Diabetes, GestationalWeBirthNCT04060056
Westlake Precision Birth Cohort
A study testing Standardized breakfast, Standardized snack and Standardized lunch in people with Diabetes, Gestational and Pregnancy in Diabetics, run by Westlake University at 1 site in China.
Trial summary
The Westlake Precision Birth Cohort (WeBirth) is a prospective cohort study among women with hyperglycemia during pregnancy and their offspring living in Hangzhou, China. The primary aim of this cohort is to characterize the continuous blood glucose response to dietary intake and physical activity among pregnant women… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes, Gestational, Pregnancy in Diabetics, Intrauterine Hyperglycemia
- What is being tested?
- Standardized breakfast, Standardized snack and Standardized lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,001 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2019to 31 Aug 2035
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Women with GDM at 24-28 weeks of gestation
- Women intended to deliver at Hangzhou Women's Hospital
- Women intended to remain in Hangzhou with their child for ≥4 years
Who cannot join
- ● Women with cancer and other serious medical disorders
Trial locations and contacts
1 site in 1 country.
About this study
The Westlake Precision Birth Cohort (WeBirth) is a prospective cohort study among women with hyperglycemia during pregnancy and their offspring living in Hangzhou, China. The primary aim of this cohort is to characterize the continuous blood glucose response to dietary intake and physical activity among pregnant women with gestational diabetes mellitus (GDM) over 2 weeks, and to facilitate the development of personalized nutritional/lifestyle recommendation among these patients. Another aim of WeBirth is to investigate the association of dietary intake and physical activity together with continuous glucose change during pregnancy on the adverse birth outcomes including preterm birth, macrosomia and large-for-gestational-age birth. The secondary aim is to investigate the prospective associations of diet, physical activity and continuous glucose change over 2 weeks among the participants with long-term metabolic health of these women and their offspring.
Read the detailed description
In China, an alarming increase in the prevalence of GDM has been observed in the past decade. GDM is of concern because it is associated with several maternal and fetal medical disorders. Lifestyle changes such as diet and physical activity modifications are key for the prevention and treatment of GDM. However, the associations between dietary intake and physical activity and health outcomes for GDM women and their children remain unclear due to subjective measurements of diet and physical activity. Recently, the development of objective measurements such as food image identification and wearable activity trackers give an opportunity to gain more precise insight into these associations. In addition, for the same food and physical activity exposures, GDM women may have different blood glucose responses, but the nature of variation is currently poorly characterized. Therefore, the present WeBirth design incorporates three unique components, 1) objective measurement of physical activity during pregnancy using accelerometer; 2) measurement of dietary intake using both the Food Frequency Questionnaire and dietary records; 3) measurement of blood glucose levels over 2 weeks using continuous glucose monitors, with three standardized test meals during the 2 weeks. We will then follow up these women participants during and after this pregnancy, and also follow up their offspring.
- Being tested
- Standardized breakfast, Standardized snack, Standardized lunch
- Keywords
- Precision Nutrition, Host and Microbiome, Birth Outcomes
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized breakfastOther
Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.
Standardized snackOther
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.
Standardized lunchOther
Participants will be provided with a standardized lunch 2 h after they have the standardized snack.
| Study group | Role | What they receive |
|---|---|---|
| Standardized breakfast | Other | Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g) Receives: Other: Standardized breakfast |
| Standardized snack | Other | Tomato (50g) and skim milk (200g) Receives: Other: Standardized snack |
| Standardized lunch | Other | Rice (40g), oats (40g), shrimp (70g), lettuce (80g), lean pork (30g), carrot (10g), soaked auricularia auricula (20g), broccoli (80g), cucumber (10g), tomato egg drop soup (200g), salt (3g), and oil (8g) Receives: Other: Standardized lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous blood glucose change over 2 weeks
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
Measured: Two weeks after enrollment
Adverse birth outcomes
Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.
Measured: 9-12 weeks after enrollment
Secondary outcomes (3)
Body fat of the maternal participants
Body fat is assessed by the equipment of dual-emission X-ray absorptiometry (DXA) for the mothers.
Measured: 6 months and 3 years after delivery
Weight changes of the children during early childhood
Weight in kilograms
Measured: at delivery, age of 6 months, 1 year, 3 years and 6 years
Number of participants developing type 2 diabetes
Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.
