NCT02526901

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2012Dec 2030

Study Start

First participant enrolled

February 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

13.9 years

First QC Date

August 13, 2015

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participant with pregnancy outcomes

    Including abortion, stillbirth, live birth, preterm birth, low birth weight and birth defects

    At delivery

Secondary Outcomes (4)

  • Neurodevelopment during early childhood

    At age of 3 years

  • Weight changes during early childhood

    At birth, age of 6 weeks, 6 months, 1 year and 3 years

  • Height changes during early childhood

    At birth, age of 6 weeks, 6 months, 1 year and 3 years

  • Changes of body composition during early childhood

    At birth, age of 6 weeks, 6 months, 1 year and 3 years

Study Arms (1)

No treatment

Other: No intervention

Interventions

No treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

RECRUITING

Related 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.

    PMID: 25821944BACKGROUND

Related Links

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.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xiu Qiu, PhD

    Guangzhou Women and Children's Medical Center, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Born in Guangzhou Cohort Study

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 18, 2015

Study Start

February 1, 2012

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations