The Born in Guangzhou Cohort Study (BIGCS)

Childhood Obesity Clinical Trial

— BIGCS  

Official title:

The Born in Guangzhou Cohort Study (BIGCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02526901
• Other study ID #: 2011Y2-00025
• Secondary ID: 201041-E00741201
• Status: Recruiting
• Start date: February 1, 2012
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: Guangzhou Women and Children's Medical Center
• Contact: Xiu Qiu, PhD
• Phone: 0086 20 38367160
• Email: qxiu0161[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Host and Microbiome
• Hyperglycemia
• Immune Development
• Intrauterine Hyperglycemia
• Neurodevelopment
• Pediatric Obesity
• Pregnancy Outcomes

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center	University of Birmingham

Country where clinical trial is conducted

China, 

References & Publications (1)

He JR, Yuan MY, Chen NN, Lu JH, Hu CY, Mai WB, Zhang RF, Pan YH, Qiu L, Wu YF, Xiao WQ, Liu Y, Xia HM, Qiu X. Maternal dietary patterns and gestational diabetes mellitus: a large prospective cohort study in China. Br J Nutr. 2015 Apr 28;113(8):1292-300. doi: 10.1017/S0007114515000707. Epub 2015 Mar 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participant with pregnancy outcomes	Including abortion, stillbirth, live birth, preterm birth, low birth weight and birth defects	At delivery
Secondary	Neurodevelopment during early childhood	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
Secondary	Weight changes during early childhood	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
Secondary	Height changes during early childhood	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
Secondary	Changes of body composition during early childhood	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

External Links

•   BIGCS website