Obese Children and AdolescentsNCT07073651
Response of Lipid Profile to Virtual Reality Games Versus Moderate Aerobic Exercise Training in Children With Obesity
A study testing Moderate Intensity Aerobic Exercise, Dietary Advices and Virtual reality games exercise in people with Obese Children and Adolescents and Adolescent Obesity, run by Badr University at 2 sites in Egypt.
Trial summary
This trial is aiming to study the effect of virtual reality video gaming in comparison with moderate intensity aerobic exercises on lipid profile in children with Obesity Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Obese Children and Adolescents, Adolescent Obesity, Obesity
- What is being tested?
- Moderate Intensity Aerobic Exercise, Dietary Advices and Virtual reality games exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obese adolescent children
- age from 11 to 18 years old only.
- Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
- Clinically and medically stable
- Without any impairment of sensation or other neurological or psychological problems.
Who cannot join
- Adolescents with visual and/or auditory defects
- Normal weight adolescent children (Body Mass Index from 18 to 24.99 kg/m2) or below average weight (BMI less than 18 kg/m2) or Class II and III Obesity (BMI above 35 kg/m2)
- Children with significant tightness and/or deformity of upper or lower limbs
- Participants with neurological disorders that affect balance or mentality (e.g. epilepsy).
- Adolescents with advanced radiographic changes include: Bone destruction, Bony ankylosis, Knee joint subluxation, and Epiphysial fracture)
- Any lower limb deformities in the lower limbs.
- Participants with cardiopulmonary diseases.
- Diabetic children or those under insulin therapy, uncontrolled bronchial asthma, anemia, and Pathological causes of obesity (endocrinal, genetic syndromes...etc.).
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Badr University in Cairo faculty of physical therapy
Cairo
El-Mahaba Specialized Charity Polyclinics.
Cairo
About this study
This trial is aiming to study the effect of virtual reality video gaming in comparison with moderate intensity aerobic exercises on lipid profile in children with Obesity
Read the detailed description
The study will assess whether virtual reality games, dietary advices and moderate intensity aerobic exercise lead to significant differences in lipid profile in class I obese adolescent children. Additionally, the study will examine whether these interventions has impacts on the children body mass index.
- Being tested
- Moderate Intensity Aerobic Exercise, Dietary Advices, Virtual reality games exercise
- Keywords
- Obesity, Body mass index, Virtual Reality games, aerobic exercise, adolescent obesity, obese children, Moderate intensity aerobic exercise, dietary advices
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Aerobic ExerciseOther
moderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes.
Dietary AdvicesOther
The Obese adolescent children participated in the study received diet advices based on a balanced low calorie diet (1500 Kcal)
Virtual reality games exerciseOther
Virtual reality games exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercises to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises)
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exercise | Experimental | The experimental group included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advices and virtual reality exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercise to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises) Receives: Other: Dietary Advices; Other: Virtual reality games exercise |
| Moderate intensity aerobic exercise | Active comparator | This group serves as the control group, it included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advice and moderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes. Receives: Other: Moderate Intensity Aerobic Exercise; Other: Dietary Advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
It is the weight (in kilograms) divided by the height (in meter squares)
Measured: From enrollment to the end of treatment at 12 weeks
Serum triglycerides
Level of triglycerides fats in blood in measured in laboratory using venous blood sample
Measured: From enrollment to the end of treatment at 12 weeks
Total Cholesterol
Level of total cholesterol in blood in measured in laboratory using venous blood sample
Measured: From enrollment to the end of treatment at 12 weeks
High Density Lipoproteins (HDL)
High Density Lipoproteins (HDL) cholesterol fats are measured in laboratory using a venous blood sample
Measured: From enrollment to the end of treatment at 12 weeks
Low Density Lipoproteins (LDL)
Low Density Lipoproteins (LDL) cholesterol fats are measured in laboratory using a venous blood sample
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
HDL ratio
The number of total cholesterol divided by high-density lipoprotein (HDL)
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start10 Jul 2024
- Primary completion31 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Children and AdolescentsStudies 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Atef Georgui Elias, Badr University
- Investigators
- Radwa S Abdulrahman, PhD, Principal investigator, Ass. Prof. Dept. of PT for Pediatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.Hayam M Mahmoud, PhD, Study chair, Professor Dept. of PT for Neurology & Neurosurgery, Faculty of Physical Therapy, Cairo Univ. EgyptWael OA Abd El-Khalek, PhD, Study chair, Lecturer, Dept. of Basic Sciences, Faculty of Physical Therapy, Badr University in Cairo, Egypt.Noha A Fouad, PhD, Study chair, Ass Prof Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, EgypMina AG Elias, PhD, Principal investigator, Department of Physical Therapy Ahmed Maher Teaching hospital, General Organization For Teaching Hospitals And Institutes (GOTHI)Ashraf H Saleh, PhD, Study chair, Prof Dept. of PT for Surgery and Burn, Faculty of Physical Therapy Badr University in Cairo, EgypMona M Abdelkhalek, PhD, Study chair, Ass. Prof. Dept. of PT for Internal Medicine, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073651
- Sponsor's protocol ID
- IRB00014233-8
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 18 Jul 2025
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Lipid Profile to Virtual Reality Games Versus Moderate Aerobic Exercise Training in Children With Obesity
- ClinicalTrials.gov ID
- NCT07073651
- Acronym / sponsor ID
- IRB00014233-8
- Keywords
- Obesity, Body mass index, Virtual Reality games, aerobic exercise, adolescent obesity, obese children, Moderate intensity aerobic exercise, dietary advices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Jul 2025 (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.
