Viewing Study NCT06359236



Ignite Creation Date: 2024-05-06 @ 8:22 PM
Last Modification Date: 2024-10-26 @ 3:26 PM
Study NCT ID: NCT06359236
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-04-11
First Post: 2024-03-06

Brief Title: Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application BIKILO
Sponsor: Eskisehir Osmangazi University
Organization: Eskisehir Osmangazi University

Study Overview

Official Title: Bilişsel Davranışçı Terapi Temelli Kilo Kontrolü Mobil BİKİLO Uygulamasının Geliştirilmesi ve Etkililiğinin Sınanması
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 BiKilo 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
Detailed Description: 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 the studies in the literature obesity assessment is evaluated with anthropometric data However the evaluation of biochemical data in studies is limited 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 Furthermore the usability of any application developed in the literature has not been evaluated Usability is a crucial variable for mobile apps and web pages In this study the usability of the mobile application to be developed will also be evaluated and reported Thus an application that can be used as well as effective will be revealed

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 BiKilo 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 minimum sample size of the study was adopted as 70 and it is aimed to be completed with a minimum of 38 people taking into account possible dropouts

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

Within the scope of this project it is stated that by using the Bi Kilo mobile application weight loss and reduction in body mass index value can be achieved in overweight and obese individuals it is possible to reduce the HOMA-IR score which shows insulin resistance and is a significant health problem in these individuals it is possible to improve the hormone values indirectly related to obesity such as leptin and ghrelin and to improve the eating attitudes and behaviors of individuals It is predicted that cognitive skills such as risk adjustment impulsivity and decision making can be improved

With this project

1 Gaining healthy eating and active living habits and measuring its change with a 10-week practice
2 Due to the increase in the frequency of use of the mobile application which is supported by scientific data and prepared in accordance with our language and culture due to geographical economic cultural and social stigma factors we do not provide weight control service Providing equal opportunity for individuals who cannot afford this service and increasing the fight against obesity-excess weight
3 Thus prevention of increased health expenditures and loss of workforce due to obesity and overweight It is thought that with the mobile application to be developed within the scope of the research a product that can be used all over the country will be revealed and this product can be made into a commercial product that can be purchased individually With the research findings it is planned to publish two international research articles two international papers and a medical specialization thesis Furthermore the studys findings will pave the way for the development of applications for problem areas in new graduate theses on the production of self-help content in different fields

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None