ObesityNCT07032415
The Effect of Cognitive Function Level in Morbidly Obese Patients
An observational study of Obesity and Morbid Obesity, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Obesity is a disease caused by many factors, such as lifestyle, eating habits, lack of physical activity, hormonal and genetic influences. These different factors make treatment planning difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid Obesity
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2025to 15 Sep 2026
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbidly obese patients who are added to the Obesity Center and agree to participate in the study are included in the study.
Who may be able to join
- Applying Kocaeli City Hospital's Obesity Center
- Morbid Obesity
- Completing the program
Who cannot join
- People with psychiatric and neurological diseases
- People using drugs
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
Kocaeli City Hospital
Kocaeli, İzmit, 41060
Adem Yüksel, +905053455259, drademyuksel@gmail.com
About this study
Official title: The Effect of a Nutrition Habit Change Program on Lifestyle and Cognitive Function Level in Morbidly Obese Patients
Obesity is a disease caused by many factors, such as lifestyle, eating habits, lack of physical activity, hormonal and genetic influences. These different factors make treatment planning difficult. Common treatments include changes in diet and lifestyle, medications, endoscopic methods (like balloon or botox), and surgery. No matter which method is used, the main goal is to help patients lose weight by creating a negative energy balance. To keep the weight off, patients need to maintain a balanced lifestyle in the long term.
However, many treatments are not successful over time. One important part of long-term success is helping patients change their lifestyle and eating habits. A person's cognitive function may affect how they understand and follow these changes. Some studies show that a high body mass index (BMI) is linked to problems with thinking and memory. While weight loss may help improve brain function, the investigators don't yet know how early cognitive differences affect treatment results.
At the obesity center in our hospital, morbidly obese patients receive support from a team of doctors, dietitians, psychologists, and physiotherapists. For at least three months, they attend individual and group sessions to help change their lifestyle and eating habits. This study aims to see how patients' cognitive function affects how much weight they lose by the end of the program.
- Conditions
- Obesity, Morbid Obesity
- Keywords
- bariatric surgery, cognition
- Medical subject headings
- Obesity, Obesity, Morbid
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 |
|---|---|---|
| Morbidly Obese Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Body Mass Index After Nutrition Habit Change Program
Patients weight and height will be used for Body Mass Index calculations
Measured: 3 months
Secondary outcomes (1)
Cognitive Function Change After Nutrition Habit Change Program
MoCA test will be used
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start22 Jul 2025 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion15 Sep 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
- 77 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Adem Yüksel, Kocaeli City Hospital
- Investigators
- Adem Yüksel, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032415
- Sponsor's protocol ID
- 2025-76
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nutrition Habit Change Program on Lifestyle and Cognitive Function Level in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT07032415
- Acronym / sponsor ID
- 2025-76
- Conditions
- Obesity, Morbid Obesity
- Keywords
- bariatric surgery, cognition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 22 Jul 2025 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 24 Jun 2025 (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.
Obesity is a disease caused by many factors, such as lifestyle, eating habits, lack of physical activity, hormonal and genetic influences. These different factors make treatment planning difficult. Common treatments include changes in diet and lifestyle, medications, endoscopic methods (like balloon or botox), and surgery. No matter which method is used, the main goal is to help patients lose weight by creating a negative energy balance. To keep the weight off, patients need to maintain a balanced lifestyle in the long term.
However, many treatments are not successful over time. One important part of long-term success is helping patients change their lifestyle and eating habits. A person's cognitive function may affect how they understand and follow these changes. Some studies show that a high body mass index (BMI) is linked to problems with thinking and memory. While weight loss may help improve brain function, the investigators don't yet know how early cognitive differences affect treatment results.
At the obesity center in our hospital, morbidly obese patients receive support from a team of doctors, dietitians, psychologists, and physiotherapists. For at least three months, they attend individual and group sessions to help change their lifestyle and eating habits. This study aims to see how patients' cognitive function affects how much weight they lose by the end of the program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbidly Obese Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbidly obese patients who are added to the Obesity Center and agree to participate in the study are included in the study.
Key inclusion criteria (3 listed)
- Applying Kocaeli City Hospital's Obesity Center
- Morbid Obesity
- Completing the program
Key exclusion criteria (2 listed)
- People with psychiatric and neurological diseases
- People using drugs
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
Change of Body Mass Index After Nutrition Habit Change Program
Time frame: 3 months
Patients weight and height will be used for Body Mass Index calculations
1 secondary outcome
Cognitive Function Change After Nutrition Habit Change Program
Time frame: 3 months
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 29 Jun 2025.
- 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.
Adem Yüksel principal investigator
Kocaeli City Hospital
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 and Morbid Obesity, run by Kocaeli City Hospital 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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 Jun 2025. 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 Sude Sezer Özkul (+905345241205, sudesezer1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Body Mass Index After Nutrition Habit Change Program (time frame: 3 months). 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 29 Jun 2025.