Clinical trial NCT06529211: Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females
Official title: Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Obesity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the differences between the effect of ultrasound cavitation and whole-body vibration on abdominal fat in obese adolescent females

Detailed description: Adolescence is a critical time associated with the development of obesity. About 80% of adolescents with obesity will continue to have this condition as an adult.

Obesity during adolescence is associated with a number of short- and long-term diseases including hypertension, diabetes mellitus type 2, hyperlipidemia, obstructive sleep apnea, psychological distress and future cardiovascular complications.

The investigators showed that there is an increasing demand for non-surgical procedures in the management of obesity that led to the development of non-invasive techniques for reducing localized subcutaneous adipose tissue.

One of these techniques is focused ultrasound cavitation. Research studies showed some benefits in the treatment of excess abdominal fat deposits with reduction in fat circumference without significant side effects.

Also, another non-invasive technique is whole body vibration (WBV). Some studies showed that when it is combined with dietary intervention leads to body weight reduction and improvement of overall body composition and fat reduction including abdominal fat

Both ultrasound cavitation (UC) and whole-body vibration (WBV) are non-invasive modalities with many positive effects on abdominal fat in obese adolescent females. The effect of both the UC and WBV has been separately investigated in previous studies. Though, no studies were found to compare the effect of both modalities in the management of abdominal fat in obese adolescent females. Therefore, this study will be conducted to explore the effect of UC versus WBV on abdominal fat in obese adolescent females.

Eligibility criteria: Inclusion Criteria:

* Adolescent females suffer from abdominal obesity.
* Their ages will be ranged from 17 to 25 years old.
* Their body mass index (BMI) will be ranged from 30 to 35 kg/m2.
* Their waist circumference will be \> 88 cm.
* Their WHR will be more than 0.88.

Exclusion Criteria:

Females will be excluded from the study if they have:

* Thyroid, hepatic and kidney disorders.
* Diabetes mellitus, coronary artery diseases, hypertension and congestive heart failure.
* Recent abdominal surgical scar or umbilical hernia.
* History of orthopedic implants insertion or cardiac pacemaker implantation.

Primary outcomes:
measure: Weight
timeFrame: Within 6 weeks
measure: BMI
timeFrame: Within 6 weeks
measure: Waist circumference
timeFrame: Within 6 weeks
measure: Waist to hip ratio (WHR)
timeFrame: Within 6 weeks
measure: Abdominal skinfold thickness
timeFrame: Within 6 weeks
measure: Bioelectrical impedance analysis (BIA)
timeFrame: Within 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Azza Kassab
role: STUDY_CHAIR
affiliation: Cairo University
name: Manal El-Shafei
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed AboEleinen
role: STUDY_DIRECTOR
References: