Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06616818
Status:
WITHDRAWN
Last Update Posted:
2025-08-14
First Post:
2024-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DASH Diet Intervention for Systemic Hypertension in Adolescents
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': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '6 months of produce delivery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding not awarded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2031-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2024-09-25', 'studyFirstSubmitQcDate': '2024-09-25', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vegetable and fruit intake', 'timeFrame': '12 weeks and 6months', 'description': 'Change in the average number of servings of vegetables and fruits consumed in a day.'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '12 weeks and 6 months', 'description': 'Change in manual, in office systolic blood pressure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Food Insecurity']}, 'descriptionModule': {'briefSummary': 'Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.', 'detailedDescription': 'Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12 to 17 years of age at baseline visit\n* Elevated blood pressure or hypertension\n\nExclusion Criteria:\n\n* Inability to eat by mouth\n* Secondary hypertension'}, 'identificationModule': {'nctId': 'NCT06616818', 'acronym': 'DISH', 'briefTitle': 'DASH Diet Intervention for Systemic Hypertension in Adolescents', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'DASH Diet Intervention for Systemic Hypertension in Adolescents', 'orgStudyIdInfo': {'id': 'Nemours DASH Diet Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'STANDARD', 'description': 'Nutrition counseling only as part of standard of care', 'interventionNames': ['Other: nutrition counselling only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DASH diet toolkit arm', 'description': 'A group of participants receiving DASH diet intervention', 'interventionNames': ['Other: DASH-FV']}], 'interventions': [{'name': 'DASH-FV', 'type': 'OTHER', 'description': '12weeks of fruit and vegetable delivery to the home', 'armGroupLabels': ['DASH diet toolkit arm']}, {'name': 'nutrition counselling only', 'type': 'OTHER', 'description': 'nutrition counselling as part of standard of care', 'armGroupLabels': ['STANDARD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours Cardiac Center', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '6 months following study completion.', 'ipdSharing': 'YES', 'description': 'Upon request and upon completion.', 'accessCriteria': 'Available upon request, but only deidentifed data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Carissa Baker-Smith', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}