Weight GainTMCHCNCT03099837
Tongji Maternal and Child Health Cohort
An observational study of Weight Gain and Maternal; Diabetes Mellitus, Affecting Fetus, run by Huazhong University of Science and Technology.
Trial summary
This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Weight Gain, Maternal; Diabetes Mellitus, Affecting Fetus, Diet Habit
- How many people
- 8,649 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2013to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Child, Adult, Older adult
Study population: The Tongji Maternal and Child Health enrolled healthy pregnant women at 8-16 weeks gestation when they attended their first antenatal visit at a maternity clinic in one of these following hospitals in Wuhan, China: Hubei Maternal and Child Health Hospital (HMCHH), The Central Hospital of Wuhan(CHW), Wuhan Maternal and Child Health Hospital (WMCHH), Jiang'an Maternal and Child Health Hospital(JMCHH). Babies born from these mothers will be followed up until the child is at least 10 years of age.
Who may be able to join
- Pregnant women attending the first visit (<16 weeks ) at at a maternity clinic in one of these following hospitals in Wuhan, China: HMCHH, CHW,WMCHH,JMCHH.
- Intention to visit the maternity clinic regularly in HMCHH or CHW or WMCHH or JMCHH.
- Intention to eventually deliver in HMCHH or CHW or WMCHH.
- The pregnant woman and her husband are Chinese.
Who cannot join
- Pregnant women on chemotherapy.
- Exclude women on certain medications - e.g. psychotropic drugs.
- Exclude women with significant medical conditions e.g. psychosis etc.
About this study
Official title: Maternal and Infant Health Survey
This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.
Read the detailed description
This is an ongoing population-based prospective cohort study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring. 8649 pregnant have been recuited from the first trimester of pregnancy. All datas including the general information, sociodemographic facts, physical exam (body weight, height, blood pressure, etc), laboratory test (hemoglobin, glucose concentration, etc.) and dietary survey (FFQ, 24h food recall) have been collected during the cohort study. Blood sample leftover from the clinical use are remained and stored at -80℃for further measurements. Obstetric characteristics, maternal and perinatal outcomes have been observed and recorded. Growth and development paremeters such as weight, length and head circumference as well as disease information of infants have been collected , feeding pattern and feeding history will be surveyed. All data collected will be used for group analysis only and all private and individual records will be kept secret.
- Conditions
- Weight Gain, Maternal; Diabetes Mellitus, Affecting Fetus, Diet Habit, Pregnancy Complications, Birth Outcomes, Breast Feeding
- Medical subject headings
- Weight Gain, Diabetes Mellitus, Feeding Behavior, Pregnancy Complications, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant mothers | Not described | |
| infants | Not described | |
| children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of weight gain during pregnancy on maternal and child health
To regularly measure the weight gains of pregnant women during pregnancy, and examine their association with maternal and child health.
Measured: During pregnancy, infancy period and childhood, assessed up to 120 months
Effect of factors in pregnancy and early postpartum period on maternal health
To examine the role of maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of metabolic disorders and even lead to complications of pregnancy, such as gestational diabetes mellitus.
Measured: During pregnancy and postpartum period, assessed up to 12 months
Influence of prenatal and early postnatal factors on child health
To examine the role of maternal nutrition, lifestyle, emotional health, breastfeeding, and other environmental factors in infancy that can influence the development of phenotypes in childhood which confer risk for later metabolic and mental disorders.
Measured: During pregnancy, infancy period and childhood, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start10 Jan 2013
- Primary completion10 Jan 2023 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 8,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Maternal and Child Health Hospital of Hubei Province, Wuhan Central Hospital, Wuhan Maternal and Child Health Hospital
- Responsible party
- Principal investigator, Nianhong Yang, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099837
- Sponsor's protocol ID
- HuazhongU-2013-02
- Acronym
- TMCHC
- Status last verified
- Aug 2020
- First submitted
- 17 Mar 2017
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao X, Lin L, Wu M, Liu J, Zhong C, Yang N. Interaction between Dietary Magnesium Intake and Genetic Risk Score on the Risk of Gestational Diabetes. Mol Nutr Food Res. 2024 Dec;68(23):e2400589. doi: 10.1002/mnfr.202400589. Epub 2024 Nov 11.
PubMed 39526506Kong M, Zhong C, Gao Q, Zhou X, Chen R, Xiong G, Hao L, Yang X, Lu Z, Yang N. Association of elevated mid-pregnancy maternal plasma ferritin concentrations and triglyceride concentrations with the risk of gestational diabetes mellitus: A prospective cohort study. Diabetes Metab Res Rev. 2023 Sep;39(6):e3637. doi: 10.1002/dmrr.3637. Epub 2023 Apr 13.
