<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452552</url>
  </required_header>
  <id_info>
    <org_study_id>98</org_study_id>
    <nct_id>NCT04452552</nct_id>
  </id_info>
  <brief_title>Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat</brief_title>
  <official_title>Effect of Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat Thickness in Postnatal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yasmin Mohamed Assim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overweight and obesity is prevalent among women of reproductive age (25-34 years) with 42%&#xD;
      having a BMI &gt; 25 kg/m2. Weight gain increases the risk of developing diabetes and&#xD;
      cardiovascular disease. The amount of weight regain postpartum can shift women from the&#xD;
      healthy weight category into the overweight or obese BMI categories. Purpose: This study was&#xD;
      conducted to compare the effectiveness of ultra-sound Cavitation versus radiofrequency on&#xD;
      abdominal fat thickness on postnatal women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifty overweight primipara women at 6 months postnatally aged from 20-35 years, BMI (25-29.9)&#xD;
      kg/m2 and have waist hip ratio (WHR) &gt; 0.8. They were assigned randomly into 2 equal groups:&#xD;
      Group (A) received ultra-sound cavitation40 KHz applied for 30 min, once time weekly for 8&#xD;
      weeks. Group (B) received radiofrequency multi-polar 5MHZ applied for 30 min, once time&#xD;
      weekly for 8 weeks. Both groups received the same diet program throughout the treatment&#xD;
      period. All females in both groups were assessed through weight scale for body weight, tape&#xD;
      measurement for waist/hip ratio and ultra-sonography for fat thickness of abdominal region&#xD;
      before and after treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2010</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_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) &gt; 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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>An independent person randomly assigned to all participated subjects to either group (A) or group (B)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>BMI calculation</measure>
    <time_frame>8 weeks</time_frame>
    <description>The woman's BMI had calculated from measured weight &amp; height for each woman in both groups (A&amp;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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waist to hip ratio Measurement</measure>
    <time_frame>8 weeks</time_frame>
    <description>WHR was calculated by dividing WC on HC. Both measurements were taken for all women in all groups (A &amp; 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.&#xD;
WHR= (waist circumference / hip circumference)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy Diet</condition>
  <arm_group>
    <arm_group_label>ultra-sound cavitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cavitation40 KHz applied for 30 min, once time weekly for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>radiofrequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>healthy diet</intervention_name>
    <description>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</description>
    <arm_group_label>radiofrequency</arm_group_label>
    <arm_group_label>ultra-sound cavitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Their age were ranged from 20 to 35 years&#xD;
&#xD;
          -  their body mass index BMI 25-29.9 kg/m2&#xD;
&#xD;
          -  their waist hip ratio (WHR) &gt; 0.8.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart disease&#xD;
&#xD;
          -  high cholesterol&#xD;
&#xD;
          -  liver&#xD;
&#xD;
          -  kidney diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ghada eb elrefaye, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghada Elrefaye</name>
      <address>
        <city>Giza</city>
        <state>Cairo</state>
        <zip>02</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ghada Ebrahim El Refaye</investigator_full_name>
    <investigator_title>assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt</investigator_title>
  </responsible_party>
  <keyword>Ultra-sound cavitation</keyword>
  <keyword>Radiofrequency</keyword>
  <keyword>fat thickness</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452552
org study id: 98
nct id: NCT04452552
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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
allocation: Randomized
intervention model: Parallel Assignment
intervention model 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
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: An independent person randomly assigned to all participated subjects to either group (A) or group (B)
measure: BMI calculation
time frame: 8 weeks
description: 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)
measure: Waist to hip ratio Measurement
time frame: 8 weeks
description: 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)
arm group label: ultra-sound cavitation
arm group type: Experimental
description: cavitation40 KHz applied for 30 min, once time weekly for 8 weeks.
arm group label: radiofrequency
arm group type: Experimental
description: radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks
intervention type: Other
intervention name: healthy diet
description: 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
arm group label: radiofrequency
arm group label: ultra-sound cavitation
criteria: 
gender: All
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ghada eb elrefaye, professor
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ghada Ebrahim El Refaye
investigator title: assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt
sharing ipd: Undecided