Comparing the effectiveness of diet based on Iranian traditional medicine and common diet in weight loss of fist high school students clinical trial study
Determining the comparison of the effectiveness of a diet based on traditional Iranian medicine and a diet based on modern medicine in reducing the weight of first high school students
Design
A clinical trial in two dietary groups of Iranian medicine and common medicine, with parallel groups, randomized, on 74 students. Randomization through a table of random numbers.
Settings and conduct
According to studies, about 20% of Iran's high school students are overweight or obese. The present study was conducted in the first high school students of Fasa city, with a random selection of 74 male and female students
Participants/Inclusion and exclusion criteria
Participants inclusion criteria:
First grade high school students (13-16 years old) who are obese and overweight.
Participants exclusion criteria:
having extreme disability to the extent of not being able to answer
psychotic mental illness
multiple sclerosis
diseases leading to lack of memory (such as Alzheimer's)
Intervention groups
Overweight or obese male and female students aged 13 to 16 who are in one of the groups 1. Diets of Iranian medicine 2. Diet of common medicine randomly receive the desired diet. In the next step, anthropometric factors and questionnaires is completed .After 30, 60 and 90 days, the amount of weight loss in these two methods is compared
Main outcome variables
Controlling overweight and obesity in students
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230610058442N1
Registration date:2023-09-10, 1402/06/19
Registration timing:prospective
Last update:2023-09-10, 1402/06/19
Update count:0
Registration date
2023-09-10, 1402/06/19
Registrant information
Name
Mohsen Farboud
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5336 3240
Email address
m.farboud@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-27, 1402/07/05
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of diet based on Iranian traditional medicine and common diet in weight loss of fist high school students clinical trial study
Public title
The diet of Iranian medicine and common medicine in reducing the weight of students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First high school students (13-16 years old) who are obese and overweight
Exclusion criteria:
Having excessive disability to the point of not being able to respond psychotic mental illness multiple sclerosis diseases leading to lack of memory (such as Alzheimer's)
Age
From 13 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Fasa University of Medical Sciences
Street address
Health Deputy Bldg,2th Floor,Salamat Street,Valiasr Blvd,FASA,IRAN
City
FASA
Province
Fars
Postal code
746175005
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.FUMS.REC.1402.064
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
The amount of weight loss
Timepoint
30, 60, and 90 days after starting the diet
Method of measurement
Digital scale with an accuracy of 100 grams
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First high school students who receive traditional Iranian medicine diet. These people receive a 14-day standard diet plan, which includes dietary recommendations regarding the type and manner of consuming foods for breakfast, lunch, dinner, and snacks. For example, it is forbidden to consume tea in the breakfast meal, or to pour cumin seeds next to the rice while boiling the rice in the lunch meal, or that you are allowed to have a snack twice a day.
Category
Prevention
2
Description
Intervention group: High school students who receive the common diet . In this diet, modification of food pattern and control of calorie intake are emphasized based on basic diet regulation. Nutritionists adjust the appropriate diet for students during adolescence to prevent the spread of overweight and obesity.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fasa Health Deputy
Full name of responsible person
Mohsen Farboud
Street address
Health Deputy Bldg,2th Floor,Salamat Street,Valiasr Blvd,FASA,IRAN
City
Fasa
Province
Fars
Postal code
746175005
Phone
+98 71 5341 1269
Email
m.farboud@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Akbar Farjadfar
Street address
Health Deputy Bldg,2th Floor,Salamat Street,Valiasr Blvd,FASA,IRAN
City
Fasa
Province
Fars
Postal code
746175005
Phone
+98 71 5341 1269
Email
m.farboud@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mohsen Farboud
Position
School health unit expert
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
Health Deputy Bldg,2th Floor,Salamat Street,Valiasr Blvd,FASA,IRAN
City
Fasa
Province
Fars
Postal code
746175005
Phone
+98 71 5341 1269
Email
m.farboud@fums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mohsen Farboud
Position
School health unit expert
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
Fasa, Valiasr Blvd., Salamat St., 2nd floor of Health Deputy Building
City
Fasa
Province
Fars
Postal code
746175005
Phone
+98 71 5341 1269
Email
m.farboud@fums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mohsen Farboud
Position
Health worker of school health department
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Ebne sina
City
Fasa
Province
Fars
Postal code
746175005
Phone
+98 71 5336 3240
Fax
Email
m.farboud@fums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Access to documents/data files starts 6 months after publishing the results.
To whom data/document is available
Researchers working in the industry and researchers of academic institutions can send requests to receive data and study documents.
Under which criteria data/document could be used
The results of the study can be used in interventions such as the effect of herbal medicines along with diet.
From where data/document is obtainable
To receive documents and study data, applicants can send email to Mr. Mohsen Farboud, an expert on the school health program of FASA health deputy, via e-mail m.farboud@fums.ac.ir or call his mobile number 09171304977.
What processes are involved for a request to access data/document
To receive documents and study data, applicants can write to Mr. Mohsen Farboud, an expert on the school health program of the FASA health department, via e-mail m.farboud@fums.ac.ir or call his mobile number 09171304977.