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NCT Number: NCT07681856

Immersive Physical Activity Program for Overweight Schoolchildren

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.

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Key information

Conditions

Childhood Overweight and Obesity Immersive Physical Activity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ies Santa Irene

Vigo, Pontevedra, 36210, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RVI_Experimental_Immersive Virtual Reality Exergame Program

Behavioral

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.

RVI_ControGroup_Immersive Virtual Reality Exergame Program

Behavioral

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.

Primary outcomes

  1. Assessment body composition

    Time frame: 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.

  2. Assessment user experience and engagement

    Time frame: 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.

  3. Assessment Safety and cybersickness symptoms

    Time frame: 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.

  4. Assessment usability

    Time frame: 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.

  5. Health-Related Quality of Life (KINDL)

    Time frame: 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.

  6. Physical Activity Level

    Time frame: 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.

  7. Assessment Muscular Strength

    Time frame: 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.

  8. Assessment Agility

    Time frame: 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.

  9. Assessment Cardiorespiratory Fitness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Collaborators

  • Ministry of Work and Welfare - Xunta de Galicia

Registry information

Official study title

Immersive Recreational Physical Exercise Program for Schoolchildren With Overweight or Obesity (PEESO)

Acronym: PEESO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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