Childhood Overweight and Obesity Immersive Physical ActivityPEESONCT07681856
Immersive Physical Activity Program for Overweight Schoolchildren
A study testing RVI_Experimental_Immersive Virtual Reality Exergame Program and RVI_ControGroup_Immersive Virtual Reality Exergame Program in people with Childhood Overweight and Obesity Immersive Physical Activity, run by University of Vigo at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Childhood Overweight and Obesity Immersive Physical Activity
- What is being tested?
- RVI_Experimental_Immersive Virtual Reality Exergame Program and RVI_ControGroup_Immersive Virtual Reality Exergame Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- RVI_Experimental_Immersive Virtual Reality Exergame Program, RVI_ControGroup_Immersive Virtual Reality Exergame Program
- Keywords
- Virtual Reality, Physical exercise, Overweight children, Training program
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVI_Experimental_Immersive Virtual Reality Exergame ProgramBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RVI_Experimental_Immersive Virtual Reality Exergame Program | Experimental | 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. Receives: Behavioral: RVI_Experimental_Immersive Virtual Reality Exergame Program |
| RVI_ControGroup_Immersive Virtual Reality Exergame Program | Placebo comparator | 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. Receives: Behavioral: RVI_ControGroup_Immersive Virtual Reality Exergame Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment body composition
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.
Measured: 24 weeks
Assessment user experience and engagement
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.
Measured: 24 weeks
Assessment Safety and cybersickness 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.
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.
Measured: 24 weeks
Assessment usability
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.
Measured: 24 weeks
Health-Related Quality of Life (KINDL)
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.
Measured: 24 weeks
Physical Activity Level
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.
Measured: 24 weeks
Assessment Muscular Strength
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.
Measured: 24 weeks
Assessment Agility
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.
Measured: 24 weeks
Assessment Cardiorespiratory Fitness
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start20 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Overweight and Obesity Immersive Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Work and Welfare - Xunta de Galicia
- Responsible party
- Principal investigator, José M. Cancela, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681856
- Sponsor's protocol ID
- CP-220126-37
- Acronym
- PEESO
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Recreational Physical Exercise Program for Schoolchildren With Overweight or Obesity (PEESO)
- ClinicalTrials.gov ID
- NCT07681856
- Acronym / sponsor ID
- PEESO / CP-220126-37
- Keywords
- Virtual Reality, Physical exercise, Overweight children, Training program
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Ministry of Work and Welfare - Xunta de Galicia
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVI_Experimental_Immersive Virtual Reality Exergame Program | Experimental | Behavioral: RVI_Experimental_Immersive Virtual Reality Exergame ProgramThe 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. |
| RVI_ControGroup_Immersive Virtual Reality Exergame Program | Placebo comparator | Behavioral: RVI_ControGroup_Immersive Virtual Reality Exergame ProgramThe 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. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVI_Experimental_Immersive Virtual Reality Exergame ProgramParticipants 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. | Behavioural | RVI_Experimental_Immersive Virtual Reality Exergame Program |
| RVI_ControGroup_Immersive Virtual Reality Exergame ProgramParticipants 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. | Behavioural | RVI_ControGroup_Immersive Virtual Reality Exergame Program |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RVI_Experimental_Immersive Virtual Reality Exergame Program and RVI_ControGroup_Immersive Virtual Reality Exergame Program in people with Childhood Overweight and Obesity Immersive Physical Activity, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment body composition (time frame: 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.