NCT06283069

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
85mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress30%
May 2023Apr 2033

Study Start

First participant enrolled

May 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2033

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

10 years

First QC Date

February 12, 2024

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    through study completion, an average of 1 year

Secondary Outcomes (10)

  • nutrition quality

    through study completion, an average of 1 year

  • weight

    through study completion, an average of 1 year

  • height

    through study completion, an average of 1 year

  • blood pressure

    through study completion, an average of 1 year

  • perception of stress, fatigue, and somatic symptoms

    through study completion, an average of 1 year

  • +5 more secondary outcomes

Interventions

compilation of a questionnaire about LifeStyle

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesSedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 28, 2024

Study Start

May 1, 2023

Primary Completion (Estimated)

April 30, 2033

Study Completion (Estimated)

April 30, 2033

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations