Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters

Cardiovascular Diseases Clinical Trial

— RICH  

Official title:

Relationship Between Lifestyle Indicators (Healthy Behaviours) and Cardiovascular Clinical Parameters (Healthy Factors)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283069
• Other study ID #: 45C301
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lifestyle
• Physical Inactivity
• Sleep
• Stress

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