MetaYouth: Metaverse-Based Healthy Life Program for Youth

Sponsor
Ayşegül İşler Dalgıç (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05332886
Collaborator
Horizon (Industry)
600
1
2
10
60.1

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MetaHealth Group
  • Behavioral: MobileHealth Group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel Desing Active Comparative Group Randomized Controlled TrialParallel Desing Active Comparative Group Randomized Controlled Trial
Masking:
Double (Participant, Outcomes 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.
Primary Purpose:
Prevention
Official Title:
The Effect of Metaverse-Based Healthy Life Program on Risk Reduction of Non-Communicable Diseases in Youth
Anticipated Study Start Date :
Jul 1, 2024
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: MetaHealth Group

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

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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Healthy Lifestyle Behavior Scale II (HLBS II) [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.

  2. Healthy Lifestyle Behavior Scale II (HLBS II) [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.

  3. Healthy Lifestyle Behavior Scale II (HLBS II) [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.

  4. International Physical Activity Questionnaire-Short Form (IPAQ-SF) [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.

  5. International Physical Activity Questionnaire-Short Form (IPAQ-SF) [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.

  6. International Physical Activity Questionnaire-Short Form (IPAQ-SF) [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.

  7. Positive and Negative Affect Schedule (PANAS-SF) [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).

  8. Positive and Negative Affect Schedule (PANAS-SF) [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).

  9. Positive and Negative Affect Schedule (PANAS-SF) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aysegul ISLER DALGIC Antalya Konyaaltı Turkey 07058

Sponsors and Collaborators

  • Ayşegül İşler Dalgıç
  • Horizon

Investigators

  • Study Director: Ayşegül İşler Dalgıç, Professor, Akdeniz University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ayşegül İşler Dalgıç, Prof. Dr., Akdeniz University
ClinicalTrials.gov Identifier:
NCT05332886
Other Study ID Numbers:
  • 123456789
First Posted:
Apr 18, 2022
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2022