Back to resultsEffect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men
Primary Purpose
Central Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high intensity electromagnetic technology device, diet restriction, and walking
diet restriction and walking
Sponsored by
About this trial
This is an interventional treatment trial for Central Obesity
Eligibility Criteria
Inclusion Criteria: men with central obesity BMI 30-34.9 kg/m2 Exclusion Criteria: metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses
Sites / Locations
- Cairo UnoversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
first group
second group
Arm Description
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.
Outcomes
Primary Outcome Measures
subcutaenous abdominal fat thickness
it will be measured using ultrasonography
Secondary Outcome Measures
visceral abdominal fat thickness
it will be measured using ultrasonography
body mass index
it will be measured at morning with empty stomach and bladder
waist circumference
it will be measured using inelastic tape
cortisol
it is a stress hormone
high density lipoprotein
it will be measured in serum
low density lipoprotein
it will be measured in serum
triglycerides
it will be measured in serum
cholesterol
it will be measured in serum
appearance of abdomen subscale of Body Q questionnaire
BODY-Q provides a set of scales focusing on topics that are relevant to weight
health related-quality-of-life subscale of Body Q questionnaire
it provids questions related to body image , physical function , psychological function , sexual function
eating related concerns subscale of Body Q questionnaire
it provids questions related to eating behavior , expectations weight loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06024018
Brief Title
Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men
Official Title
Efficacy of High Intensity Electromagnetic Body Shaping in Obese Men
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free fatty acids, so it can be used in weight loss
Detailed Description
sixty obese males will be grouped to: first group (30 males) and second group (30 males). first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. only the first group will will undergo high intensity electromagnetic technique on abdomen of males which will be 3 sessions per week for 3 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
first group
Arm Type
Experimental
Arm Description
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
Arm Title
second group
Arm Type
Active Comparator
Arm Description
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.
Intervention Type
Device
Intervention Name(s)
high intensity electromagnetic technology device, diet restriction, and walking
Intervention Description
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
Intervention Type
Behavioral
Intervention Name(s)
diet restriction and walking
Intervention Description
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.
Primary Outcome Measure Information:
Title
subcutaenous abdominal fat thickness
Description
it will be measured using ultrasonography
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
visceral abdominal fat thickness
Description
it will be measured using ultrasonography
Time Frame
12 weeks
Title
body mass index
Description
it will be measured at morning with empty stomach and bladder
Time Frame
12 weeks
Title
waist circumference
Description
it will be measured using inelastic tape
Time Frame
12 weeks
Title
cortisol
Description
it is a stress hormone
Time Frame
12 weeks
Title
high density lipoprotein
Description
it will be measured in serum
Time Frame
12 weeks
Title
low density lipoprotein
Description
it will be measured in serum
Time Frame
12 weeks
Title
triglycerides
Description
it will be measured in serum
Time Frame
12 weeks
Title
cholesterol
Description
it will be measured in serum
Time Frame
12 weeks
Title
appearance of abdomen subscale of Body Q questionnaire
Description
BODY-Q provides a set of scales focusing on topics that are relevant to weight
Time Frame
12 weeks
Title
health related-quality-of-life subscale of Body Q questionnaire
Description
it provids questions related to body image , physical function , psychological function , sexual function
Time Frame
12 weeks
Title
eating related concerns subscale of Body Q questionnaire
Description
it provids questions related to eating behavior , expectations weight loss
Time Frame
12 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
men with central obesity
BMI 30-34.9 kg/m2
Exclusion Criteria:
metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail, lecturer
Phone
01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ebtahal ATEF RAMADAN Afya
Phone
02 1024666329
Email
dr.ebtehalpt@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali MA Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com
First Name & Middle Initial & Last Name & Degree
EBTEHAL ATEF RAMADAN AFYA
Phone
020 102 466 6329
Email
dr.ebtehalpt@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men
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