Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-04-17 @ 8:03 PM
Study NCT ID:
NCT02763150
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2016-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women
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': 'D006293', 'term': 'Health Promotion'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-30', 'studyFirstSubmitDate': '2016-04-29', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Gestational Diabetes Mellitus', 'timeFrame': '26 weeks gestation'}], 'secondaryOutcomes': [{'measure': 'Changes in maternal levels of fasting glucose', 'timeFrame': 'study entry, 16 weeks, 26 weeks gestation'}, {'measure': 'Changes in maternal levels of fasting insulin', 'timeFrame': 'study entry, 16 weeks, 26 weeks gestation'}, {'measure': 'Changes in maternal levels of systolic and diastolic blood pressure', 'timeFrame': 'study entry, 16 weeks, 26 weeks gestation'}, {'measure': 'Changes in maternal levels of C-reactive protein', 'timeFrame': 'study entry, 16 weeks, 26 weeks gestation'}, {'measure': 'Incidence of preeclampsia', 'timeFrame': 'Delivery'}, {'measure': 'Incidence of cesarean delivery', 'timeFrame': 'Delivery'}, {'measure': 'Weight changes', 'timeFrame': 'study entry, 16 weeks, 26 weeks gestation'}, {'measure': 'Daily caloric intake', 'timeFrame': 'study entry, 16 weeks, 26 weeks gestation'}, {'measure': 'Minutes per week of moderate physical activity', 'timeFrame': 'study entry, 16 weeks, 26 weeks gestation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes Prevention'], 'conditions': ['Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '36758710', 'type': 'DERIVED', 'citation': 'Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Aug;229(2):158.e1-158.e14. doi: 10.1016/j.ajog.2023.01.037. Epub 2023 Feb 8.'}, {'pmid': '33827659', 'type': 'DERIVED', 'citation': 'Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevencion de la Diabetes Gestacional. Trials. 2021 Apr 7;22(1):256. doi: 10.1186/s13063-021-05204-w.'}]}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior diagnosis of gestational diabetes.\n* BMI \\> 25 kg/m2\n* Planning to have a baby in the next 1-3 years\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Women with Type 2 or Type 1 diabetes\n* Current pregnancy\n* Relocating in the next 2 years\n* Medications that affect weight/diabetes\n* Serious current physical disease\n* History of eating disorders\n* History of bariatric surgery\n* Current problems with drug abuse\n* Current treatment of a serious psychological disorder'}, 'identificationModule': {'nctId': 'NCT02763150', 'briefTitle': 'Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'California Polytechnic State University-San Luis Obispo'}, 'officialTitle': 'Gestational Diabetes Prevention Program', 'orgStudyIdInfo': {'id': 'CP-GDPP-trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Intervention', 'description': 'Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies.', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Promotion', 'description': 'Health promotion group will receive education on healthy eating and activity before pregnancy.', 'interventionNames': ['Other: Health Promotion']}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention group will receive comprehensive behavioral weight loss program.', 'armGroupLabels': ['Lifestyle Intervention']}, {'name': 'Health Promotion', 'type': 'OTHER', 'description': 'The health promotion group will receive education on healthy eating and activity', 'armGroupLabels': ['Health Promotion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93401', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'California Polytechnic State University', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Suzanne Phelan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Polytechnic State University-San Luis Obispo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'A de-identified dataset will be made available to outside investigators after the primary and secondary analyses are completed and in accordance with local institutional review board and NIH policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Polytechnic State University-San Luis Obispo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Suzanne Phelan', 'investigatorAffiliation': 'California Polytechnic State University-San Luis Obispo'}}}}