Immersive Physical Activity Program for Overweight Schoolchildren (PEESO)
Immersive Recreational Physical Exercise Program for Schoolchildren With Overweight or Obesity (PEESO)
Childhood overweight and obesity are major public health concerns associated with increased cardiometabolic risk and reduced quality of life. In Galicia (Spain), approximately one-third of schoolchildren aged 7-15 years are affected. Physical inactivity and sedentary behaviors contribute significantly to this condition.
The PEESO Project is a clinical trial designed to evaluate the effects of an immersive virtual reality-based physical exercise program delivered during school recess in children with overweight or obesity. The intervention uses head-mounted displays to promote moderate-to-vigorous intensity physical activity in an engaging environment.
研究概览
地位
详细说明
Childhood overweight and obesity are major public health concerns worldwide and are associated with increased risk of cardiometabolic disease, musculoskeletal disorders, and reduced quality of life. In Galicia (Spain), approximately one-third of schoolchildren aged 7-15 years present overweight or obesity. Physical inactivity and excessive sedentary behaviors, particularly screen time, contribute significantly to this condition.
The PEESO Project is a clinical trial designed to evaluate the effects of an immersive recreational physical exercise program delivered during school recess in children diagnosed with overweight or obesity. The intervention uses immersive virtual reality (IVR) technology through head-mounted displays to create an interactive and engaging environment that promotes moderate-to-vigorous intensity physical activity.
Immersive virtual reality may enhance exercise adherence and enjoyment by increasing motivation and reducing perceived exertion through distraction. Although active video games (exergames) have demonstrated potential to increase daily physical activity and reduce body mass index (BMI), most previous studies have focused on non-immersive systems and adult populations.
The primary objective of this study is to determine the effect of a moderate-to-vigorous intensity immersive virtual exercise program on body composition in schoolchildren with overweight or obesity. Secondary objectives include assessing its impact on quality of life and other health-related outcomes. The intervention is implemented during academic recess periods to ensure feasibility and integration within the school setting.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Pontevedra
-
Vigo、Pontevedra、西班牙、36210
- Ies Santa Irene
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion criteria:
- Age: >12 to 16 years (n>15).
- BMI: >25.5 kg/m² (overweight) and >30 kg/m² (obesity classes I-IV).
- Agreement to participate in the study.
- Signed informed consent from parents or guardians.
Exclusion criteria:
- Presence of cardiovascular, pulmonary, or musculoskeletal conditions that would prevent participation in the virtual session.
- Inability to comply with the assessment protocol.
- Presence of severe visual or hearing impairment, vertigo, epilepsy, or uncontrolled psychosis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：RVI_Experimental_Immersive Virtual Reality Exergame Program
The PEESO intervention is an immersive recreational physical exercise program designed for schoolchildren with overweight or obesity.
The intervention is delivered during school recess periods using Head-Mounted Display (HMD)-based immersive virtual reality exergames.
The program aims to provide moderate-to-vigorous intensity physical activity through personalized exercise sessions in a motivating and interactive environment.
|
Participants assigned to the experimental group will perform immersive virtual reality exercise sessions THREE (3) TIMES A WEEK during school breaks.
The intervention lasts 24 weeks, following a one-week adaptation period to the head-mounted devices (HMDs) and exercise video games.
Exercise routines will be personalized to each participant's characteristics using a "Weight Loss" mode and will include three training categories: Full Body (6 weeks), Strength (9 weeks), and Boxing (9 weeks).
The exercise load will be programmed individually through the exercise video game platform based on each participant's progress and performance.
The sessions are designed to achieve a moderate to vigorous level of physical activity.
|
|
安慰剂比较：RVI_ControGroup_Immersive Virtual Reality Exergame Program
The PEESO intervention in the control group will be the same as in the experimental group: a recreational and immersive physical exercise program designed for overweight or obese schoolchildren.
It is conducted during school recess using immersive virtual reality exercise video games with virtual reality headsets (HMDs).
The program aims to provide moderate-to-vigorous physical activity through personalized exercise sessions in a motivating and interactive environment.
|
Participants assigned to the control group will perform immersive virtual reality exercise sessions ONE TIMES (1) A WEEK during school breaks.
The intervention lasts 24 weeks, following a one-week adaptation period to the head-mounted devices (HMDs) and exercise video games.
Exercise routines will be personalized to each participant's characteristics using a "Weight Loss" mode and will include three training categories: Full Body ( 6 weeks), Strength (9 weeks), and Boxing (9 weeks).
The exercise load will be programmed individually through the exercise video game platform based on each participant's progress and performance.
