Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO"

NCT06359236 | Completed

• 1 other identifier: 122S049
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Weight Loss; Obesity; Overweight and Obesity; Eating Behavior; Eating Habit

Keywords

cognitive behavioral therapy; e-health applications; obesity; weight control

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI)

  Body Mass Index is a person's weight in kilograms divided by the square of height in meters.

  Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)

Secondary Outcomes (20)

• Weight

  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)

• 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)

Other Outcomes (5)

• Demographic Information Form

  Pre-test

• Structured Clinical Interview for DSM-5 Disorders (SCID-5)

  Pre-test

• The Eating Disorder Assessment for DSM-5 (EDA-5)

  Pre-test

Study Arms (2)

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.

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.

Interventions

BI'KILO Intervention OTHER

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Weight Loss; Obesity; Overweight; Feeding Behavior

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. of Psychiatry

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 11, 2024
• Study Start: July 15, 2022
• Primary Completion: July 15, 2024
• Study Completion: September 15, 2024
• Last Updated: April 16, 2025

Record last verified: 2024-04

Locations

TU (1)