Immersive Recreational Physical Exercise Program for Schoolchildren With Overweight or Obesity (PEESO)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assessment body composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment body composition
时间窗: 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.
Assessment user experience and engagement
时间窗: 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.
Assessment Safety and cybersickness symptoms
时间窗: 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.
Assessment usability
时间窗: 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.
Health-Related Quality of Life (KINDL)
时间窗: 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.
Physical Activity Level
时间窗: 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.
Assessment Muscular Strength
时间窗: 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.
Assessment Agility
时间窗: 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.
Assessment Cardiorespiratory Fitness
时间窗: 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.
次要结局
未报告次要终点
研究者
José M. Cancela
Principal investigador
University of Vigo