NCT04596358

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

12 months

First QC Date

October 8, 2020

Last Update Submit

October 15, 2020

Conditions

Keywords

Mediterranean DietLipid profileHealthcare workers

Outcome Measures

Primary Outcomes (1)

  • Adherence to the Mediterranean diet greater control of circulating lipid levels

    Score of adherence (points)

    at Baseline

Secondary Outcomes (8)

  • Fasting plasma glucose

    Baseline

  • Serum insulin

    Baseline

  • systolic blood pressure

    Baseline

  • diastolic blood pressure

    Baseline

  • Waist circumference

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

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.

Other: Observational

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.

Other: Observational

Interventions

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

Healtcare workersNon-Healthcare workers

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Women of working age
  • Level of education at least equal to Bachelor's degree

You may not qualify if:

  • Men
  • Women under 20 years old or over 65 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonella Pipoli

Bari, Apulia, 70125, Italy

Location

Related Publications (6)

  • 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: 10485342BACKGROUND
  • 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: 25325250BACKGROUND
  • 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: 32255377BACKGROUND
  • 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: 25797688BACKGROUND
  • 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: 17126772BACKGROUND
  • 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.

MeSH Terms

Conditions

Feeding BehaviorHypercholesterolemiaHypertension

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 22, 2020

Study Start

March 10, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations