Clinical trial NCT06359236: Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO"
Official title: Bilişsel Davranışçı Terapi Temelli Kilo Kontrolü Mobil "Bİ'KİLO" Uygulamasının Geliştirilmesi ve Etkililiğinin Sınanması
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Overweight and Obesity
Eating Behavior
Eating Habit
Keywords: cognitive behavioral therapy
e-health applications
obesity
weight control
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-04-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* volunteering to participate in the study
* being literate
* being overweight
* being over the age of 18

Exclusion Criteria:

* 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Secondary outcomes:
measure: Weight
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: Height
timeFrame: Pre-test
measure: Waist Circumference (WC)
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: Hip Circumference
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: Waist-Hip Ratio (WHR)
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: Body Fat Percentage (BFP)
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: Visceral Fat
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: Blood Glucose Level
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Blood Insulin Level
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Serum Leptin Level
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Serum Ghrelin Level
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Emotional Eating Scale (EES) Turkish Form
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Mindful Eating Questionnaire (MEQ) Turkish Form
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0)
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Motor Screening Task (MOT)
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Spatial Working Memory (SWM)
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Stop Signal Task (SST)
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Rapid Visual Information Processing (RVP)
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
measure: Cambridge Gambling Test (CGT)
timeFrame: Pre-test, follow up (10 weeks later from pre-test)
Other outcomes:
measure: Demographic Information Form
timeFrame: Pre-test
measure: Structured Clinical Interview for DSM-5 Disorders (SCID-5)
timeFrame: Pre-test
measure: The Eating Disorder Assessment for DSM-5 (EDA-5)
timeFrame: Pre-test
measure: Blood ACTH Level (ACTH)
timeFrame: Pre-test
measure: Blood Growth Hormone Level (GH)
timeFrame: Pre-test
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University Faculty of Medicine
Study officials:
References: