Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females

Not Applicable

Not yet recruiting

• Conditions: Abdominal Obesity
• Interventions: Dietary Supplement: Low caloric diet; Device: Ultrasound cavitation; Device: Whole body vibration

• Registration Number: NCT06529211
• Lead Sponsor: Cairo University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-22
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound cavitation group	Low caloric diet	The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1500 kcal/day.
Low caloric diet group	Low caloric diet	low-caloric diet of 1500 kcal/day.
ultrasound cavitation group	Ultrasound cavitation	The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1500 kcal/day.
whole-body vibration group	Low caloric diet	The participants will be treated by whole body vibration, in addition to the low-caloric diet of 1500 kcal/day.
whole-body vibration group	Whole body vibration	The participants will be treated by whole body vibration, in addition to the low-caloric diet of 1500 kcal/day.

Primary Outcome Measures

Name	Time	Method
Waist to hip ratio (WHR)	Within 6 weeks	Waist-to-hip ratio (WHR) is a measurement that compares the circumference of the waist to that of the hips. The waist circumference is measured at the narrowest point of the torso, usually just above the belly button (umbilicus), and the hip circumference is measured at the widest part, 9 around the buttocks at level of greater trochanters; then dividing the waist circumference by the hip circumference. The formula is as follows: WHR = Waist Circumference / Hip Circumference. For women, a WHR above 0.85 is often considered high and indicative of an increased health risk.
BMI	Within 6 weeks	Weight/ height scale will be used to measure the weight and height of all females in all groups to calculate their BMI before and after treatment according to the following equation BMI = weight/ height² (kg/m²)
Waist circumference	Within 6 weeks	It is a measurement taken around the waist at the level of the narrowest part of the torso, typically located between the bottom of the rib cage and the top of the hip bones (iliac crest). It is used as an indicator of central obesity. However, as a general guideline, a waist circumference of over 35 inches (88 cm) in women is often considered high and indicative of an increased health risk .
Weight	Within 6 weeks
Bioelectrical impedance analysis (BIA)	Within 6 weeks	In BIA, a small, safe electrical current is passed through the body using electrodes typically placed on the hands and feet. The electrical current encounters resistance from tissues with lower water content, such as fat and bone, while it easily passes through tissues with higher water content, such as muscle. By measuring the impedance (resistance and reactance) of the electrical current, BIA devices can estimate body composition parameters such as body fat percentage, lean body mass, and hydration levels. BIA can provide a quick and non-invasive estimation of body composition. Also, it is a useful tool for tracking changes in body composition over time and monitoring progress in fitness or weight loss programs.
Abdominal skinfold thickness	Within 6 weeks	Abdominal skinfold thickness is a specific measurement used to estimate the amount of subcutaneous fat in that area. It provides insights into the distribution of fat in the abdominal region. The measurement is typically taken at a site approximately 2 cm to the right side of the belly button, and the skinfold is pinched with calipers to measure the thickness. The measurement process involves firmly grasping the skin and underlying fat tissue with the calipers, ensuring that only the skin and fat are included in the measurement and not muscle or other tissues. The measurement is recorded in millimeters (mm)