Westlake Precision Birth Cohort (WeBirth)

Westlake University

Status: Active, not recruiting

Conditions: Diabetes, Gestational; Pregnancy in Diabetics; Intrauterine Hyperglycemia

Treatments: Other: Standardized snack; Other: Standardized breakfast; Other: Standardized lunch

Study type: Interventional

Funder types: Other

Identifiers

NCT04060056

20190701ZJS0007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,001 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,001 participants in 3 patient groups

Standardized breakfast

Other group

Description:

Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g)

Treatment:

Other: Standardized breakfast

Standardized snack

Other group

Description:

Tomato (50g) and skim milk (200g)

Treatment:

Other: Standardized snack

Standardized lunch

Other group

Description:

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)

Treatment:

Other: Standardized lunch