- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514377
JiGenerations Health Cohort Study:Parental Exposure and Intergenerational Health in China
A Population-based Prospective Cohort Study Aimed at Examining the Effects of Parental Exposure Before and During Pregnancy on Adverse Pregnancy Outcomes, Offspring Health, and Mental Development for Chinese Ethnics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The impact of maternal conditions on offspring health and disease has garnered increasing attention, underscoring the necessity of large-scale, prospective, multicenter cohort studies spanning the entire maternal-child life cycle to elucidate this relationship.
This study aims to establish a family-centered birth cohort of 100,000 individuals, beginning at the preconception stage and tracking offspring through adolescence, to investigate early-life health trajectories. By doing so, we seek to enhance understanding of the intergenerational transmission of disease, health status, longevity, and psychological-behavioral patterns in the Chinese population. Furthermore, this research will identify critical intervention windows and underlying mechanisms, enabling the development of targeted health interventions. Ultimately, these efforts will contribute to improved population health and the advancement of healthy aging strategies rooted in early-life interventions.
Data and Biospecimen Collection Information and biological samples will be collected from couples before conception, during pregnancy, at birth, and throughout childhood (0-14 years), establishing a family-centered cohort spanning preconception, pregnancy, birth, and childhood.
Key health outcomes include metabolic disorders, cardiovascular diseases, neurodevelopmental abnormalities, immune-related conditions, and mental health issues.
Multi-Omics Biobank A comprehensive database will be built using biospecimens such as placenta, umbilical cord blood, umbilical tissue, breast milk, oral epithelial cells, blood, urine, and feces, integrating genomic, proteomic, metabolomic, and microbiomic data.
Study Population and Timeline The target population consists of Chinese couples of reproductive age (18-49 years) and their offspring, with a focus on multigenerational health linkages, urban-rural disparities, and regional representation.
The study will launch in 2025, with long-term follow-up until 2039, conducted in phases from preconception to offspring adolescence.
Geographical and Environmental Coverage A stratified sampling approach will cover 24 research sites across Northwest, Southwest, Central, North, East, South, and Northeast China, ensuring diversity in climate, socioeconomic status, and pollution levels.
Real-time air pollution monitoring (e.g., PM2.5, SO₂), meteorological data (temperature, humidity), and sociogeographic factors (green space, urbanization) will be included.
Significance: By integrating genetic, environmental, and lifestyle data, this study will uncover how early-life exposures influence chronic disease transmission across generations, providing targeted intervention strategies to support China's "Healthy China" initiative and address aging-related challenges.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- National Research Institute for Family Planning
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The participants come from 24 survey sites in the northwest, southwest, central, northern, eastern, southern, and northeastern regions, include parental and offspring generations.
- Parental Generation: Eligible participants include couples of reproductive age who undergo free pre-pregnancy eugenic health examinations, or pregnant women registered for prenatal care at healthcare institutions during early pregnancy (≤14 weeks).
- Offspring Generation: Newborns whose parents participated in pre-pregnancy eugenic health checks and/or maternal prenatal examinations are enrolled in the cohort upon parental (guardian) consent.
Description
Inclusion Criteria:
- Parental Generation: Eligible participants include couples of reproductive age who undergo free pre-pregnancy eugenic health examinations, or pregnant women registered for prenatal care at healthcare institutions during early pregnancy (≤14 weeks). The participants are aged 18-45 years old and have mobile phones and internet (computer) devices. All participants must provide informed consent and commit to long-term follow-up. The participants have no serious neuropsychiatric disorders, with sufficient understanding and expression to complete the survey.
- Offspring Generation: Newborns whose parents participated in pre-pregnancy eugenic health checks and/or maternal prenatal examinations are enrolled in the cohort upon parental (guardian) consent. Designated hospitals will provide expedited medical services, free physical examinations, free child healthcare, and free psychological counseling to ensure comprehensive follow-up spanning infancy, preschool, school age, and early adolescence (0-14 years).
Exclusion Criteria:
- Intellectual disability or other serious mental disorders;
- Suffering from serious underlying diseases and may have a significant impact on pregnancy outcome;
- Those with poor compliance and difficulty in follow-up.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Condition or exposure
individuals with Condition or exposure.
|
This is an observational cohort study.
