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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05332886
Other study ID # 123456789
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date May 1, 2025

Study information

Verified date April 2022
Source Akdeniz University
Contact Aysegül ISLER DALGIC, Professor
Phone +90 242 310 6103
Email aisler@akdeniz.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date May 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 24 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Turkey Aysegul ISLER DALGIC Antalya Konyaalti

Sponsors (2)

Lead Sponsor Collaborator
Aysegül Isler Dalgiç Horizon

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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