Westlake Precision Birth Cohort

Diabetes, Gestational Clinical Trial

— WeBirth  

Official title:

Westlake Precision Birth Cohort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04060056
• Other study ID #: 20190701ZJS0007
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: August 31, 2029

Study information

• Verified date: November 2023
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2001
• Est. completion date: August 31, 2029
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria: ? Women with cancer and other serious medical disorders

Related Conditions & MeSH terms

• Diabetes, Gestational
• Hyperglycemia
• Intrauterine Hyperglycemia
• Pregnancy in Diabetics

Intervention

Other:
• Standardized breakfast
Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.
• Standardized snack
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.
• Standardized lunch
Participants will be provided with a standardized lunch 2 h after they have the standardized snack.

Locations

Country	Name	City	State
China	Hangzhou Women's Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	Hangzhou Maternal and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous blood glucose change over 2 weeks	Glucose levels are assessed by continuous glucose monitoring over 2 weeks.	Two weeks after enrollment
Primary	Adverse birth outcomes	Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.	9-12 weeks after enrollment
Secondary	Body fat of the maternal participants	Body fat is assessed by the equipment of dual-emission X-ray absorptiometry (DXA) for the mothers.	6 months and 3 years after delivery
Secondary	Weight changes of the children during early childhood	Weight in kilograms	at delivery, age of 6 months, 1 year, 3 years and 6 years
Secondary	Number of participants developing type 2 diabetes	Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.	6 years and 10 years after delivery