OutcomeOIVITANCT03305276
Observatory on Impact of Life Styles on Health Outcomes
An observational study of Outcome, run by Guido Iaccarino at 1 site in Italy.
Trial summary
The present is an observational study conducted on the general population in villages of Southern Italy every year during the world hypertension day. So far, A total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the XI and XII World Hypertension Day (2015 and 2016). Read more about this study
- Who is it for?
- Ages 14 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Outcome
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2014to 16 May 2024
- 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 14 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Volunteers from Southern Italy will be recruited in occasion of health promoting events in villages.
Who may be able to join
- General population
Who cannot join
- Subjects who do not sign informed consent and do not give authorization will be excluded from the study
- Subjects fed through parenteral feeding
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Giovanni e Ruggi Hospital
Salerno, 84100
Guido Iaccarino, MD, 39089672335, guido.iaccarino@sangiovannieruggi.it
About this study
Official title: Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health
The present is an observational study conducted on the general population in villages of Southern Italy every year during the world hypertension day. So far, A total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the XI and XII World Hypertension Day (2015 and 2016). The study was approved by the relevant institutional Ethical Committee of Salerno University.
Read the detailed description
In occasion of the World Hypertension Day in may , boots are organized in the major squares of the southern italy villages, and volunteers of the Medical School of Salerno collect through means of questionnaires, anamnestic data and dietary habits, and measure blood pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events (coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn from the antecubital vein and blood is stored for biochemical analysis at the University Hospital Centralized Service. Data are digitally stored for analysis.
Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol, systolic BP and cigarette smoking pre-existing conditions and way of life are used for the calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score. Familiarity for cardiovascular disease is defined as cardiovascular events in parents and siblings less than 50 years old.
The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the last meal was recorded during the data collection. Blood glucose, insulin, blood urea nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed. Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) .
- Conditions
- Outcome
- Keywords
- diet;, exercise;, hypertension;, vitamin d
- Medical subject headings
- Motor Activity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| general population | the study is open to all population, (14-90 years, male/female) to verify the impact of lifestyles (mediterranean style) on intermediate and hard endpoint. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular events
Presence of events in the anamnesis of subjects enrolled
Measured: 10 year
Secondary outcomes (1)
cardiovascular risk
Framingham Risk Score
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start16 May 2014
- Primary completion16 Jul 2020 (estimated)
- Study completion16 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutcomeStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guido Iaccarino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guido Iaccarino, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305276
- Sponsor's protocol ID
- 1234
- Acronym
- OIVITA
- Status last verified
- Oct 2017
- First submitted
- 6 Jul 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health
- ClinicalTrials.gov ID
- NCT03305276
- Acronym / sponsor ID
- OIVITA / 1234
- Conditions
- Outcome
- Keywords
- diet;, exercise;, hypertension;, vitamin d
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Guido IaccarinoUniversity, hospital or other
- Study start
- 16 May 2014 (actual)
- Primary completion
- 16 Jul 2020 (estimated)
- Study completion
- 16 May 2024 (estimated)
- First posted
- 9 Oct 2017 (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 present is an observational study conducted on the general population in villages of Southern Italy every year during the world hypertension day. So far, A total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the XI and XII World Hypertension Day (2015 and 2016). The study was approved by the relevant institutional Ethical Committee of Salerno University.
Detailed description
In occasion of the World Hypertension Day in may , boots are organized in the major squares of the southern italy villages, and volunteers of the Medical School of Salerno collect through means of questionnaires, anamnestic data and dietary habits, and measure blood pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events (coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn from the antecubital vein and blood is stored for biochemical analysis at the University Hospital Centralized Service. Data are digitally stored for analysis.
Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol, systolic BP and cigarette smoking pre-existing conditions and way of life are used for the calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score. Familiarity for cardiovascular disease is defined as cardiovascular events in parents and siblings less than 50 years old.
The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the last meal was recorded during the data collection. Blood glucose, insulin, blood urea nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed. Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) .
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general population | – | –the study is open to all population, (14-90 years, male/female) to verify the impact of lifestyles (mediterranean style) on intermediate and hard endpoint. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Volunteers from Southern Italy will be recruited in occasion of health promoting events in villages.
Key inclusion criteria (1 listed)
- General population
Key exclusion criteria (2 listed)
- Subjects who do not sign informed consent and do not give authorization will be excluded from the study
- Subjects fed through parenteral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiovascular events
Time frame: 10 year
Presence of events in the anamnesis of subjects enrolled
1 secondary outcome
cardiovascular risk
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- 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.
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 Outcome, run by Guido Iaccarino 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 1 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: status not confirmed, as of the sponsor's last update on 9 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular events (time frame: 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2017.