Maternal Grandmothers in the Born in Guangzhou Cohort Study (MGBIG)

September 27, 2024 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center
The MGBIG is a study exploring cross-generational effects in 5000 women and their children and grandchildren located in Guangzhou, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology and on explaining the cause of the disease from the perspective of "grandmother-mother-child" heredity. Data are collected regarding environmental exposures, lifestyle, and social support on grandmother from birth to old age. Biological samples including blood and tissue samples are collected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It was previously believed that heredity strictly follows Mendel's laws, but recent studies have found that through placental material exchange, mammals may transfer maternal immune-related factors vertically, thus promoting the protection of "non-heredited maternal antigenic traits". Thus, the transmission of reproductive information across generations is realized. Since the unusual genetic pattern of the X chromosome, grandmother's influence may be gender specific. Since grandchildren were usually took care by grandparents in China, it could be achievable to attach and recruit maternal grandmother together with mother and children. Cohort including three generations of women is rare in Asia at present. In the MGBIG, extensive information including demographic characteristics, lifestyle, history of diseases, mental health, and behaviors is collected from the participants. Longitudinal follow up and surveillance of common chronic diseases are also to be conducted. The MGBIG intends to recruit maternal grandmothers to study the effects of maternal genetic and environmental exposure on the health of their children and grandchildren.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All maternal grandmothers of the children in the Born in Guangzhou Cohort Study (BIGCS) would be recruited.

Description

Inclusion Criteria:

  1. Maternal Grandmother' grandchildren delivered in Guangzhou Women and Children's Medical Center
  2. Baseline information of maternal grandmother's daughter during pregnancy available

Exclusion Criteria:

  1. Significant cardiovascular abnormalities
  2. Intelligent obstacle, intellectual disabilities or gawkish condition

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Haplotypes transfered by non-inherited maternal antigens from maternal grandmother to female offspring
Time Frame: From the date of her daughter get pregnant until the date her grandchild/grandchildren is/are given birth
Assessed by analyses of MHC haplotypes, HLA haplotypes, and levels of non-inherited maternal antigens of mother and offspring, and pregnancy complication of maternal grandmothers and mothers
From the date of her daughter get pregnant until the date her grandchild/grandchildren is/are given birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum levels of Inflammatory factors at grandchildren's birth and early neonatal life
Time Frame: At the birth date of her grandchild/grandchildren, at the date 42 days after the birth of the certain grandchild/grandchildren
Assessed by analyses of IL-1, IL-6, IL-10, IL-12, etc.
At the birth date of her grandchild/grandchildren, at the date 42 days after the birth of the certain grandchild/grandchildren
The prevalence of eczema of grandchildren
Time Frame: At the age of 6 weeks, 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Assessed by self-reported time of onset and electronic medical record
At the age of 6 weeks, 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
The incidence of asthma of grandchildren
Time Frame: At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Assessed by self-reported time of onset and electronic medical record
At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
The prevalence of Allergic rhinitis of grandchildren
Time Frame: At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Assessed by self-reported time of onset and electronic medical record
At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
The prevalence of Food allergy of children and grandchildren
Time Frame: At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Assessed by self-reported time of onset and electronic medical record
At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Changes of body composition of grandchildren
Time Frame: At age of 3 years,6 years, 12years and 18years
Body composition is assessed using Dual Energy X-Ray Absorptiometry
At age of 3 years,6 years, 12years and 18years
Changes of bone density of grandchildren
Time Frame: At age of 3 years,6 years, 12years and 18years
Bone density is assessed using Dual Energy X-Ray Absorptiometry
At age of 3 years,6 years, 12years and 18years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Women and Children's Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital Medical Center, Cincinnati
University of Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018041801
  • 81673181 (Other Grant/Funding Number: National Natural Science Foundation of China)
  • 201508030037 (Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Childhood Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings