We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Born in Guangzhou Cohort Study (BIGCS) (BIGCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02526901
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : March 22, 2022
Sponsor:
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
Xiu Qiu, Guangzhou Women and Children's Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and long-term effects of exposure in early life on health consequences in Guangzhou, China. Data are collected regarding environmental, occupational and lifestyle exposures as well as health outcomes in later life. Biological samples including blood and tissue samples are also collected from the participants.

Condition or disease Intervention/treatment
Intrauterine Hyperglycemia Pregnancy Outcomes Neurodevelopment Immune Development Childhood Obesity Host and Microbiome Other: No intervention

Detailed Description:
Over the past three decades, China is undergoing rapidly economic development. At the same time, the Western diet and urban lifestyle has been more common than before, which may lead to an increase of incidence of non-communicable chronic diseases, such as diabetes and malignancies. Notably, the current generation of Chinese adults, particularly those in their middle age or older, were born in an era where hardship and rationing was the norm and witnessed a social and epidemiological transition that might have a profound effect on their present health. In contrast, the younger generation is raised in relative material abundance, under the influence of traditional Chinese values such as a strong family orientation and an emphasis on academic success. A birth cohort with would provide an opportunity to examine the short- and long-term effects of exposure in early life on health consequences in this younger generation, in the context of rapid development in China.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Born in Guangzhou Cohort Study (BIGCS)
Study Start Date : February 1, 2012
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2030
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
No treatment Other: No intervention


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participant with pregnancy outcomes [ Time Frame: At delivery ]
    Including abortion, stillbirth, live birth, preterm birth, low birth weight and birth defects


Secondary Outcome Measures :
  1. Neurodevelopment during early childhood [ Time Frame: At age of 3 years ]
    Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules and Ages and Stages Questionnaire

  2. Weight changes during early childhood [ Time Frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years ]
    Weight changes from birth, 6 weeks, 6 months, 1 year to 3 years

  3. Height changes during early childhood [ Time Frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years ]
    Height changes from birth, 6 weeks, 6 months, 1 year to 3 years

  4. Changes of body composition during early childhood [ Time Frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years ]
    Changes of body composition from birth, 6 weeks, 6 months, 1 year to 3 years. Body composition is assessed using Dual Energy X-Ray Absorptiometry


Biospecimen Retention:   Samples With DNA
During pregnancy: maternal blood, urine and stool. At delivery: cord, cord blood and placenta. During infancy: dry blood spot, stool and blood. Druing childhood: blood, buccal swab and stool.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping
Criteria

Inclusion Criteria:

  • Pregnant women with <20 weeks of gestation
  • Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
  • Permanent residents or families intended to remain in Guangzhou with their child for ≥3 years
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526901


Contacts
Layout table for location contacts
Contact: Xiu Qiu, PhD 0086 20 38367160 qxiu0161@163.com
Contact: Jianrong He, MS 0086 20 38367159 hjr0703@163.com

Locations
Layout table for location information
China, Guangdong
Guangzhou Women and Children's Medical Center Recruiting
Guangzhou, Guangdong, China, 510623
Contact: Xiu Qiu, PhD    0086 20 38367160    qxiu0161@163.com   
Contact: Jianrong He, MS    0086 20 38367160    hjr0703@163.com   
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
University of Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Xiu Qiu, PhD Guangzhou Women and Children's Medical Center, China
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT02526901    
Other Study ID Numbers: 2011Y2-00025
201041-E00741 ( Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China )
2012J5100038 ( Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China )
201508030037 ( Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China )
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperglycemia
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Obesity
 Overweight
Overnutrition
Nutrition Disorders
Body Weight