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Metaverse-Based Healthy Life Program for Youth (MetaYouth)

Primary Purpose

Health Risk Behaviors, Healthy Lifestyle, Non Communicable Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MetaHealth Group
MobileHealth Group
Sponsored by
Ayşegül İşler Dalgıç
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Risk Behaviors

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Aysegul ISLER DALGIC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MetaHealth Group

MobileHealth Group

Arm Description

It is intervention group that aims to provide youth with healthy lifestyle behaviors by using metaverse technology.

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.

Outcomes

Primary Outcome Measures

Healthy Lifestyle Behavior Scale II (HLBS II)
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.
Healthy Lifestyle Behavior Scale II (HLBS II)
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.
Healthy Lifestyle Behavior Scale II (HLBS II)
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.
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
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.
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
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.
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
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.
Positive and Negative Affect Schedule (PANAS-SF)
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).
Positive and Negative Affect Schedule (PANAS-SF)
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).
Positive and Negative Affect Schedule (PANAS-SF)
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).

Secondary Outcome Measures

Full Information

First Posted
March 24, 2022
Last Updated
April 15, 2022
Sponsor
Ayşegül İşler Dalgıç
Collaborators
Horizon
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1. Study Identification

Unique Protocol Identification Number
NCT05332886
Brief Title
Metaverse-Based Healthy Life Program for Youth
Acronym
MetaYouth
Official Title
The Effect of Metaverse-Based Healthy Life Program on Risk Reduction of Non-Communicable Diseases in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2024 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ayşegül İşler Dalgıç
Collaborators
Horizon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Risk Behaviors, Healthy Lifestyle, Non Communicable Diseases, Health-Related Behavior, Healthy Eating Index, Healthy Nutrition, Physical Inactivity, Stress, Emotional

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Desing Active Comparative Group Randomized Controlled Trial
Masking
ParticipantOutcomes Assessor
Masking Description
In the study, there will be interventions in both groups, as metaverse-based education and activity programme will be given to the MetaHealth Group and digital health education with a mobile application materials will be given to the MobileHealth Group. In both groups, the participants will be aware that an attempt has been made on them, but since they will not know which group they are in, the participant will be blinded. Since the interventions will be managed by the research team, researcher blinding will not be possible. However, the statistician will be blinded. At the end of the research, the groups will be coded as "A" and "B". Statistical analysis will be made by the statistics expert who is blinded to the groups in the project partner company. After the statistical analysis are made and the research report is written, the situations expressed by A and B will be explained to the statistician. In this way, it is planned to control the bias in statistics and reporting.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MetaHealth Group
Arm Type
Experimental
Arm Description
It is intervention group that aims to provide youth with healthy lifestyle behaviors by using metaverse technology.
Arm Title
MobileHealth Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MetaHealth Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MobileHealth Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healthy Lifestyle Behavior Scale II (HLBS II)
Description
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.
Time Frame
The HLBS II score will evaluate at baseline
Title
Healthy Lifestyle Behavior Scale II (HLBS II)
Description
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.
Time Frame
The HLBS II score will evaluate at third month
Title
Healthy Lifestyle Behavior Scale II (HLBS II)
Description
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.
Time Frame
The HLBS II score will evaluate at sixth month
Title
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Description
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.
Time Frame
The IPAQ-SF score will evaluate at baseline
Title
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Description
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.
Time Frame
The IPAQ-SF score will evaluate at third month
Title
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Description
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.
Time Frame
The IPAQ-SF score will evaluate at sixth month
Title
Positive and Negative Affect Schedule (PANAS-SF)
Description
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).
Time Frame
The PANAS-SF score will evaluate at baseline
Title
Positive and Negative Affect Schedule (PANAS-SF)
Description
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).
Time Frame
The PANAS-SF score will evaluate at third month
Title
Positive and Negative Affect Schedule (PANAS-SF)
Description
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).
Time Frame
The PANAS-SF score will evaluate at sixth month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşegül ISLER DALGIC, Professor
Phone
+90 242 310 6103
Ext
6124
Email
aisler@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşegül İşler Dalgıç, Professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Aysegul ISLER DALGIC
City
Antalya
State/Province
Konyaaltı
ZIP/Postal Code
07058
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysegul ISLER DALGIC, Prof. Dr.
Phone
+90 242 310 6103
Ext
6124
Email
aisler@akdeniz.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It has been decided not to share data within the scope of the General Data Protection Regulation.

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Metaverse-Based Healthy Life Program for Youth

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