Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT06257550
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessors and data analysts will be masked to treatment allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)', 'timeFrame': '0, 12 weeks and 24 weeks', 'description': 'Adherence will be assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). The scores range from 0 to 100, with higher scores reflecting greater adherence.'}], 'secondaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': '0, 12 weeks, 24 weeks', 'description': 'Recruitment yield per time'}, {'measure': 'Cost of the intervention', 'timeFrame': '0, 12 weeks, 24 weeks', 'description': 'Intervention cost/person will be estimated based on the cost of the intervention'}, {'measure': 'Participant Accrual', 'timeFrame': '0, 12 weeks and 24 weeks', 'description': 'Referrals, participation rates, and recruitment yields.'}, {'measure': 'Number of referrals to health and social need resources', 'timeFrame': '0, 12 weeks and 24 weeks', 'description': 'Social needs as assessed by the number of participants connected to health services and services for social needs.'}, {'measure': 'Systolic Blood pressure', 'timeFrame': '0, 12 and 24 weeks', 'description': 'Blood pressure measured in millimeters of mercury (mmHg)'}, {'measure': 'Diastolic Blood pressure', 'timeFrame': '0, 12 and 24 weeks', 'description': 'Blood pressure measured in millimeters of mercury (mmHg)'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '0, 12 and 24 weeks', 'description': 'Hemoglobin A1c (percent)'}, {'measure': 'Height in inches', 'timeFrame': '0, 12 and 24 weeks', 'description': 'Height will be measured'}, {'measure': 'Weight in pounds', 'timeFrame': '0, 12 weeks and 24 weeks', 'description': 'Weight will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 80 Black adults with hypertension.', 'detailedDescription': 'Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 80 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services.\n\nThe investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 \\& 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or older\n2. Self-identify as Black/African American\n3. Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (\\>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)\n4. Live in census tracts identified by Montgomery County Department of Planning as HFPA:\n\n 1. Healthy Food Availability Index score is low (0-9.5),\n 2. Median household income ≤185% of Federal Poverty Level\n 3. \\>30% households have no vehicle, Distance to supermarket \\>1/4 mile.\n5. Participants must have refrigeration, food appliances (microwave, stove),\n6. Cell phone to receive messages\n\nExclusion Criteria:\n\n1. Age \\<18 years\n2. Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment\n3. Diagnosis of end-stage renal disease (ESRD)\n4. Condition which interferes with outcome measurement (e.g., dialysis)\n5. Serious medical condition which either limits life expectancy or requires active management (e.g. cancer)\n6. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence\n7. Patients with cognitive impairment or other condition preventing their participation in the intervention\n8. Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)\n9. Current participation in another clinical trial that could interfere with the study protocol\n10. Those planning to move out of the geographic area in 12 months\n11. Unwillingness to provide informed consent\n12. Other conditions or situations at the discretion of the Investigative team'}, 'identificationModule': {'nctId': 'NCT06257550', 'acronym': 'THRIVE', 'briefTitle': 'AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors', 'orgStudyIdInfo': {'id': 'IRB00427492'}, 'secondaryIdInfos': [{'id': '24FIM1264121', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THRIVE Intervention Arm', 'description': 'The THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services.', 'interventionNames': ['Behavioral: THRIVE Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Arm', 'description': 'The comparator arm will receive standard produce bags; and linkages to social services.', 'interventionNames': ['Behavioral: Active Comparator']}], 'interventions': [{'name': 'THRIVE Intervention', 'type': 'BEHAVIORAL', 'description': 'THRIVE Intervention includes:\n\n1. Weekly Pulse Surveys\n2. Adaptive culturally tailored messages\n3. Personalized Dietitian Coaching\n4. Produce Prescription "FARMacy" Mobile Market\n5. Linkages to Social Services', 'armGroupLabels': ['THRIVE Intervention Arm']}, {'name': 'Active Comparator', 'type': 'BEHAVIORAL', 'description': 'The Active Comparator arm will receive standard produce bags through our food is medicine partner, and will receive the linkages to needed social and health resources intervention components.', 'armGroupLabels': ['Comparator Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Oluwabunmi Ogungbe, PhD, MPH, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JHU School Of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}