PubMed 36958940Zhong C, Xiong G, Lin L, Li Q, Chen X, Zhang X, Zhang Y, Xu S, Wang X, Gao D, Wu M, Yang S, Han W, Sun G, Yang X, Hao L, Jin Z, Yang N. The association of maternal vaginal bleeding and progesterone supplementation in early pregnancy with offspring outcomes: a prospective cohort study. BMC Pregnancy Childbirth. 2022 May 5;22(1):390. doi: 10.1186/s12884-022-04711-1.
PubMed 35513779Li Y, Zhou X, Zhang Y, Zhong C, Huang L, Chen X, Chen R, Wu J, Li Q, Sun G, Yin H, Xiong G, Hao L, Yang N, Yang X. Association of Maternal Dietary Patterns With Birth Weight and the Mediation of Gestational Weight Gain: A Prospective Birth Cohort. Front Nutr. 2021 Nov 26;8:782011. doi: 10.3389/fnut.2021.782011. eCollection 2021.
PubMed 34901129Xiong T, Wu Y, Huang L, Chen X, Zhang Y, Zhong C, Gao Q, Hong M, Hu X, Yang X, Yang N, Hao L. Association of the maternal serum albumin level with fetal growth and fetal growth restriction in term-born singletons: a prospective cohort study. Fertil Steril. 2022 Feb;117(2):368-375. doi: 10.1016/j.fertnstert.2021.09.016. Epub 2021 Oct 20.
PubMed 34686372Gao Q, Zhong C, Zhou X, Chen R, Xiong T, Hong M, Li Q, Kong M, Xiong G, Han W, Sun G, Yang X, Yang N, Hao L. Inverse association of total polyphenols and flavonoids intake and the intake from fruits with the risk of gestational diabetes mellitus: A prospective cohort study. Clin Nutr. 2021 Feb;40(2):550-559. doi: 10.1016/j.clnu.2020.05.053. Epub 2020 Jun 13.
PubMed 32593522Zhou X, Chen R, Zhong C, Wu J, Li X, Li Q, Cui W, Yi N, Xiao M, Yin H, Xiong G, Han W, Hao L, Yang X, Yang N. Fresh fruit intake in pregnancy and association with gestational diabetes mellitus: A prospective cohort study. Nutrition. 2019 Apr;60:129-135. doi: 10.1016/j.nut.2018.09.022. Epub 2018 Oct 24.
PubMed 30572275
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Infant Health Survey
- ClinicalTrials.gov ID
- NCT03099837
- Acronym / sponsor ID
- TMCHC / HuazhongU-2013-02
- Conditions
- Weight Gain, Maternal; Diabetes Mellitus, Affecting Fetus, Diet Habit, Pregnancy Complications, Birth Outcomes, Breast Feeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,649 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Maternal and Child Health Hospital of Hubei Province, Wuhan Central Hospital, Wuhan Maternal and Child Health Hospital
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 10 Jan 2023 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 4 Apr 2017 (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.
This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.
Detailed description
This is an ongoing population-based prospective cohort study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring. 8649 pregnant have been recuited from the first trimester of pregnancy. All datas including the general information, sociodemographic facts, physical exam (body weight, height, blood pressure, etc), laboratory test (hemoglobin, glucose concentration, etc.) and dietary survey (FFQ, 24h food recall) have been collected during the cohort study. Blood sample leftover from the clinical use are remained and stored at -80℃for further measurements. Obstetric characteristics, maternal and perinatal outcomes have been observed and recorded. Growth and development paremeters such as weight, length and head circumference as well as disease information of infants have been collected , feeding pattern and feeding history will be surveyed. All data collected will be used for group analysis only and all private and individual records will be kept secret.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant mothers | – | – |
| infants | – | – |
| children | – | – |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- The Tongji Maternal and Child Health enrolled healthy pregnant women at 8-16 weeks gestation when they attended their first antenatal visit at a maternity clinic in one of these following hospitals in Wuhan, China: Hubei Maternal and Child Health Hospital (HMCHH), The Central Hospital of Wuhan(CHW), Wuhan Maternal and Child Health Hospital (WMCHH), Jiang'an Maternal and Child Health Hospital(JMCHH). Babies born from these mothers will be followed up until the child is at least 10 years of age.
Key inclusion criteria (4 listed)
- Pregnant women attending the first visit (<16 weeks ) at at a maternity clinic in one of these following hospitals in Wuhan, China: HMCHH, CHW,WMCHH,JMCHH.
- Intention to visit the maternity clinic regularly in HMCHH or CHW or WMCHH or JMCHH.
- Intention to eventually deliver in HMCHH or CHW or WMCHH.
