Obesity and Obesity-related Medical ConditionsNCT06604429
Quality of Life Variations Among Adolescent Females Following Virtual Reality Games Approach
A study testing Aerobic exercise, Diet Advice and Virtual reality exercise in people with Obesity and Obesity-related Medical Conditions and Menstrual Pain, run by Mina Atef Georgui Elias at 3 sites in Egypt.
Trial summary
to compare the effects of virtual reality games, aerobic exercise, and dietary modifications on Quality of Life among adolescent females. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Menstrual Pain, Adolescent Obesity
- What is being tested?
- Aerobic exercise, Diet Advice and Virtual reality exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Oct 2023to 1 Nov 2024
- 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 12 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Obese adolescent girls
- Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
- Have regular menstruation
- Clinically and medically stable
- no impairment of sensation or other neurological or psychological problems
Who cannot join
- Visual and/or auditory defects
- Normal weight girls (Body Mass Index from 18 to 24.99 kg/m2) or below average weight (BMI less than 18 kg/m2) or Class II \& III Obesity (BMI above 35 kg/m2)
- Girls with significant tightness and/or fixed deformity of lower limbs
- Participants with neurological disorders that affect balance or mentality (e.g. epilepsy).
- Girls with advanced radiographic changes include: Bone destruction, Bony ankylosis, Knee joint subluxation, and Epiphysial fracture)
- Congenital or acquired lower limb deformities in the lower limbs.
- Cardiopulmonary dysfunction.
- Girls under insulin therapy, uncontrolled bronchial asthma, anemia, and Pathological causes of obesity (endocrinal, genetic syndromes...etc.).
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Badr University in Cairo faculty of physical therapy
Cairo
El-Mahaba Specialized Charity Polyclinics
Cairo
Life clinic (Private Clinic) - Minya Al Qamh - Sharqia Governorate
Zagazig
About this study
to compare the effects of virtual reality games, aerobic exercise, and dietary modifications on Quality of Life among adolescent females.
Read the detailed description
The study will assess whether virtual reality games, aerobic exercise, and dietary modifications lead to significant differences in Quality of Life scores, and perceived exertion as measured by the Borg scale. Additionally, the study will evaluate whether these interventions produce varying impacts on psychological factors such as depression, anxiety, and stress, and on physical measurements like waist circumference (WC) and body fat composition.
- Conditions
- Obesity and Obesity-related Medical Conditions, Menstrual Pain, Adolescent Obesity, Body Fat Composition, Obesity, Depression, Anxiety
- Being tested
- Aerobic exercise, Diet Advice, Virtual reality exercise
- Keywords
- Obesity, Adolescent girls, Body Fat Composition, Menstrual Pain, Virtual reality Games, Aerobic exercise, Diet, Adolescent Obesity, Quality of Life, Depression, Anxiety, Stress, DASS-21
- Medical subject headings
- Obesity, Dysmenorrhea, Pediatric Obesity, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
aerobic exercises in form of cycle ergometer training (Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes). Finally, a 5 min cool-down period is permitted, the total session that would be applied about 30 min.
Diet AdviceOther
Adolescent girls participated in the study receive diet advices based on a balanced low calorie diet (1500 Kcal)
Virtual reality exerciseOther
Virtual reality game exercise involves 25 min of exercise where adolescent girl immersed in the game and did physical activities for the upper and lower extremities according to the game's requirements, and finally a 5 min cool-down part to lower the heart rate and end the session with static flexibility routines, the total session that would be applied about 30 min of Virtual reality exercises.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exercise | Experimental | The group included 50 girls who received diet advice, aerobic and virtual reality exercises 3 times per week for 8 weeks. they received diet advice and aerobic exercises in form of cycle ergometer training (Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes). Then This was followed by the main part, which consisted of 25 min of exercise when girl immersed in the game and did physical activities for the upper and lower extremities according to the game's requirements, and finally a 5 min cool-down part to lower the heart rate and end the session with static flexibility routines, the total session that would be applied about 50 min (including 30 mins of Virtual reality exercises) Receives: Other: Aerobic exercise; Other: Diet Advice; Other: Virtual reality exercise |
| Control group (aerobic exercise) | Active comparator | This group serves as the control group, it included 50 girls who received diet advice and aerobic exercises in form of cycle ergometer training for 3 times per week for 8 weeks. Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes. Finally, a 5 min cool-down period is permitted, the total session that would be applied about 30 min. Receives: Other: Aerobic exercise; Other: Diet Advice |
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 8 weeks
Fat Mass
Body fat mass percentage measured by body composition analysis device
Measured: From enrollment to the end of treatment at 8 weeks
Body Water Content
Total body water content percentage measured by body composition analysis device.