The sessions are designed to achieve a moderate to vigorous level of physical activity.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment body composition
大体时间：24 weeks
|
Description: Body composition was assessed using the Tanita MC-780 bioelectrical impedance analyzer. Measured variables included fat mass (FM), fat-free mass (FFM), muscle mass (MM), total body water (TBW), and segmental body composition of the trunk and limbs. Unit of Measurement: Fat Mass (FM): kg Fat-Free Mass (FFM): kg Muscle Mass (MM): kg Total Body Water (TBW): kg Segmental Body Composition: kg Interpretation: Higher FFM, MM, and TBW indicate better physical fitness. Lower FM indicates better body composition. |
24 weeks
|
|
Assessment user experience and engagement
大体时间：24 weeks
|
User experience and engagement will be assessed using the Game Experience Questionnaire (GEQ - Post-Game Module). Items are rated from 0 to Unit of Measure: GEQ subscale scores (0-4) Interpretation: Higher scores indicate better experience for positive dimensions and poorer experience for negative dimensions. |
24 weeks
|
|
Assessment Safety and cybersickness symptoms
大体时间：24 weeks
|
Safety and cybersickness symptoms will be assessed using the Simulator Sickness Questionnaire (SSQ). Higher scores indicate greater severity of cybersickness symptoms. Unit of Measure: SSQ total score Interpretation: Lower scores indicate better tolerability and safety; a score of 0 indicates no symptoms. Safety and cybersickness symptoms will be assessed using the Simulator Sickness Questionnaire (SSQ). Higher scores indicate greater severity of cybersickness symptoms. Unit of Measure: SSQ total score Interpretation: Lower scores indicate better tolerability and safety; a score of 0 indicates no symptoms. |
24 weeks
|
|
Assessment usability
大体时间：24 weeks
|
System usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Scores range from 0 to 100, with higher scores indicating better usability. Unit of Measure: SUS score (0-100) Interpretation: Scores ≥68 indicate acceptable usability; scores >80 indicate excellent usability. |
24 weeks
|
|
Health-Related Quality of Life (KINDL)
大体时间：24 weeks
|
Description: Health-related quality of life will be assessed using the KINDL Questionnaire, a validated instrument that evaluates children's and adolescents' well-being across multiple domains, including physical well-being, emotional well-being, self-esteem, social relationships, and school functioning. Scores are calculated according to the instrument scoring manual and transformed to a scale from 0 to 100. Unit of Measure: KINDL total score (0-100) Emotional well-being (0-100) Physical well-being (0-100) Self-esteem (0-100) Social relationships (0-100) School functioning (0-100) Interpretation: Higher scores indicate better health-related quality of life and well-being in the corresponding domain. Lower scores indicate poorer perceived quality of life and greater difficulties in physical, emotional, social, or school-related functioning. |
24 weeks
|
|
Physical Activity Level
大体时间：24 weeks
|
Description: Physical activity and sedentary behavior will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), child/adapted version. The questionnaire evaluates moderate-to-vigorous physical activity (MVPA), sedentary time, and total physical activity. Unit of Measure: Moderate-to-vigorous physical activity (MVPA): minutes/week Sedentary time: minutes/day or hours/day Total physical activity: MET-minutes/week Interpretation: Higher MVPA and total physical activity scores indicate greater participation in physical activity and better activity levels. Higher sedentary time indicates more time spent inactive and poorer movement behavior. Lower sedentary time and higher physical activity levels reflect a healthier lifestyle. |
24 weeks
|
|
Assessment Muscular Strength
大体时间：24 weeks
|
Outcome Measure: Muscular Strength Description: Muscular strength will be assessed using the ALPHA-Fitness battery, including handgrip strength testing. Unit of Measure: kg Interpretation: Higher values indicate greater muscular strength and better physical fitness. |
24 weeks
|
|
Assessment Agility
大体时间：24 weeks
|
Outcome Measure: Agility Description: Agility will be assessed using the ALPHA-Fitness battery, through a standardized agility and speed test. Unit of Measure: seconds Interpretation: Lower completion times indicate better agility, speed, and motor performance. |
24 weeks
|
|
Assessment Cardiorespiratory Fitness
大体时间：24 weeks
|
Outcome Measure: Cardiorespiratory Fitness Description: Cardiorespiratory fitness will be assessed using the ALPHA-Fitness battery and expressed as estimated maximal oxygen consumption (VO₂max). Unit of Measure: mL/kg/min (VO₂max) Interpretation: Higher VO₂max values indicate better cardiorespiratory fitness and aerobic capacity. Lower values indicate poorer aerobic fitness. |
24 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.