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临床试验/NCT05332886
NCT05332886尚未招募不适用

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

Ayşegül İşler Dalgıç2 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
600
试验地点
2
主要终点
Healthy Lifestyle Behavior Scale II (HLBS II)

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.)

结局指标

主要结局

Healthy Lifestyle Behavior Scale II (HLBS II)

时间窗: 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)

时间窗: 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)

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Ayşegül İşler Dalgıç
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ayşegül İşler Dalgıç

Prof. Dr.

Akdeniz University

研究点 (2)

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