- The pregnant woman and her husband are Chinese.
Key exclusion criteria (3 listed)
- Pregnant women on chemotherapy.
- Exclude women on certain medications - e.g. psychotropic drugs.
- Exclude women with significant medical conditions e.g. psychosis etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of weight gain during pregnancy on maternal and child health
Time frame: During pregnancy, infancy period and childhood, assessed up to 120 months
To regularly measure the weight gains of pregnant women during pregnancy, and examine their association with maternal and child health.
Effect of factors in pregnancy and early postpartum period on maternal health
Time frame: During pregnancy and postpartum period, assessed up to 12 months
To examine the role of maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of metabolic disorders and even lead to complications of pregnancy, such as gestational diabetes mellitus.
Influence of prenatal and early postnatal factors on child health
Time frame: During pregnancy, infancy period and childhood, assessed up to 120 months
To examine the role of maternal nutrition, lifestyle, emotional health, breastfeeding, and other environmental factors in infancy that can influence the development of phenotypes in childhood which confer risk for later metabolic and mental disorders.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Derived from this study: PubMed 39526506Cao X, Lin L, Wu M, Liu J, Zhong C, Yang N. Interaction between Dietary Magnesium Intake and Genetic Risk Score on the Risk of Gestational Diabetes. Mol Nutr Food Res. 2024 Dec;68(23):e2400589. doi: 10.1002/mnfr.202400589. Epub 2024 Nov 11.
- Derived from this study: PubMed 36958940Kong M, Zhong C, Gao Q, Zhou X, Chen R, Xiong G, Hao L, Yang X, Lu Z, Yang N. Association of elevated mid-pregnancy maternal plasma ferritin concentrations and triglyceride concentrations with the risk of gestational diabetes mellitus: A prospective cohort study. Diabetes Metab Res Rev. 2023 Sep;39(6):e3637. doi: 10.1002/dmrr.3637. Epub 2023 Apr 13.
- Derived from this study: PubMed 35513779Zhong C, Xiong G, Lin L, Li Q, Chen X, Zhang X, Zhang Y, Xu S, Wang X, Gao D, Wu M, Yang S, Han W, Sun G, Yang X, Hao L, Jin Z, Yang N. The association of maternal vaginal bleeding and progesterone supplementation in early pregnancy with offspring outcomes: a prospective cohort study. BMC Pregnancy Childbirth. 2022 May 5;22(1):390. doi: 10.1186/s12884-022-04711-1.
- Derived from this study: PubMed 34901129Li Y, Zhou X, Zhang Y, Zhong C, Huang L, Chen X, Chen R, Wu J, Li Q, Sun G, Yin H, Xiong G, Hao L, Yang N, Yang X. Association of Maternal Dietary Patterns With Birth Weight and the Mediation of Gestational Weight Gain: A Prospective Birth Cohort. Front Nutr. 2021 Nov 26;8:782011. doi: 10.3389/fnut.2021.782011. eCollection 2021.
- Derived from this study: PubMed 34686372Xiong T, Wu Y, Huang L, Chen X, Zhang Y, Zhong C, Gao Q, Hong M, Hu X, Yang X, Yang N, Hao L. Association of the maternal serum albumin level with fetal growth and fetal growth restriction in term-born singletons: a prospective cohort study. Fertil Steril. 2022 Feb;117(2):368-375. doi: 10.1016/j.fertnstert.2021.09.016. Epub 2021 Oct 20.
- Derived from this study: PubMed 32593522Gao Q, Zhong C, Zhou X, Chen R, Xiong T, Hong M, Li Q, Kong M, Xiong G, Han W, Sun G, Yang X, Yang N, Hao L. Inverse association of total polyphenols and flavonoids intake and the intake from fruits with the risk of gestational diabetes mellitus: A prospective cohort study. Clin Nutr. 2021 Feb;40(2):550-559. doi: 10.1016/j.clnu.2020.05.053. Epub 2020 Jun 13.
- Derived from this study: PubMed 30572275Zhou X, Chen R, Zhong C, Wu J, Li X, Li Q, Cui W, Yi N, Xiao M, Yin H, Xiong G, Han W, Hao L, Yang X, Yang N. Fresh fruit intake in pregnancy and association with gestational diabetes mellitus: A prospective cohort study. Nutrition. 2019 Apr;60:129-135. doi: 10.1016/j.nut.2018.09.022. Epub 2018 Oct 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Maternal; Diabetes Mellitus, Affecting Fetus, run by Huazhong University of Science and Technology.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Effect of weight gain during pregnancy on maternal and child health (time frame: During pregnancy, infancy period and childhood, assessed up to 120 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03099837, which also lists 7 linked publications.
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 4 Aug 2020.