate the association between climate, diet and lifestyle and risks for the development of chronic diseases.
Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of chronic diseases will be investigated during follow-up.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
110,000 adult Chinese (35 to 74 years old) without chronic diseases and major disability who have been living in South China including Guangdong, Fujian, Guangxi and Hainan for more than 5 years will be recruited.
All participants will be prospectively followed up for the incidence of chronic diseases (stroke, coronary heart disease, malignant neoplasms, chronic obstructive pulmonary diseases, diabetes and hypertension) and their risk factors (impaired glucose tolerance and obesity).
Information about socio-demographic, diet, lifestyle, psychological status, medical history and current medication will be collected by questionnaires.
Physical examinations including height, weight, waist and hip circumferences, blood pressure, fat mass and vital capacity will be conducted.
Besides, blood, urine and fecal samples will be collected for further analysis.
Annual meteorological data throughout the study period will also be collected.
The associations between climate, diet and lifestyle and risks for chronic diseases will be evaluated.
Study Type
Observational
Enrollment (Anticipated)
110000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510080
- Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult Chinese (35-74 years old) who have been living in South China including Guangdong, Fujian, Guangxi and Hainan provinces for more than 5 years.
Description
Inclusion Criteria:
- adult Chinese (35-74 years old) who have been living in South China including Guangdong, Fujian, Guangxi and Hainan provinces for more than 5 years.
Exclusion Criteria:
- any subject diagnosed with stroke, coronary heart disease, malignancy, chronic obstructive pulmonary disease, diabetes and hypertension.
- any subject who suffer from major disability and cannot participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of chronic disease
Time Frame: 4 years
|
Incidence of chronic disease, including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors for chronic diseases
Time Frame: 4 years
|
Incidence of impaired glucose tolerance and obesity
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
December 31, 2030
Study Completion (Anticipated)
December 31, 2030
Study Registration Dates
First Submitted
September 18, 2017
First Submitted That Met QC Criteria
September 18, 2017
First Posted (Actual)
September 20, 2017
Study Record Updates
Last Update Posted (Actual)
May 5, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017YFC0907100
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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