Environmental ExposureNCT07514377
JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China
An observational study of Environmental Exposure and Fertility, run by National Research Institute for Family Planning, China at 1 site in China.
Trial summary
The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle. This study establishes a family-centered birth cohort of 100,000 Chinese participants, tracking from preconception through offspring adolescence to investigate… Read more about this study
- Who is it for?
- Ages 1 day to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure, Fertility, Health Problems in Pregnancy
- What is being tested?
- N/A (Observational Study)
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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. 1. 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). 2. 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
National Research Institute for Family Planning
Beijing, Beijing Municipality
About this study
Official title: 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
The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle. This study establishes a family-centered birth cohort of 100,000 Chinese participants, tracking from preconception through offspring adolescence to investigate early-life health trajectories and intergenerational transmission of diseases, health status, and psychological-behavioral patterns. Data collection includes biospecimens (placenta, cord blood, breast milk, blood, urine, feces) and multi-omics analysis (genomic, proteomic, metabolomic, microbiomic), alongside clinical information from preconception, pregnancy, birth through childhood (0-14 years). The cohort covers 24 stratified sites across China, incorporating real-time environmental monitoring (air pollution, meteorological data) and sociogeographic factors. Targeting reproductive-age couples (18-45 years) and their offspring, the study addresses multigenerational health linkages, urban-rural disparities, and regional diversity from 2025 to 2039. By integrating genetic, environmental and lifestyle data, this research will identify critical intervention windows and mechanisms for chronic disease transmission across generations, supporting China's "Healthy China" initiative and developing targeted strategies for population health and aging.
Read the 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.
- Conditions
- Environmental Exposure, Fertility, Health Problems in Pregnancy, Adverse Pregnancy Outcomes, Birth Defects, Child Development
- Being tested
- N/A (Observational Study)
- Keywords
- birth cohort study, environmental exposures, birth defects, pregnant outcomes, children development, Child psychological development
- Medical subject headings
- Congenital Abnormalities, Overweight, Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A (Observational Study)Other
This is an observational cohort study. No interventions are assigned. Groups are defined based on different condition or exposure.
| Study group | Role | What they receive |
|---|---|---|
| Condition or exposure | individuals with Condition or exposure. Receives: Other: N/A (Observational Study) | |
| Non-Condition or exposure | individuals without Condition or exposure. Receives: Other: N/A (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse pregnancy outcomes
the rate of different adverse pregnancy outcomes
Measured: At delivery
Secondary outcomes (2)
Complications during pregnancy
The rate of maternal nutritional and pathological health issues.
Measured: From enrollment during pregnancy until delivery or pregnancy termination, up to 40 weeks
Associations between prenatal environmental exposures and offspring health outcomes
The Odds Ratio for offspring health outcomes in different prenatal environmental exposures.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2039 (estimated)
- Study completion31 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Institute for Family Planning, China
- Sponsor type
- Other government
- Collaborators
- West China Second University Hospital
- Responsible party
- Principal investigator, Yuan He, National Research Institute for Family Planning, China
- Investigators
- Yuan He, Study director, National Centre for Human Genetic Resources, National Research Institute for Family Planning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514377
- Sponsor's protocol ID
- NRIFP2025002
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07514377
- Acronym / sponsor ID
- NRIFP2025002
- Conditions
- Environmental Exposure, Fertility, Health Problems in Pregnancy, Adverse Pregnancy Outcomes, Birth Defects, Child Development
- Keywords
- birth cohort study, environmental exposures, birth defects, pregnant outcomes, children development, Child psychological development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- National Research Institute for Family Planning, ChinaOther government
- Collaborators
- West China Second University Hospital
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2039 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle. This study establishes a family-centered birth cohort of 100,000 Chinese participants, tracking from preconception through offspring adolescence to investigate early-life health trajectories and intergenerational transmission of diseases, health status, and psychological-behavioral patterns. Data collection includes biospecimens (placenta, cord blood, breast milk, blood, urine, feces) and multi-omics analysis (genomic, proteomic, metabolomic, microbiomic), alongside clinical information from preconception, pregnancy, birth through childhood (0-14 years). The cohort covers 24 stratified sites across China, incorporating real-time environmental monitoring (air pollution, meteorological data) and sociogeographic factors. Targeting reproductive-age couples (18-45 years) and their offspring, the study addresses multigenerational health linkages, urban-rural disparities, and regional diversity from 2025 to 2039. By integrating genetic, environmental and lifestyle data, this research will identify critical intervention windows and mechanisms for chronic disease transmission across generations, supporting China's "Healthy China" initiative and developing targeted strategies for population health and aging.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition or exposure | – | Other: N/A (Observational Study)individuals with Condition or exposure. |
| Non-Condition or exposure | – | Other: N/A (Observational Study)individuals without Condition or exposure. |
Who may qualify
- Ages
- 1 day to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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. 1. 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). 2. 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A (Observational Study)This is an observational cohort study. No interventions are assigned. Groups are defined based on different condition or exposure. | Other | Condition or exposure, Non-Condition or exposure |
Primary outcome
Adverse pregnancy outcomes
Time frame: At delivery
the rate of different adverse pregnancy outcomes
2 secondary outcomes
Complications during pregnancy
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan He study director
National Centre for Human Genetic Resources, National Research Institute for Family Planning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Exposure and Fertility, run by National Research Institute for Family Planning, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse pregnancy outcomes (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.