Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-30 @ 3:05 AM
Study NCT ID:
NCT05752292
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2023-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Understand Risk Information to Support and Empower
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': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-05', 'size': 372225, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-16T14:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of recommended postpartum diabetes screening.', 'timeFrame': '4-12 weeks postpartum', 'description': 'Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT)'}], 'secondaryOutcomes': [{'measure': 'Completion of any recommended postpartum diabetes screening test.', 'timeFrame': '4-52 weeks postpartum', 'description': 'Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c)'}, {'measure': 'Uptake of a lifestyle program for diabetes prevention.', 'timeFrame': '4-52 weeks postpartum', 'description': 'Enrollment in a lifestyle program for diabetes prevention among women without type 2 diabetes mellitus according to any screening result'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes', 'Diabetes Mellitus, Type 2 Prevention', 'Preventive Health Services', 'Health Communication'], 'conditions': ['Diabetes, Gestational', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current pregnancy complicated by gestational diabetes mellitus (GDM)\n* Age: 18 years and older\n* Contact with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Diagnosis of diabetes before pregnancy\n* Maternal or infant current hospitalization\n* Pregnancy loss\n* History of eating disorder\n* Previously requested not to receive research invitations'}, 'identificationModule': {'nctId': 'NCT05752292', 'acronym': 'SUNRISE', 'briefTitle': 'Study to Understand Risk Information to Support and Empower', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing After GDM', 'orgStudyIdInfo': {'id': '1826240'}, 'secondaryIdInfos': [{'id': 'R01DK122087', 'link': 'https://reporter.nih.gov/quickSearch/R01DK122087', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Condition 1', 'description': 'Standard health message + VA + TRI + MI+ AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)', 'Behavioral: Tailored Risk Information (TRI)', 'Behavioral: Motivational Interviewing-based (MI)', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 2', 'description': 'Standard health message + VA + TRI + MI', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)', 'Behavioral: Tailored Risk Information (TRI)', 'Behavioral: Motivational Interviewing-based (MI)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 3', 'description': 'Standard health message + VA + TRI + AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)', 'Behavioral: Tailored Risk Information (TRI)', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 4', 'description': 'Standard health message + VA + TRI', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)', 'Behavioral: Tailored Risk Information (TRI)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 5', 'description': 'Standard health message + VA + MI+ AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)', 'Behavioral: Motivational Interviewing-based (MI)', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 6', 'description': 'Standard health message + VA + MI', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)', 'Behavioral: Motivational Interviewing-based (MI)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 7', 'description': 'Standard health message + VA + AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 8', 'description': 'Standard health message + VA', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Values Affirmation (VA)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 9', 'description': 'Standard health message + TRI + MI+ AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Tailored Risk Information (TRI)', 'Behavioral: Motivational Interviewing-based (MI)', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 10', 'description': 'Standard health message + TRI + MI', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Tailored Risk Information (TRI)', 'Behavioral: Motivational Interviewing-based (MI)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 11', 'description': 'Standard health message + TRI + AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Tailored Risk Information (TRI)', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 12', 'description': 'Standard health message + TRI', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Tailored Risk Information (TRI)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 13', 'description': 'Standard health message + MI+ AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Motivational Interviewing-based (MI)', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 14', 'description': 'Standard health message + MI', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Motivational Interviewing-based (MI)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 15', 'description': 'Standard health message + AP', 'interventionNames': ['Behavioral: Standard Health Information', 'Behavioral: Action planning (AP)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 16', 'description': 'Standard health message', 'interventionNames': ['Behavioral: Standard Health Information']}], 'interventions': [{'name': 'Standard Health Information', 'type': 'BEHAVIORAL', 'description': 'Standard health information about postpartum screening and lifestyle programs for diabetes prevention', 'armGroupLabels': ['Condition 1', 'Condition 10', 'Condition 11', 'Condition 12', 'Condition 13', 'Condition 14', 'Condition 15', 'Condition 16', 'Condition 2', 'Condition 3', 'Condition 4', 'Condition 5', 'Condition 6', 'Condition 7', 'Condition 8', 'Condition 9']}, {'name': 'Values Affirmation (VA)', 'type': 'BEHAVIORAL', 'description': 'Interactive prompts to reflect on core personal values', 'armGroupLabels': ['Condition 1', 'Condition 2', 'Condition 3', 'Condition 4', 'Condition 5', 'Condition 6', 'Condition 7', 'Condition 8']}, {'name': 'Tailored Risk Information (TRI)', 'type': 'BEHAVIORAL', 'description': 'Interactive prompts to provide tailored information on risk factors for type 2 diabetes', 'armGroupLabels': ['Condition 1', 'Condition 10', 'Condition 11', 'Condition 12', 'Condition 2', 'Condition 3', 'Condition 4', 'Condition 9']}, {'name': 'Motivational Interviewing-based (MI)', 'type': 'BEHAVIORAL', 'description': 'Interactive prompts based on principles of motivational interviewing', 'armGroupLabels': ['Condition 1', 'Condition 10', 'Condition 13', 'Condition 14', 'Condition 2', 'Condition 5', 'Condition 6', 'Condition 9']}, {'name': 'Action planning (AP)', 'type': 'BEHAVIORAL', 'description': 'Interactive prompts to problem solve challenges', 'armGroupLabels': ['Condition 1', 'Condition 11', 'Condition 13', 'Condition 15', 'Condition 3', 'Condition 5', 'Condition 7', 'Condition 9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}], 'overallOfficials': [{'name': 'Susan D Brown, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Foundation Research Institute', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}