Abdominal ObesityNCT06529211
Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females
A study testing Low caloric diet, Ultrasound cavitation and Whole body vibration in people with Abdominal Obesity, run by Cairo University.
Trial summary
This study aims to determine the differences between the effect of ultrasound cavitation and whole-body vibration on abdominal fat in obese adolescent females Read more about this study
- Who is it for?
- Ages 17 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Low caloric diet, Ultrasound cavitation and Whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2024to 10 Dec 2024
- 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 17 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent females suffer from abdominal obesity.
- Their ages will be ranged from 17 to 25 years old.
- Their body mass index (BMI) will be ranged from 30 to 35 kg/m2.
- Their waist circumference will be > 88 cm.
- Their WHR will be more than 0.88.
Who cannot join
- Females will be excluded from the study if they have:
- Thyroid, hepatic and kidney disorders.
- Diabetes mellitus, coronary artery diseases, hypertension and congestive heart failure.
- Recent abdominal surgical scar or umbilical hernia.
- History of orthopedic implants insertion or cardiac pacemaker implantation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females: a Randomized Controlled Trial
This study aims to determine the differences between the effect of ultrasound cavitation and whole-body vibration on abdominal fat in obese adolescent females
Read the detailed description
Adolescence is a critical time associated with the development of obesity. About 80% of adolescents with obesity will continue to have this condition as an adult.
Obesity during adolescence is associated with a number of short- and long-term diseases including hypertension, diabetes mellitus type 2, hyperlipidemia, obstructive sleep apnea, psychological distress and future cardiovascular complications.
The investigators showed that there is an increasing demand for non-surgical procedures in the management of obesity that led to the development of non-invasive techniques for reducing localized subcutaneous adipose tissue.
One of these techniques is focused ultrasound cavitation. Research studies showed some benefits in the treatment of excess abdominal fat deposits with reduction in fat circumference without significant side effects.
Also, another non-invasive technique is whole body vibration (WBV). Some studies showed that when it is combined with dietary intervention leads to body weight reduction and improvement of overall body composition and fat reduction including abdominal fat
Both ultrasound cavitation (UC) and whole-body vibration (WBV) are non-invasive modalities with many positive effects on abdominal fat in obese adolescent females. The effect of both the UC and WBV has been separately investigated in previous studies. Though, no studies were found to compare the effect of both modalities in the management of abdominal fat in obese adolescent females. Therefore, this study will be conducted to explore the effect of UC versus WBV on abdominal fat in obese adolescent females.
- Conditions
- Abdominal Obesity
- Being tested
- Low caloric diet, Ultrasound cavitation, Whole body vibration
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low caloric dietDietary supplement
Low caloric diet: the participants will receive low caloric diet program (1500 Kcal/ day) for 6 weeks as follows: 45% carbohydrate, 20% fat and 35% proteins of total calorie intake.
Ultrasound cavitationDevice
Ultrasound cavitation + Low caloric diet Low caloric diet program (1500 Kcal/ day): for 6 weeks.
Ultrasound cavitation: It will be on abdomen for 30 minutes/session, 2 sessions/week for 6 weeks as follows:
- The participants will be in supine lying position and the abdomen is divided into two sides right and left from the midline.
- The Ultrasound pulsed waves will be set with power input (AC100/ 240V), frequency (40 KHz), and Power output (45W). This will be for 15 minutes on each abdominal side.
Whole body vibrationDevice
Whole body vibration + Low caloric diet Low caloric diet program (1500 Kcal/ day) for 6 weeks.
Whole body vibration: for 30 minutes/session, 2 sessions/week for 6 weeks as follows:
- The participants will begin with a brief warm-up for 5 minutes by doing deep breathing exercises.
- Then they will stand with feet shoulder-width apart on the platform while holding handrails to maintain balance and stability. They will be instructed to relax and allow the vibrations to pass through her body. This will be applied for 20 minutes per session.
- The vibration will be started with lower settings and gradually will be increased till the desired frequency and amplitude (45 HZ) will be reached.
- After the session will be completed, the participant will be instructed to cool down gradually by doing deep breathing for 5 minutes to help their body to return to a resting state. They will be advised to drink plenty of water to be hydrated and recovered after the WBV session.
| Study group | Role | What they receive |
|---|---|---|
| Low caloric diet group | Active comparator | low-caloric diet of 1500 kcal/day. Receives: Dietary Supplement: Low caloric diet |
| ultrasound cavitation group | Experimental | The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1500 kcal/day. Receives: Dietary Supplement: Low caloric diet; Device: Ultrasound cavitation |
| whole-body vibration group | Experimental | The participants will be treated by whole body vibration, in addition to the low-caloric diet of 1500 kcal/day. Receives: Dietary Supplement: Low caloric diet; Device: Whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: Within 6 weeks
BMI
Weight/ height scale will be used to measure the weight and height of all females in all groups to calculate their BMI before and after treatment according to the following equation BMI = weight/ height² (kg/m²)
Measured: Within 6 weeks
Waist circumference
It is a measurement taken around the waist at the level of the narrowest part of the torso, typically located between the bottom of the rib cage and the top of the hip bones (iliac crest). It is used as an indicator of central obesity. However, as a general guideline, a waist circumference of over 35 inches (88 cm) in women is often considered high and indicative of an increased health risk .
