Protocol summary

Study aim
Comparing the effects of diet therapy and exercise, acupuncture and laser acupuncture in weight loss
Design
Patients are divided into 4 groups by chance. The first patient enters one of the four groups by random selection. The second patient enters one of the other three groups by random selection. The third patient enters one of the two remaining groups by random selection, and the fourth patient enters the remaining group . The random selection continues for each patient until each group reaches enough.
Settings and conduct
Eligible people are included in the study after obtaining personal consent. After the anthropometric evaluation, the patients are randomly divided into 4 groups: a group of diet therapy and exercise, an acupuncture group with diet therapy and exercise, a laser therapy group with diet therapy and exercise, and a combination group of laser and acupuncture with diet therapy and exercise. Evaluations will be done at baseline and three months later with 12 sessions of interventions. Laboratory information including blood sugar and blood pressure will also be measured. Acupuncture and laser points will be performed based on existing standard protocols by two therapists trained in this field.
Participants/Inclusion and exclusion criteria
without history of mood disorders, anxiety and psychotic disorders, and other psychiatric disorders, and not used psychotropic, hormonal, or steroid drugs in the last 6 months, and he has no history of electroshock therapy.
Intervention groups
Diet therapy and exercise group Acupuncture group with diet therapy and exercise Laser acupuncture group with diet therapy and exercise The combination group of acupuncture and laser acupuncture along with diet therapy and exercise
Main outcome variables
weight, fat mass and fat-free mass

General information

Reason for update
Acronym
طب سوزنی لیزری
IRCT registration information
IRCT registration number: IRCT20111121008146N42
Registration date: 2023-04-18, 1402/01/29
Registration timing: prospective

Last update: 2023-04-18, 1402/01/29
Update count: 0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effects of Dietary Therapy and exercise, Acupuncture, Laser Acupuncture therapy in weight loss of obese and overweight women
Public title
Comparison between the effects of Dietary Therapy and exercise, Acupuncture, Laser Acupuncture therapy in weight loss of obese and overweight women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18 to 50 years old Has a bmi between 25 and 39.9
Exclusion criteria:
Dissatisfaction at any time A history of suffering from mood disorders, anxiety and psychotic disorders and other psychiatric disorders in the last 6 months using of psychotropic and hormonal drugs and steroid drugs in the last 6 months
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into 4 groups by chance. The first patient enters one of the four groups by random selection. The second patient enters one of the other three groups by random selection. The third patient enters one of the two remaining groups by random selection, and the fourth patient enters the remaining group . The random selection continues for each patient until each group reaches enough.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته سازمانی اخلاق در پژوهشهای زیست پزشکی
Street address
Tehran - Shahid Chamran Highway, Yemen Street - Shahid Arabi Street, next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.544

Health conditions studied

1

Description of health condition studied
Overweight and obese women
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Overweight
Timepoint
Three months later
Method of measurement
measuring weight with a Seka scale

Secondary outcomes

1

Description
Abdominal fat
Timepoint
Three months later
Method of measurement
determining fat mass with a Body Composition Analyzer

Intervention groups

1

Description
control group: diet therapy and excercise group
Category
Treatment - Devices

2

Description
Intervention group 1: In addition to diet and exercise, acupuncture treatment should also be done.
Category
Treatment - Other

3

Description
Intervention group 2: In addition to diet and exercise, laser acupuncture is performed.
Category
Treatment - Other

4

Description
Intervention group 3: In addition to diet and exercise, acupuncture treatment and laser acupuncture are also performed respectively.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina medical center
Full name of responsible person
Arista Shojaedin
Street address
Imam Khomeini St, Hasan abad sq
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 2274 9221
Fax
+98 21 6634 8587
Email
dr.shojaeddin@outlook.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
َAfshin Zarghi, Vice-Chancellor of Research Affairs
Street address
Tajrish Square, Tajrish Martyrs Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Laser Application Research Center in Medical Sciences
Full name of responsible person
Arista Shojaeddin
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Shohada Tajrish Hospital, Shahrdary st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
dr.shojaeddin@outlook.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Laser Application Research Center in Medical Sciences
Full name of responsible person
Arista Shojaedin
Position
پژوهشگر غیر هیات علمی
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
میدان تجریش -خ شهرداری- بیمارستان شهدا تجریش
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
dr.shojaeddin@outlook.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arista Shojaedin
Position
Non-academic researcher
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Shohada Tajrish Hospital, Shahrdary st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 2198
Email
dr.shojaeddin@outlook.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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