Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Waist to hip ratio (WHR)
研究概览
简要总结
This study aims to determine the differences between the effect of ultrasound cavitation and whole-body vibration on abdominal fat in obese adolescent females
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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/m
- •Their waist circumference will be > 88 cm.
- •Their WHR will be more than 0.88.
排除标准
- •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.
结局指标
主要结局
Waist to hip ratio (WHR)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Within 6 weeks
Bioelectrical impedance analysis (BIA)
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
Christina Samir Harmakes
principle investigator
Cairo University