Westlake Precision Birth Cohort (WeBirth)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes, Gestational; Pregnancy in Diabetics; Intrauterine Hyperglycemia
• Intervention / Treatment: Other: Standardized breakfast; Other: Standardized snack; Other: Standardized lunch

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 Type: Interventional
• Enrollment (Actual): 2001
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310030
      • Hangzhou Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients who are diagnosed with GDM or DIP at 24-32 weeks of gestation will be recruited at the Hangzhou Women's Hospital, China.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standardized breakfast; Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g)	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.
Other: Standardized snack; Tomato (50g) and skim milk (200g)	Other: Standardized snack; Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.
Other: Standardized lunch; 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)	Other: Standardized lunch; Participants will be provided with a standardized lunch 2 h after they have the standardized snack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous blood glucose change over 2 weeks	Glucose levels are assessed by continuous glucose monitoring over 2 weeks.	Two weeks after enrollment
Adverse birth outcomes	Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.	9-12 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Weight changes of the children during early childhood	Weight in kilograms	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.	6 years and 10 years after delivery

Collaborators and Investigators

• Sponsor: Westlake University
• Collaborators: Hangzhou Maternal and Child Health Hospital
• Investigators: Principal Investigator: Ju-Sheng Zheng, PhD, Westlake University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Precision Nutrition; Host and Microbiome; Birth Outcomes
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes, Gestational; Hyperglycemia; Pregnancy in Diabetics
• Other Study ID Numbers: 20190701ZJS0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No