Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04596358
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the Mediterranean diet greater control of circulating lipid levels', 'timeFrame': 'at Baseline', 'description': 'Score of adherence (points)'}], 'secondaryOutcomes': [{'measure': 'Fasting plasma glucose', 'timeFrame': 'Baseline', 'description': 'Fasting plasma glucose in mg/dl'}, {'measure': 'Serum insulin', 'timeFrame': 'Baseline', 'description': 'Serum insulin microU/ml'}, {'measure': 'systolic blood pressure', 'timeFrame': 'Baseline', 'description': 'systolic blood pressure (mmHg)'}, {'measure': 'diastolic blood pressure', 'timeFrame': 'Baseline', 'description': 'diastolic blood pressure (mmHg)'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline', 'description': 'Waist circumference in centimeters'}, {'measure': 'BMI (Body Mass Index)', 'timeFrame': 'Baseline', 'description': 'BMI in kilograms/(meters)2'}, {'measure': 'LDL-Cholesterol', 'timeFrame': 'Baseline', 'description': 'LDL-Cholesterol in mg/dl'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline', 'description': 'Triglyceridesin mg/dl'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mediterranean Diet', 'Lipid profile', 'Healthcare workers'], 'conditions': ['Diet Habit', 'Hypercholesterolemia', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '10485342', 'type': 'BACKGROUND', 'citation': 'Menotti A, Kromhout D, Blackburn H, Fidanza F, Buzina R, Nissinen A. Food intake patterns and 25-year mortality from coronary heart disease: cross-cultural correlations in the Seven Countries Study. The Seven Countries Study Research Group. Eur J Epidemiol. 1999 Jul;15(6):507-15. doi: 10.1023/a:1007529206050.'}, {'pmid': '25325250', 'type': 'BACKGROUND', 'citation': "D'Alessandro A, De Pergola G. Mediterranean diet pyramid: a proposal for Italian people. Nutrients. 2014 Oct 16;6(10):4302-16. doi: 10.3390/nu6104302."}, {'pmid': '32255377', 'type': 'BACKGROUND', 'citation': 'Di Lorenzo L, Pipoli A, Manghisi NM, Clodoveo ML, Corbo F, De Pergola G, Sabba C. Nutritional hazard analysis and critical control points at work (NACCPW): interdisciplinary assessment of subjective and metabolic work-related risk of the workers and their prevention. Int J Food Sci Nutr. 2020 Nov;71(7):902-908. doi: 10.1080/09637486.2020.1750572. Epub 2020 Apr 7.'}, {'pmid': '25797688', 'type': 'BACKGROUND', 'citation': 'Juarez-Perez CA, Aguilar-Madrid G, Haro-Garcia LC, Gopar-Nieto R, Cabello-Lopez A, Jimenez-Ramirez C, Aguado A, Martinez-Mendez LM, Chavez-Negrete A. Increased Cardiovascular Risk Using Atherogenic Index Measurement Among Healthcare Workers. Arch Med Res. 2015 Apr;46(3):233-9. doi: 10.1016/j.arcmed.2015.03.002. Epub 2015 Mar 19.'}, {'pmid': '17126772', 'type': 'BACKGROUND', 'citation': 'Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. doi: 10.1016/j.numecd.2005.08.006. Epub 2006 Feb 9.'}, {'pmid': '34805058', 'type': 'DERIVED', 'citation': 'Di Lorenzo L, Vimercati L, Pipoli A, Manghisi NM, Lampignano L, Caputi A, De Maria L, Zupo R, De Pergola G. Interplay Between Adherence to the Mediterranean Diet and Lipid Profile: A Comparative Survey Between Day-Time Healthcare and Non-healthcare Female Workers. Front Public Health. 2021 Nov 4;9:649760. doi: 10.3389/fpubh.2021.649760. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The study aims at testing the level of adherence to the Mediterranean diet among health-workers, comparing this aspect to the extra-working physical activity, anthropometric measures and prevalence of cardiovascular, metabolic and neoplastic diseases previously diagnosed.', 'detailedDescription': 'The study had a cross-sectional setting and included employees of both genders currently in service.\n\nBaseline data collection was structured as follows:\n\n* Clinical assessment and pathological history\n* Anthropometric measurements;\n* Haematochemical examinations;\n* Screening to adherence to Med-Diet by using "MedDietScore" questionnaire\n* Assessment of the Harvard Cancer Risk Index for the evaluation of risk factors, modifiable and not, of the most frequent oncological diseases in Italy (colon, lung, breast and prostate). The index provides an estimate of individual cancer risk and is not equivalent to a cancer diagnosis. In addition, the Harvard Cancer Risk Index itself can allow the doctor to advise the worker on useful measures to reduce it;\n* International Physical Activity Questionnairre (IPAQ)\n* Major anthropometric and haematochemical data also allow to obtain one of the most used risk indexes for cardiovascular diseases in the scientific literature the Framingham Score.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred and forty-seven subjects were randomly recruited at the Operating Unit of Occupational Medicine of the University Polyclinic Hospital of Bari in the last quarter of 2019. The whole sample included only female employees of public companies with at least 16 years of schooling, and subject to health surveillance by the occupational physicians of the above Operating Unit, subdivided as follows: fifty-nine HCWs (doctors and professional nurses) employees at the University Hospital of Bari, and eighty-eight employees of other public companies but not operating in the field of healthcare (non-HCWs).', 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women of working age\n* Level of education at least equal to Bachelor's degree\n\nExclusion Criteria:\n\n* Men\n* Women under 20 years old or over 65 years old"}, 'identificationModule': {'nctId': 'NCT04596358', 'briefTitle': 'Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers', 'organization': {'class': 'OTHER', 'fullName': 'University of Bari Aldo Moro'}, 'officialTitle': 'Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers', 'orgStudyIdInfo': {'id': '10/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healtcare workers', 'description': 'Women who work as nurses or doctors in public hospitals of which anthropometric and haematochemical data have been collected. Workers were given a questionnaire for the evaluation of the adherence to the Mediterranean diet.', 'interventionNames': ['Other: Observational']}, {'label': 'Non-Healthcare workers', 'description': 'Women who perform technical and managerial professions in a public administration body of which anthropometric and haematochemical data have been collected. Workers were given a questionnaire for the evaluation of the adherence to the Mediterranean diet.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.', 'armGroupLabels': ['Healtcare workers', 'Non-Healthcare workers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70125', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Antonella Pipoli', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bari Aldo Moro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Antonella Pipoli', 'investigatorAffiliation': 'University of Bari Aldo Moro'}}}}