Metaverse-Based Healthy Life Program for Youth (MetaYouth)

April 15, 2022 updated by: Ayşegül İşler Dalgıç

The Effect of Metaverse-Based Healthy Life Program on Risk Reduction of Non-Communicable Diseases in Youth

This study was planned within the scope of the call titled "Non-communicable diseases risk reduction in adolescence and youth (Global Alliance for Chronic Diseases - GACD)" with identity number HORIZON-HLTH-2022-DISEASE-07-03. The purpose of this project; is to determine the effect of the Metaverse-Based Healthy Life Program to be developed in the project to support youths in decreasing future risks of developing non-communicable diseases (NCDs) and in gaining healthy lifestyle behaviors (HLBs).

Study Overview

Detailed Description

The project consists of three phases. Phase 1 Testing the content, quality, reliability, and usability of the "Metaverse-Based Healthy Life Program for Youth" to be developed within the scope of the project Phase 2 Identifying youth at high risk of chronic non-communicable diseases in the research population Phase 3 Evaluating the effect of "Metaverse-Based Healthy Life Program for Youth" implementation on inculcating healthy lifestyle behaviors in youth

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ayşegül ISLER DALGIC, Professor
  • Phone Number: 6124 +90 242 310 6103
  • Email: aisler@akdeniz.edu.tr

Study Locations

    • Konyaaltı
      • Antalya, Konyaaltı, Turkey, 07058
        • Aysegul ISLER DALGIC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being a university student in the project partner countries and not older than 24,
  • Having a score of 130 or lower on the HLBS II in the first stage of the research,
  • Determining that BMI ≥ 25-34.99 kg/m2 in the first stage of the research and
  • Using a smartwatch during the research,
  • Accepting to participate in the research voluntarily

Exclusion Criteria:

  • Having chronic diseases (asthma, diabetes, heart, kidney failure, hypertension, cancer, etc.)
  • Those who have a drug that they use constantly
  • Having a psychiatric diagnosis (depression, anxiety, bipolar disorder, schizophrenia, etc.)
  • Having a disease that prevents the use of metaverse (vertigo, vision, hearing, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MetaHealth Group
It is intervention group that aims to provide youth with healthy lifestyle behaviors by using metaverse technology.
Three metaverse rooms will be created via metaverse technology that aims to develop healthy nutrition, physical activity, and psychological resilience skills to reduce the risk of of NCDs in youth.
ACTIVE_COMPARATOR: MobileHealth Group
It is comparator group that aims to provide youth with healthy lifestyle behaviors by using mobile application materials with digital health education will be given to the MobileHealth Group.
The intervention aims to develop healthy nutrition, physical activity, and psychological resilience skills using mobile application materials to reduce the risk of NCDs in youth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy Lifestyle Behavior Scale II (HLBS II)
Time Frame: The HLBS II score will evaluate at baseline
The HLBS II consists of 52 items in total and has 6 sub-factors. Sub-factors are spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships, and stress management. All items on the scale are positive. The rating is in the form of a 4-point Likert. Never (1), sometimes (2), often (3), regularly (4). The lowest score for the whole scale is 52, and the highest score is 208. The Cronbach Alpha reliability coefficient of the scale is 0.94.
The HLBS II score will evaluate at baseline
Healthy Lifestyle Behavior Scale II (HLBS II)
Time Frame: The HLBS II score will evaluate at third month
The HLBS II consists of 52 items in total and has 6 sub-factors. Sub-factors are spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships, and stress management. All items on the scale are positive. The rating is in the form of a 4-point Likert. Never (1), sometimes (2), often (3), regularly (4). The lowest score for the whole scale is 52, and the highest score is 208. The Cronbach Alpha reliability coefficient of the scale is 0.94.
The HLBS II score will evaluate at third month
Healthy Lifestyle Behavior Scale II (HLBS II)
Time Frame: The HLBS II score will evaluate at sixth month
The HLBS II consists of 52 items in total and has 6 sub-factors. Sub-factors are spiritual growth, health responsibility, physical activity, nutrition, interpersonal relationships, and stress management. All items on the scale are positive. The rating is in the form of a 4-point Likert. Never (1), sometimes (2), often (3), regularly (4). The lowest score for the whole scale is 52, and the highest score is 208. The Cronbach Alpha reliability coefficient of the scale is 0.94.
The HLBS II score will evaluate at sixth month
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time Frame: The IPAQ-SF score will evaluate at baseline
The IPAQ-SF is a standardized questionnaire prepared to measure the physical activity of people between the ages of 15 and 65. In the survey, there are 7 questions in total in 4 separate sections about the activities that have been done for a minimum of 10 minutes in the last 7 days. The results obtained in the assessment are calculated as metabolic equivalent task (MET) - min/week.
The IPAQ-SF score will evaluate at baseline
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time Frame: The IPAQ-SF score will evaluate at third month
The IPAQ-SF is a standardized questionnaire prepared to measure the physical activity of people between the ages of 15 and 65. In the survey, there are 7 questions in total in 4 separate sections about the activities that have been done for a minimum of 10 minutes in the last 7 days. The results obtained in the assessment are calculated as metabolic equivalent task (MET) - min/week.
The IPAQ-SF score will evaluate at third month
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time Frame: The IPAQ-SF score will evaluate at sixth month
The IPAQ-SF is a standardized questionnaire prepared to measure the physical activity of people between the ages of 15 and 65. In the survey, there are 7 questions in total in 4 separate sections about the activities that have been done for a minimum of 10 minutes in the last 7 days. The results obtained in the assessment are calculated as metabolic equivalent task (MET) - min/week.
The IPAQ-SF score will evaluate at sixth month
Positive and Negative Affect Schedule (PANAS-SF)
Time Frame: The PANAS-SF score will evaluate at baseline
The PANAS-SF is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
The PANAS-SF score will evaluate at baseline
Positive and Negative Affect Schedule (PANAS-SF)
Time Frame: The PANAS-SF score will evaluate at third month
The PANAS-SF is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
The PANAS-SF score will evaluate at third month
Positive and Negative Affect Schedule (PANAS-SF)
Time Frame: The PANAS-SF score will evaluate at sixth month
The PANAS-SF is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
The PANAS-SF score will evaluate at sixth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2024

Primary Completion (ANTICIPATED)

March 1, 2025

Study Completion (ANTICIPATED)

May 1, 2025

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (ACTUAL)

April 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 123456789 (Bandirma Onyedi Eylul University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It has been decided not to share data within the scope of the General Data Protection Regulation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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