This trial is aiming to study the effect of virtual reality video gaming in comparison with moderate intensity aerobic exercises on lipid profile in children with Obesity
Detailed description
The study will assess whether virtual reality games, dietary advices and moderate intensity aerobic exercise lead to significant differences in lipid profile in class I obese adolescent children. Additionally, the study will examine whether these interventions has impacts on the children body mass index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exercise | Experimental | Other: Dietary Advices, Other: Virtual reality games exerciseThe experimental group included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advices and virtual reality exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercise to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises) |
| Moderate intensity aerobic exercise | Active comparator | Other: Moderate Intensity Aerobic Exercise, Other: Dietary AdvicesThis group serves as the control group, it included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advice and moderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Obese adolescent children
- age from 11 to 18 years old only.
- Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
- Clinically and medically stable
- Without any impairment of sensation or other neurological or psychological problems.
Key exclusion criteria (8 listed)
- Adolescents with visual and/or auditory defects
- Normal weight adolescent children (Body Mass Index from 18 to 24.99 kg/m2) or below average weight (BMI less than 18 kg/m2) or Class II and III Obesity (BMI above 35 kg/m2)
- Children with significant tightness and/or deformity of upper or lower limbs
- Participants with neurological disorders that affect balance or mentality (e.g. epilepsy).
- Adolescents with advanced radiographic changes include: Bone destruction, Bony ankylosis, Knee joint subluxation, and Epiphysial fracture)
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 |
|---|---|---|
| Moderate Intensity Aerobic Exercisemoderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes. | Other | Moderate intensity aerobic exercise |
| Dietary AdvicesThe Obese adolescent children participated in the study received diet advices based on a balanced low calorie diet (1500 Kcal) | Other | Moderate intensity aerobic exercise, Virtual Reality Exercise |
| Virtual reality games exerciseVirtual reality games exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercises to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises) | Other | Virtual Reality Exercise |
Primary outcome
Body mass index
Time frame: From enrollment to the end of treatment at 12 weeks
It is the weight (in kilograms) divided by the height (in meter squares)
Serum triglycerides
Time frame: From enrollment to the end of treatment at 12 weeks
Level of triglycerides fats in blood in measured in laboratory using venous blood sample
Total Cholesterol
Time frame: From enrollment to the end of treatment at 12 weeks
Level of total cholesterol in blood in measured in laboratory using venous blood sample
High Density Lipoproteins (HDL)
Time frame: From enrollment to the end of treatment at 12 weeks
High Density Lipoproteins (HDL) cholesterol fats are measured in laboratory using a venous blood sample
Low Density Lipoproteins (LDL)
Time frame: From enrollment to the end of treatment at 12 weeks
Low Density Lipoproteins (LDL) cholesterol fats are measured in laboratory using a venous blood sample
1 secondary outcome
HDL ratio
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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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. This study is not recruiting at the moment.
Radwa S Abdulrahman, PhD principal investigator
Ass. Prof. Dept. of PT for Pediatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
Hayam M Mahmoud, PhD study chair
Professor Dept. of PT for Neurology & Neurosurgery, Faculty of Physical Therapy, Cairo Univ. Egypt
Wael OA Abd El-Khalek, PhD study chair
Lecturer, Dept. of Basic Sciences, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Aerobic Exercise, Dietary Advices and Virtual reality games exercise in people with Obese Children and Adolescents and Adolescent Obesity, run by Badr University at 2 sites in Egypt.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body mass index (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 5 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 18 Jul 2025.