Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-13 @ 5:43 PM
Study NCT ID:
NCT07263412
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gestational Lifestyle & Outcomes Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement Rate of Glucose Metabolism During the Perinatal Period', 'timeFrame': 'From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.'}], 'secondaryOutcomes': [{'measure': 'Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention', 'timeFrame': 'From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum'}, {'measure': 'Long-term Incidence of Type 2 Diabetes Mellitus (T2DM)', 'timeFrame': 'From 6 months postpartum to 2 years postpartum'}, {'measure': 'Incidence of Adverse Outcomes', 'timeFrame': 'From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum'}, {'measure': 'Long-term Incidence of Cardiovascular Disease (CVD)', 'timeFrame': 'From 6 months postpartum to 2 years postpartum'}, {'measure': 'Abnormal Blood Glucose Status in Offspring', 'timeFrame': "From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)"}, {'measure': 'Obesity Rate in Offspring', 'timeFrame': "From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)"}]}, 'conditionsModule': {'conditions': ['GDM']}, 'descriptionModule': {'briefSummary': 'A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 1,000 pregnant women with antenatal care registration in the study hospital are enrolled, including 500 Gestational Diabetes Mellitus (GDM) cases (diagnosed via 75g OGTT at 24-28 weeks of gestation with ≥1 abnormal blood glucose value) and 500 normal controls.\n\nAll participants meet: aged 18-40 years, pre-pregnancy BMI 18.5-28 kg/m², ability to sign informed consent, and prenatal care/delivery in the hospital. Those with multiple pregnancies, pre-gestational diabetes, poorly controlled hypertension, severe organ diseases, or poor compliance are excluded. Participants and their offspring complete perinatal and 2-year postnatal follow-ups.', 'eligibilityCriteria': 'Inclusion Criteria: All must be met\n\n1. Aged 18-40 years;\n2. Pre-pregnancy BMI: 18.5 kg/m² \\< BMI \\< 28 kg/m²;\n3. Able to read, understand and sign the informed consent form;\n4. Receive prenatal care and deliver in the study hospital.\n\nExclusion Criteria: Any one met leads to exclusion\n\n1. Twin or multiple pregnancies;\n2. Pre-gestational diabetes mellitus (PGDM), including new-onset diabetes during pregnancy;\n3. Poorly controlled pre-pregnancy chronic hypertension (BP ≥140/90 mmHg);\n4. Complicated with severe liver/kidney diseases;\n5. Current/recent use of drugs affecting glucose metabolism;\n6. Mental illness or severe psychological disorders;\n7. Complicated with severe infection;\n8. Poor compliance or refusal to use CGM/SMBG.'}, 'identificationModule': {'nctId': 'NCT07263412', 'briefTitle': 'Gestational Lifestyle & Outcomes Wellness', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)', 'orgStudyIdInfo': {'id': 'GLOW-GDM-COHORT-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CGM group', 'interventionNames': ['Device: cgm']}, {'label': 'SMBG group', 'interventionNames': ['Behavioral: Behavioral Self-Monitoring of Blood Glucose']}, {'label': 'Control group', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'cgm', 'type': 'DEVICE', 'description': 'Participants will wear a continuous glucose monitoring device to continuously record glucose levels throughout the study period, in addition to receiving standard prenatal care.', 'armGroupLabels': ['CGM group']}, {'name': 'Behavioral Self-Monitoring of Blood Glucose', 'type': 'BEHAVIORAL', 'description': 'Participants will perform regular self-monitoring of blood glucose using a finger-prick glucose meter, along with standard prenatal care.', 'armGroupLabels': ['SMBG group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Participants will receive standard prenatal care without additional glucose monitoring interventions', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wu', 'role': 'CONTACT', 'email': '2543481029@stu.njmu.edu.cn', 'phone': '+8618155394955'}, {'role': 'CONTACT', 'email': '2543481029@stu.njmu.edu.cn'}], 'facility': 'Jiangsu women and children health hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Wu', 'role': 'CONTACT', 'email': '2543481029@stu.njmu.edu.cn', 'phone': '8618155394955'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}