Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-16 @ 9:35 AM
Study NCT ID:
NCT03281850
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2017-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The GLOWING Study: Growing Life, Optimizing Wellness 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine energy expenditure in children', 'timeFrame': '2 years', 'description': 'Using stable isotope techniques to determine energy expenditure'}, {'measure': 'Determine fat oxidation in children', 'timeFrame': '2 years', 'description': 'Using stable isotope techniques to determine fat oxidation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '35404455', 'type': 'DERIVED', 'citation': 'Diaz EC, Williams DK, Cotter M, Sims CR, Wolfe RR, Andres A, Borsheim E. Breastfeeding duration modifies the association between maternal weight status and offspring dietary palmitate oxidation. Am J Clin Nutr. 2022 Aug 4;116(2):404-414. doi: 10.1093/ajcn/nqac097.'}]}, 'descriptionModule': {'briefSummary': 'This study will help us learn more about how maternal health can influence child health.', 'detailedDescription': "This study follows people who are healthy and less than 36 weeks pregnant to see how the mother's health can impact their child's growth and development. Up to 300 people including the mother and their future child will be a part of this study. The study will follow the child until they are two years of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A prospective longitudinal cohort of 150 dyads (pregnant women and offspring)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-pregnancy BMI 18.5-45\n* Singleton pregnancy\n* at least 18 years of age\n* conceived without assisted fertility treatments\n\nExclusion Criteria:\n\n* Preexisting medical conditions (e.g. DM, GDM, CRF, HTN, pre-eclampsia or eclampsia, malignancies, seizure disorder, lupus, serious psychiatric disorders)\n* sexually transmitted diseases\n* medications during pregnancy known to influence fetal growth\n* smoking, alcohol drinking or drug use during pregnancy'}, 'identificationModule': {'nctId': 'NCT03281850', 'briefTitle': 'The GLOWING Study: Growing Life, Optimizing Wellness 2', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'The GLOWING Study: Growing Life, Optimizing Wellness 2', 'orgStudyIdInfo': {'id': '206846'}}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Aline Andres, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Nutrition Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}