Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT07194733
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supporting VETerans With Kidney Disease Through Food As Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male 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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'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': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative participant perspectives, experiences, and engagement themes', 'timeFrame': '3-months and 6-months', 'description': 'Qualitative semi-structured recorded interviews capturing participant perspectives for themes.'}], 'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline (0-months), 3-months, and 6-months', 'description': 'Systolic Blood Pressure'}], 'secondaryOutcomes': [{'measure': 'Creatinine', 'timeFrame': 'Baseline (0-months), 3-months, 6-months', 'description': 'Measure of kidney function'}, {'measure': 'Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline (0-months), 3-months, and 6-months', 'description': 'Measure of kidney function'}, {'measure': 'Blood urea nitrogen (BUN)', 'timeFrame': 'Baseline (0-months), 3-months, 6-months', 'description': 'A waster product formed from protein breakdown, also filtered by the kidneys'}, {'measure': 'Albumin', 'timeFrame': 'Baseline (0-months), 3-months, 6-months', 'description': 'A protein that may indication kidney damage, inflammation, nutritional status or other measures'}, {'measure': 'HbA1c', 'timeFrame': 'Baseline (0-months), 3-months, and 6-months', 'description': 'Glycosylated hemoglobin A1c'}, {'measure': 'Kidney disease quality of life (KDQOL)', 'timeFrame': 'Baseline (0-months), 3-months, 6-months', 'description': 'Kidney disease quality of life measured by the KDQOL short form instrument'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Diseases', 'Food/Nutrition Insecurity', 'Diabetes', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot clinical trial is primarily learn if produce boxes improve clinical outcomes among Veterans with kidney disease and food or nutrition insecurity. Secondly, the study will capture Veterans qualitative perspectives, experience, and engagement through semi-structured interviews.', 'detailedDescription': "This study aims to address kidney health disparities by implementing and evaluating a Food is/as Medicine intervention tailored for up to 20 Veterans with CKD. These community-engaged efforts seek to better understand the interrelation of nutrition, health, and socioeconomic factors affecting kidney related or patient-centered, along with quantitative clinical, outcomes. The long-term goal of this work is to develop and demonstrate community-based interventions or efforts that improve dietary adherence/quality, reduce food insecurity, improve nutrition security, and enhance kidney health outcomes while providing sustainability, scalable insights for broader public/kidney health and VA healthcare policies or programs.\n\nObjectives:\n\nObjective 1: Evaluate the short-term impact of culturally and medically tailored food boxes and produce (3-month mid-point):\n\n* Understand Veterans' perceptions of food access, intervention acceptability, education effectiveness, and dietary challenges through semi-structured interviews.\n* Investigate participant satisfaction, perceived barriers, and facilitators within the food box program and towards healthy/kidney diet adherence or practices.\n* Examine Veterans' nutrition security status and quality of life from baseline to 3-months.\n\nObjective 2: Assess the longitudinal impact and perceived future long-term impact of food boxes (6- month endpoint):\n\n* Investigate Veterans' long-term program experiences, perspectives, satisfaction, and preferences.\n* Understand participant confidence, self-efficacy, ability to sustain dietary habits, plans and resources needed post-intervention.\n* Examine Veterans' nutrition security status and quality of life from baseline, 3-months, to 6-months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+\n* CKD stage 3b or 4\n* Positive screen for nutrition insecurity (e.g., Tufts screener)\n* Receiving care at the VA and residing in Food Bank of the Rockies service area\n* Ability to provide informed consent, English\n\nExclusion Criteria:\n\n* Stage 1-3a CKD and stage 5 CKD/ESRD (dialysis or transplant)\n* Currently enrolled in a conflicting dietary trial\n* Unwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07194733', 'acronym': 'VETFAM', 'briefTitle': 'Supporting VETerans With Kidney Disease Through Food As Medicine', 'organization': {'class': 'FED', 'fullName': 'VA Eastern Colorado Health Care System'}, 'officialTitle': 'Supporting VETerans With Kidney Disease Through Food As Medicine: the Community-based VET FAM Study', 'orgStudyIdInfo': {'id': '25-1288'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VET FAM Product Box and Nutrition Education', 'description': 'Veterans with kidney disease stages 3b-4 will receive weekly produce boxes through the Food Bank of the Rockies Food for Health program. Boxes include fresh/canned fruits, vegetables, and other items. Participants will also receive nutrition education materials and brief support to encourage preparation and consumption of the provided foods over the study period.', 'interventionNames': ['Other: VET FAM Product Box and Nutrition Education']}], 'interventions': [{'name': 'VET FAM Product Box and Nutrition Education', 'type': 'OTHER', 'description': 'Food boxes and nutrition education', 'armGroupLabels': ['VET FAM Product Box and Nutrition Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luis M Perez, PhD, RD', 'role': 'CONTACT'}, {'name': 'Luis M Perez, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rocky Mountain Regional VA Medical Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Luis M Perez, PhD, RD', 'role': 'CONTACT', 'email': 'luis.perez2@va.gov', 'phone': '720-467-0757'}], 'overallOfficials': [{'name': 'Luis M Perez, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'US Department of Veterans Affairs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Veterans Affairs data may only be shared with VA approved investigators and per VA policy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Eastern Colorado Health Care System', 'class': 'FED'}, 'collaborators': [{'name': 'Food Bank of the Rockies', 'class': 'UNKNOWN'}, {'name': 'National Kidney Foundation, United States', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}