Health Risk BehaviorsMetaYouthNCT05332886
Metaverse-Based Healthy Life Program for Youth
A study testing MetaHealth Group and MobileHealth Group in people with Health Risk Behaviors and Healthy Lifestyle, run by Ayşegül İşler Dalgıç at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Risk Behaviors, Healthy Lifestyle, Non Communicable Diseases
- What is being tested?
- MetaHealth Group and MobileHealth Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aysegul ISLER DALGIC
Antalya, Konyaaltı, 07058
Aysegul ISLER DALGIC, Prof. Dr., +90 242 310 6103 ext. 6124, aisler@akdeniz.edu.tr
About this study
Official title: The Effect of Metaverse-Based Healthy Life Program on Risk Reduction of Non-Communicable Diseases in Youth
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).
Read the 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
- Conditions
- Health Risk Behaviors, Healthy Lifestyle, Non Communicable Diseases, Health-Related Behavior, Healthy Eating Index, Healthy Nutrition
- Being tested
- MetaHealth Group, MobileHealth Group
- Medical subject headings
- Health Risk Behaviors, Noncommunicable Diseases, Health Behavior, Sedentary Behavior, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaHealth GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MetaHealth Group | Experimental | It is intervention group that aims to provide youth with healthy lifestyle behaviors by using metaverse technology. Receives: 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. Receives: Behavioral: MobileHealth Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: The PANAS-SF score will evaluate at sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Jul 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Risk BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Desing Active Comparative Group Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayşegül İşler Dalgıç
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon
- Responsible party
- Sponsor-investigator, Ayşegül İşler Dalgıç, Akdeniz University
- Investigators
- Ayşegül İşler Dalgıç, Professor, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332886
- Sponsor's protocol ID
- 123456789
- Acronym
- MetaYouth
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It has been decided not to share data within the scope of the General Data Protection Regulation.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metaverse-Based Healthy Life Program on Risk Reduction of Non-Communicable Diseases in Youth
- ClinicalTrials.gov ID
- NCT05332886
- Acronym / sponsor ID
- MetaYouth / 123456789
- Conditions
- Health Risk Behaviors, Healthy Lifestyle, Non Communicable Diseases, Health-Related Behavior, Healthy Eating Index, Healthy Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ayşegül İşler DalgıçUniversity, hospital or other
- Collaborators
- Horizon
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Desing Active Comparative Group Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| MetaHealth Group | Experimental | Behavioral: MetaHealth GroupIt is intervention group that aims to provide youth with healthy lifestyle behaviors by using metaverse technology. |
| MobileHealth Group | Active comparator | Behavioral: MobileHealth GroupIt 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. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetaHealth GroupThree 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. | Behavioural | MetaHealth Group |
| MobileHealth GroupThe intervention aims to develop healthy nutrition, physical activity, and psychological resilience skills using mobile application materials to reduce the risk of NCDs in youth. | Behavioural | MobileHealth Group |
Primary outcome
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.
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 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.
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 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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No. It has been decided not to share data within the scope of the General Data Protection Regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşegül İşler Dalgıç, Professor study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetaHealth Group and MobileHealth Group in people with Health Risk Behaviors and Healthy Lifestyle, run by Ayşegül İşler Dalgıç at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşegül ISLER DALGIC, Professor (+90 242 310 6103 ext. 6124, aisler@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Lifestyle Behavior Scale II (HLBS II) (time frame: The HLBS II score will evaluate at baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.