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Westlake Precision Birth Cohort (WeBirth)

Primary Purpose

Diabetes, Gestational, Pregnancy in Diabetics, Intrauterine Hyperglycemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standardized breakfast
Standardized snack
Standardized lunch
Sponsored by
Westlake University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes, Gestational focused on measuring Precision Nutrition, Host and Microbiome, Birth Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women aged 18 yrs or older
  • Women with GDM or DIP 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

Sites / Locations

  • Hangzhou Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Standardized breakfast

Standardized snack

Standardized lunch

Arm Description

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

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

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)

Outcomes

Primary Outcome Measures

Continuous blood glucose change over 2 weeks
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
Adverse birth outcomes
Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.

Secondary Outcome Measures

Body fat of the maternal participants
Body fat is assessed by the equipment of dual-emission X-ray absorptiometry (DXA) for the mothers.
Weight changes of the children during early childhood
Weight in kilograms
Number of participants developing type 2 diabetes
Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.

Full Information

First Posted
August 8, 2019
Last Updated
March 29, 2023
Sponsor
Westlake University
Collaborators
Hangzhou Maternal and Child Health Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04060056
Brief Title
Westlake Precision Birth Cohort
Acronym
WeBirth
Official Title
Westlake Precision Birth Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Westlake University
Collaborators
Hangzhou Maternal and Child Health Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational, Pregnancy in Diabetics, Intrauterine Hyperglycemia
Keywords
Precision Nutrition, Host and Microbiome, Birth Outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standardized breakfast
Arm Type
Other
Arm Description
Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g)
Arm Title
Standardized snack
Arm Type
Other
Arm Description
Tomato (50g) and skim milk (200g)
Arm Title
Standardized lunch
Arm Type
Other
Arm 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)
Intervention Type
Other
Intervention Name(s)
Standardized breakfast
Intervention Description
Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.
Intervention Type
Other
Intervention Name(s)
Standardized snack
Intervention Description
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.
Intervention Type
Other
Intervention Name(s)
Standardized lunch
Intervention Description
Participants will be provided with a standardized lunch 2 h after they have the standardized snack.
Primary Outcome Measure Information:
Title
Continuous blood glucose change over 2 weeks
Description
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
Time Frame
Two weeks after enrollment
Title
Adverse birth outcomes
Description
Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.
Time Frame
9-12 weeks after enrollment
Secondary Outcome Measure Information:
Title
Body fat of the maternal participants
Description
Body fat is assessed by the equipment of dual-emission X-ray absorptiometry (DXA) for the mothers.
Time Frame
6 months and 3 years after delivery
Title
Weight changes of the children during early childhood
Description
Weight in kilograms
Time Frame
at delivery, age of 6 months, 1 year, 3 years and 6 years
Title
Number of participants developing type 2 diabetes
Description
Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.
Time Frame
6 years and 10 years after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ju-Sheng Zheng, PhD
Phone
86-0571-86915303
Email
zhengjusheng@westlake.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju-Sheng Zheng, PhD
Organizational Affiliation
Westlake University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou Women's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ju-Sheng Zheng, PhD
Phone
86-0571-86915303
Email
zhengjusheng@westlake.edu.cn
First Name & Middle Initial & Last Name & Degree
Xinxiu Liang
Phone
86-0571-86915303
Email
liangxinxiu@westlake.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Westlake Precision Birth Cohort

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