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).
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 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 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 study's 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
The study consists of three stages: preparation phase, implementation phase and follow-up phase. During the preparation phase, participants' weight and body fat ratio will be calculated using a body analysis scale, and their height, waist and hip circumference will be measured. The implementation phase will last six weeks and consists of six modules, each lasting one week. The skills and practices aimed to be acquired in each module will be required to be applied in the following practice modules. At the end of the implementation phase, participants' weight, waist and hip circumferences will be measured again. The final phase, called the follow-up phase, will last four weeks. During this phase, participants will continue to keep a self-monitoring record of their eating and physical exercise, complete a hunger scale, and application card notifications will continue to be displayed.
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir, Turkey (Türkiye)
Body Mass Index (BMI)
Body Mass Index is a person's weight in kilograms divided by the square of height in meters.
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Weight
The value of body weight in kilograms.
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Height
The value of a person's height in centimeters.
Time frame: Pre-test
Waist Circumference (WC)
Waist circumference is measured halfway between the lower ribs and the iliac crest, while hip circumference is measured at the largest circumference around the buttocks.
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Hip Circumference
The distance around the human body at the level of maximum posterior extension of the buttocks.
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Waist-Hip Ratio (WHR)
The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement.
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Body Fat Percentage (BFP)
Body fat percentage (BFP) is a person's total fat mass divided by total body mass multiplied by 100; body fat includes essential body fat and stored body fat. Body fat percentage will be measured using a body analysis scale.
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Visceral Fat
Visceral fat is belly fat found deep within person's abdominal cavity. Visceral fat will be measured using a body analysis scale.
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Blood Glucose Level
The measure of glucose concentrated in the blood. At 08.00 in the morning, after at least 8 hours of fasting, 8 ml of blood will be collected into vacuum gel tubes with a vacuum blood collection system and after waiting for the clotting time of the blood samples, they will be centrifuged at 1500 g for 10 minutes. Blood glucose level measurements will be made from the separated serums.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Blood Insulin Level
A hormone made by the islet cells of the pancreas. At 08.00 in the morning, after at least 8 hours of fasting, 8 ml of blood will be collected into vacuum gel tubes with a vacuum blood collection system and after waiting for the clotting time of the blood samples, they will be centrifuged at 1500 g for 10 minutes. Blood insulin level measurements will be made from the separated serums.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Homeostasis model assessment of insulin resistance (HOMA-IR) is a method to measure insulin resistance. HOMA-IR score will be calculated as Fasting Glucose (mg/dL) X Fasting Insulin (uIU/mL) /405.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Serum Leptin Level
Leptin is an adipocyte-derived hormone and has shown positive correlation with obesity and metabolic syndrome (MetS). At 08.00 in the morning, after at least 8 hours of fasting, 8 ml of blood will be collected into vacuum gel tubes with a vacuum blood collection system and after waiting for the clotting time of the blood samples, they will be centrifuged at 1500 g for 10 minutes. The remaining serum will be stored at -80°C, and Leptin levels will be studied from these stored samples.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Serum Ghrelin Level
Ghrelin is an orexigenic peptide predominantly secreted from the stomach and stimulates appetite and growth hormone release. At 08.00 in the morning, after at least 8 hours of fasting, 8 ml of blood will be collected into vacuum gel tubes with a vacuum blood collection system and after waiting for the clotting time of the blood samples, they will be centrifuged at 1500 g for 10 minutes. The remaining serum will be stored at -80°C, and Ghrelin levels will be studied from these stored samples.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Emotional Eating Scale (EES) Turkish Form
The scale is a Likert-type scale consisting of 30 items, developed by Bilgen et al. and whose validity and reliability study was conducted (Bilgen, 2018). Developed as a result of the findings obtained from validity and reliability studies, TEES consists of 30 items expressing eating behavior in positive and negative emotions and includes 4 subtypes: Eating in situations of tension, eating to cope with negative emotions, self-control, control over stimuli.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Mindful Eating Questionnaire (MEQ) Turkish Form
The validity and reliability study of the Turkey form was conducted by Köse et al. in 2016 (Köse, Tayfur, Birincioğlu, \& Dönmez, 2016). The Eating Awareness Scale, which consists of 30 Likert-type questions, includes 7 subtypes: eating without thinking, emotional eating, eating control, awareness, eating discipline, conscious nutrition, being affected by external factors.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0)
The Yale Food Addiction Scale (YFAS) operationalizes indicators of addictive-like eating, originally based on the Diagnostic and Statistical Manual of Mental Disorders 4th edition Text Revision (DSM-IV-TR) criteria for substance-use disorders. The YFAS has multiple adaptations, including a briefer scale (mYFAS). Recently, the YFAS 2.0 was developed to reflect changes to diagnostic criteria in the DSM-5 (Schulte 2017).
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Motor Screening Task (MOT)
The Motor Screening Task provides a general assessment of whether sensorimotor deficits or lack of comprehension, will limit the collection of valid data from the participant.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Spatial Working Memory (SWM)
Spatial Working Memory Test: In this test, comprehension and management of visual-spatial information is measured. This test, which also requires the use of some executive functions, provides measurements for working memory errors and strategy determination. It is implemented through CANTAB. It takes approximately 10-12 minutes.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Stop Signal Task (SST)
In this test, response inhibition (impulse control) is measured. It is implemented through CANTAB. It takes approximately 14 minutes.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Rapid Visual Information Processing (RVP)
Developed to measure sustained attention. It is implemented through CANTAB. It takes approximately 5-9 minutes and outcome measures include response rate, false alarms, and specificity.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Cambridge Gambling Test (CGT)
This test was developed to assess decision-making and risk-taking behavior outside a learning context. It is implemented through CANTAB. The outcome measures of this test, which takes approximately 15-20 minutes, include risk taking, decision-making quality, decision time, risk adjustment, delay reluctance and impulsivity measurements.
Time frame: Pre-test, follow up (10 weeks later from pre-test)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.