Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05776420
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2023-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '6 months', 'description': 'Change in hemoglobin A1c'}], 'secondaryOutcomes': [{'measure': 'General health ("In general, how would you rate your health today?")', 'timeFrame': '6 months', 'description': 'Self-reported health. Potential responses are: very good, good, moderate, bad, very bad and decline to respond.'}, {'measure': 'Financial security ("Do you have trouble making ends meet at the end of the month?")', 'timeFrame': '6 months', 'description': 'Self-reported financial security'}, {'measure': 'Food insecurity measured by 6 questions from Household Food Security Survey', 'timeFrame': '6 months', 'description': 'Self-reported food insecurity'}, {'measure': 'Fruit and vegetable consumption', 'timeFrame': '6 months', 'description': 'Self-reported fruit and vegetable consumption'}, {'measure': 'Health care utilization using administrative data', 'timeFrame': '6 months', 'description': 'Includes hospitalizations, outpatient visits and primary care visits'}, {'measure': 'Carotenoid level', 'timeFrame': '6 months', 'description': 'Serum caortenoid level'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabete Type 2']}, 'referencesModule': {'references': [{'pmid': '41114992', 'type': 'DERIVED', 'citation': 'Persaud N, Ul Haq MZ, Buadu A, Sabir A, Sinha L, Thorpe KE, Xu K, Hwang SW, Pinto AD, Gucciardi E. Voucher for Healthy Foods and Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2025 Dec 1;185(12):1434-1441. doi: 10.1001/jamainternmed.2025.5420.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemoglobin A1c 6.0 to 11.0\n* report food insecurity or financial insecurity\n\nExclusion Criteria:\n\n* live with a current study participant\n* life expectancy \\< 6 months\n* multiple life-threatening allergies to common foods\n* require total parenteral nutrion\n* blood dyscrasia that interferes with hemoglobin A1c interpretation\n* hemoglobin A1c \\>11'}, 'identificationModule': {'nctId': 'NCT05776420', 'acronym': 'VOUCH4DIABETES', 'briefTitle': 'Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '21-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food voucher', 'interventionNames': ['Behavioral: Food voucher']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Food voucher', 'type': 'BEHAVIORAL', 'description': 'A voucher of $65 (or $85 for people in larger households) that can be redeemed for food at grocery stores.', 'armGroupLabels': ['Food voucher']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'country': 'Canada', 'facility': "St Michael's Hospital Academic Family Health Team", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We plan to share de-identified individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}