No interventions are assigned.
Groups are defined based on different condition or exposure.
|
|
Non-Condition or exposure
individuals without Condition or exposure.
|
This is an observational cohort study.
No interventions are assigned.
Groups are defined based on different condition or exposure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse pregnancy outcomes
Time Frame: At delivery
|
the rate of different adverse pregnancy outcomes
|
At delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications during pregnancy
Time Frame: From enrollment during pregnancy until delivery or pregnancy termination, up to 40 weeks
|
The rate of maternal nutritional and pathological health issues.
|
From enrollment during pregnancy until delivery or pregnancy termination, up to 40 weeks
|
|
Associations between prenatal environmental exposures and offspring health outcomes
Time Frame: at baseline (preconception), during pregnancy (12weeks,24weeks and 32weeks), at delivery, and during offspring follow-up visits (at 3 months,6 months,9months, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 years)
|
The Odds Ratio for offspring health outcomes in different prenatal environmental exposures.
|
at baseline (preconception), during pregnancy (12weeks,24weeks and 32weeks), at delivery, and during offspring follow-up visits (at 3 months,6 months,9months, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 years)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Yuan He, National Centre for Human Genetic Resources, National Research Institute for Family Planning
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Digestive System Diseases
- Liver Diseases
- Fatty Liver
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Congenital Abnormalities
- Overweight
- Obesity
- Non-alcoholic Fatty Liver Disease
- Investigative Techniques
- Methods
- Observation
Other Study ID Numbers
- NRIFP2025002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Non-alcoholic Fatty Liver Disease
-
Naga P. ChalasaniDSM Nutritional Products, Inc.CompletedNon-Alcoholic Fatty Liver Disease | Non-Alcoholic Steatohepatitis | Non-Alcoholic Fatty LiverUnited States
-
Medical College of WisconsinENDRA Life Sciences, Inc.WithdrawnFatty Liver | NAFLD | Non-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non-alcoholic Fatty Liver | NASH | Fatty Liver DiseaseUnited States
-
Michael Ohliger, MD PhDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingNAFLD | Non-Alcoholic Fatty Liver Disease | NASH | Non Alcoholic Fatty Liver | Non Alcoholic SteatohepatitisUnited States
-
Hywel Dda Health BoardCompletedNon-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non Alcoholic Fatty Liver | Steatosis of LiverUnited Kingdom
-
Cairo UniversityRecruitingNon-Alcoholic Fatty Liver DiseaseEgypt
-
Nehal Abou SeadaCompletedNon-Alcoholic Fatty Liver Disease
-
Better TherapeuticsArizona Liver HealthCompletedNon-Alcoholic Fatty Liver Disease | Non-alcoholic Steatohepatitis | Non-alcoholic Fatty LiverUnited States
-
Badr UniversityNot yet recruitingNon-alcoholic Steatohepatitis NASH | Non-alcoholic Fatty Liver Disease NAFLDEgypt
-
University Hospital, ToulouseNot yet recruiting
-
Puerta de Hierro University HospitalHospital Universitario Marqués de ValdecillaNot yet recruitingNon-Alcoholic Fatty Liver Disease | Non Alcoholic SteatohepatitisSpain
Clinical Trials on N/A (Observational Study)
-
VASCage GmbHMedical University Innsbruck; St John of God Hospital, ViennaRecruiting
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
University College DublinUniversity College CorkCompletedFood Consumption Database AnalysisIreland
-
Center for Eye Research AustraliaRecruitingAge-related Macular Degeneration | Geographic Atrophy | Age Related Macular Degeneration | AMDAustralia
-
University of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
Ohio State UniversityUSDA North Central - Nutrition Education Center of ExcellenceCompleted
-
George Clinical Pty LtdActelion; The George InstituteCompletedTreatment Resistant Hypertension
-
3Shape A/SNew York UniversityNot yet recruitingCaries,Dental | Caries; Initial | Caries Assessment | Caries Active | Caries Root
-
University of Texas at AustinEnrolling by invitation
-
University of North Carolina, CharlotteEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting