Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-02 @ 5:52 AM
Study NCT ID:
NCT06818669
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized 1:1 to CVD-FIT (a multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training) or enhanced usual care (CVD risk reduction education).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10-Year CVD Risk', 'timeFrame': 'baseline, 3-months, 6-months, and 12-months post randomization', 'description': '10-year CVD risk will be measured by the Pooled Cohort risk reduction equation recommended for race- and sex- specific risk calculation for African Americans 40 to 79 years of age.'}, {'measure': 'CVD Risk - PREVENT', 'timeFrame': 'baseline, 3-months, 6-months, and 12-months post randomization', 'description': 'CVD Risk will be measured using the PREVENT equation'}], 'secondaryOutcomes': [{'measure': 'Physical and Mental Health Related Quality of Life', 'timeFrame': 'baseline, 3-months, 6-months, and 12-months post randomization', 'description': 'Quality of Life will be measured using the SF-12 questionnaire and reported as physical health related and mental health related scores (score ranges from 0 to 100 with higher numbers indicating better quality of life)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Insecurity', 'Financial Incentives'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The overarching aim of this proposal is to test the efficacy and cost-effectiveness of CVD-FIT, a novel, multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training in African Americans with food insecurity.', 'detailedDescription': 'Study Overview: 200 African American adults at risk for CVD with food insecurity will be randomized 1:1 to CVD-FIT or enhanced usual care (CVD risk reduction education). Each patient will be followed for 12 months, with study visits at baseline, 3, 6, and 12 months. The primary outcome will be 10-year CVD risk using the Pooled Cohort Equation at 12 months post-randomization while the secondary outcomes will be quality of life at 12 months post-randomization and cost-effectiveness of the CVD-FIT intervention compared to enhanced usual care.\n\nPatient Randomization. A permuted block randomization method will be used to assign subjects to intervention or control. All subjects who are randomized will be entered into the study database and analyzed according to CONSORT guidelines.\n\nDescription of the CVD-FIT Intervention: The CVD-FIT intervention will incorporate 1) $100 monthly income supplementation; 2) $50 weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training.\n\nEnhanced Usual Care Control Group: Participants randomized to the enhanced usual care group will receive the same mailed education and health educator delivered education and skills training sessions as the CVD-FIT intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* self-report as African American/non-Hispanic Black\n* screen positive for food insecurity over the past 12-months using a food insecurity risk tool developed through completion of the research team's current NIH funded R01 (R01MD013826)\n* at risk for CVD defined as age ≥40 years and having a clinical diagnosis of diabetes, or hypertension, or hyperlipidemia, or being overweight/obese (defined as a BMI\\>25), or being a current smoker\n* able to communicate in English.\n\nExclusion Criteria:\n\n* Mental confusion on interview suggesting significant dementia\n* Participation in other cardiovascular disease clinical trials\n* Alcohol or drug abuse/dependency based on screening using CAGE questionnaire\n* Active psychosis or acute mental disorder based on self-report\n* Life expectancy \\<12 months."}, 'identificationModule': {'nctId': 'NCT06818669', 'acronym': 'CVD-FIT', 'briefTitle': 'Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives (CVD-FIT)', 'orgStudyIdInfo': {'id': 'R01MD018721', 'link': 'https://reporter.nih.gov/quickSearch/R01MD018721', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01MD018721-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MD018721-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVD-FIT', 'description': 'The structured incentive will include monthly supplemental income plus weekly reimbursement for the purchase of healthy food options. Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.', 'interventionNames': ['Behavioral: CVD-FIT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': 'Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.', 'interventionNames': ['Behavioral: Enhanced Usual Care']}], 'interventions': [{'name': 'CVD-FIT', 'type': 'BEHAVIORAL', 'description': 'The structured incentive will include monthly supplemental income plus weekly reimbursement for the purchase of healthy food options. Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.', 'armGroupLabels': ['CVD-FIT']}, {'name': 'Enhanced Usual Care', 'type': 'BEHAVIORAL', 'description': 'Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebekah J Walker, PhD', 'role': 'CONTACT', 'email': 'rbwalker@buffalo.edu', 'phone': '716-829-5741'}], 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Rebekah J Walker, PhD', 'role': 'CONTACT', 'email': 'rbwalker@buffalo.edu', 'phone': '716-829-5741'}, {'name': 'Jocelyn Stooks, MPH', 'role': 'CONTACT', 'email': 'jstooks@buffalo.edu', 'phone': '716-829-2364'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data will not be shared to protect privacy of participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rebekah Jo Walker', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}