Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT07084805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017321', 'term': 'Clinical Trials, Phase I as Topic'}, {'id': 'D017322', 'term': 'Clinical Trials, Phase II as Topic'}], 'ancestors': [{'id': 'D002986', 'term': 'Clinical Trials as Topic'}, {'id': 'D000068456', 'term': 'Clinical Studies as Topic'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Waitlist Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '9 months', 'description': 'Blood glucose management'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatrics', 'Culinary medicine', 'Teaching kitchen', 'Culinary nutrition'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Diabetes Inspired Culinary Education (DICE) is an innovative family- and community-based culinary medicine intervention designed to mitigate racial/ethnic and socioeconomic status disparities in the treatment and health outcomes of at-risk youth with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Child Inclusion Criteria:\n\n* Type 1 diabetes diagnosis for at least 12 months by study completion\n* Poor glycemic control (1 HbA1c test results ≥ 7.0 % over the past 12 months or blood sugar levels \\> 155 mg/dL 3 or more times a week\n* 8-14 years old\n* English speaking\n\nCaregiver Inclusion Criteria:\n\n* Must be the primary caregiver of the participating child, (i.e., the individual who takes the lead role in helping the child manage their type 1 diabetes (e.g., monitoring blood sugars, planning meals/snacks, carbohydrate counting, etc.)\n* 18 years of age or older\n* English speaking\n\nChild Exclusion Criteria:\n\n* Not aged 8-14\n* No demonstration of poor glycemic control\n* Diagnosis of type 1 diabetes for less than 1 year by program completion\n* Not English speaking\n\nCaregiver Exclusion Criteria:\n\n* Not the child's primary caregiver, (i.e., the individual who takes the lead role in helping the child manage their type 1 diabetes)\n* Less than 18 years of age\n* Not English speaking"}, 'identificationModule': {'nctId': 'NCT07084805', 'acronym': 'DICE', 'briefTitle': 'Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Diabetes Inspired Culinary Education (DICE): An Innovative Approach to Type 1 Diabetes Management for At-Risk Youth With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'STUDY20230091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Receive DICE intervention during phase 1 while waitlist control arm receives usual clinical care.', 'interventionNames': ['Behavioral: Diabetes Inspired Culinary Education (DICE) - Phase 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'description': 'Receive DICE intervention during phase 2 while intervention arm receives usual clinical care.', 'interventionNames': ['Behavioral: Diabetes Inspired Culinary Education (DICE) - Phase 2']}], 'interventions': [{'name': 'Diabetes Inspired Culinary Education (DICE) - Phase 1', 'type': 'BEHAVIORAL', 'description': 'The DICE intervention is a 10-lesson family-and community-based culinary nutrition and diabetes education program. Intervention Mapping, a protocol for developing theory- and evidence-based health promotion programs, was utilized to develop the DICE intervention. Rooted in the Social Cognitive Theory, the DICE intervention targets key personal, behavioral, and environmental constructs as mechanistic pathways for eliciting change in the consequential health outcomes of poor glycemic control in children and adolescents with type 1 diabetes.', 'armGroupLabels': ['Intervention']}, {'name': 'Diabetes Inspired Culinary Education (DICE) - Phase 2', 'type': 'BEHAVIORAL', 'description': 'The DICE intervention is a 10-lesson family-and community-based culinary nutrition and diabetes education program. Intervention Mapping, a protocol for developing theory- and evidence-based health promotion programs, was utilized to develop the DICE intervention. Rooted in the Social Cognitive Theory, the DICE intervention targets key personal, behavioral, and environmental constructs as mechanistic pathways for eliciting change in the consequential health outcomes of poor glycemic control in children and adolescents with type 1 diabetes.', 'armGroupLabels': ['Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Catherine R McManus, PhD, RDN, LD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}, {'name': "Rainbow Babies and Children's Hospital", 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'Breakthrough T1D', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}