Investigating the effect of Iranian medicine measures and group schema therapy on body mass index in overweight women
Design
Clinical trials without blindness in the face of a parallel group with a sample size of 60 people are randomly divided between groups.
Settings and conduct
Women are selected from among those who go to the Imam Reza Hospital Clinic in Mashhad and, after evaluating the entry criteria, are randomly assigned to groups. Training in Iranian medicine and schema therapy in eight weeks and two sessions per week is two hours. All questionnaires and indicators are determined before and after the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women between 19 and 40 years old, body mass index between 25 and 30, consent to study
Exclusion: having a malignant disease and liver failure, addiction, alcohol, pregnancy and lactation, drug consumption affecting weight gain and appetite
Intervention groups
Four groups: the first group receives the intervention of Iranian medicine, the second group receives the intervention of schema therapy, the third group receives the combination of these two interventions.
The fourth group does not receive any intervention.
Main outcome variables
BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131125015533N3
Registration date:2020-06-05, 1399/03/16
Registration timing:registered_while_recruiting
Last update:2020-06-05, 1399/03/16
Update count:0
Registration date
2020-06-05, 1399/03/16
Registrant information
Name
Mohammadreza Noras
Name of organization / entity
Faculty of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
norasmr901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of schema therapy interventions, Iranian medicine and combined intervention on body mass index in overweight women
Public title
Schema therapy, Iranian Medicine BMI in overweight women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index between 25 to 30 kg / m2
Women
Age between 19 and 40
Satisfaction with participating in the study
Exclusion criteria:
Having malignant disease, liver failure
Addiction
Pregnancy breastfeeding
alcohol consumption
Medication is effective in increasing weight and appetite
Age
From 19 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with a table of random numbers : To select sample people from the table, the researcher randomly starts from one point in the table in the direction of the row or column. Individuals fall into two random groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Integrated approach: psychosomatic medicine and traditional medicine
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad, Daneshgah Street- 18
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2020-04-16, 1399/01/28
Ethics committee reference number
IR.MUMS.REC.1399.121
Health conditions studied
1
Description of health condition studied
Women who are overweight
ICD-10 code
E66.09
ICD-10 code description
Other obesity due to excess calories
Primary outcomes
1
Description
Body Mass Index
Timepoint
Start of study (before of the intervention) and 4 and 8 weeks after the of the study
Method of measurement
Scales and meters
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Lifestyle training and modification of nutrition habits based on Iranian medicine are taught for 8 weeks and two sessions per week.
Category
Lifestyle
2
Description
Second Intervention Group: Teaching and modifying maladaptive patterns (schema therapy) inconsistently during two weeks and two sessions per week.
Category
Treatment - Other
3
Description
Third intervention group: A combination of lifestyle modification training and nutritional habits of Iranian medicine and training and modification of maladaptive schema patterns (schema therapy) during two weeks and two sessions per week.
Category
Treatment - Other
4
Description
Control group: They do not receive any intervention during the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital Clinic in Mashhad
Full name of responsible person
Mohammad Reza Noras
Street address
Khorasan Razavi, Mashhad, Imam Reza Hospital Square, Imam Reza Research and Medical Training Center
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Fax
+98 51 3854 3031
Email
norasmr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghdi
Street address
Mashhad, Daneshgah Street -18
City
Mohsen Tafaghdi
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad University of Medical Sciences Vice Chancellor for Research
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
Mohammad Reza Nors
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
82/5000 Vakilabad Blvd., Azadi Square, Ferdowsi University, Faculty of Medicine, Faculty of Traditional and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Fax
+98 51 3884 8930
Email
norasmr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Nors
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vakilabad Blvd., Azadi Square, Ferdowsi University, Faculty of Medicine, Faculty of Iranian Medicine and Supplement
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Fax
+98 51 3884 8930
Email
norasmr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Nors
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vakilabad Blvd., Azadi Square, Ferdowsi University, Faculty of Medicine, Faculty of Traditional and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Fax
+98 51 3884 8930
Email
norasmr@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
Statistical results of demographic and treatment data
When the data will become available and for how long
After reading and printing the results
To whom data/document is available
public
Under which criteria data/document could be used
Research and training
From where data/document is obtainable
Email to the person in charge of the project: norasmr@mums.ac.ir
What processes are involved for a request to access data/document
The request will be reviewed and sent to the university's ethics committee