An interventional study of BI'KILO Intervention in Weight Loss, Obesity and Overweight and Obesity, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Treatment
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;
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 70 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
Participants in the treatment group will be involved in a process that includes three phases of the study: preparation phase, implementation phase and follow-up phase.
Other: BI'KILO Intervention
The control group will not be able to access the entire treatment program content. However, they will be able to access animation contents such as energy balance training, eating change, planning where and when and what to eat, healthy weight loss targets, three main and three snacks, determining weight loss targets and informational content titled diet types specified in the nutrition education module for a period of 6 weeks.
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.
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)
Demographic Information Form
In this form, in addition to the participant's gender, age and education level, information such as marital status, occupation, education level, past or current use of psychiatric medication, history of psychiatric illness in family history, history of physical illness in family history, alcohol and substance use, and economic status are also gathered.
Time frame: Pre-test
Structured Clinical Interview for DSM-5 Disorders (SCID-5)
SCID-5 was developed by First et al. It consists of 10 modules. Modules include psychotic symptoms, psychotic disorders, mood disorders, substance use disorders, anxiety disorders, obsessive-compulsive disorder and related disorders, as well as post-traumatic stress disorder, attention deficit and hyperactivity disorder, probing questions for other disorders, and adjustment disorder (American Psychiatric Association 2015) . SCID-5 can be applied to individuals over the age of 18 who do not have severe cognitive deficits, severe psychotic symptoms, or agitation. Sources of information are the patient himself, the patient's family and relatives, the healthcare team, medical sources and observations. If necessary, corrections can be made in the light of additional information and can be completed in more than one session. Average application time is 40-60 minutes. Its adaptation into Turkish and its reliability were investigated by Elbir et al.
Time frame: Pre-test
The Eating Disorder Assessment for DSM-5 (EDA-5)
The EDA-5 is a semi-structured interview intended to assist in the assessment of a feeding or eating disorder or related conditions according to DSM-5 criteria. It is designed for use by clinicians (across disciplines) with some familiarity with feeding and eating disorder diagnoses. The Turkish version was adapted by Ezgi Deveci, H. Özlem Sertel Berk and Başak Yücel (Deveci, 2019).
Time frame: Pre-test
Blood ACTH Level (ACTH)
The ACTH test measures the level of adrenocorticotropic hormone (ACTH) in the blood. ACTH is a hormone released from the pituitary gland at the base of the brain. 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.ACTH measurements will be made from the separated serums.
Time frame: Pre-test
Blood Growth Hormone Level (GH)
Growth Hormone, peptide hormone secreted by the anterior lobe of the pituitary gland. GH stimulates protein synthesis and increases fat breakdown to provide the energy necessary for tissue growth. 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. GH measurements will be made from the separated serums.
Time frame: Pre-test
Plan to share: Undecided — The data that support the findings of this study are available on request from the corresponding author, A.E.A. The data are not publicly available due to restrictions that their containing information that could compromise the privacy of research participants.
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Eskisehir Osmangazi University