Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-12 @ 1:49 AM
Study NCT ID:
NCT05973760
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Assessment and Prevention of Hypertension in Nigeria
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-19', 'size': 432971, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-24T15:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of Clinical food frequency questionnaire (FFQ)', 'timeFrame': 'Phase 1 (4-8 weeks)', 'description': 'Demonstrate the ability of a novel short clinical FFQ to accurately reflect diet habits'}, {'measure': 'Feasibility of FFQ clinical tool in Nigerian clinic', 'timeFrame': 'Phase1 (4-8 weeks) and Phase 2 (4-8 weeks)', 'description': "Do patients, clinicians, and nurses see value in the tool in a clinical setting and accepting of it's use in the clinic"}], 'secondaryOutcomes': [{'measure': 'Hypertension/Blood Pressure', 'timeFrame': 'Phase 2 (4 - 8 weeks)', 'description': 'Association between FFQ clinical tool and blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diet', 'West Africa', 'nutrition', 'LMIC'], 'conditions': ['Hypertension', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '39429509', 'type': 'DERIVED', 'citation': 'Batubo NP, Auma CI, Moore JB, Zulyniak MA. Relative Validity and Reproducibility of a Dietary Screening Tool in Nigerian Health Care. Curr Dev Nutr. 2024 Sep 20;8(10):104459. doi: 10.1016/j.cdnut.2024.104459. eCollection 2024 Oct.'}, {'pmid': '38662712', 'type': 'DERIVED', 'citation': 'Batubo NP, Nwanze NM, Alikor CA, Auma CI, Moore JB, Zulyniak MA. Empowering healthcare professionals in West Africa-A feasibility study and qualitative assessment of a dietary screening tool to identify adults at high risk of hypertension. PLoS One. 2024 Apr 25;19(4):e0294370. doi: 10.1371/journal.pone.0294370. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa and, currently, there are no simple dietary assessment tools for clinicians to offer personalized dietary support to their patients. This study aims to:\n\n1. Evaluate the feasibility and validate the a short dietary screening tool for hypertension for use in Nigerian clinics; and\n2. Test the accuracy and estimate the potential value of the validated short dietary assessment tool in Nigeria clinics.', 'detailedDescription': 'Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa. With a transition from whole foods to processed foods in Nigeria, diet is considered a key driver of hypertension. To combat this, the national nutritional guidelines in Nigeria were implemented but their translation into actionable tools for clinicians remains a challenge. Currently, there are no simple dietary assessment tools that are concise and suitable to be incorporated into clinical care without requiring extensive data analysis while still providing personalized dietary support to their patients. This study aims to deliver a clinically tested and validated short dietary assessment tool for clinicians, patients, and researchers across Nigeria to provide personalised dietary advice for patients with hypertension.\n\nThe study will be conducted in two phases: Phase 1 (n=75), will investigate the feasibility of the short FFQ and its agreement with 24-hour dietary recalls (3x) in a clinical setting in Nigeria. During the analysis of Phase 1 data, a scoring system will be developed based on the associations between individual food items in the FFQ and measures of hypertension. Phase 2 (n=50) will assess the acceptability of the FFQ and validate the association between the FFQ score and hypertension.\n\nWe anticipate that the development of a clinically tested and validated short food frequency questionnaire that will be ready for implementation analysis for use by clinicians, patients, and researchers across Nigerian that will support the prevention and management of hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women deciding in Nigeria visiting River State University Teaching Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women of generally good health or with hypertension\n\nExclusion Criteria:\n\n* history of chronic diseases such as cardiovascular diseases (heart diseases), stroke, chronic kidney diseases, or pregnant or breastfeeding women, children below 18 years and adults above 70 years are also excluded from this study. Additionally, individuals who have made significant changes to their diet in the past six months or are currently following specific dietary restrictions will also be excluded from this study'}, 'identificationModule': {'nctId': 'NCT05973760', 'briefTitle': 'Dietary Assessment and Prevention of Hypertension in Nigeria', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Dietary Assessment and Prevention of Hypertension in Nigeria', 'orgStudyIdInfo': {'id': 'FREC 2023-0484-572'}, 'secondaryIdInfos': [{'id': 'RSUTH/REC/2023316', 'type': 'OTHER', 'domain': 'Rivers State University Teaching Hospital, Nigeria'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertensive', 'description': 'Men or women previously diagnosed with hypertension'}, {'label': 'Non-hypertensive', 'description': 'Men or women not previously diagnosed with hypertension'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Port Harcourt', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Michael Zulyniak, PhD', 'role': 'CONTACT', 'email': 'prcmaz@leeds.ac.uk'}, {'name': 'Nimisoere Batubo, MBBS', 'role': 'CONTACT', 'email': 'fsnpb@leeds.ac.uk'}, {'name': 'Michael Zulyniak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nimisoere Batubo, MMBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Royal State University', 'geoPoint': {'lat': 4.77742, 'lon': 7.0134}}], 'centralContacts': [{'name': 'Nimisoere Batubo, MMBS', 'role': 'CONTACT', 'email': 'fsnpb@leeds.ac.uk', 'phone': '01782 715444'}, {'name': 'Michael Zulyniak, PhD', 'role': 'CONTACT', 'email': 'prcmaz@leeds.ac.uk'}], 'overallOfficials': [{'name': 'Michael Zulyniak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leeds'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rivers State University Teaching Hospital', 'class': 'UNKNOWN'}, {'name': 'Tertiary Education Trust Fund (TETFund)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Michael A Zulyniak', 'investigatorAffiliation': 'University of Leeds'}}}}