Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 6:10 PM
Study NCT ID:
NCT05343494
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2022-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Health Diabetes Prevention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diet', 'timeFrame': '2 months', 'description': '2-month change in self-reported dietary intake assessed by Dietary Screener Questionnaire'}, {'measure': 'Physical activity', 'timeFrame': '2 months', 'description': '2-month change in self-reported physical activity (metabolic equivalents) assessed by International Physical Activity Questionnaire'}, {'measure': 'Weight', 'timeFrame': '2 months', 'description': 'Change in weight from baseline to 2-month visit'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '2 months', 'description': 'Change in hemoglobin A1c from baseline to 2-month visit'}, {'measure': 'Fasting plasma glucose', 'timeFrame': '2 months', 'description': 'Change in fasting plasma glucose from baseline to 2-month visit'}, {'measure': 'Recruitment yield', 'timeFrame': 'Pre-enrollment (before enrollment into the study)', 'description': 'Yield of participants recruited (out of number of prescreening calls, screening visits)'}, {'measure': 'Retention', 'timeFrame': 'Through 2-month study period', 'description': 'Proportion of participants retained to end of 2-month study'}, {'measure': 'Staff time involved in intervention delivery', 'timeFrame': 'Through 2-month study period'}, {'measure': 'Staff time involved in recruitment', 'timeFrame': 'Pre-enrollment (before enrollment into the study)'}, {'measure': 'Staff time involved in data collection', 'timeFrame': 'Through 2-month study period'}, {'measure': 'Qualitative interviews', 'timeFrame': '2 months', 'description': 'Qualitative interviews with staff delivering intervention and WIC participants participating in the intervention. Topics covered: barriers and facilitators, intervention feasibility, appropriateness and acceptability, fidelity, potential for scalability and sustainability, usability of the technology and apps used in the intervention, recommendations to improve the intervention/implementation,'}], 'primaryOutcomes': [{'measure': 'Fidelity - sessions attended', 'timeFrame': '8-week intervention', 'description': 'Number of sessions attended throughout the 8 week intervention'}], 'secondaryOutcomes': [{'measure': 'Fidelity - sessions held', 'timeFrame': '8-week intervention', 'description': 'Number of sessions held throughout the 8 week intervention'}, {'measure': 'Fidelity - session content', 'timeFrame': '8-week intervention', 'description': 'Assessment of whether key concepts were covered during sessions'}, {'measure': 'Intervention feasibility', 'timeFrame': '2-month data collection visit', 'description': 'Feasibility questionnaire delivered to participants and staff delivering the intervention'}, {'measure': 'Intervention appropriateness', 'timeFrame': '2-month data collection visit', 'description': 'Appropriateness questionnaire delivered to participants and staff delivering the intervention'}, {'measure': 'Intervention acceptability', 'timeFrame': '2-month data collection visit', 'description': 'Acceptability questionnaire delivered to participants and staff delivering the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Prevention Program', 'Behavioral Intervention', 'Diet', 'Physical Activity', 'Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)'], 'conditions': ['Gestational Diabetes', 'PreDiabetes', 'Hyperglycemia', 'Glucose Intolerance During Pregnancy']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to collect pilot data on the implementation of a Diabetes Prevention Program-like intervention in the Women, Infants, and Children (WIC) program.', 'detailedDescription': 'In this study, investigators will pilot a 2-month Diabetes Prevention Program-like program (delivered by WIC staff) to 20 women with recent gestational diabetes (6 weeks to 12 months postpartum) who receive WIC services.\n\nThe goal of this pilot is to evaluate the feasibility, acceptability, appropriateness, fidelity of implementing this intervention in the setting of WIC clinics and feasibility of conducting a larger-scale study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* 6 weeks to 12 months postpartum\n* Medical record documented diagnosis of GDM during most recent pregnancy\n* Access to a device that can access the internet\n* English speaking\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant in the next two months\n* Planning to move out of the area in the next two months\n* Self-report of diagnosed diabetes\n* Use of glucose-lowering medications\n* Plasma glucose \\>200 mg/dL and classic symptoms of hyperglycemia (thirst, polyuria, weight loss, blurry vision) or HbA1c \\>6.5% (based on screening visit blood draw)\n* Unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05343494', 'briefTitle': 'Maternal Health Diabetes Prevention Study', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'Maternal Health Diabetes Prevention Project Pilot Study', 'orgStudyIdInfo': {'id': '2021-1234'}, 'secondaryIdInfos': [{'id': 'OT2HL158287', 'link': 'https://reporter.nih.gov/quickSearch/OT2HL158287', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Intervention', 'description': 'The intervention has been modified from a subset of sessions from the National DPP Prevent T2 Curriculum (an adapted DPP for community settings that improves cardiometabolic outcomes and is implemented nationwide).\n\nThe intervention will consist of 8 weekly sessions. The first session will be one-on-one and subsequent sessions will be in small groups. Sessions 1, 2, and 6 will be in-person and other sessions will be held by Zoom.', 'interventionNames': ['Behavioral: Lifestyle Intervention']}], 'interventions': [{'name': 'Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention has been modified from a subset of sessions from the National DPP Prevent T2 Curriculum (an adapted DPP for community settings that improves cardiometabolic outcomes and is implemented nationwide).\n\nThe intervention will consist of 8 weekly sessions. The first session will be one-on-one and subsequent sessions will be in small groups. Sessions 1, 2, and 6 will be in-person and other sessions will be held by Zoom.', 'armGroupLabels': ['Lifestyle Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Office of Health Research', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Westat', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}