NCT07032415

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Jul 2025Sep 2026

First Submitted

Initial submission to the registry

June 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

July 22, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

June 14, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

bariatric surgerycognition

Outcome Measures

Primary Outcomes (1)

  • Change of Body Mass Index After Nutrition Habit Change Program

    Patients weight and height will be used for Body Mass Index calculations

    3 months

Secondary Outcomes (1)

  • Cognitive Function Change After Nutrition Habit Change Program

    3 months

Study Arms (1)

Morbidly Obese Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbidly obese patients who are added to the Obesity Center and agree to participate in the study are included in the study.

You may qualify if:

  • Applying Kocaeli City Hospital's Obesity Center
  • Morbid Obesity
  • Completing the program

You may not qualify if:

  • People with psychiatric and neurological diseases
  • People using drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, İzmit, 41060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityObesity, Morbid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adem Yüksel

    Kocaeli City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof.

Study Record Dates

First Submitted

June 14, 2025

First Posted

June 24, 2025

Study Start

July 22, 2025

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations