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

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

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

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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