Measured: Within 6 weeks
Waist to hip ratio (WHR)
Waist-to-hip ratio (WHR) is a measurement that compares the circumference of the waist to that of the hips. The waist circumference is measured at the narrowest point of the torso, usually just above the belly button (umbilicus), and the hip circumference is measured at the widest part, 9 around the buttocks at level of greater trochanters; then dividing the waist circumference by the hip circumference. The formula is as follows: WHR = Waist Circumference / Hip Circumference. For women, a WHR above 0.85 is often considered high and indicative of an increased health risk.
Measured: Within 6 weeks
Abdominal skinfold thickness
Abdominal skinfold thickness is a specific measurement used to estimate the amount of subcutaneous fat in that area. It provides insights into the distribution of fat in the abdominal region. The measurement is typically taken at a site approximately 2 cm to the right side of the belly button, and the skinfold is pinched with calipers to measure the thickness. The measurement process involves firmly grasping the skin and underlying fat tissue with the calipers, ensuring that only the skin and fat are included in the measurement and not muscle or other tissues. The measurement is recorded in millimeters (mm)
Measured: Within 6 weeks
Bioelectrical impedance analysis (BIA)
In BIA, a small, safe electrical current is passed through the body using electrodes typically placed on the hands and feet. The electrical current encounters resistance from tissues with lower water content, such as fat and bone, while it easily passes through tissues with higher water content, such as muscle. By measuring the impedance (resistance and reactance) of the electrical current, BIA devices can estimate body composition parameters such as body fat percentage, lean body mass, and hydration levels. BIA can provide a quick and non-invasive estimation of body composition. Also, it is a useful tool for tracking changes in body composition over time and monitoring progress in fitness or weight loss programs.
Measured: Within 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start22 Jul 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Samir Harmakes, Cairo University
- Investigators
- Azza Kassab, Study chair, Cairo UniversityManal El-Shafei, Study director, Cairo UniversityMohamed AboEleinen, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529211
- Sponsor's protocol ID
- P.T.REC/012/004858
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06529211
- Acronym / sponsor ID
- P.T.REC/012/004858
- Conditions
- Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jul 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 31 Jul 2024 (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.
This study aims to determine the differences between the effect of ultrasound cavitation and whole-body vibration on abdominal fat in obese adolescent females
Detailed description
Adolescence is a critical time associated with the development of obesity. About 80% of adolescents with obesity will continue to have this condition as an adult.
Obesity during adolescence is associated with a number of short- and long-term diseases including hypertension, diabetes mellitus type 2, hyperlipidemia, obstructive sleep apnea, psychological distress and future cardiovascular complications.
The investigators showed that there is an increasing demand for non-surgical procedures in the management of obesity that led to the development of non-invasive techniques for reducing localized subcutaneous adipose tissue.
One of these techniques is focused ultrasound cavitation. Research studies showed some benefits in the treatment of excess abdominal fat deposits with reduction in fat circumference without significant side effects.
Also, another non-invasive technique is whole body vibration (WBV). Some studies showed that when it is combined with dietary intervention leads to body weight reduction and improvement of overall body composition and fat reduction including abdominal fat
Both ultrasound cavitation (UC) and whole-body vibration (WBV) are non-invasive modalities with many positive effects on abdominal fat in obese adolescent females. The effect of both the UC and WBV has been separately investigated in previous studies. Though, no studies were found to compare the effect of both modalities in the management of abdominal fat in obese adolescent females. Therefore, this study will be conducted to explore the effect of UC versus WBV on abdominal fat in obese adolescent females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low caloric diet group | Active comparator | Dietary Supplement: Low caloric dietlow-caloric diet of 1500 kcal/day. |
| ultrasound cavitation group | Experimental | Dietary Supplement: Low caloric diet, Device: Ultrasound cavitationThe participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1500 kcal/day. |
| whole-body vibration group | Experimental | Dietary Supplement: Low caloric diet, Device: Whole body vibrationThe participants will be treated by whole body vibration, in addition to the low-caloric diet of 1500 kcal/day. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescent females suffer from abdominal obesity.
- Their ages will be ranged from 17 to 25 years old.
- Their body mass index (BMI) will be ranged from 30 to 35 kg/m2.
- Their waist circumference will be > 88 cm.
- Their WHR will be more than 0.88.
