Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05926193
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2023-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food as Medicine Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'satisfaction with nutrition education sessions', 'timeFrame': '12 weeks', 'description': 'Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments'}, {'measure': 'satisfaction with the DASH diet,', 'timeFrame': '12 weeks', 'description': 'Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments'}], 'primaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Systolic and diastolic BP will be documented at end of visit'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction with culturally relevant foods', 'timeFrame': '12 weeks', 'description': 'Survey/ Likert Scale 1- not satisfied- 5 Very Satisfied and open comments'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in Durham County. The goal of this research study is to determine the efficacy of the modified Dietary Approach to Stop Hypertension (DASH) diet in Black/African American and Hispanic/Latinx participants with chronic hypertension who identify as food insecure using a randomized controlled trial. This research will leverage FPP's innovative distribution system to deliver medically-tailored produce bags and provide education workshops to the experimental participants relative to their experimental group. The study population group intends to include members of the Durham community and surrounding areas that identify as members of either the Black/African American or Hispanic/Latinx populations. Success will be measured in pre- and post-intervention biomarkers and qualitative participant experience data. Recognizing the risk of using Protected Health Information of Durham community members, many of whom are members of historically excluded populations that have been subjugated to harmful and extractive research practices, steps will be taken to ensure that collected information about research participants' personal and health information is protected and used only for the purposes of research. Ultimately, this research aims to work directly with the community to address hypertension outside of the clinic using food and education delivered directly to participants. The success of such an intervention could lead to expansion of delivering medically and culturally tailored foods to the larger FPP population and beyond."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult parent/legal guardian (age 18 or older)\n2. Documented essential hypertension (systolic BP \\>140 and/or diastolic BP \\>90, at least two documented clinical measurements)\n3. Self-reported African American or Latino\n\nExclusion Criteria:\n\n1. Hypertension due to secondary cause (e.g. renovascular hypertension, hyperthyroidism, Cushing's disease etc.)\n2. Homelessness or insecure/transitional housing\n3. Inability to prepare or cook food for themselves\n4. Participants not living in Durham County, N.C.\n5. Pregnant women"}, 'identificationModule': {'nctId': 'NCT05926193', 'briefTitle': 'Food as Medicine Project', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Arraigados Juntos - Rooted Together, Food as Medicine Project', 'orgStudyIdInfo': {'id': 'Pro00111072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition Workshops', 'interventionNames': ['Dietary Supplement: Tailor Food Bags']}, {'type': 'NO_INTERVENTION', 'label': 'No Workshops'}], 'interventions': [{'name': 'Tailor Food Bags', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutrition Workshops'], 'description': 'The treatment group will participate in 6 nutrition workshops over the course of 6 months as well as receive weekly food bags that have been tailored for a DASH diet.', 'armGroupLabels': ['Nutrition Workshops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}