Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters (RICH)

November 17, 2025 updated by: Istituto Auxologico Italiano

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:
        • Principal Investigator:
          • Daniela Lucini, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

- ability to provide informed consent in compliance with the rules of Good Clinical Practice and current national regulations

Exclusion Criteria:

  • inability to fill in the questionnaire
  • inability to provide informed consent
  • unwillingness to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nutrition quality
Time Frame: through study completion, an average of 1 year
American Heart Association (AHA) Diet Score
through study completion, an average of 1 year
weight
Time Frame: through study completion, an average of 1 year
kg
through study completion, an average of 1 year
height
Time Frame: through study completion, an average of 1 year
cm
through study completion, an average of 1 year
blood pressure
Time Frame: through study completion, an average of 1 year
mmHg
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
short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40)
through study completion, an average of 1 year
glycemia
Time Frame: through study completion, an average of 1 year
mg/dl
through study completion, an average of 1 year
cholesterol
Time Frame: through study completion, an average of 1 year
mg/dl
through study completion, an average of 1 year
creatinine
Time Frame: through study completion, an average of 1 year
mg/dl
through study completion, an average of 1 year
waist circumference
Time Frame: through study completion, an average of 1 year
cm
through study completion, an average of 1 year
heart rate
Time Frame: through study completion, an average of 1 year
bpm
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 30, 2033

Study Completion (Estimated)

April 30, 2033

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45C301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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