- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04596358
Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers
October 15, 2020 updated by: Antonella Pipoli, University of Bari Aldo Moro
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study had a cross-sectional setting and included employees of both genders currently in service.
Baseline data collection was structured as follows:
- Clinical assessment and pathological history
- Anthropometric measurements;
- Haematochemical examinations;
- Screening to adherence to Med-Diet by using "MedDietScore" questionnaire
- 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;
- International Physical Activity Questionnairre (IPAQ)
- 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.
Study Type
Observational
Enrollment (Actual)
147
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Puglia
-
Bari, Puglia, Italy, 70125
- Antonella Pipoli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
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).
Description
Inclusion Criteria:
- Women of working age
- Level of education at least equal to Bachelor's degree
Exclusion Criteria:
- Men
- Women under 20 years old or over 65 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healtcare workers
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.
|
Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.
|
|
Non-Healthcare workers
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.
|
Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to the Mediterranean diet greater control of circulating lipid levels
Time Frame: at Baseline
|
Score of adherence (points)
|
at Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting plasma glucose
Time Frame: Baseline
|
Fasting plasma glucose in mg/dl
|
Baseline
|
|
Serum insulin
Time Frame: Baseline
|
Serum insulin microU/ml
|
Baseline
|
|
systolic blood pressure
Time Frame: Baseline
|
systolic blood pressure (mmHg)
|
Baseline
|
|
diastolic blood pressure
Time Frame: Baseline
|
diastolic blood pressure (mmHg)
|
Baseline
|
|
Waist circumference
Time Frame: Baseline
|
Waist circumference in centimeters
|
Baseline
|
|
BMI (Body Mass Index)
Time Frame: Baseline
|
BMI in kilograms/(meters)2
|
Baseline
|
|
LDL-Cholesterol
Time Frame: Baseline
|
LDL-Cholesterol in mg/dl
|
Baseline
|
|
Triglycerides
Time Frame: Baseline
|
Triglyceridesin mg/dl
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2018
Primary Completion (Actual)
February 28, 2019
Study Completion (Actual)
February 28, 2019
Study Registration Dates
First Submitted
October 8, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 15, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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