Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT06499194
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073601', 'term': 'Dietary Approaches To Stop Hypertension'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'an Open-label parallel design prospective controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-06', 'studyFirstSubmitDate': '2024-07-06', 'studyFirstSubmitQcDate': '2024-07-06', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '9 month', 'description': 'patient on DASH diet showing decrease on blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DASH diet', 'hypertension', 'health expense'], 'conditions': ['Hypertension,Essential']}, 'referencesModule': {'references': [{'pmid': '21860783', 'type': 'BACKGROUND', 'citation': 'Abolfotouh MA, Soliman LA, Abolfotouh SM, Raafat M. Knowledge and Practice of PHC Physicians toward the Detection and Management of Hypertension and Other CVD Risk Factors in Egypt. Int J Hypertens. 2011;2011:983869. doi: 10.4061/2011/983869. Epub 2011 Aug 11.'}, {'pmid': '31358075', 'type': 'BACKGROUND', 'citation': 'Akhlaghi M. Dietary Approaches to Stop Hypertension (DASH): potential mechanisms of action against risk factors of the metabolic syndrome. Nutr Res Rev. 2020 Jun;33(1):1-18. doi: 10.1017/S0954422419000155. Epub 2019 Jul 30.'}, {'pmid': '35547452', 'type': 'BACKGROUND', 'citation': 'Al-Smair A, Saadeh O, Saadeh A, Al-Ali A. Renovascular Compression by the Diaphragmatic Crus: A Case Report. Cureus. 2022 Apr 10;14(4):e24004. doi: 10.7759/cureus.24004. eCollection 2022 Apr.'}, {'pmid': '9099655', 'type': 'BACKGROUND', 'citation': 'Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.'}, {'pmid': '28335429', 'type': 'BACKGROUND', 'citation': 'Ancker OV, Wehland M, Bauer J, Infanger M, Grimm D. The Adverse Effect of Hypertension in the Treatment of Thyroid Cancer with Multi-Kinase Inhibitors. Int J Mol Sci. 2017 Mar 14;18(3):625. doi: 10.3390/ijms18030625.'}]}, 'descriptionModule': {'briefSummary': 'DASH diet can reduce hypertension and decrease health expenses', 'detailedDescription': "Hypertension is a prevalent cardiovascular risk factor associated with adverse outcomes and obesity. Egypt's prevalence is 26.3%, exceeding rates in the U.S. and sub-Saharan Africa. Lifestyle interventions like the DASH diet effectively manage hypertension, offering a cost-effective alternative to pharmacological treatments. This study aims to assess the effects of the DASH diet on blood pressure, BMI, waist circumference, and fasting blood glucose, as well as its cost-effectiveness compared to pharmacological treatments. This open-label prospective controlled clinical trial was conducted in Esna Health Administration, Luxor Governorate. The FMREC of Beni-Suef University approved the study, which included 364 hypertensive patients aged 30-60. Exclusions were patients with severe comorbidities or those who declined participation. Measurements included height, weight, BMI, blood pressure, and laboratory tests. The intervention group received a DASH diet education program. Outcomes measured were blood pressure, BMI, waist circumference, weight, and fasting blood glucose at baseline and post-intervention. Our study demonstrates the significant benefits of the DASH diet in managing blood pressure, weight, and fasting blood glucose levels in the Egyptian population. The DASH diet substantially reduced systolic and diastolic blood pressure, with a notable decrease in the number of antihypertensive medications needed. Additionally, participants on the DASH diet experienced significant weight loss and reduced BMI and waist circumference compared to the control group. The economic implications of the DASH diet are also promising, with a notable decrease in the total cost of therapy due to reduced medication costs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with primary hypertension (all stages) in the family medicine units of Esna Health Administration, located in Luxor Governorate.\n* Individuals between the ages of 30 and 60, of both male and female genders.\n\nExclusion Criteria:\n\n* • Patients with cancer and either hepatic failure or renal impairment.\n\n * Patients diagnosed with diabetes, metabolic illness, or terminal organ failure.\n * A patient with severe or malignant hypertension.\n * Individuals who decline to partake in our research.'}, 'identificationModule': {'nctId': 'NCT06499194', 'briefTitle': 'Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension', 'orgStudyIdInfo': {'id': 'DASH diet and hypertension'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention group', 'description': 'Participants will taken a medical history review, anthropometric assessments, and waist circumference measurements. Tests included hemoglobin levels, kidney and liver function tests, fasting blood glucose, and lipid profiles. Baseline antihypertensive medications will be recorded in an Excel sheet and taken DASH diet .', 'interventionNames': ['Other: DASH diet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Participants will taken a medical history review, anthropometric assessments, and waist circumference measurements. Tests included hemoglobin levels, kidney and liver function tests, fasting blood glucose, and lipid profiles. Baseline antihypertensive medications will be recorded in an Excel sheet and without taken DASH diet .', 'interventionNames': ['Other: DASH diet']}], 'interventions': [{'name': 'DASH diet', 'type': 'OTHER', 'description': 'The Dietary Approaches to Stop Hypertension (DASH) diets rich in fruits and vegetables and reduced in saturated fat can lower the risk for high blood pressure and assist with blood pressure control in hypertensive persons', 'armGroupLabels': ['control group', 'intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '621125', 'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mohamed Hassan Street from Salah Salem Street, Beni-Suef', 'investigatorFullName': 'Ola Abu hashima abd elwahab', 'investigatorAffiliation': 'Beni-Suef University'}}}}