protocolSection identificationModule nctId: NCT06359236, orgStudyIdInfo id: 122S049, briefTitle: Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO", statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: The primary purpose of this project is to observe the effects of Cognitive Behavioral Psychotherapy-based weight-loss mobile application (Bi' Kilo) in 4 essential areas (Anthropometric, Biochemical, Psychometric, Cognitive) in overweight and obese individuals and to test whether these effects will persist after ten weeks. In this context, the original value of the proposed study is that a mobile application will be produced that is suitable for the culture and whose effectiveness has been scientifically proven.In our current project proposal, the measurements of the participants will be evaluated holistically together with both tests and inventories, as well as physical measurements and biochemical data. In this study, the usability of the mobile application to be developed will also be evaluated and reported.The study group of the research will consist of overweight and obese individuals. The first stage will be a pilot study to identify the shortcomings of the Bi'Kilo mobile application. After eliminating the deficiencies of the Bi' Kilo mobile application, a working group will be formed in the second phase of the research. At this stage, the sample will be divided into two different groups within the scope of the study and a study group and a control group will be formed.The study consists of three phases as preparation, implementation, and follow-up. Measurements of the participants will be made at the beginning (Anthropometric, Biochemical, Psychometric, Cognitive), at the end of the six-week implementation phase (Anthropometric), and at the end of the four-week follow-up phase (Anthropometric, Biochemical, Psychometric, Cognitive)., conditionsModule conditions: Weight Loss, conditions: Obesity, conditions: Overweight and Obesity, conditions: Eating Behavior, conditions: Eating Habit, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: BI'KILO Intervention, outcomesModule primaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Waist Circumference (WC), secondaryOutcomes measure: Hip Circumference, secondaryOutcomes measure: Waist-Hip Ratio (WHR), secondaryOutcomes measure: Body Fat Percentage (BFP), secondaryOutcomes measure: Visceral Fat, secondaryOutcomes measure: Blood Glucose Level, secondaryOutcomes measure: Blood Insulin Level, secondaryOutcomes measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), secondaryOutcomes measure: Serum Leptin Level, secondaryOutcomes measure: Serum Ghrelin Level, secondaryOutcomes measure: Emotional Eating Scale (EES) Turkish Form, secondaryOutcomes measure: Mindful Eating Questionnaire (MEQ) Turkish Form, secondaryOutcomes measure: Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0), secondaryOutcomes measure: Motor Screening Task (MOT), secondaryOutcomes measure: Spatial Working Memory (SWM), secondaryOutcomes measure: Stop Signal Task (SST), secondaryOutcomes measure: Rapid Visual Information Processing (RVP), secondaryOutcomes measure: Cambridge Gambling Test (CGT), otherOutcomes measure: Demographic Information Form, otherOutcomes measure: Structured Clinical Interview for DSM-5 Disorders (SCID-5), otherOutcomes measure: The Eating Disorder Assessment for DSM-5 (EDA-5), otherOutcomes measure: Blood ACTH Level (ACTH), otherOutcomes measure: Blood Growth Hormone Level (GH), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eskisehir Osmangazi University Faculty of Medicine, city: Eskişehir, country: Turkey, geoPoint lat: 39.77667, lon: 30.52056, hasResults: False