Healthy DietNCT04452552
Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat
A study testing healthy diet in people with Healthy Diet, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- healthy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2010to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- heart disease
- high cholesterol
- liver
- kidney diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Healthy Diet
- Being tested
- healthy diet
- Keywords
- Ultra-sound cavitation, Radiofrequency, fat thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy dietOther
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
| Study group | Role | What they receive |
|---|---|---|
| ultra-sound cavitation | Experimental | cavitation40 KHz applied for 30 min, once time weekly for 8 weeks. Receives: Other: healthy diet |
| radiofrequency | Experimental | radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks Receives: Other: healthy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start24 Jan 2010
- Primary completion30 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Yasmin Mohamed Assim
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
- Investigators
- ghada eb elrefaye, professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452552
- Sponsor's protocol ID
- 98
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat Thickness in Postnatal Women
- ClinicalTrials.gov ID
- NCT04452552
- Acronym / sponsor ID
- 98
- Conditions
- Healthy Diet
- Keywords
- Ultra-sound cavitation, Radiofrequency, fat thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Yasmin Mohamed Assim
- Study start
- 24 Jan 2010 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ultra-sound cavitation | Experimental | Other: healthy dietcavitation40 KHz applied for 30 min, once time weekly for 8 weeks. |
| radiofrequency | Experimental | Other: healthy dietradiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks |
Who may qualify
- Ages
- 25 to 35 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- heart disease
- high cholesterol
- liver
- kidney diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healthy dietbalanced 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 | Other | radiofrequency, ultra-sound cavitation |
Primary outcome
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)
1 secondary outcome
Waist to hip ratio Measurement
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ghada eb elrefaye, professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healthy diet in people with Healthy Diet, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI calculation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.