Clinical trial NCT04060056: Westlake Precision Birth Cohort
Official title: Westlake Precision Birth Cohort
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes, Gestational
Pregnancy in Diabetics
Intrauterine Hyperglycemia
Keywords: Precision Nutrition
Host and Microbiome
Birth Outcomes
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: Hangzhou Maternal and Child Health Hospital
First posted: 2019-08-16
Enrollment: 2001
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous blood glucose change over 2 weeks
timeFrame: Two weeks after enrollment
measure: Adverse birth outcomes
timeFrame: 9-12 weeks after enrollment
Secondary outcomes:
measure: Body fat of the maternal participants
timeFrame: 6 months and 3 years after delivery
measure: Weight changes of the children during early childhood
timeFrame: at delivery, age of 6 months, 1 year, 3 years and 6 years
measure: Number of participants developing type 2 diabetes
timeFrame: 6 years and 10 years after delivery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Women's Hospital
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: