NCT03331133

Brief Summary

The 2-BIG is a twin birth cohort study located in Guangzhou, China.Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental, family and lifestyle exposures on twins from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the twins and their parents.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
154mo 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

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Study Timeline

Key milestones and dates

Study Progress53%
Feb 2012Dec 2038

Study Start

First participant enrolled

February 1, 2012

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

13.9 years

First QC Date

October 20, 2017

Last Update Submit

February 22, 2024

Conditions

Keywords

TwinEarly DevelopmentCohort

Outcome Measures

Primary Outcomes (3)

  • Neurodevelopment at early childhood

    Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.

    At age of 1 year old

  • Intelligence quotient

    Assessed using the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition including 5 verbal and 3 performance subtests. Intelligence quotient ranges 40-160, in which under 70 is defined as mental retardation. The total score was calculated by an online system.

    At age of 6 years old

  • Change of gene expression during childhood

    DNA methylation, histone acetylation etc. assessed by analyses of blood samples

    Age at 1 year , 6 years, 12years and 18years

Secondary Outcomes (4)

  • Change of intestinal flora during early childhood

    Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years

  • Changes of body composition and bone density during early childhood

    At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years

  • Height in kilometer changes during childhood

    At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year

  • Weight in kilogram changes during childhood

    At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year

Study Arms (2)

Identical Twins

Twins develop from one zygote with no intervention

Other: No intervention

Dizygotic Twins

Twins develop from two different zygote with no intervention

Other: No intervention

Interventions

Dizygotic TwinsIdentical Twins

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Twins delivered in Guangzhou, China and their parents

You may qualify if:

  • Live twins delivered in Guangzhou Women and Children's Medical Center
  • Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years
  • Baseline information during pregnancy available

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)

  • Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.

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 During childhood: blood, buccal swab and stool

MeSH Terms

Conditions

Diseases in TwinsPediatric Obesity

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • Xiu Qiu, PhD

    Born in Guangzhou Cohort Study in Guangzhou Women and Children's Medical Center

    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

October 20, 2017

First Posted

November 6, 2017

Study Start

February 1, 2012

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2038

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations