NCT06110767

Brief 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). 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Change from baseline dynmic balance at week 4

Secondary Outcomes (1)

  • Dynamic Balance

    Change from baseline dynmic balance at week 4

Study Arms (3)

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.

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.

Device: non-immersive virtual realityBehavioral: Healty Diet Programme

Diet program for healthy eating

EXPERIMENTAL

4-week diet program will be applied.

Behavioral: Healty Diet Programme

Interventions

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.

Diet Program for healthy eating + Non-immersive virtual reality-based physical activity appRoutine diet + Non-immersive virtual reality-based physical activity application

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.

Diet Program for healthy eating + Non-immersive virtual reality-based physical activity appDiet program for healthy eating

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt will consist of healthy female individuals between the ages of 18-64.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Betül KOCAADAM_BOZKURT, PhD

    Erzurum Technical University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This research is a cross-sectional, prospective and experimental study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

November 20, 2023

Primary Completion

February 15, 2024

Study Completion

April 1, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share