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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05394441
Other study ID # 922022/4.3.1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2022
Est. completion date December 31, 2023

Study information

Verified date March 2024
Source ITMO University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study assess various indicators of physical and mental health, quality of life, well-being and satisfaction among students, faculty and staff of ITMO University. Participants are invited to join the study via informational web-site. Several quality of life indicators are obtained via surveys and some blood samples are taken to assess health condition.


Description:

Students, faculty and staff from ITMO University are invited to participate in health examination on the campus. Surveys, such as EQ-5D-5L, K10+OHQ29, PSQI and others, assess different aspects of quality of life related to health. Also participants are asked to undergo several measurements by the interviewer (waist, hips, height, weight and others). Moreover blood samples are taken from the participants and lipidogram, cholesterol and glycohemoglobin are checked.


Recruitment information / eligibility

Status Completed
Enrollment 830
Est. completion date December 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - student, faculty or staff from ITMO University - participants, who signed informed consent and consent for data gathering - participants, who signed consent to enroll in following surveys and health check-ups Exclusion Criteria: - participants younger than 16 years old - participants with acute conditions distorting quality of life assessment - participants, who did not sign informed consent and consent for data gathering - participants, who did not sign consent to enroll in following surveys and health check-ups

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Russian Federation ITMO University Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
ITMO University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cholesterol Measured by A15 biochemical automatic analyzer (Biosystem, Spain) 30 days
Primary Lipidogram Measured by A15 biochemical automatic analyzer (Biosystem, Spain) 30 days
Primary Glycohemoglobin Measured by Architect c8000 30 days
Primary Distress Global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period measured by Kessler-10 questionnaire 30 days
Primary Psychological well-being Measured by Oxford Happiness Questionnaire (OHQ) 30 days
Primary Health status and quality of life Measured by EuroQOL-5 Dimension Questionnaire (EQ-5D-5L) 30 days
Primary Nicotine dependence Nicotine dependence across all nicotine product types including cigarettes and electronic cigarettes measured by The Penn State Nicotine Dependence Index 30 days
Primary Diabetes risk score The 10-year risk of type 2 diabetes mellitus (DM), including asymptomatic diabetes mellitus and impaired glucose tolerance (IGT) measured by The Finnish Diabetes Risk Score 30 days
Primary Sleep quality and disturbances. Measured by Pittsburgh Sleep Quality Index 30 days
Primary Physical activity The types of intensity of physical activity and sitting time that people do as part of their daily lives measured by International Physical Activity Questionnaire - Short Form 30 days
Primary Emotional eating, external eating, and restrained eating behavior Qualitative and quantitative assessment of eating disorders associated with overeating and accompanying obesity measured by Dutch Eating Behavior Questionnaire 30 days
Primary Alcohol use Problematic alcohol use, including possible alcohol use disorders measured by The Russian version of the Alcohol Use Disorders Identification Test (AUDIT) 30 days
Primary Ischemic heart disease prediction Measured by The Rose angina screening questionnaire 30 days
Primary Retinopathy Measured with non-mydriatic fundus camera 30 days
Primary Ocular fundus condition Measured with non-mydriatic fundus camera 30 days
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