Metaverse-Based Healthy Life Program for Youth

Physical Inactivity Clinical Trial

— MetaYouth  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05332886
• Other study ID #: 123456789
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2022
• Source: Akdeniz University
• Contact: Aysegül ISLER DALGIC, Professor
• Phone: +90 242 310 6103
• Email: aisler[@]akdeniz.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Health Risk Behaviors
• Healthy Lifestyle
• Non Communicable Diseases
• Noncommunicable Diseases
• Physical Inactivity
• Stress, Emotional

Intervention

Behavioral:
• MetaHealth Group
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.
• 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.

Locations

Country	Name	City	State
Turkey	Aysegul ISLER DALGIC	Antalya	Konyaalti

Sponsors (2)

Lead Sponsor	Collaborator
Aysegül Isler Dalgiç	Horizon

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The HLBS II score will evaluate at baseline
Primary	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.	The HLBS II score will evaluate at third month
Primary	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.	The HLBS II score will evaluate at sixth month
Primary	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.	The IPAQ-SF score will evaluate at baseline
Primary	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.	The IPAQ-SF score will evaluate at third month
Primary	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.	The IPAQ-SF score will evaluate at sixth month
Primary	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).	The PANAS-SF score will evaluate at baseline
Primary	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).	The PANAS-SF score will evaluate at third month
Primary	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).	The PANAS-SF score will evaluate at sixth month