Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT01600534
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2012-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000085002', 'term': 'Glycemic Control'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-10', 'studyFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glycosylated hemoglobin', 'timeFrame': 'Baseline and 36 weeks gestation'}], 'secondaryOutcomes': [{'measure': 'Change in weight after pregnancy', 'timeFrame': '6 weeks postpartum to 24 weeks postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gestational diabetes'], 'conditions': ['Gestational Diabetes Mellitus', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '17554614', 'type': 'BACKGROUND', 'citation': 'Setse R, Grogan R, Cooper LA, Strobino D, Powe NR, Nicholson W. Weight loss programs for urban-based, postpartum African-American women: perceived barriers and preferred components. Matern Child Health J. 2008 Jan;12(1):119-27. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.'}, {'pmid': '27654119', 'type': 'DERIVED', 'citation': 'Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.'}]}, 'descriptionModule': {'briefSummary': 'This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM).', 'detailedDescription': 'This is a pilot trial in which 30 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2) self-directed educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with gestational diabetes\n* Planning to delivery with the study area\n\nExclusion Criteria:\n\n* Pre-existing diabetes (type 1 or type 2 diabetes)\n* Non-English speaking\n* Not planning to delivery in the study area'}, 'identificationModule': {'nctId': 'NCT01600534', 'briefTitle': 'GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'GooDMomS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics', 'orgStudyIdInfo': {'id': '12-0810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'description': 'Participants obtain access to an internet-based educational intervention.', 'interventionNames': ['Behavioral: lifestyle counseling']}, {'type': 'OTHER', 'label': 'Usual Care Lifestyle counseling', 'description': 'Self directed educational intervention', 'interventionNames': ['Behavioral: lifestyle counseling']}], 'interventions': [{'name': 'lifestyle counseling', 'type': 'BEHAVIORAL', 'otherNames': ['healthy lifestyle', 'glucose control'], 'description': 'Participants receive lifestyle counseling on healthy eating and physical activity through an internet-based program or self-directed educational program.', 'armGroupLabels': ['Lifestyle counseling', 'Usual Care Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina clinics', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Wanda Nicholson, MD MPH MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}