- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05332886
Metaverse-Based Healthy Life Program for Youth (MetaYouth)
April 15, 2022 updated by: Ayşegül İşler Dalgıç
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayşegül ISLER DALGIC, Professor
- Phone Number: 6124 +90 242 310 6103
- Email: aisler@akdeniz.edu.tr
Study Locations
-
-
Konyaaltı
-
Antalya, Konyaaltı, Turkey, 07058
- Aysegul ISLER DALGIC
-
Contact:
- Aysegul ISLER DALGIC, Prof. Dr.
- Phone Number: 6124 +90 242 310 6103
- Email: aisler@akdeniz.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 24 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: MetaHealth Group
It is intervention group that aims to provide youth with healthy lifestyle behaviors by using metaverse technology.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
The HLBS II score will evaluate at baseline
|
|
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.
|
The HLBS II score will evaluate at third month
|
|
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.
|
The HLBS II score will evaluate at sixth month
|
|
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.
|
The IPAQ-SF score will evaluate at baseline
|
|
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.
|
The IPAQ-SF score will evaluate at third month
|
|
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.
|
The IPAQ-SF score will evaluate at sixth month
|
|
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).
|
The PANAS-SF score will evaluate at baseline
|
|
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).
|
The PANAS-SF score will evaluate at third month
|
|
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).
|
The PANAS-SF score will evaluate at sixth month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2024
Primary Completion (ANTICIPATED)
March 1, 2025
Study Completion (ANTICIPATED)
May 1, 2025
Study Registration Dates
First Submitted
March 24, 2022
First Submitted That Met QC Criteria
April 15, 2022
First Posted (ACTUAL)
April 18, 2022
Study Record Updates
Last Update Posted (ACTUAL)
April 18, 2022
Last Update Submitted That Met QC Criteria
April 15, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123456789 (Bandirma Onyedi Eylul University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It has been decided not to share data within the scope of the General Data Protection Regulation.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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