ObesityNCT06110767
The Effects of a Healthy Nutrition Program and Virtual Reality Applications on Body Composition
A study testing non-immersive virtual reality and Healty Diet Programme in people with Obesity and Virtual Reality, run by Erzurum Technical University.
Trial summary
The most commonly used method in the management of body compositions of healthy individuals in the recent times is the application of physical activity together with a healthy nutrition (diet). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Virtual Reality, Body Composition
- What is being tested?
- non-immersive virtual reality and Healty Diet Programme
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2023to 1 Apr 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 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having BMI value between 25.0-39.9
- Female gender
- Volunteer between the ages of 18-64
- Not having any cardiovascular or orthopedic problems that would prevent attendance
Who cannot join
- Having a BMI value of 40.0 and above
- Having conditions that would prevent the implementation of a healthy nutrition program and virtual reality-based physical activity practices.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of a Healthy Nutrition Program and Virtual Reality Applications on Body Composition and Physical Fitness in Female Individuals.
The most commonly used method in the management of body compositions of healthy individuals in the recent times is the application of physical activity together with a healthy nutrition (diet). The application of diet together with physical activity cause significant changes in the body composition (fat ratio, muscle mass, lean body mass, etc.). Physical activity can be done with traditional physical activity methods as well as with virtual reality applications. Virtual reality is a simulation or a metaversal facet of a real environment created by a computer or various other electronic devices that allows one or more users to interact with certain elements in a simulated virtual frame through a human-machine interface. Virtual reality applications are generally classified as immersive and non-immersive virtual reality . Commercial games such as Sony Playstation, Microsoft Kinect Xbox 360, Nintendo Wii can be given as examples of non-immersive virtual reality . In order to preserve body composition, different exercise applications can be recommended in addition to the diet program. In the literature, many studies involving diet, physical activity or a combination of these two applications have been experimentally planned and carried out in a controlled manner. In these studies, moderate body weight loss (1-5 kg) was reported with only physical activity. It is a general opinion that diet therapy in addition to planned physical activity (exercise) provides more effective and healthier results than people who lose weight with only diet programs or only exercise. It has been stated in previous studies that body composition and physical fitness improve with virtual reality application as happened wih diet intervention. However, due to the fact that access to virtual reality applications is not very easy, longitudinal studies are needed to evaluate whether they should be included in general body composition and physical fitness improvement programs. At this point, the main purpose of this study is to compare and evaluate the effects of virtual reality applications and healthy nutrition program on improving body composition and physical fitness.
Read the detailed description
Physical inactivity is one of the main causes of many diseases. The development of technology causes some activities in daily life not to be performed and physical activity to decrease. Many diseases such as obesity, cardiovascular diseases and diabetes are more common in inactive and sedentary individuals.
In order to maintain body weight in sedentary individuals, the energy intake and expenditure must be equal. Today, mechanized social life reduces physical activity and keeps the energy that needs to be spent in the body, and this accumulation negatively affects the balance of energy intake and expenditure. In recent years, the increased consumption of highly processed food and beverages has caused changes in the world's diet. The main changes observed include imbalance in energy intake, change in eating frequency, and faster production and consumption of food. Obesity is not only among adults due to the decrease in physical activity in the world and in our country, the time spent in front of the television and computer reaching serious levels, high-energy - high-fat foods becoming more accessible and cheaper, and the rapid increase in industrial food production that is rich in salt but poor in fiber and vitamins; It is also seen among children and adolescents.
The most commonly used method today in the management of body composition of healthy individuals is the implementation of physical activity along with healthy nutrition (diet). Application of diet along with physical activity creates significant changes in body composition (fat ratio, muscle mass, lean body mass, etc.). Physical activity can be done with traditional physical activity methods or with virtual reality applications.
Virtual reality is a simulation or metaversal aspect of a real environment created by a computer or other various electronic devices that allows one or more users to interact with certain elements in a simulated virtual framework through a human-machine interface. Virtual reality applications are generally classified as immersive and non-immersive virtual reality . In immersive virtual reality, the user's interaction with the real world is usually limited by using virtual reality glasses. In non-immersive virtual reality, the user can manipulate the avatars on the screen, thanks to sensors that detect body movements, in order to maintain their connection with the outside world. Non-immersive virtual reality applications generally include a display, a receiving sensor, and a main application device. Commercial games such as Sony Playstation, Microsoft Kinect Xbox 360, Nintendo Wii can be given as examples of non-immersive virtual reality.
It has been observed that the use of virtual reality applications as a rehabilitation approach in various diseases has increased over the last 2 decades. It is seen to be used in areas such as stroke rehabilitation, various psychotherapy applications, improving physical fitness and improving body composition. Physical activity and nutrition are one of the few consistent factors associated with body composition. In addition to the diet program, different exercise practices can be recommended to maintain body weight. In the literature, many studies involving diet, physical activity, or combinations of these two practices have been experimentally planned and carried out in a controlled manner. In these studies, moderate body weight losses (1-5 kg) were reported only with physical activity . It is a general opinion that a healthy nutrition program, in addition to planned physical activity (exercise), provides more effective and healthy results than people who lose weight with diet programs or exercise alone. Just as body composition and physical fitness improve thanks to diet practices, it has been stated in previous studies that changes in body composition are also observed thanks to virtual reality-based physical activity applications. However, since access to virtual reality applications is not very easy, longitudinal studies are needed to evaluate whether they should be included in programs to improve general body composition and physical fitness.
The aim of this study is to compare and evaluate the effects of virtual reality-based physical activity applications and a healthy nutrition program on improving body composition and physical fitness.
The sample of the study will be female adult volunteers. The total number of participants required for the study to provide 92% accuracy was calculated as 27 people in the G power 3.1 program, based on the study of Zeng et al. (2021). A consent form will be obtained from each participant. Approval was received for this research from Erzurum Technical University Ethics Committee.
The sample of the study will consist of healthy individuals between the ages of 18-64 who do not have any health problems and do not need a special diet, living in Erzurum.
Exclusion criteria of the study: BMI value of 40.0 and above will prevent the implementation of a healthy nutrition program and virtual reality-based physical activity applications.
having situations. A total of 45 healthy individuals are planned to participate in the study. Participants will be classified into three groups using the stratified randomization method so that their current Body Mass Index (BMI) average and physical activity levels are equal. There will be 15 participants in each group.
- Conditions
- Obesity, Virtual Reality, Body Composition, Healthy Nutrition, Physical Fitness
- Being tested
- non-immersive virtual reality, Healty Diet Programme
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-immersive virtual realityDevice
Non-Immersive Virtual Reality Based Physical Activity Application: Application will be carried out 3 days a week, 30 minutes a day, for 4 weeks. Kinect Adventures and Kinect Sports game packages will be used using the Microsoft Kinect Xbox 360 game console. It is planned that the participants will engage in physical activity with these game packages.
Healty Diet ProgrammeBehavioural
Healthy nutrition program: It will be implemented for 4 weeks.Healthy Nutrition Program: Türkiye Ministry of Health nutrition program will be prepared based on the recommendations of the Turkey Nutrition Guide published by the Ministry of Health in 2016 (TÜBER-2016). A personalized healthy nutrition program will be created in line with this guide, taking into account the age, gender and physical activity status of healthy individuals.
| Study group | Role | What they receive |
|---|---|---|
| Routine diet + Non-immersive virtual reality-based physical activity application | Experimental | Non-immersive virtual reality will be applied 30 minutes a day, 3 days a week for 4 weeks. Receives: Device: non-immersive virtual reality |
| Diet Program for healthy eating + Non-immersive virtual reality-based physical activity app | Experimental | In addition to the 4-week diet program,Non-immersive virtual reality will be applied 30 minutes a day, 3 days a week for 4 weeks. Receives: Device: non-immersive virtual reality; Behavioral: Healty Diet Programme |
| Diet program for healthy eating | Experimental | 4-week diet program will be applied. Receives: Behavioral: Healty Diet Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
The height of the participants will be determined with the Tanita Stadiometer with an accuracy of 0.01 mm. Body weights, Body Mass Index (BMI), Body fat percentage, Total fat mass, muscle mass, bone mass, etc. A lot of data regarding body composition will be recorded using the Tanita body analyzer. Individuals' height and body analysis will be carried out in accordance with measurement techniques.
Measured: Change from baseline body composition at week 4
Waist to hip ratio
It will be carried out with a non-flexible tape measure and the waist and hip values will be proportional to each other.
Measured: Change from baseline waist to hip ratio at week 4
Functional Capacity
6-minute walk test: In the 6-minute walk test, the patient walks as fast as he can in a straight corridor of at least 30 meters, but without running. It is measured how many meters he walked. The patient should not change his tempo and speed during the test.
Measured: Change from baseline functional capacity at week 4
Balance
The Y Balance Test (YBT) is a simple, yet reliable, test used to measure dynamic balance.The YBT requires the athlete to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial. Therefore, this test measures the athlete's strength, stability and balance in various directions. The YBT composite score is calculated by summing the three reach directions and normalising the results to the lower limb length, whereas asymmetry is the difference between right and left limb reach (1) - this is explained in greater detail in the scoring system section.
Measured: Change from baseline dynmic balance at week 4
Secondary outcomes (1)
Dynamic Balance
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.The patient is instructed to stand next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist.
The assessor records the starting position at the 3rd metacarpal head on the yardstick.
Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches.
Measured: Change from baseline dynmic balance at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start20 Nov 2023 (estimated)
- Primary completion15 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Model description
- This research is a cross-sectional, prospective and experimental study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betül KOCAADAM_BOZKURT, PhD, Study director, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110767
- Sponsor's protocol ID
- Bozkurt.osman
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Healthy Nutrition Program and Virtual Reality Applications on Body Composition and Physical Fitness in Female Individuals.
- ClinicalTrials.gov ID
- NCT06110767
- Acronym / sponsor ID
- Bozkurt.osman
- Conditions
- Obesity, Virtual Reality, Body Composition, Healthy Nutrition, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (estimated)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 1 Nov 2023 (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 most commonly used method in the management of body compositions of healthy individuals in the recent times is the application of physical activity together with a healthy nutrition (diet). The application of diet together with physical activity cause significant changes in the body composition (fat ratio, muscle mass, lean body mass, etc.). Physical activity can be done with traditional physical activity methods as well as with virtual reality applications. Virtual reality is a simulation or a metaversal facet of a real environment created by a computer or various other electronic devices that allows one or more users to interact with certain elements in a simulated virtual frame through a human-machine interface. Virtual reality applications are generally classified as immersive and non-immersive virtual reality . Commercial games such as Sony Playstation, Microsoft Kinect Xbox 360, Nintendo Wii can be given as examples of non-immersive virtual reality . In order to preserve body composition, different exercise applications can be recommended in addition to the diet program. In the literature, many studies involving diet, physical activity or a combination of these two applications have been experimentally planned and carried out in a controlled manner. In these studies, moderate body weight loss (1-5 kg) was reported with only physical activity. It is a general opinion that diet therapy in addition to planned physical activity (exercise) provides more effective and healthier results than people who lose weight with only diet programs or only exercise. It has been stated in previous studies that body composition and physical fitness improve with virtual reality application as happened wih diet intervention. However, due to the fact that access to virtual reality applications is not very easy, longitudinal studies are needed to evaluate whether they should be included in general body composition and physical fitness improvement programs. At this point, the main purpose of this study is to compare and evaluate the effects of virtual reality applications and healthy nutrition program on improving body composition and physical fitness.
Detailed description
Physical inactivity is one of the main causes of many diseases. The development of technology causes some activities in daily life not to be performed and physical activity to decrease. Many diseases such as obesity, cardiovascular diseases and diabetes are more common in inactive and sedentary individuals.
In order to maintain body weight in sedentary individuals, the energy intake and expenditure must be equal. Today, mechanized social life reduces physical activity and keeps the energy that needs to be spent in the body, and this accumulation negatively affects the balance of energy intake and expenditure. In recent years, the increased consumption of highly processed food and beverages has caused changes in the world's diet. The main changes observed include imbalance in energy intake, change in eating frequency, and faster production and consumption of food. Obesity is not only among adults due to the decrease in physical activity in the world and in our country, the time spent in front of the television and computer reaching serious levels, high-energy - high-fat foods becoming more accessible and cheaper, and the rapid increase in industrial food production that is rich in salt but poor in fiber and vitamins; It is also seen among children and adolescents.
The most commonly used method today in the management of body composition of healthy individuals is the implementation of physical activity along with healthy nutrition (diet). Application of diet along with physical activity creates significant changes in body composition (fat ratio, muscle mass, lean body mass, etc.). Physical activity can be done with traditional physical activity methods or with virtual reality applications.
Virtual reality is a simulation or metaversal aspect of a real environment created by a computer or other various electronic devices that allows one or more users to interact with certain elements in a simulated virtual framework through a human-machine interface. Virtual reality applications are generally classified as immersive and non-immersive virtual reality . In immersive virtual reality, the user's interaction with the real world is usually limited by using virtual reality glasses. In non-immersive virtual reality, the user can manipulate the avatars on the screen, thanks to sensors that detect body movements, in order to maintain their connection with the outside world. Non-immersive virtual reality applications generally include a display, a receiving sensor, and a main application device. Commercial games such as Sony Playstation, Microsoft Kinect Xbox 360, Nintendo Wii can be given as examples of non-immersive virtual reality.
It has been observed that the use of virtual reality applications as a rehabilitation approach in various diseases has increased over the last 2 decades. It is seen to be used in areas such as stroke rehabilitation, various psychotherapy applications, improving physical fitness and improving body composition. Physical activity and nutrition are one of the few consistent factors associated with body composition. In addition to the diet program, different exercise practices can be recommended to maintain body weight. In the literature, many studies involving diet, physical activity, or combinations of these two practices have been experimentally planned and carried out in a controlled manner. In these studies, moderate body weight losses (1-5 kg) were reported only with physical activity . It is a general opinion that a healthy nutrition program, in addition to planned physical activity (exercise), provides more effective and healthy results than people who lose weight with diet programs or exercise alone. Just as body composition and physical fitness improve thanks to diet practices, it has been stated in previous studies that changes in body composition are also observed thanks to virtual reality-based physical activity applications. However, since access to virtual reality applications is not very easy, longitudinal studies are needed to evaluate whether they should be included in programs to improve general body composition and physical fitness.
The aim of this study is to compare and evaluate the effects of virtual reality-based physical activity applications and a healthy nutrition program on improving body composition and physical fitness.
The sample of the study will be female adult volunteers. The total number of participants required for the study to provide 92% accuracy was calculated as 27 people in the G power 3.1 program, based on the study of Zeng et al. (2021). A consent form will be obtained from each participant. Approval was received for this research from Erzurum Technical University Ethics Committee.
The sample of the study will consist of healthy individuals between the ages of 18-64 who do not have any health problems and do not need a special diet, living in Erzurum.
Exclusion criteria of the study: BMI value of 40.0 and above will prevent the implementation of a healthy nutrition program and virtual reality-based physical activity applications.
having situations. A total of 45 healthy individuals are planned to participate in the study. Participants will be classified into three groups using the stratified randomization method so that their current Body Mass Index (BMI) average and physical activity levels are equal. There will be 15 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This research is a cross-sectional, prospective and experimental study.
| Arm | Type | Receives |
|---|---|---|
| Routine diet + Non-immersive virtual reality-based physical activity application | Experimental | Device: non-immersive virtual realityNon-immersive virtual reality will be applied 30 minutes a day, 3 days a week for 4 weeks. |
| Diet Program for healthy eating + Non-immersive virtual reality-based physical activity app | Experimental | Device: non-immersive virtual reality, Behavioral: Healty Diet ProgrammeIn addition to the 4-week diet program,Non-immersive virtual reality will be applied 30 minutes a day, 3 days a week for 4 weeks. |
| Diet program for healthy eating | Experimental | Behavioral: Healty Diet Programme4-week diet program will be applied. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having BMI value between 25.0-39.9
- Female gender
- Volunteer between the ages of 18-64
- Not having any cardiovascular or orthopedic problems that would prevent attendance
Key exclusion criteria (2 listed)
- Having a BMI value of 40.0 and above
- Having conditions that would prevent the implementation of a healthy nutrition program and virtual reality-based physical activity practices.
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 |
|---|---|---|
| non-immersive virtual realityNon-Immersive Virtual Reality Based Physical Activity Application: Application will be carried out 3 days a week, 30 minutes a day, for 4 weeks. Kinect Adventures and Kinect Sports game packages will be used using the Microsoft Kinect Xbox 360 game console. It is planned that the participants will engage in physical activity with these game packages. | Device | Diet Program for healthy eating + Non-immersive virtual reality-based physical activity app, Routine diet + Non-immersive virtual reality-based physical activity application |
| Healty Diet ProgrammeHealthy nutrition program: It will be implemented for 4 weeks.Healthy Nutrition Program: Türkiye Ministry of Health nutrition program will be prepared based on the recommendations of the Turkey Nutrition Guide published by the Ministry of Health in 2016 (TÜBER-2016). A personalized healthy nutrition program will be created in line with this guide, taking into account the age, gender and physical activity status of healthy individuals. | Behavioural | Diet Program for healthy eating + Non-immersive virtual reality-based physical activity app, Diet program for healthy eating |
Primary outcome
Body composition
Time frame: Change from baseline body composition at week 4
The height of the participants will be determined with the Tanita Stadiometer with an accuracy of 0.01 mm. Body weights, Body Mass Index (BMI), Body fat percentage, Total fat mass, muscle mass, bone mass, etc. A lot of data regarding body composition will be recorded using the Tanita body analyzer. Individuals' height and body analysis will be carried out in accordance with measurement techniques.
Waist to hip ratio
Time frame: Change from baseline waist to hip ratio at week 4
It will be carried out with a non-flexible tape measure and the waist and hip values will be proportional to each other.
Functional Capacity
Time frame: Change from baseline functional capacity at week 4
6-minute walk test: In the 6-minute walk test, the patient walks as fast as he can in a straight corridor of at least 30 meters, but without running. It is measured how many meters he walked. The patient should not change his tempo and speed during the test.
Balance
Time frame: Change from baseline dynmic balance at week 4
The Y Balance Test (YBT) is a simple, yet reliable, test used to measure dynamic balance.The YBT requires the athlete to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial. Therefore, this test measures the athlete's strength, stability and balance in various directions. The YBT composite score is calculated by summing the three reach directions and normalising the results to the lower limb length, whereas asymmetry is the difference between right and left limb reach (1) - this is explained in greater detail in the scoring system section.
1 secondary outcome
Dynamic Balance
Time frame: Change from baseline dynmic balance at week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Betül KOCAADAM_BOZKURT, PhD study director
Erzurum Technical University
Questions about this trial
What is this clinical trial studying?
A study testing non-immersive virtual reality and Healty Diet Programme in people with Obesity and Virtual Reality, run by Erzurum Technical University.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osman BOZKURT, PhD (+905321547478, osman.bozkurt@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Change from baseline body composition at week 4). The study lists 4 primary outcomes in all. 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 1 Nov 2023.