Measured: 6 years and 10 years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start30 Aug 2019
- Primary completion30 Apr 2024
- Study completion31 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Maternal and Child Health Hospital
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060056
- Sponsor's protocol ID
- 20190701ZJS0007
- Acronym
- WeBirth
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Westlake Precision Birth Cohort
- ClinicalTrials.gov ID
- NCT04060056
- Acronym / sponsor ID
- WeBirth / 20190701ZJS0007
- Keywords
- Precision Nutrition, Host and Microbiome, Birth Outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,001 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Maternal and Child Health Hospital
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Aug 2035 (estimated)
- First posted
- 16 Aug 2019 (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 Westlake Precision Birth Cohort (WeBirth) is a prospective cohort study among women with hyperglycemia during pregnancy and their offspring living in Hangzhou, China. The primary aim of this cohort is to characterize the continuous blood glucose response to dietary intake and physical activity among pregnant women with gestational diabetes mellitus (GDM) over 2 weeks, and to facilitate the development of personalized nutritional/lifestyle recommendation among these patients. Another aim of WeBirth is to investigate the association of dietary intake and physical activity together with continuous glucose change during pregnancy on the adverse birth outcomes including preterm birth, macrosomia and large-for-gestational-age birth. The secondary aim is to investigate the prospective associations of diet, physical activity and continuous glucose change over 2 weeks among the participants with long-term metabolic health of these women and their offspring.
Detailed description
In China, an alarming increase in the prevalence of GDM has been observed in the past decade. GDM is of concern because it is associated with several maternal and fetal medical disorders. Lifestyle changes such as diet and physical activity modifications are key for the prevention and treatment of GDM. However, the associations between dietary intake and physical activity and health outcomes for GDM women and their children remain unclear due to subjective measurements of diet and physical activity. Recently, the development of objective measurements such as food image identification and wearable activity trackers give an opportunity to gain more precise insight into these associations. In addition, for the same food and physical activity exposures, GDM women may have different blood glucose responses, but the nature of variation is currently poorly characterized. Therefore, the present WeBirth design incorporates three unique components, 1) objective measurement of physical activity during pregnancy using accelerometer; 2) measurement of dietary intake using both the Food Frequency Questionnaire and dietary records; 3) measurement of blood glucose levels over 2 weeks using continuous glucose monitors, with three standardized test meals during the 2 weeks. We will then follow up these women participants during and after this pregnancy, and also follow up their offspring.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized breakfast | Other | Other: Standardized breakfastEgg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g) |
| Standardized snack | Other | Other: Standardized snackTomato (50g) and skim milk (200g) |
| Standardized lunch | Other | Other: Standardized lunchRice (40g), oats (40g), shrimp (70g), lettuce (80g), lean pork (30g), carrot (10g), soaked auricularia auricula (20g), broccoli (80g), cucumber (10g), tomato egg drop soup (200g), salt (3g), and oil (8g) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 years or older
- Women with GDM at 24-28 weeks of gestation
- Women intended to deliver at Hangzhou Women's Hospital
- Women intended to remain in Hangzhou with their child for ≥4 years
Key exclusion criteria (1 listed)
- ● Women with cancer and other serious medical disorders
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 |
|---|---|---|
| Standardized breakfastParticipants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device. | Other | Standardized breakfast |
| Standardized snackParticipants will be provided with a standardized snack 2 hour after they have the standardized breakfast. | Other | Standardized snack |
| Standardized lunchParticipants will be provided with a standardized lunch 2 h after they have the standardized snack. | Other | Standardized lunch |
Primary outcome
Continuous blood glucose change over 2 weeks
Time frame: Two weeks after enrollment
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
Adverse birth outcomes
Time frame: 9-12 weeks after enrollment
Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.
3 secondary outcomes
Body fat of the maternal participants
Time frame: 6 months and 3 years after delivery
Weight changes of the children during early childhood
Time frame: at delivery, age of 6 months, 1 year, 3 years and 6 years
Number of participants developing type 2 diabetes
Time frame: 6 years and 10 years after delivery
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 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ju-Sheng Zheng, PhD principal investigator
Westlake University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized breakfast, Standardized snack and Standardized lunch in people with Diabetes, Gestational and Pregnancy in Diabetics, run by Westlake University 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 4 inclusion and 1 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 25 Sep 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?
Continuous blood glucose change over 2 weeks (time frame: Two weeks after enrollment). The study lists 2 primary outcomes in all. 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 25 Sep 2026.