Diet HabitNCT04596358
Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers
An observational study of Diet Habit and Hypercholesterolemia, run by University of Bari Aldo Moro at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Hypercholesterolemia, Hypertension
- What is being tested?
- Observational
- How many people
- 147 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2018to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Women of working age
- Level of education at least equal to Bachelor's degree
Who cannot join
- Men
- Women under 20 years old or over 65 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diet Habit, Hypercholesterolemia, Hypertension
- Being tested
- Observational
- Keywords
- Mediterranean Diet, Lipid profile, Healthcare workers
- Medical subject headings
- Feeding Behavior, Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Mediterranean diet greater control of circulating lipid levels
Score of adherence (points)
Measured: at Baseline
Secondary outcomes (8)
Fasting plasma glucose
Fasting plasma glucose in mg/dl
Measured: Baseline
Serum insulin
Serum insulin microU/ml
Measured: Baseline
systolic blood pressure
systolic blood pressure (mmHg)
Measured: Baseline
diastolic blood pressure
diastolic blood pressure (mmHg)
Measured: Baseline
Waist circumference
Waist circumference in centimeters
Measured: Baseline
BMI (Body Mass Index)
BMI in kilograms/(meters)2
Measured: Baseline
LDL-Cholesterol
LDL-Cholesterol in mg/dl
Measured: Baseline
Triglycerides
Triglyceridesin mg/dl
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start10 Mar 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Responsible party
- Principal investigator, Antonella Pipoli, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596358
- Sponsor's protocol ID
- 10/2018
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 10485342D'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.
PubMed 25325250Di 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.
PubMed 32255377Juarez-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.
PubMed 25797688Panagiotakos 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.
PubMed 17126772Di 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.
PubMed 34805058
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers
- ClinicalTrials.gov ID
- NCT04596358
- Acronym / sponsor ID
- 10/2018
- Conditions
- Diet Habit, Hypercholesterolemia, Hypertension
- Keywords
- Mediterranean Diet, Lipid profile, Healthcare workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healtcare workers | – | Other: ObservationalWomen 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. |
| Non-Healthcare workers | – | Other: ObservationalWomen 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Women of working age
- Level of education at least equal to Bachelor's degree
Key exclusion criteria (2 listed)
- Men
- Women under 20 years old or over 65 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalEvaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire. | Other | Healtcare workers, Non-Healthcare workers |
Primary outcome
Adherence to the Mediterranean diet greater control of circulating lipid levels
Time frame: at Baseline
Score of adherence (points)
8 secondary outcomes
Fasting plasma glucose
Time frame: Baseline
Serum insulin
Time frame: Baseline
systolic blood pressure
Time frame: Baseline
diastolic blood pressure
Time frame: Baseline
Waist circumference
Time frame: Baseline
BMI (Body Mass Index)
Time frame: Baseline
LDL-Cholesterol
Time frame: Baseline
Triglycerides
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 10485342Menotti 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.
- Background: PubMed 25325250D'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.
- Background: PubMed 32255377Di 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.
- Background: PubMed 25797688Juarez-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.
- Background: PubMed 17126772Panagiotakos 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.
- Derived from this study: PubMed 34805058Di 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit and Hypercholesterolemia, run by University of Bari Aldo Moro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Mediterranean diet greater control of circulating lipid levels (time frame: at Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596358, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.