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OpenTrials
Completed

NCT Number: NCT04596358

Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Antonella Pipoli

Bari, Apulia, 70125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.

Primary outcomes

  1. Adherence to the Mediterranean diet greater control of circulating lipid levels

    Time frame: at Baseline

    Score of adherence (points)

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: Baseline

    Fasting plasma glucose in mg/dl

  2. Serum insulin

    Time frame: Baseline

    Serum insulin microU/ml

  3. systolic blood pressure

    Time frame: Baseline

    systolic blood pressure (mmHg)

  4. diastolic blood pressure

    Time frame: Baseline

    diastolic blood pressure (mmHg)

  5. Waist circumference

    Time frame: Baseline

    Waist circumference in centimeters

  6. BMI (Body Mass Index)

    Time frame: Baseline

    BMI in kilograms/(meters)2

  7. LDL-Cholesterol

    Time frame: Baseline

    LDL-Cholesterol in mg/dl

  8. Triglycerides

    Time frame: Baseline

    Triglyceridesin mg/dl

Sponsors and collaborators

Lead sponsor

University of Bari Aldo Moro

Other

Collaborators

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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