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Clinical Trials/NCT05332886
NCT05332886UnknownNot Applicable

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

Ayşegül İşler Dalgıç1 site in 1 country600 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
600
Locations
1
Primary Endpoint
Healthy Lifestyle Behavior Scale II (HLBS II)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
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.

Eligibility Criteria

Ages
15 Years to 24 Years (Child, Adult)
Sex
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.)

Arms & Interventions

MetaHealth Group

Experimental

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

Intervention: MetaHealth Group (Behavioral)

MobileHealth Group

Active Comparator

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: MobileHealth Group (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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).

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.

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.

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.

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.

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).

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ayşegül İşler Dalgıç
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ayşegül İşler Dalgıç

Prof. Dr.

Akdeniz University

Study Sites (1)

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