Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-06 @ 4:36 PM
Study NCT ID:
NCT06503861
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-designed Food Is Medicine for Adults With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participants' diabetes level or severity", 'timeFrame': 'Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)', 'description': "Participants' glycated hemoglobin - Hemoglobin A1c (HbA1c)"}, {'measure': "Participants' obesity level or severity", 'timeFrame': 'Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)', 'description': 'Body mass index (BMI)'}], 'secondaryOutcomes': [{'measure': 'Dietary behaviors', 'timeFrame': 'Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)', 'description': 'Self-reported food consumption frequencies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if an educational intervention can affect clinical outcomes in adults with diabetes. The main question it aims to answer is:\n\nCan a Food Is Medicine intervention affect obesity and/or diabetes markers in adults?\n\nResearchers will compare a Food Is Medicine arm to a control arm to answer the research question.\n\nParticipants will provide biometrics and questionnaire responses at three time points. Those in the Food Is Medicine arm will receive regular free meal kits combined with cooking and nutritional education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ years, weight 100+ pounds, HbA1c \\>7% in 2020\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06503861', 'acronym': 'FarmtoHealth', 'briefTitle': 'Community-designed Food Is Medicine for Adults With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Southern Indiana Farm to Health Initiative: Evaluation of Produce Prescription Intervention', 'orgStudyIdInfo': {'id': '2002563351'}, 'secondaryIdInfos': [{'id': 'IU-IIR-FARM2HEALTH', 'type': 'OTHER', 'domain': 'IU Office of Clinical Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food Is Medicine intervention', 'interventionNames': ['Behavioral: Food Is Medicine intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Food Is Medicine intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention provides regular meal kits as well as cooking and nutritional education.', 'armGroupLabels': ['Food Is Medicine intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47454', 'city': 'Paoli', 'state': 'Indiana', 'country': 'United States', 'facility': 'Southern Indiana Community Health Care', 'geoPoint': {'lat': 38.55617, 'lon': -86.46832}}], 'overallOfficials': [{'name': 'Julia CD Valliant, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Scientist', 'investigatorFullName': 'Julia Valliant', 'investigatorAffiliation': 'Indiana University'}}}}