Quality of LifeNCT05394441
Health and Quality of Life of ITMO University's Students, Faculty and Staff
An observational study of Quality of Life, run by ITMO University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- 830 participants
- Where
- 1 siteRussia
- Study dates
- 2 Jun 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Students, faculty and staff from ITMO University
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selected Health and Quality of Life Indicators Among ITMO University Students, Faculty and Staff
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.
Read the detailed 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.
- Conditions
- Quality of Life
- Keywords
- students, faculty, academia, university
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults (16+) | Healthy students, faculty and staff of ITMO University older than 16 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol
Measured by A15 biochemical automatic analyzer (Biosystem, Spain)
Measured: 30 days
Lipidogram
Measured by A15 biochemical automatic analyzer (Biosystem, Spain)
Measured: 30 days
Glycohemoglobin
Measured by Architect c8000
Measured: 30 days
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
Measured: 30 days
Psychological well-being
Measured by Oxford Happiness Questionnaire (OHQ)
Measured: 30 days
Health status and quality of life
Measured by EuroQOL-5 Dimension Questionnaire (EQ-5D-5L)
Measured: 30 days
Nicotine dependence
Nicotine dependence across all nicotine product types including cigarettes and electronic cigarettes measured by The Penn State Nicotine Dependence Index
Measured: 30 days
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
Measured: 30 days
Sleep quality and disturbances.
Measured by Pittsburgh Sleep Quality Index
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
Alcohol use
Problematic alcohol use, including possible alcohol use disorders measured by The Russian version of the Alcohol Use Disorders Identification Test (AUDIT)
Measured: 30 days
Ischemic heart disease prediction
Measured by The Rose angina screening questionnaire
Measured: 30 days
Retinopathy
Measured with non-mydriatic fundus camera
Measured: 30 days
Ocular fundus condition
Measured with non-mydriatic fundus camera
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start2 Jun 2022
- Primary completion31 Mar 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITMO University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394441
- Sponsor's protocol ID
- 922022/4.3.1
- Status last verified
- Mar 2024
- First submitted
- 24 May 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selected Health and Quality of Life Indicators Among ITMO University Students, Faculty and Staff
- ClinicalTrials.gov ID
- NCT05394441
- Acronym / sponsor ID
- 922022/4.3.1
- Conditions
- Quality of Life
- Keywords
- students, faculty, academia, university
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- ITMO UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults (16+) | – | –Healthy students, faculty and staff of ITMO University older than 16 years |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students, faculty and staff from ITMO University
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cholesterol
Time frame: 30 days
Measured by A15 biochemical automatic analyzer (Biosystem, Spain)
Lipidogram
Time frame: 30 days
Measured by A15 biochemical automatic analyzer (Biosystem, Spain)
Glycohemoglobin
Time frame: 30 days
Measured by Architect c8000
Distress
Time frame: 30 days
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
Psychological well-being
Time frame: 30 days
Measured by Oxford Happiness Questionnaire (OHQ)
Health status and quality of life
Time frame: 30 days
Measured by EuroQOL-5 Dimension Questionnaire (EQ-5D-5L)
Nicotine dependence
Time frame: 30 days
Nicotine dependence across all nicotine product types including cigarettes and electronic cigarettes measured by The Penn State Nicotine Dependence Index
Diabetes risk score
Time frame: 30 days
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
Sleep quality and disturbances.
Time frame: 30 days
Measured by Pittsburgh Sleep Quality Index
Physical activity
Time frame: 30 days
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
Emotional eating, external eating, and restrained eating behavior
Time frame: 30 days
Qualitative and quantitative assessment of eating disorders associated with overeating and accompanying obesity measured by Dutch Eating Behavior Questionnaire
Alcohol use
Time frame: 30 days
Problematic alcohol use, including possible alcohol use disorders measured by The Russian version of the Alcohol Use Disorders Identification Test (AUDIT)
Ischemic heart disease prediction
Time frame: 30 days
Measured by The Rose angina screening questionnaire
Retinopathy
Time frame: 30 days
Measured with non-mydriatic fundus camera
Ocular fundus condition
Time frame: 30 days
Measured with non-mydriatic fundus camera
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by ITMO University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol (time frame: 30 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.