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Completed

NCT Number: NCT04452552

Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat

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

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Key information

Conditions

Healthy Diet

Age range

25 year–35 year

Study type

Interventional

Phase

Not applicable

Primary location

Ghada Elrefaye

Giza, Cairo Governorate, 02, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

healthy diet

Other

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

Primary outcomes

  1. BMI calculation

    Time frame: 8 weeks

    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)

Secondary outcomes

  1. Waist to hip ratio Measurement

    Time frame: 8 weeks

    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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Yasmin Mohamed Assim

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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