Metaverse-Based Healthy Life Program for Youth

NCT05332886 | Unknown DMC

• 1 other identifier: 123456789
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Health Risk Behaviors; Healthy Lifestyle; Non Communicable Diseases; Health-Related Behavior; Healthy Eating Index; Healthy Nutrition; Physical Inactivity; Stress, Emotional

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

MetaHealth Group

EXPERIMENTAL

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

Behavioral: MetaHealth Group

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.

Behavioral: MobileHealth Group

Interventions

MetaHealth Group BEHAVIORAL

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.

MetaHealth Group

MobileHealth Group BEHAVIORAL

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.

MobileHealth Group

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ayşegül İşler Dalgıç: lead
• Horizon: collaborator

Study Sites (1)

Aysegul ISLER DALGIC

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Risk Behaviors; Noncommunicable Diseases; Health Behavior; Sedentary Behavior; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms

Study Officials

• Ayşegül İşler Dalgıç, Professor

  Akdeniz University

  STUDY DIRECTOR

Central Study Contacts

Ayşegül ISLER DALGIC, Professor

CONTACT

+90 242 310 6103; aisler@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Parallel Desing Active Comparative Group Randomized Controlled Trial

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 18, 2022
• Study Start: July 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)