Measured: From enrollment to the end of treatment at 8 weeks
Muscle mass
Body muscle mass percentage measured by body composition analysis device.
Measured: From enrollment to the end of treatment at 8 weeks
Waist Circumference
Waist circumference measured in centimeters, where the patient would be in standing position while investigator applied the tape round the abdomen at its narrowest point between the lower rib margin and top of iliac crest at the end of quiet expiration.
Measured: From enrollment to the end of treatment at 8 weeks
Waist hip ratio
It is the ratio between the waist circumference and the hip circumference. Where the waist circumference should be measured at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest, using a tape measurement. While, the hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor.
Measured: From enrollment to the end of treatment at 8 weeks
Borg Scale (rate of perceived exertion)
This is the modified Borg scale (rating from 0 to 10) where 0 means \"no exertion at all\" and 20 means \"maximal exertion.\" When a measurement is taken, a number is chosen from the scale by the participant that best describes their perceived level of exertion during physical activity (Six-Minute walk test)
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (5)
Menstrual pain by Visual Analogue Scale (VAS)
The VAS is a 10-point scale comprising a number from 0 through 10; 0 indicates no pain, and 10 indicates the worst imaginable pain. Adolescent girls participating in the study were instructed to choose a single number from the scale that best indicates their level of menstrual pain
Measured: From enrollment to the end of treatment at 8 weeks
Pediatric Quality of Life Inventory (PedsQL)
It is a 23-item generic health status instrument that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in adolescents.
The PedsQL 4.0 has been proposed as a valid and reliable generic pediatric HRQOL measurement that can be used for self-reports in age groups ranging from 2 to 18 years and can also be used in clinical practice, clinical trials, and research, as well as school health settings, and community populations.
It is a questionnaire for the child about child's physical, emotional, social, and school functioning in the past one month. On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).
Measured: From enrollment to the end of treatment at 8 weeks
Depression Score
Through the DAAS-21 scale (Depression, Anxiety and Stress scoring and degree)
It consists of 21 questions, seven questions for depression, seven for anxiety and seven for stress assessment. The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.
Measured: From enrollment to the end of treatment at 8 weeks
Anxiety Score
Through the DAAS-21 scale (Depression, Anxiety and Stress scoring and degree)
It consists of 21 questions, seven questions for depression, seven for anxiety and seven for stress assessment. The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.
Measured: From enrollment to the end of treatment at 8 weeks
Stress Score
Through the DAAS-21 scale (Depression, Anxiety and Stress scoring and degree)
It consists of 21 questions, seven questions for depression, seven for anxiety and seven for stress assessment. The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2023
- Primary completion30 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mina Atef Georgui Elias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mina Atef Georgui Elias, Badr University
- Investigators
- Doaa Saeed, PhD, Study chair, Lecturer Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, EgyptRadwa 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604429
- Sponsor's protocol ID
- IRB00014233-7
- Other IDs
- IRB00014233-7
- Status last verified
- Dec 2024
- First submitted
- 17 Sep 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Variations Among Adolescent Females Following Virtual Reality Games Approach
- ClinicalTrials.gov ID
- NCT06604429
- Acronym / sponsor ID
- IRB00014233-7
- Conditions
- Obesity and Obesity-related Medical Conditions, Menstrual Pain, Adolescent Obesity, Body Fat Composition, Obesity, Depression, Anxiety
- Keywords
- Obesity, Adolescent girls, Body Fat Composition, Menstrual Pain, Virtual reality Games, Aerobic exercise, Diet, Adolescent Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mina Atef Georgui EliasUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 19 Sep 2024 (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.
to compare the effects of virtual reality games, aerobic exercise, and dietary modifications on Quality of Life among adolescent females.
Detailed description
The study will assess whether virtual reality games, aerobic exercise, and dietary modifications lead to significant differences in Quality of Life scores, and perceived exertion as measured by the Borg scale. Additionally, the study will evaluate whether these interventions produce varying impacts on psychological factors such as depression, anxiety, and stress, and on physical measurements like waist circumference (WC) and body fat composition.
