Weight LossNCT06359236
Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO"
A study testing BI'KILO Intervention in people with Weight Loss and Obesity, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity, Overweight and Obesity
- What is being tested?
- BI'KILO Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteering to participate in the study
- being literate
- being overweight
- being over the age of 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir
About this study
Official title: Bilişsel Davranışçı Terapi Temelli Kilo Kontrolü Mobil "Bİ'KİLO" Uygulamasının Geliştirilmesi ve Etkililiğinin Sınanması
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.
Read more
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).
Read the 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;
- Gaining healthy eating and active living habits and measuring its change with a 10-week practice,
- 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
- 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.
- Conditions
- Weight Loss, Obesity, Overweight and Obesity, Eating Behavior, Eating Habit
- Being tested
- BI'KILO Intervention
- Keywords
- cognitive behavioral therapy, e-health applications, obesity, weight control
- Medical subject headings
- Weight Loss, Obesity, Overweight, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI'KILO InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Other: BI'KILO Intervention |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Body Mass Index is a person's weight in kilograms divided by the square of height in meters.
Measured: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Secondary outcomes (20)
Weight
The value of body weight in kilograms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-test, follow up (10 weeks later from pre-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Jul 2022
- Primary completion15 Jul 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ali Ercan Altinoz, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359236
- Sponsor's protocol ID
- 122S049
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilişsel Davranışçı Terapi Temelli Kilo Kontrolü Mobil "Bİ'KİLO" Uygulamasının Geliştirilmesi ve Etkililiğinin Sınanması
- ClinicalTrials.gov ID
- NCT06359236
- Acronym / sponsor ID
- 122S049
- Conditions
- Weight Loss, Obesity, Overweight and Obesity, Eating Behavior, Eating Habit
- Keywords
- cognitive behavioral therapy, e-health applications, obesity, weight control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Gaining healthy eating and active living habits and measuring its change with a 10-week practice,
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: BI'KILO InterventionParticipants 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. |
| Control Group | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- volunteering to participate in the study
- being literate
- being overweight
- being over the age of 18
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI'KILO InterventionThe 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. | Other | Treatment Group |
Primary outcome
Body Mass Index (BMI)
Time frame: 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.
20 secondary outcomes
Weight
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Height
Time frame: Pre-test
Waist Circumference (WC)
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Hip Circumference
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Waist-Hip Ratio (WHR)
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Body Fat Percentage (BFP)
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Visceral Fat
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Blood Glucose Level
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Blood Insulin Level
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Serum Leptin Level
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Serum Ghrelin Level
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Emotional Eating Scale (EES) Turkish Form
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Mindful Eating Questionnaire (MEQ) Turkish Form
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)
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Motor Screening Task (MOT)
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Spatial Working Memory (SWM)
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Stop Signal Task (SST)
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Rapid Visual Information Processing (RVP)
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Cambridge Gambling Test (CGT)
Time frame: Pre-test, follow up (10 weeks later from pre-test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BI'KILO Intervention in people with Weight Loss and Obesity, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.