Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06283069
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2033-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weekly physical activity volume', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'nutrition quality', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'American Heart Association (AHA) Diet Score'}, {'measure': 'weight', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'kg'}, {'measure': 'height', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cm'}, {'measure': 'blood pressure', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mmHg'}, {'measure': 'perception of stress, fatigue, and somatic symptoms', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40)'}, {'measure': 'glycemia', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mg/dl'}, {'measure': 'cholesterol', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mg/dl'}, {'measure': 'creatinine', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mg/dl'}, {'measure': 'waist circumference', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cm'}, {'measure': 'heart rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'bpm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Lifestyle', 'Nutrition, Healthy', 'Physical Inactivity', 'Stress', 'Sleep']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nOnly those persons who voluntarily provide their consent will participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- ability to provide informed consent in compliance with the rules of Good Clinical Practice and current national regulations\n\nExclusion Criteria:\n\n* inability to fill in the questionnaire\n* inability to provide informed consent\n* unwillingness to participate in the study'}, 'identificationModule': {'nctId': 'NCT06283069', 'acronym': 'RICH', 'briefTitle': 'Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Relationship Between Lifestyle Indicators (Healthy Behaviours) and Cardiovascular Clinical Parameters (Healthy Factors)', 'orgStudyIdInfo': {'id': '45C301'}}, 'armsInterventionsModule': {'interventions': [{'name': 'compilation of a questionnaire about LifeStyle', 'type': 'BEHAVIORAL', 'description': 'compilation of a questionnaire about LifeStyle'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Giovanelli, MD', 'role': 'CONTACT', 'email': 'luca.giovanelli@unimi.it', 'phone': '+3902619112808'}, {'name': 'Daniela Lucini, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Auxologico Italiano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Luca Giovanelli, MD', 'role': 'CONTACT', 'email': 'luca.giovanelli@unimi.it', 'phone': '+390261911', 'phoneExt': '2808'}, {'name': 'Luca Grappiolo', 'role': 'CONTACT', 'email': 'luca.grappiolo@auxologico.it', 'phone': '+390261911', 'phoneExt': '2894'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}