Key exclusion criteria (5 listed)
- Thyroid, hepatic and kidney disorders.
- Diabetes mellitus, coronary artery diseases, hypertension and congestive heart failure.
- Recent abdominal surgical scar or umbilical hernia.
- History of orthopedic implants insertion or cardiac pacemaker implantation.
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 |
|---|---|---|
| Low caloric dietLow caloric diet: the participants will receive low caloric diet program (1500 Kcal/ day) for 6 weeks as follows: 45% carbohydrate, 20% fat and 35% proteins of total calorie intake. | Dietary supplement | Low caloric diet group, ultrasound cavitation group, whole-body vibration group |
| Ultrasound cavitationUltrasound cavitation + Low caloric diet Low caloric diet program (1500 Kcal/ day): for 6 weeks. Ultrasound cavitation: It will be on abdomen for 30 minutes/session, 2 sessions/week for 6 weeks as follows: * The participants will be in supine lying position and the abdomen is divided into two sides right and left from the midline. * The Ultrasound pulsed waves will be set with power input (AC100/ 240V), frequency (40 KHz), and Power output (45W). This will be for 15 minutes on each abdominal side. | Device | ultrasound cavitation group |
| Whole body vibrationWhole body vibration + Low caloric diet Low caloric diet program (1500 Kcal/ day) for 6 weeks. Whole body vibration: for 30 minutes/session, 2 sessions/week for 6 weeks as follows: * The participants will begin with a brief warm-up for 5 minutes by doing deep breathing exercises. * Then they will stand with feet shoulder-width apart on the platform while holding handrails to maintain balance and stability. They will be instructed to relax and allow the vibrations to pass through her body. This will be applied for 20 minutes per session. * The vibration will be started with lower settings and gradually will be increased till the desired frequency and amplitude (45 HZ) will be reached. * After the session will be completed, the participant will be instructed to cool down gradually by doing deep breathing for 5 minutes to help their body to return to a resting state. They will be advised to drink plenty of water to be hydrated and recovered after the WBV session. | Device | whole-body vibration group |
Primary outcome
Weight
Time frame: Within 6 weeks
BMI
Time frame: Within 6 weeks
Weight/ height scale will be used to measure the weight and height of all females in all groups to calculate their BMI before and after treatment according to the following equation BMI = weight/ height² (kg/m²)
Waist circumference
Time frame: Within 6 weeks
It is a measurement taken around the waist at the level of the narrowest part of the torso, typically located between the bottom of the rib cage and the top of the hip bones (iliac crest). It is used as an indicator of central obesity. However, as a general guideline, a waist circumference of over 35 inches (88 cm) in women is often considered high and indicative of an increased health risk .
Waist to hip ratio (WHR)
Time frame: Within 6 weeks
Waist-to-hip ratio (WHR) is a measurement that compares the circumference of the waist to that of the hips. The waist circumference is measured at the narrowest point of the torso, usually just above the belly button (umbilicus), and the hip circumference is measured at the widest part, 9 around the buttocks at level of greater trochanters; then dividing the waist circumference by the hip circumference. The formula is as follows: WHR = Waist Circumference / Hip Circumference. For women, a WHR above 0.85 is often considered high and indicative of an increased health risk.
Abdominal skinfold thickness
Time frame: Within 6 weeks
Abdominal skinfold thickness is a specific measurement used to estimate the amount of subcutaneous fat in that area. It provides insights into the distribution of fat in the abdominal region. The measurement is typically taken at a site approximately 2 cm to the right side of the belly button, and the skinfold is pinched with calipers to measure the thickness. The measurement process involves firmly grasping the skin and underlying fat tissue with the calipers, ensuring that only the skin and fat are included in the measurement and not muscle or other tissues. The measurement is recorded in millimeters (mm)
Bioelectrical impedance analysis (BIA)
Time frame: Within 6 weeks
In BIA, a small, safe electrical current is passed through the body using electrodes typically placed on the hands and feet. The electrical current encounters resistance from tissues with lower water content, such as fat and bone, while it easily passes through tissues with higher water content, such as muscle. By measuring the impedance (resistance and reactance) of the electrical current, BIA devices can estimate body composition parameters such as body fat percentage, lean body mass, and hydration levels. BIA can provide a quick and non-invasive estimation of body composition. Also, it is a useful tool for tracking changes in body composition over time and monitoring progress in fitness or weight loss programs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: Yes
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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.
Azza Kassab study chair
Cairo University
Manal El-Shafei study director
Cairo University
Mohamed AboEleinen study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Low caloric diet, Ultrasound cavitation and Whole body vibration in people with Abdominal Obesity, run by Cairo University.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina yassa, Master (+201228294939, christina.haram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Within 6 weeks). The study lists 6 primary outcomes in all. 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 31 Jul 2024.