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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06283069
Other study ID # 45C301
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date April 30, 2033

Study information

Verified date February 2024
Source Istituto Auxologico Italiano
Contact Luca Giovanelli, MD
Phone +390261911
Email luca.giovanelli@unimi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 30, 2033
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility 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 Design


Intervention

Behavioral:
compilation of a questionnaire about LifeStyle
compilation of a questionnaire about LifeStyle

Locations

Country Name City State
Italy Istituto Auxologico Italiano Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 nutrition quality American Heart Association (AHA) Diet Score through study completion, an average of 1 year
Secondary weight kg through study completion, an average of 1 year
Secondary height cm through study completion, an average of 1 year
Secondary blood pressure mmHg through study completion, an average of 1 year
Secondary perception of stress, fatigue, and somatic symptoms short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40) through study completion, an average of 1 year
Secondary glycemia mg/dl through study completion, an average of 1 year
Secondary cholesterol mg/dl through study completion, an average of 1 year
Secondary creatinine mg/dl through study completion, an average of 1 year
Secondary waist circumference cm through study completion, an average of 1 year
Secondary heart rate bpm through study completion, an average of 1 year
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