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

NCT06529211 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004858
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (6)

• Weight

  Within 6 weeks

• BMI

  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)

  Within 6 weeks

• Waist circumference

  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 .

  Within 6 weeks

• Waist to hip ratio (WHR)

  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.

  Within 6 weeks

• Abdominal skinfold thickness

  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)

  Within 6 weeks

• Bioelectrical impedance analysis (BIA)

  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.

  Within 6 weeks

Study Arms (3)

Low caloric diet group

ACTIVE COMPARATOR

low-caloric diet of 1500 kcal/day.

Dietary Supplement: Low caloric diet

ultrasound cavitation group

EXPERIMENTAL

The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1500 kcal/day.

Dietary Supplement: Low caloric diet; Device: Ultrasound cavitation

whole-body vibration group

EXPERIMENTAL

The participants will be treated by whole body vibration, in addition to the low-caloric diet of 1500 kcal/day.

Dietary Supplement: Low caloric diet; Device: Whole body vibration

Interventions

Low caloric diet DIETARY_SUPPLEMENT

Low caloric diet: the participants will receive low caloric diet program (1500 Kcal/ day) for 6 weeks as follows: 45% carbohydrate, 20% fat and 35% proteins of total calorie intake.

Low caloric diet group; ultrasound cavitation group; whole-body vibration group

Ultrasound cavitation DEVICE

Ultrasound cavitation + Low caloric diet Low caloric diet program (1500 Kcal/ day): for 6 weeks. Ultrasound cavitation: It will be on abdomen for 30 minutes/session, 2 sessions/week for 6 weeks as follows: * The participants will be in supine lying position and the abdomen is divided into two sides right and left from the midline. * The Ultrasound pulsed waves will be set with power input (AC100/ 240V), frequency (40 KHz), and Power output (45W). This will be for 15 minutes on each abdominal side.

ultrasound cavitation group

Whole body vibration DEVICE

Whole body vibration + Low caloric diet Low caloric diet program (1500 Kcal/ day) for 6 weeks. Whole body vibration: for 30 minutes/session, 2 sessions/week for 6 weeks as follows: * The participants will begin with a brief warm-up for 5 minutes by doing deep breathing exercises. * Then they will stand with feet shoulder-width apart on the platform while holding handrails to maintain balance and stability. They will be instructed to relax and allow the vibrations to pass through her body. This will be applied for 20 minutes per session. * The vibration will be started with lower settings and gradually will be increased till the desired frequency and amplitude (45 HZ) will be reached. * After the session will be completed, the participant will be instructed to cool down gradually by doing deep breathing for 5 minutes to help their body to return to a resting state. They will be advised to drink plenty of water to be hydrated and recovered after the WBV session.

whole-body vibration group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Gender Eligibility Details: Adolescent females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Azza Kassab

  Cairo University

  STUDY CHAIR

• Manal El-Shafei

  Cairo University

  STUDY DIRECTOR

• Mohamed AboEleinen

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Christina yassa, Master

CONTACT

+201228294939; christina.haram@gmail.com

Peter Armanious

CONTACT

+201017816200; peterfayek1985@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: July 22, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 10, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL