Obesity and Obesity-related Medical Conditions, Menstrual Pain, Adolescent Obesity, Body Fat Composition, Obesity, Depression, Anxiety
Conditions
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
Brief summary
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.
Interventions
OTHERAerobic exercise
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.
OTHERDiet Advice
Adolescent girls participated in the study receive diet advices based on a balanced low calorie diet (1500 Kcal)
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.
Sponsors
Mina Atef Georgui Elias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index | 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 | From enrollment to the end of treatment at 8 weeks | Body fat mass percentage measured by body composition analysis device |
| Body Water Content | From enrollment to the end of treatment at 8 weeks | Total body water content percentage measured by body composition analysis device. |
| Muscle mass | From enrollment to the end of treatment at 8 weeks | Body muscle mass percentage measured by body composition analysis device. |
| Waist Circumference | 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 | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual pain by Visual Analogue Scale (VAS) | From enrollment to the end of treatment at 8 weeks | 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 |
| Pediatric Quality of Life Inventory (PedsQL) | From enrollment to the end of treatment at 8 weeks | 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). |
| Depression Score | From enrollment to the end of treatment at 8 weeks | 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. |
| Anxiety Score | From enrollment to the end of treatment at 8 weeks | 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. |
| Stress Score | From enrollment to the end of treatment at 8 weeks | 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. |
Countries
Egypt
Outcome results
None listed