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Survey the effect of standard diet, acupuncture and chi-gong on the weight loss of overweight and Non-morbid obese patient

Protocol summary

Study aim
The effects of a standard diet, acupuncture, and Qigong exercise on weight control of overweight and obese individuals (with a BMI less than 35) Specific objectives: The effects of acupuncture on weight control/BMI chang/reducing waist circumference/weight control/reducing BMI/waist reduction/weight control/weight change/reducing waist circumference
Design
Randomized clinical trial double blind.Final sample size is 195 patients
Settings and conduct
Through general and intra-university calls, overweight and non-morbidly obese people are registered in the clinic office of the Chinese Medicine Department. Then, all the anthropometric measurements calculated in the plan, including weight, height and waist circumference, are measured by a partner expert, and then the BMI of the individuals is calculated.Based on entry and exit criteria, the equivalent of the sample size of individuals are counted. Then, based on the standard extended random distribution model mentioned below, they are divided into 3 groups:The first group to a nutritionist to receive a standard diet/The second group is in accordance with the adaptation plan to acupuncturists, male and female/The third group is trained to teach Chi-gong sports movement to an expert
Participants/Inclusion and exclusion criteria
Study group: Overweight and non-morbidly obese (BMI under 35) over 18 years and under 65 years of age/Inclusion criteria/Age over 18 and under 65 years/BMI above 25 and below 35/Living in Mashhad/Fluency in Persian/Being literate
Intervention groups
Three interventions in three different groups, in one group the intervention is receiving a standard diet, in the second group the intervention is acupuncture , and in the third group the intervention is the Qigong exercise.
Main outcome variables
Weight, BMI,waist circumference in 3 times: prior to the intervention/immediately after the invention/one month after the invention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200919048763N1
Registration date: 2021-02-11, 1399/11/23
Registration timing: registered_while_recruiting

Last update: 2021-02-11, 1399/11/23
Update count: 0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
ghazaleh donyadideh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 0330
Email address
donyadidehg931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of standard diet, acupuncture and chi-gong on the weight loss of overweight and Non-morbid obese patient
Public title
The Effect of Standard Acupuncture and Qigong Diet on Weight Loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAge over 18 and under 65 BMI over 25 and under 35 Living in Mashhad Fluency in Persian Being literate
Exclusion criteria:
Age under 18 and over 65 BMI under 25 and over 35 Not living in Mashhad Lack of fluency in Persian Being illiterate
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 195
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be in the form of triple blocks which is done by SPSS software. The method is as follows: The letters A, B, C can be put together in six ways. ABC, ACB, BAC, CAB, CBA are selected by a number of numbers, random numbers.We keep the numbers from zero to 5, then if the random number was zero, the expression ABC, if it was 1, the expression ACB, if it was 2, the expression BAC, if it was 3, the expression CAB, and if it was 5, the expression CBA. Put together. Individuals are referred to one of groups A, B, and C, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind(Assessor blind, Analyzer blind)
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
17 unit, No. 92, between 27 & 29 St., Saremi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9178657877
Approval date
2019-12-22, 1398/10/01
Ethics committee reference number
ir.MUMS.MEDical.REC.1398.819

Health conditions studied

1

Description of health condition studied
Overweight patients and Non-morbid obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of individuals with BMI above 25 and below 35, Weight, body mass index, and waist circumference
Timepoint
1- Prior to the intervention 2- Immediately after the intervention 3- One month after the intervention
Method of measurement
Use of body mass index (the variable resulting from dividing patient's weight in kilograms by patient's height squared in meters, which is more than 25); Patient waist size in centimeters, which can be measured from the perimeter of the highest part of the pelvic wall; patient weight in kilograms

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: are referred to a nutritionist to receive a standard diet.
Category
Lifestyle

2

Description
Second intervention group (in control group): Acupuncture is given in the form of a standard 12-session course of treatment (every other day) for one month. Each session of acupuncture lasts 30 minutes, using JUK needles from South Korea with a size of 40 by 0.25 mm.
Category
Treatment - Devices

3

Description
Control group: In addition to acupuncture، they use the Qigong exercise, on which are fully instructed by a trained expert. The exercises will betwice a day (during a month of acupuncture).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Acupuncture Clinic of Imam Reza Hospital
Full name of responsible person
Hamidreza Bahrami Thaghanaki
Street address
Unit 17, No 92, before Honarestan Sq., between 27 and 29 St., Saremi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9178657877
Phone
+98 51 3880 0330
Email
donyadidehg931@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research, Mashhad University of Medical Sciences
Street address
Unit 17, No 92, before Honarestan Sq., between 27 and 29 St., Saremi Ave, Mashhad
City
Mashad
Province
Razavi Khorasan
Postal code
9178657877
Phone
+98 51 3880 0330
Email
donyadidehg931@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Bahrami Taghanaki
Position
Assiciate professor of Chinese medecine
Latest degree
Ph.D.
Other areas of specialty/work
Chinese and complementary medicine
Street address
Unit 17, No. 92, between 27 and 29 St., Saermi Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178657877
Phone
+98 51 3880 0330
Email
BahramiHR@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Bahrami Taghanaki
Position
Assiciate professor of Chinese medecine
Latest degree
Ph.D.
Other areas of specialty/work
Chinese and complementary Medicine
Street address
Unit 17, No. 92, between 27 and 29 St., Saermi Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178657877
Phone
+98 51 3880 0330
Email
BahramiHR@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Bahrami Taghanaki
Position
Assiciate professor of Chinese medecine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Unit 17, No. 92, between 27 and 29 St., Saermi Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178657877
Phone
+98 51 3880 0330
Email
BahramiHR@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data accessible by the researcher, student, analyst, project supervisor, and the Vice Chancellor for Research. The data is only available to the public through academic publication in the form of an article. Access to the data and the sampling process is possible through a written request approved by the Vice Chancellor for Research. The data is only available to the public through academic publication in the form of an article.
When the data will become available and for how long
Access time is from the end of sampling until the results are presented.
To whom data/document is available
The data accessible by the researcher, student, analyst, project supervisor, and the Vice Chancellor for Research.
Under which criteria data/document could be used
The data and the sampling process are accessible through a written request approved by the Vice Chancellor for Research. The data is available to the public only through academic publication in the form of an article.
From where data/document is obtainable
Data are accessible through a written request approved by the Vice Chancellor for Research
What processes are involved for a request to access data/document
Data are accessible through a written request approved by the Vice Chancellor for Research
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