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Enrolling by invitation NCT07681856

Immersive Physical Activity Program for Overweight Schoolchildren

No phase Interventional Childhood Overweight and Obesity Immersive Physical Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RVI_Experimental_Immersive Virtual Reality Exergame Program, RVI_ControGroup_Immersive Virtual Reality Exergame Program.
Who it may be relevant to
Registry conditions: Childhood Overweight and Obesity Immersive Physical Activity. Basic parameters: 12 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral RVI_Experimental_Immersive Virtual Reality Exergame Program
    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 ex
  • Behavioral RVI_ControGroup_Immersive Virtual Reality Exergame Program
    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

Primary outcome measures

  • Assessment body composition [Time frame: 24 weeks]
  • Assessment user experience and engagement [Time frame: 24 weeks]
  • Assessment Safety and cybersickness symptoms [Time frame: 24 weeks]
  • Assessment usability [Time frame: 24 weeks]
  • Health-Related Quality of Life (KINDL) [Time frame: 24 weeks]
  • Physical Activity Level [Time frame: 24 weeks]
  • Assessment Muscular Strength [Time frame: 24 weeks]
  • Assessment Agility [Time frame: 24 weeks]
  • Assessment Cardiorespiratory Fitness [Time frame: 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Ies Santa Irene — Vigo

Identifiers

NCT: NCT07681856 · CP-220126-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