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

February 22, 2024 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jianrong He, MS
  • Phone Number: 0086 20 38367159
  • Email: hjr0703@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Recruiting
        • Guangzhou Women And Children's Medical Center
        • Contact:
        • Contact:

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

  • Child
  • Adult
  • Older Adult

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

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participant with pregnancy outcomes
Time Frame: At delivery
Including abortion, stillbirth, live birth, preterm birth, low birth weight and birth defects
At delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At age of 3 years
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
At birth, age of 6 weeks, 6 months, 1 year and 3 years
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
At birth, age of 6 weeks, 6 months, 1 year and 3 years
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
At birth, age of 6 weeks, 6 months, 1 year and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Collaborators

University of Birmingham

Investigators

  • Principal Investigator: Xiu Qiu, PhD, Guangzhou Women and Children's Medical Center, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

February 1, 2012

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 16, 2015

First Posted (Estimated)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011Y2-00025
  • 201508030037 (Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China)
  • 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)

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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