Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 8:27 AM
Study NCT ID:
NCT04060056
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Westlake Precision Birth Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011254', 'term': 'Pregnancy in Diabetics'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2001}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-30', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-15', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous blood glucose change over 2 weeks', 'timeFrame': 'Two weeks after enrollment', 'description': 'Glucose levels are assessed by continuous glucose monitoring over 2 weeks.'}, {'measure': 'Adverse birth outcomes', 'timeFrame': '9-12 weeks after enrollment', 'description': 'Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.'}], 'secondaryOutcomes': [{'measure': 'Body fat of the maternal participants', 'timeFrame': '6 months and 3 years after delivery', 'description': 'Body fat is assessed by the equipment of dual-emission X-ray absorptiometry (DXA) for the mothers.'}, {'measure': 'Weight changes of the children during early childhood', 'timeFrame': 'at delivery, age of 6 months, 1 year, 3 years and 6 years', 'description': 'Weight in kilograms'}, {'measure': 'Number of participants developing type 2 diabetes', 'timeFrame': '6 years and 10 years after delivery', 'description': 'Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Precision Nutrition', 'Host and Microbiome', 'Birth Outcomes'], 'conditions': ['Diabetes, Gestational', 'Pregnancy in Diabetics', 'Intrauterine Hyperglycemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 18 years or older\n* Women with GDM at 24-28 weeks of gestation\n* Women intended to deliver at Hangzhou Women's Hospital\n* Women intended to remain in Hangzhou with their child for ≥4 years\n\nExclusion Criteria:\n\n● Women with cancer and other serious medical disorders"}, 'identificationModule': {'nctId': 'NCT04060056', 'acronym': 'WeBirth', 'briefTitle': 'Westlake Precision Birth Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Westlake University'}, 'officialTitle': 'Westlake Precision Birth Cohort', 'orgStudyIdInfo': {'id': '20190701ZJS0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standardized breakfast', 'description': 'Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g)', 'interventionNames': ['Other: Standardized breakfast']}, {'type': 'OTHER', 'label': 'Standardized snack', 'description': 'Tomato (50g) and skim milk (200g)', 'interventionNames': ['Other: Standardized snack']}, {'type': 'OTHER', 'label': 'Standardized lunch', '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)', 'interventionNames': ['Other: Standardized lunch']}], 'interventions': [{'name': 'Standardized breakfast', 'type': 'OTHER', 'description': 'Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.', 'armGroupLabels': ['Standardized breakfast']}, {'name': 'Standardized snack', 'type': 'OTHER', 'description': 'Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.', 'armGroupLabels': ['Standardized snack']}, {'name': 'Standardized lunch', 'type': 'OTHER', 'description': 'Participants will be provided with a standardized lunch 2 h after they have the standardized snack.', 'armGroupLabels': ['Standardized lunch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310030', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou Women's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Ju-Sheng Zheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westlake University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westlake University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hangzhou Maternal and Child Health Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}