Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 4:34 PM
Study NCT ID:
NCT01858233
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2013-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2013-05-08', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The IBEP Study', 'timeFrame': '2 years', 'description': 'To evaluate mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks in women enrolled in an intensive behavioral educational program compared to women with GDM who undergo routine GDM education and counseling.'}], 'secondaryOutcomes': [{'measure': 'The IBEP Study', 'timeFrame': '2 years', 'description': 'To evaluate the amount of weight lost in women enrolled in an intensive behavioral program and whether it correlates with more favorable lipid profiles at 6 weeks postpartum.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gestational diabetes'], 'conditions': ['Gestational Diabetes', 'Weight Gain During Pregnancy', 'Weight Loss After Pregnancy']}, 'referencesModule': {'references': [{'pmid': '27398697', 'type': 'DERIVED', 'citation': 'Durnwald CP, Kallan MJ, Allison KC, Sammel MD, Wisch S, Elovitz M, Parry S. A Randomized Clinical Trial of an Intensive Behavior Education Program in Gestational Diabetes Mellitus Women Designed to Improve Glucose Levels on the 2-Hour Oral Glucose Tolerance Test. Am J Perinatol. 2016 Oct;33(12):1145-51. doi: 10.1055/s-0036-1585085. Epub 2016 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'The IBEP study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. The primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (IBEP) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women diagnosed with gestational diabetes between 20 and 34 weeks gestation\n\nExclusion Criteria:\n\n* women on chronic steroid therapy\n* women with a diagnosis of GDM \\<20 weeks or \\>34 weeks'}, 'identificationModule': {'nctId': 'NCT01858233', 'acronym': 'IBEP', 'briefTitle': 'The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.', 'orgStudyIdInfo': {'id': 'IBEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Behavioral Modification', 'description': 'intensive dietary counseling, increased activity, lactation consult', 'interventionNames': ['Behavioral: Intensive Behavioral Modification']}, {'type': 'NO_INTERVENTION', 'label': 'Routine care', 'description': 'standard dietary counseling'}], 'interventions': [{'name': 'Intensive Behavioral Modification', 'type': 'BEHAVIORAL', 'description': 'Intensive dietary counseling, increased physical activity, lactation counseling', 'armGroupLabels': ['Intensive Behavioral Modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Celeste Durnwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}