Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat

Effect of Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat Thickness in Postnatal Women

Overweight and obesity is prevalent among women of reproductive age (25-34 years) with 42% having a BMI > 25 kg/m2. Weight gain increases the risk of developing diabetes and cardiovascular disease. The amount of weight regain postpartum can shift women from the healthy weight category into the overweight or obese BMI categories. Purpose: This study was conducted to compare the effectiveness of ultra-sound Cavitation versus radiofrequency on abdominal fat thickness on postnatal women

Study Overview

• Status: Completed
• Conditions: Healthy Diet
• Intervention / Treatment: Other: healthy diet

Detailed Description

Fifty overweight primipara women at 6 months postnatally aged from 20-35 years, BMI (25-29.9) kg/m2 and have waist hip ratio (WHR) > 0.8. They were assigned randomly into 2 equal groups: Group (A) received ultra-sound cavitation40 KHz applied for 30 min, once time weekly for 8 weeks. Group (B) received radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks. Both groups received the same diet program throughout the treatment period. All females in both groups were assessed through weight scale for body weight, tape measurement for waist/hip ratio and ultra-sonography for fat thickness of abdominal region before and after treatment

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Giza, Cairo, Egypt, 02
      • Ghada Elrefaye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Their age were ranged from 20 to 35 years
• their body mass index BMI 25-29.9 kg/m2
• their waist hip ratio (WHR) > 0.8.

Exclusion Criteria:

• heart disease
• high cholesterol
• liver
• kidney diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultra-sound cavitation; cavitation40 KHz applied for 30 min, once time weekly for 8 weeks.	Other: healthy diet; balanced diet program which ranged from 1600 kcal to 2000 kcal/day, which was calculated in an individual basis for each woman according to her basal metabolic rate (BMR) for 8 weeks
Experimental: radiofrequency; radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks	Other: healthy diet; balanced diet program which ranged from 1600 kcal to 2000 kcal/day, which was calculated in an individual basis for each woman according to her basal metabolic rate (BMR) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI calculation	The woman's BMI had calculated from measured weight & height for each woman in both groups (A&B) before beginning of the study and weight only had measured after 8 weeks of treatment sessions to according to the following equation: BMI=weight (Kg) /height (m2)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist to hip ratio Measurement	WHR was calculated by dividing WC on HC. Both measurements were taken for all women in all groups (A & B) before starting the study and after 8 weeks of treatment sessions (end of study). All measurements were with the women in standing position. Skin of the anterior abdominal wall was cleaned while the woman in hip circumference worn light clothes and sometimes measurements repeated twice for more accurate. That measured WC, HC to measure (WHR) calculated by dividing the measurement of the waist by the measurement of the hips. WHR= (waist circumference / hip circumference)	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Yasmin Mohamed Assim
• Investigators: Principal Investigator: ghada eb elrefaye, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2010
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Radiofrequency; Ultra-sound cavitation; fat thickness
• Other Study ID Numbers: 98

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No