ObesityNCT06578091
Executive Function in Obese
An observational study of Obesity, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of executive function problems on physical performance and general well-being in obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with BMI ≥30 kg/m2
Who may be able to join
- For the study group;
- Individuals volunteering for the study with BMI ≥30 kg/m2
- Individuals between the ages of 18-65 who volunteer to work
- Individuals who scored 21 points and above in the cognitive assessment
- For the control group;
- Individuals volunteering for the study with BMI ≥30 kg/m2
- Individuals between the ages of 18 and 65 who are willing to work
- Scoring less than 21 points on the cognitive assessment
Who cannot join
- Being at a mental level that cannot understand and answer the questions posed
- Having a diagnosed neurological disease
- Having had cancer within the last 2 years
- Having major organ dysfunction
- Having uncontrolled type 2 diabetes
- Loss of vision, hearing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Sciences University
Kütahya, Central, 43100
Cagri Delibay, +905071357105, cagri.28.11@gmail.com
İsmail Okur, Assist. Prof.
About this study
Official title: Effects of Executive Dysfunction on Physical Performance and General Well-Being in Obese Individuals
This study was planned to examine the effect of executive function problems on physical performance and general well-being in obese individuals.
- Conditions
- Obesity
- Keywords
- obesity, executive functions, physical performance, well-being
- Medical subject headings
- Obesity
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 |
|---|---|---|
| Executive Function Deficit Group | Not described | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function
It will be assessed with the Montreal Cognitive Assessment. Accordingly, a score of 21 points and above is considered normal. Individuals who score 21 points or less on this test will be included in the executive function deficit group. The others will included in control group.
Measured: Baseline
General Well-Being-Sleep Quality
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. The scale consists of 18 questions and 7 components and was developed to assess sleep disturbances and sleep quality in the last 1 month. These components include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction. For scoring, it is applied as 0 if it has never occurred during the last month, 1 if it occurs less than once a week, 2 if it occurs once or twice a week, and 3 if it occurs three or more times a week. The total score has a value between 0-21. If the total score obtained as a result of the questionnaire is above 5, sleep quality is clinically poor.
Measured: Baseline
General Well-Being-Quality of Life
Quality of life, sleep quality and depression levels will be assessed. Quality of life will be assessed with the 12-item Short Health Scale. Short Health Scale consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). Items related to physical and emotional role are answered as yes or no, while other items have Likert-type options ranging from 3 to 6. A higher score represents better health.
Measured: Baseline
Physical Performance-Timed Up and Go
The timed up and go test is a functional dynamic balance test. The Timed Up and Go test is a timed measurement in which the individual has to get up from a chair, walk 3 meters, turn around, walk back and sit down. The Timed Up and Go is used to assess functional mobility and dynamic balance control in older people to identify increased risk of falls. Participants will be asked to wear the shoes they regularly wear to walk at a normal pace and will be allowed walking aids. The time between the participants getting up from the chair and sitting down again will be recorded in seconds.
Measured: Baseline
General Well-Being-Depression and Anxiety
Depression and anxiety level will be assessed with the Hospital Depression and Anxiety Scale. It consists of 14 items. Seven of these items measure anxiety and the other seven items measure depression symptoms. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as not ill, 2 as borderline ill, and 2-3 as severely ill. Higher scores indicate more severe depression and anxiety.
Measured: Baseline
Physical Performance-Hand Grip Strength
A digital Jamar dynamometer calibrated for hand grip strength (Performance Health, Warrenville, IL), Participants will be instructed to squeeze the dynamometer as hard as possible while sitting in an upright position as recommended by the American Association of Hand Therapists, with arms at their sides, elbows flexed 90° and forearms in a neutral position. A trial will be requested beforehand. For hand grip strength, 3 measurements will be made with one-minute intervals between each measurement and the average value will be recorded.
Measured: Baseline
Physical Performance-Walking Speed
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. A clear distance of at least 10 meters in length will be determined and marks will be added at 2 meters and 8 meters. Timing will start when the individual\'s toes cross the 2 meter mark. The person will be instructed to walk as fast as you can safely walk until I say stop. The timing will stop when the toes cross the 8 meter mark. Three trials will be performed and the average of the three trials will be taken.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 Jan 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Okur, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578091
- Sponsor's protocol ID
- KSBU-2024/03-33
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Executive Dysfunction on Physical Performance and General Well-Being in Obese Individuals
- ClinicalTrials.gov ID
- NCT06578091
- Acronym / sponsor ID
- KSBU-2024/03-33
- Conditions
- Obesity
- Keywords
- obesity, executive functions, physical performance, well-being
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Aug 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.
This study was planned to examine the effect of executive function problems on physical performance and general well-being in obese individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive Function Deficit Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with BMI ≥30 kg/m2
Key inclusion criteria (8 listed)
- For the study group;
- Individuals volunteering for the study with BMI ≥30 kg/m2
- Individuals between the ages of 18-65 who volunteer to work
- Individuals who scored 21 points and above in the cognitive assessment
- For the control group;
Key exclusion criteria (6 listed)
- Being at a mental level that cannot understand and answer the questions posed
- Having a diagnosed neurological disease
- Having had cancer within the last 2 years
- Having major organ dysfunction
- Having uncontrolled type 2 diabetes
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
Executive function
Time frame: Baseline
It will be assessed with the Montreal Cognitive Assessment. Accordingly, a score of 21 points and above is considered normal. Individuals who score 21 points or less on this test will be included in the executive function deficit group. The others will included in control group.
General Well-Being-Sleep Quality
Time frame: Baseline
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. The scale consists of 18 questions and 7 components and was developed to assess sleep disturbances and sleep quality in the last 1 month. These components include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction. For scoring, it is applied as 0 if it has never occurred during the last month, 1 if it occurs less than once a week, 2 if it occurs once or twice a week, and 3 if it occurs three or more times a week. The total score has a value between 0-21. If the total score obtained as a result of the questionnaire is above 5, sleep quality is clinically poor.
General Well-Being-Quality of Life
Time frame: Baseline
Quality of life, sleep quality and depression levels will be assessed. Quality of life will be assessed with the 12-item Short Health Scale. Short Health Scale consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). Items related to physical and emotional role are answered as yes or no, while other items have Likert-type options ranging from 3 to 6. A higher score represents better health.
Physical Performance-Timed Up and Go
Time frame: Baseline
The timed up and go test is a functional dynamic balance test. The Timed Up and Go test is a timed measurement in which the individual has to get up from a chair, walk 3 meters, turn around, walk back and sit down. The Timed Up and Go is used to assess functional mobility and dynamic balance control in older people to identify increased risk of falls. Participants will be asked to wear the shoes they regularly wear to walk at a normal pace and will be allowed walking aids. The time between the participants getting up from the chair and sitting down again will be recorded in seconds.
General Well-Being-Depression and Anxiety
Time frame: Baseline
Depression and anxiety level will be assessed with the Hospital Depression and Anxiety Scale. It consists of 14 items. Seven of these items measure anxiety and the other seven items measure depression symptoms. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as not ill, 2 as borderline ill, and 2-3 as severely ill. Higher scores indicate more severe depression and anxiety.
Physical Performance-Hand Grip Strength
Time frame: Baseline
A digital Jamar dynamometer calibrated for hand grip strength (Performance Health, Warrenville, IL), Participants will be instructed to squeeze the dynamometer as hard as possible while sitting in an upright position as recommended by the American Association of Hand Therapists, with arms at their sides, elbows flexed 90° and forearms in a neutral position. A trial will be requested beforehand. For hand grip strength, 3 measurements will be made with one-minute intervals between each measurement and the average value will be recorded.
Physical Performance-Walking Speed
Time frame: Baseline
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. A clear distance of at least 10 meters in length will be determined and marks will be added at 2 meters and 8 meters. Timing will start when the individual\'s toes cross the 2 meter mark. The person will be instructed to walk as fast as you can safely walk until I say stop. The timing will stop when the toes cross the 8 meter mark. Three trials will be performed and the average of the three trials will be taken.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Obesity, run by Kutahya Health Sciences 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İsmail Okur, Assist. Prof. (+905552436726, ismail.okur@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive function (time frame: Baseline). The study lists 7 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 10 Mar 2026.