Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO"
- Conditions
- Eating HabitObesityEating BehaviorWeight LossOverweight and Obesity
- Interventions
- Other: BI'KILO Intervention
- Registration Number
- NCT06359236
- Lead Sponsor
- Eskisehir Osmangazi University
- 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 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).
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- volunteering to participate in the study
- being literate
- being overweight
- being over the age of 18
- Being diagnosed with substance and/or alcohol use disorder
- being illiterate
- Being pregnant or having a pregnancy plan during the research period
- Being diagnosed with a disease that causes neuroendocrine obesity (Cushing's disease, hypothyroidism, hypothalamic obesity, growth hormone deficiency, hypogonadism, pseudohypoparathyroidism, polycystic ovary syndrome)
- Using antipsychotics, antiobesity drugs or cortisone-containing drugs
- Being a cigarette-smoker
- If the participant withdraws his/her consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group BI'KILO Intervention 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.
- Primary Outcome Measures
Name Time Method Body Mass Index (BMI) Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test) Body Mass Index is a person's weight in kilograms divided by the square of height in meters.
- Secondary Outcome Measures
Name Time Method Height Pre-test The value of a person's height in centimeters.
Waist Circumference (WC) Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test) 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.
Weight Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test) The value of body weight in kilograms.
Hip Circumference Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test) The distance around the human body at the level of maximum posterior extension of the buttocks.
Waist-Hip Ratio (WHR) Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test) 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.
Visceral Fat Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test) Visceral fat is belly fat found deep within person's abdominal cavity. Visceral fat will be measured using a body analysis scale.
Blood Insulin Level Pre-test, follow up (10 weeks later from pre-test) 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.
Body Fat Percentage (BFP) Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test) 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.
Emotional Eating Scale (EES) Turkish Form Pre-test, follow up (10 weeks later from pre-test) 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.
Motor Screening Task (MOT) Pre-test, follow up (10 weeks later from pre-test) 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.
Rapid Visual Information Processing (RVP) Pre-test, follow up (10 weeks later from pre-test) 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.
Blood Glucose Level Pre-test, follow up (10 weeks later from pre-test) 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.
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Pre-test, follow up (10 weeks later from pre-test) 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.
Serum Ghrelin Level Pre-test, follow up (10 weeks later from pre-test) 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.
Mindful Eating Questionnaire (MEQ) Turkish Form Pre-test, follow up (10 weeks later from pre-test) 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.
Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0) Pre-test, follow up (10 weeks later from pre-test) 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).
Spatial Working Memory (SWM) Pre-test, follow up (10 weeks later from pre-test) 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.
Stop Signal Task (SST) Pre-test, follow up (10 weeks later from pre-test) In this test, response inhibition (impulse control) is measured. It is implemented through CANTAB. It takes approximately 14 minutes.
Cambridge Gambling Test (CGT) Pre-test, follow up (10 weeks later from pre-test) 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.
Serum Leptin Level Pre-test, follow up (10 weeks later from pre-test) 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.
Trial Locations
- Locations (1)
Eskisehir Osmangazi University Faculty of Medicine
🇹🇷Eskişehir, Turkey