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: Aerobic exercise, Other: Diet Advice, Other: Virtual reality exerciseThe group included 50 girls who received diet advice, aerobic and virtual reality exercises 3 times per week for 8 weeks. they received diet advice and aerobic exercises in form of cycle ergometer training (Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes). Then This was followed by the main part, which consisted of 25 min of exercise when girl immersed in the game and did physical activities for the upper and lower extremities according to the game's requirements, and finally a 5 min cool-down part to lower the heart rate and end the session with static flexibility routines, the total session that would be applied about 50 min (including 30 mins of Virtual reality exercises) |
| Control group (aerobic exercise) | Active comparator | Other: Aerobic exercise, Other: Diet AdviceThis group serves as the control group, it included 50 girls who received diet advice and aerobic exercises in form of cycle ergometer training for 3 times per week for 8 weeks. Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes. Finally, a 5 min cool-down period is permitted, the total session that would be applied about 30 min. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Obese adolescent girls
- Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
- Have regular menstruation
- Clinically and medically stable
- no impairment of sensation or other neurological or psychological problems
Key exclusion criteria (8 listed)
- Visual and/or auditory defects
- Normal weight girls (Body Mass Index from 18 to 24.99 kg/m2) or below average weight (BMI less than 18 kg/m2) or Class II \& III Obesity (BMI above 35 kg/m2)
- Girls with significant tightness and/or fixed deformity of lower limbs
- Participants with neurological disorders that affect balance or mentality (e.g. epilepsy).
- Girls 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 |
|---|---|---|
| Aerobic exerciseaerobic exercises in form of cycle ergometer training (Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes). Finally, a 5 min cool-down period is permitted, the total session that would be applied about 30 min. | Other | Control group (aerobic exercise), Virtual Reality Exercise |
| Diet AdviceAdolescent girls participated in the study receive diet advices based on a balanced low calorie diet (1500 Kcal) | Other | Control group (aerobic exercise), Virtual Reality Exercise |
| Virtual reality exerciseVirtual reality game exercise involves 25 min of exercise where adolescent girl immersed in the game and did physical activities for the upper and lower extremities according to the game's requirements, and finally a 5 min cool-down part to lower the heart rate and end the session with static flexibility routines, the total session that would be applied about 30 min of Virtual reality exercises. | Other | Virtual Reality Exercise |
Primary outcome
Body mass index
Time frame: From enrollment to the end of treatment at 8 weeks
It is the weight (in kilograms) divided by the height (in meter squares)
Fat Mass
Time frame: From enrollment to the end of treatment at 8 weeks
Body fat mass percentage measured by body composition analysis device
Body Water Content
Time frame: From enrollment to the end of treatment at 8 weeks
Total body water content percentage measured by body composition analysis device.
Muscle mass
Time frame: From enrollment to the end of treatment at 8 weeks
Body muscle mass percentage measured by body composition analysis device.
Waist Circumference
Time frame: From enrollment to the end of treatment at 8 weeks
Waist circumference measured in centimeters, where the patient would be in standing position while investigator applied the tape round the abdomen at its narrowest point between the lower rib margin and top of iliac crest at the end of quiet expiration.
Waist hip ratio
Time frame: From enrollment to the end of treatment at 8 weeks
It is the ratio between the waist circumference and the hip circumference. Where the waist circumference should be measured at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest, using a tape measurement. While, the hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor.
Borg Scale (rate of perceived exertion)
Time frame: From enrollment to the end of treatment at 8 weeks
This is the modified Borg scale (rating from 0 to 10) where 0 means \"no exertion at all\" and 20 means \"maximal exertion.\" When a measurement is taken, a number is chosen from the scale by the participant that best describes their perceived level of exertion during physical activity (Six-Minute walk test)
5 secondary outcomes
Menstrual pain by Visual Analogue Scale (VAS)
Time frame: From enrollment to the end of treatment at 8 weeks
Pediatric Quality of Life Inventory (PedsQL)
Time frame: From enrollment to the end of treatment at 8 weeks
Depression Score
Time frame: From enrollment to the end of treatment at 8 weeks
Anxiety Score
Time frame: From enrollment to the end of treatment at 8 weeks
Stress Score
Time frame: From enrollment to the end of treatment at 8 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 5 Dec 2024.
Related trials for Obesity and Obesity-related Medical Conditions
Recruiting
Transition to Ambulatory Bariatric Surgery (TABS) Trial
Obesity and Obesity-related Medical Conditions, Bariatric Surgery
Active, not recruitingEarly Phase 1
Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Obesity and Obesity-related Medical Conditions
Recruiting
A Wearable Device and AI-Supported Diet and Exercise Intervention
Obesity and Obesity-related Medical Conditions
Recruiting
Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)
Appetite, Obesity and Obesity-related Medical Conditions
Active, not recruitingPhase 4
Bariatric Surgery vs. Semaglutide vs. Tirzepatide
Obesity and Obesity-related Medical Conditions
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.
Doaa Saeed, PhD study chair
Lecturer Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, Egypt
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise, Diet Advice and Virtual reality exercise in people with Obesity and Obesity-related Medical Conditions and Menstrual Pain, run by Mina Atef Georgui Elias at 3 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 8 weeks). The study lists 7 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 5 Dec 2024.