Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT07176793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001942', 'term': 'Breast Feeding'}], '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': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Design novel implementation strategies for future mixed method trial', 'timeFrame': 'September 2026', 'description': 'Implementation mapping data will systematically inform the design of a multilevel implementation strategy to be tested in a future pilot trial. Following guidance for rigorous early-phase studies that avoid the futility of premature, underpowered trials, this design focuses on a patient-centered, informant-engaged approach within a systematic framework; with future plans to test the implementation strategy in a feasibility trial that generates proof-of-concept evidence on a primary prevention strategy for diabetes by supporting breastfeeding for patients with GDM.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes', 'Preventing Diabetes Type 2 after GDM', 'Breastfeeding', 'Focus Groups', 'Implementation mapping', 'Breastfeeding support strategy'], 'conditions': ['Gestational Diabetes Mellitus (GDM)', 'Diabetes Type 2', 'Breastfeeding Continuation', 'Breastfeeding Support']}, 'descriptionModule': {'briefSummary': 'The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.', 'detailedDescription': "Gestational diabetes (GDM) is common and happens in about 8 of every 100 births. GDM can cause health problems right away and later in life. People who have GDM are 10 times more likely to get diabetes later on. Breastfeeding can help prevent diabetes. If a mother breastfeeds for 12 months or more, their chance of getting type 2 diabetes goes down by 30%. For people with GDM, not breastfeeding makes it more than twice as likely they'll get type 2 diabetes compared to those who do breastfeed. Infants also benefit-being breastfed lowers their chances of getting type 1 or type 2 diabetes later in life.\n\nThere are many barriers that people with GDM experience when breastfeeding. Compared to postpartum patients without GDM, those with GDM are 38% more likely to stop breastfeeding early. Right after birth, patients with GDM are 3.5 times less likely to be breastfeeding only (no formula) when they leave the hospital.\n\nThere are ways to help people with GDM breastfeed more, like meeting with a lactation consultant, getting help over the phone, and learning about healthy eating and exercise. But these programs aren't used much outside the hospital. Clinicians need better plans to support breastfeeding for mothers with GDM.\n\nThis study will use implementation mapping and the consolidated framework for implementation research to co-design a plan that helps mothers with GDM keep breastfeeding. The study will take place at UC Davis Health in Sacramento, California over a 1-year period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Gestational Diabetes Mellitus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old and able to communicate in English\n* Fits into one of the following:\n\n 1. patients with GDM who are recently pregnant and/or postpartum;\n 2. health care providers (nurses, physicians, lactation consultants, etc.) who would implement the strategy\n 3. executive leadership\n\nExclusion Criteria:\n\n* Subjects not meeting the inclusion criteria will be considered ineligible for participation'}, 'identificationModule': {'nctId': 'NCT07176793', 'briefTitle': 'Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Preventing Type 2 Diabetes Following Gestational Diabetes: Implementation Mapping for a Multilevel Breastfeeding Support Strategy', 'orgStudyIdInfo': {'id': '23362821'}, 'secondaryIdInfos': [{'id': '5P30DK092924-15', 'link': 'https://reporter.nih.gov/quickSearch/5P30DK092924-15', 'type': 'NIH'}, {'id': 'RNG211604-12', 'type': 'OTHER_GRANT', 'domain': 'NIDDK'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Panel of key informants', 'description': 'The informant panel will include pregnant or postpartum individuals with a diagnosis of GDM. Staff at the UC Davis Health Campus including health care providers and staff who would be involved in implementing the breastfeeding support strategy and department leadership. All participants will be ≥18 years old and able to communicate in English', 'interventionNames': ['Other: Implementation mapping to develop a multilevel health system strategy for prevention of type 2 diabetes through targeted breastfeeding support for patients with gestational diabetes']}], 'interventions': [{'name': 'Implementation mapping to develop a multilevel health system strategy for prevention of type 2 diabetes through targeted breastfeeding support for patients with gestational diabetes', 'type': 'OTHER', 'otherNames': ['Consolidated Framework for Implementation Research'], 'description': "Conduct implementation mapping to develop a multilevel health system breastfeeding support strategy for patients with GDM at UC Davis Health in Sacramento, California, a large academic medical center. The study design for this mapping process will include five steps in this 1-year proposal: (1) conduct a needs and assets assessment and identify implementers; (2) identify implementation outcomes and determinants; (3) choose mechanisms of change and design implementation strategies; (4) produce implementation protocols and materials; and prepare for the final step, (5) evaluate implementation outcomes, by selecting outcome measures for a future trial . This disciplined and systematic approach to intervention development will directly inform my future directions: a mixed methods feasibility trial to pilot the implementation strategy developed here, followed by a full-scale randomized trial to test the strategy's effectiveness in reducing diabetes risk.", 'armGroupLabels': ['Panel of key informants']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adrienne Hoyt-Austin, DO, MAS, IBCLC', 'role': 'CONTACT', 'email': 'aehoyt@health.ucdavis.edu', 'phone': '916-734-4580'}, {'name': 'Elva T Horath, MD', 'role': 'CONTACT', 'email': 'ethorath@health.ucdavis.edu', 'phone': '510-910-4443'}], 'overallOfficials': [{'name': 'Adrienne Hoyt-Austin, DO, MAS, IBCLC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}