Cardiovascular DiseasesRICHNCT06283069
Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters
An observational study of Cardiovascular Diseases and Lifestyle, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Lifestyle, Nutrition, Healthy
- What is being tested?
- compilation of a questionnaire about LifeStyle
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 30 Apr 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants / patients (both adults and children from 6 years of age) who are referred by their General Practitioner to the Exercise Medicine Unit of the IRCCS Istituto Auxologico Italiano for an internal medicine visit, or other clinical examinations such as evaluation of the autonomic nervous system through spectral analysis of the variability of cardiovascular parameters, or bioimpedance analysis. Only those persons who voluntarily provide their consent will participate in the study.
Who may be able to join
- ability to provide informed consent in compliance with the rules of Good Clinical Practice and current national regulations
Who cannot join
- inability to fill in the questionnaire
- inability to provide informed consent
- unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan
Luca Giovanelli, MD, +3902619112808, luca.giovanelli@unimi.it
Daniela Lucini, Prof
About this study
Official title: Relationship Between Lifestyle Indicators (Healthy Behaviours) and Cardiovascular Clinical Parameters (Healthy Factors)
The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies.
- Conditions
- Cardiovascular Diseases, Lifestyle, Nutrition, Healthy, Physical Inactivity, Stress, Sleep
- Being tested
- compilation of a questionnaire about LifeStyle
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compilation of a questionnaire about LifeStyleBehavioural
compilation of a questionnaire about LifeStyle
What is being measured
The primary outcome is the main question the study is designed to answer.
weekly physical activity volume
short version of International Physical Activity Questionnaire, which focuses on intensity (nominally estimated in Metabolic Equivalents - MET - according to the type of activity) and duration (in minutes) of physical activity. The following levels will be considered: brisk walking (≈ 3.3 METs), other modalities of activity of moderate intensity (≈ 4.0 METs), and activities of vigorous intensity (≈ 8.0 METs)
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
nutrition quality
American Heart Association (AHA) Diet Score
Measured: through study completion, an average of 1 year
weight
kg
Measured: through study completion, an average of 1 year
height
cm
Measured: through study completion, an average of 1 year
blood pressure
mmHg
Measured: through study completion, an average of 1 year
perception of stress, fatigue, and somatic symptoms
short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40)
Measured: through study completion, an average of 1 year
glycemia
mg/dl
Measured: through study completion, an average of 1 year
cholesterol
mg/dl
Measured: through study completion, an average of 1 year
creatinine
mg/dl
Measured: through study completion, an average of 1 year
waist circumference
cm
Measured: through study completion, an average of 1 year
heart rate
bpm
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2023
- Primary completion30 Apr 2033 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283069
- Sponsor's protocol ID
- 45C301
- Acronym
- RICH
- Status last verified
- Nov 2025
- First submitted
- 12 Feb 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Lifestyle Indicators (Healthy Behaviours) and Cardiovascular Clinical Parameters (Healthy Factors)
- ClinicalTrials.gov ID
- NCT06283069
- Acronym / sponsor ID
- RICH / 45C301
- Conditions
- Cardiovascular Diseases, Lifestyle, Nutrition, Healthy, Physical Inactivity, Stress, Sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2033 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 28 Feb 2024 (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 goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants / patients (both adults and children from 6 years of age) who are referred by their General Practitioner to the Exercise Medicine Unit of the IRCCS Istituto Auxologico Italiano for an internal medicine visit, or other clinical examinations such as evaluation of the autonomic nervous system through spectral analysis of the variability of cardiovascular parameters, or bioimpedance analysis. Only those persons who voluntarily provide their consent will participate in the study.
Key inclusion criteria (1 listed)
- ability to provide informed consent in compliance with the rules of Good Clinical Practice and current national regulations
Key exclusion criteria (3 listed)
- inability to fill in the questionnaire
- inability to provide informed consent
- unwillingness to participate in the study
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 |
|---|---|---|
| compilation of a questionnaire about LifeStylecompilation of a questionnaire about LifeStyle | Behavioural | – |
Primary outcome
weekly physical activity volume
Time frame: through study completion, an average of 1 year
short version of International Physical Activity Questionnaire, which focuses on intensity (nominally estimated in Metabolic Equivalents - MET - according to the type of activity) and duration (in minutes) of physical activity. The following levels will be considered: brisk walking (≈ 3.3 METs), other modalities of activity of moderate intensity (≈ 4.0 METs), and activities of vigorous intensity (≈ 8.0 METs)
10 secondary outcomes
nutrition quality
Time frame: through study completion, an average of 1 year
weight
Time frame: through study completion, an average of 1 year
height
Time frame: through study completion, an average of 1 year
blood pressure
Time frame: through study completion, an average of 1 year
perception of stress, fatigue, and somatic symptoms
Time frame: through study completion, an average of 1 year
glycemia
Time frame: through study completion, an average of 1 year
cholesterol
Time frame: through study completion, an average of 1 year
creatinine
Time frame: through study completion, an average of 1 year
waist circumference
Time frame: through study completion, an average of 1 year
heart rate
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
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 Cardiovascular Diseases and Lifestyle, run by Istituto Auxologico Italiano 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 3 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Giovanelli, MD (+390261911 ext. 2808, luca.giovanelli@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weekly physical activity volume (time frame: through study completion, an average of 1 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 18 Nov 2025.