Health BehaviorNCT06262672
Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process
An observational study of Health Behavior and Sleep, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Sleep, Body Weight
- What is being tested?
- Evaluation form
- How many people
- 236 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2021to 20 Nov 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students registered to Kırklareli University Faculty of Health Sciences and attending distance education due to COVID-19 pandema
Who may be able to join
- Students who are registered to Kırklareli University Faculty of Health Sciences and aged 18 years and older who agreed to participate in the study
- Those who are capable of filling out surveys online
- Those with internet access
- With the fully answered to the questionnaire and scale questions
Who cannot join
- Students who are not registered to Kırklareli University Faculty of Health Sciences
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirklareli University
Kırklareli, Kayalı, 39000
About this study
Official title: The Relationship Between Healthy Lifestyle Behaviors, Sleep Quality, and Body Weight in University Students During the COVID-19 Epidemic Process
The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail.
Read the detailed description
This study focuses on distance education, remote working, etc. during the pandemic period. It is compatible with the findings of studies on the subject and reveals that the nutrition and physical activity sub-parameters of the healthy lifestyle behaviors scale are related to anthropometric characteristics and sleep quality. Considering that the online working model has become widespread, from this perspective, for future studies, the effects of behavioral change strategies on individuals' sleep quality and anthropometric values can be investigated.
- Conditions
- Health Behavior, Sleep, Body Weight
- Being tested
- Evaluation form
- Medical subject headings
- Health Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation formOther
This form is a form of demographic information, questions that question the habits of COVİD-19 era, and evaluation scales.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Promotion Life-Style Profile (HPLP-II)
The scale measures health-promoting behaviors in relation to an individual's healthy lifestyle. The scale consists of a total of 52 items and has six sub-factors. The subgroups are spiritual development, health responsibility, physical activity, nutrition, interpersonal relationships, and stress management.
Measured: Students who filled the survey between 20/11/2021 with 20/05/2021
Pittsburgh Sleep Quality Index (PSQI)
PSQI, which evaluates the individual's sleep quality in the last month, contains a total of 24 questions. 19 of these are self-reported questions and are answered by the patient himself.
Measured: Students who filled the survey between 20/11/2021 with 20/05/2021
Anthropometric Measurements
Body weights (kg) and height lengths (cm) were taken as anthropometric measurements of individuals, and body mass indexes (BMI) were calculated. WHO classification was used in the evaluation of BMI. According to this classification, the BMI is less than 18.5 kg/m2, weak, 18.5-24.9 kg/m2 are normal, 25.0-29.9 kg/m2 are classified as slightly fat, and over 30 kg/m2
Measured: Students who filled the survey between 20/11/2021 with 20/05/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start20 May 2021
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Demirhan, Kırklareli University
- Investigators
- Merve PEHLIVAN, Assoc. prof., Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262672
- Sponsor's protocol ID
- PR0319R01
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 28 Feb 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Healthy Lifestyle Behaviors, Sleep Quality, and Body Weight in University Students During the COVID-19 Epidemic Process
- ClinicalTrials.gov ID
- NCT06262672
- Acronym / sponsor ID
- PR0319R01
- Conditions
- Health Behavior, Sleep, Body Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 16 Feb 2024 (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.
The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail.
Detailed description
This study focuses on distance education, remote working, etc. during the pandemic period. It is compatible with the findings of studies on the subject and reveals that the nutrition and physical activity sub-parameters of the healthy lifestyle behaviors scale are related to anthropometric characteristics and sleep quality. Considering that the online working model has become widespread, from this perspective, for future studies, the effects of behavioral change strategies on individuals' sleep quality and anthropometric values can be investigated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students registered to Kırklareli University Faculty of Health Sciences and attending distance education due to COVID-19 pandema
Key inclusion criteria (4 listed)
- Students who are registered to Kırklareli University Faculty of Health Sciences and aged 18 years and older who agreed to participate in the study
- Those who are capable of filling out surveys online
- Those with internet access
- With the fully answered to the questionnaire and scale questions
Key exclusion criteria (1 listed)
- Students who are not registered to Kırklareli University Faculty of Health Sciences
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation formThis form is a form of demographic information, questions that question the habits of COVİD-19 era, and evaluation scales. | Other | – |
Primary outcome
Health Promotion Life-Style Profile (HPLP-II)
Time frame: Students who filled the survey between 20/11/2021 with 20/05/2021
The scale measures health-promoting behaviors in relation to an individual's healthy lifestyle. The scale consists of a total of 52 items and has six sub-factors. The subgroups are spiritual development, health responsibility, physical activity, nutrition, interpersonal relationships, and stress management.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Students who filled the survey between 20/11/2021 with 20/05/2021
PSQI, which evaluates the individual's sleep quality in the last month, contains a total of 24 questions. 19 of these are self-reported questions and are answered by the patient himself.
Anthropometric Measurements
Time frame: Students who filled the survey between 20/11/2021 with 20/05/2021
Body weights (kg) and height lengths (cm) were taken as anthropometric measurements of individuals, and body mass indexes (BMI) were calculated. WHO classification was used in the evaluation of BMI. According to this classification, the BMI is less than 18.5 kg/m2, weak, 18.5-24.9 kg/m2 are normal, 25.0-29.9 kg/m2 are classified as slightly fat, and over 30 kg/m2
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 28 Feb 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.
Merve PEHLIVAN, Assoc. prof. principal investigator
Trakya University
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 Health Behavior and Sleep, run by Kırklareli University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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 28 Feb 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 Turkey (Türkiye). 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?
Health Promotion Life-Style Profile (HPLP-II) (time frame: Students who filled the survey between 20/11/2021 with 20/05/2021). The study lists 3 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 28 Feb 2024.