Bilişsel Davranışçı Terapi Temelli Kilo Kontrolü Mobil "Bİ'KİLO" Uygulamasının Geliştirilmesi ve Etkililiğinin Sınanması
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •volunteering to participate in the study
- •being literate
- •being overweight
- •being over the age of 18
排除标准
- •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
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 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.
次要结局
- Visceral Fat(Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test))
- Height(Pre-test)
- Waist Circumference (WC)(Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test))
- Weight(Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test))
- Hip Circumference(Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test))
- Waist-Hip Ratio (WHR)(Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test))
- Blood Insulin Level(Pre-test, follow up (10 weeks later from pre-test))
- Body Fat Percentage (BFP)(Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test))
- Emotional Eating Scale (EES) Turkish Form(Pre-test, follow up (10 weeks later from pre-test))
- Motor Screening Task (MOT)(Pre-test, follow up (10 weeks later from pre-test))
- Rapid Visual Information Processing (RVP)(Pre-test, follow up (10 weeks later from pre-test))
- Blood Glucose Level(Pre-test, follow up (10 weeks later from pre-test))
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(Pre-test, follow up (10 weeks later from pre-test))
- Serum Ghrelin Level(Pre-test, follow up (10 weeks later from pre-test))
- Mindful Eating Questionnaire (MEQ) Turkish Form(Pre-test, follow up (10 weeks later from pre-test))
- Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0)(Pre-test, follow up (10 weeks later from pre-test))
- Spatial Working Memory (SWM)(Pre-test, follow up (10 weeks later from pre-test))
- Stop Signal Task (SST)(Pre-test, follow up (10 weeks later from pre-test))
- Cambridge Gambling Test (CGT)(Pre-test, follow up (10 weeks later from pre-test))
- Serum Leptin Level(Pre-test, follow up (10 weeks later from pre-test))
研究者
Ali Ercan Altinoz
Assoc. Prof. of Psychiatry
Eskisehir Osmangazi University