CClinicalTrials.gg
CompletedNCT04452552Updated Jul 7, 2020

Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat

An interventional study of healthy diet in Healthy Diet, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 years 5 months after the study started (first participant enrolled Jan 2010, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 35 Years
01

Study summary

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

Read the 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

02

Conditions studied

  • Healthy Diet

Keywords

  • Ultra-sound cavitation
  • Radiofrequency
  • fat thickness
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • heart disease
  • high cholesterol
  • liver
  • kidney diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    ultra-sound cavitation

    cavitation40 KHz applied for 30 min, once time weekly for 8 weeks.

    Other: healthy diet

  • Experimental
    radiofrequency

    radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks

    Other: healthy diet

Interventions

  • Otherhealthy 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 8 weeks

Secondary outcomes

  1. 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)

    Time frame: 8 weeks

07

Study locations

1 site
  • Ghada Elrefaye
    Giza, Cairo 02, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04452552
Lead sponsor
Cairo University
Collaborators
Yasmin Mohamed Assim
Responsible party
Ghada Ebrahim El Refaye (assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt, Cairo University) — Principal investigator
First posted
Jun 30, 2020
Start date
Jan 24, 2010
Primary completion
May 30, 2020
Completion
Jun 1, 2020
Last update
Jul 7, 2020

Study contacts

ghada eb elrefaye, professor
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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