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The Born in Guangzhou Cohort Study (BIGCS) (BIGCS)
This study is currently recruiting participants.
Verified August 2015 by Xiu Qiu, Guangzhou Women and Children's Medical Center
Sponsor:
Guangzhou Women and Children's Medical Center
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
Xiu Qiu, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier:
NCT02526901
First received: August 13, 2015
Last updated: August 16, 2015
Last verified: August 2015
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Purpose
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 | Intervention |
|---|---|
| Intrauterine Hyperglycemia Pregnancy Outcomes Neurodevelopment Immune Development Childhood Obesity Host and Microbiome | Other: No intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Born in Guangzhou Cohort Study (BIGCS) |
Further study details as provided by Xiu Qiu, Guangzhou Women and Children's Medical Center:
Primary Outcome Measures:
- 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:
- 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
- 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
- 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
- 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.
| Estimated Enrollment: | 30000 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| No treatment | 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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02526901
Please refer to this study by its ClinicalTrials.gov identifier: NCT02526901
Contacts
| Contact: Xiu Qiu, PhD | 0086 20 38367160 | qxiu0161@163.com | |
| Contact: Jianrong He, MS | 0086 20 38367159 | hjr0703@163.com |
Locations
| 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
| Principal Investigator: | Xiu Qiu, PhD | Guangzhou Women and Children's Medical Center, China |
More Information
Additional Information:
Publications:
| Responsible Party: | Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center |
| ClinicalTrials.gov Identifier: | NCT02526901 History of Changes |
| 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 ) |
| Study First Received: | August 13, 2015 |
| Last Updated: | August 16, 2015 |
Additional relevant MeSH terms:
|
Pediatric Obesity Hyperglycemia Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on July 07, 2017