Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-01 @ 8:26 PM
Study NCT ID:
NCT06999369
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-31
First Post:
2025-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Baseline and 6 months', 'description': 'Blood pleasure will be measure by mmHg'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline and 6 months', 'description': 'Weight will be measured in pounds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'nutrition app', 'evidence-based nutrition recommendations', 'guideline-based nutrition app', 'app-based dietary intervention'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Measuring the impact of a guideline-based nutrition digital tool in heart failure patients', 'detailedDescription': 'The goal of this research clinical trial is to learn understand or learn whether a guideline-based nutrition application (app) called MedChefs can help heart failure patients adopt and sustain an evidence-based dietary patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-89 years old at time of enrollment\n* Any type of Heart failure diagnosis (e.g., I50.x) between 1/1/2023-present\n* Recent hospital admission (within a year)\n* Race/ethnicity: All race/ethnic groups\n* Location: patients have been treated in the Greater East Bay division and Greater Silicon Valley division areas.\n* Patients with have at least 1 office/outpatient visit with a primary care physician or cardiologist visit before index date\n\nExclusion Criteria:\n\n* • Patients with certain patient history (cognitive disabilities) and end stage renal or metastatic cancer diagnosis\n\n * Patients with active drug/substance use. Patients with heart failure who have active substance use are excluded from the study. HF patients with substance use require additional monitoring and follow up due to potential severe withdrawal symptoms, acute HF exacerbation and drug overdose or medication errors. Standard protocol includes additional monitor vital signs (e.g., blood pressure, heart rate) and HF symptoms (e.g., edema, dyspnea), and performing regular laboratory tests (e.g., renal function, electrolytes) which is beyond the clinical and logistical capabilities of this study.'}, 'identificationModule': {'nctId': 'NCT06999369', 'acronym': 'HF-FIT', 'briefTitle': 'Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Sutter Health'}, 'officialTitle': 'Heart Failure Food Intervention Trial (HF-FIT): Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes', 'orgStudyIdInfo': {'id': '2024.112EXP'}, 'secondaryIdInfos': [{'id': '382101125-0525', 'type': 'OTHER', 'domain': 'Sutter Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control arm will be asked to complete a baseline survey questionnaire and a final survey questionnaire 6 months after they enroll. During enrollment or (if not obtained at baseline) up to 1 month after, patients will be asked to provide their baseline BP and weight measurements. Study team members will contact patients at month 3 and 6 to ask how they are doing and get follow up BP and weight measurements.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: MedChefs', 'description': 'Once patients have been randomized to the MedChefs arm, they will be contacted by the research team and sent an email link to use the MedChefs app During enrollment or up to 1 month after, patients will be contacted to provide their baseline BP and weight measurements. Patients will be contacted at month 3 and 6 by the research team to see how they are doing, about their app use, get their BP and weight measurements and will be sent a final survey 6 months after they first log into MedChefs.', 'interventionNames': ['Other: MedChef App']}, {'type': 'EXPERIMENTAL', 'label': 'MedChefs plus Instacart Food Voucher', 'description': 'Once patients have been randomized to the MedChefs arm and voucher arm, they will be contacted by the research team and sent an email link to use the MedChefs app. Patients will also be given a $100 voucher to buy food recommended by the app. Vouchers will be provided once a month for the 6 months of the study. During enrollment or up to 1 month after, patients will be asked to provide their baseline BP and weight measurements. At month 3 and 6 the research team will contact the patients to see how they are doing and ask for patients follow up BP and weight measurements. Patients will also be asked to complete a final survey 6 months after they first log into MedChefs.', 'interventionNames': ['Other: MedChef App', 'Other: MedChefs and Instacart food voucher']}], 'interventions': [{'name': 'MedChef App', 'type': 'OTHER', 'otherNames': ['Nutritional App'], 'description': 'Once patients have been randomized to the MedChefs arm, they will be contacted by the research team and sent an email link to use the MedChefs app. The research team will contact the patient based on their preferred contact method and will walk through how to use the app and share education on its use.', 'armGroupLabels': ['Intervention: MedChefs', 'MedChefs plus Instacart Food Voucher']}, {'name': 'MedChefs and Instacart food voucher', 'type': 'OTHER', 'otherNames': ['nutrition app', 'food voucher'], 'description': 'Once patients have been randomized to the MedChefs arm and voucher arm, they will be contacted by the research team and sent an email link to use the MedChefs app. The research team will contact the patient based on their preferred contact method and will walk through how to use the app and share education on its use and use of Instacart food vouchers. Patients will also be given a $100 voucher to buy food recommended by the app. Vouchers will be provided once a month for the 6 months of the study', 'armGroupLabels': ['MedChefs plus Instacart Food Voucher']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': '2121 N. California Blvd., Suite 310', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sutter Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}