Determining the effect of nutritional interventions on blood sugar and lipid factors in Arfa Steel Company workers
Design
At the beginning of this study, the blood pressure, height and weight of the participants were measured, as well as the data related to blood sugar-lipid factors were collected in a laboratory. Then, all of them are given nutritional interventions that include changes in the menu of foods, training in the correct cooking method, and training in nutrition concepts individually and in groups. After a period of six months, blood sugar-lipid factors as well as blood pressure, height and weight of people are measured again. Then, using the paired t test, we will investigate the effect of nutrition interventions on these factors.
Settings and conduct
A field trial will conduct on Arfa Steel Company workers
Participants/Inclusion and exclusion criteria
Inclusion criteria: Be employed in Arfa steel factory in Yazd
Exclusion criteria: Having any type of cancer
Intervention groups
Arfa Steel Company workers
Main outcome variables
Weight - body mass index - fasting blood sugar - liver enzymes(SGPT , SGOT) - blood total cholesterol - blood triglyceride - blood LDL cholesterol - blood HDL cholesterol- blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120913010826N34
Registration date:2023-08-13, 1402/05/22
Registration timing:prospective
Last update:2023-08-13, 1402/05/22
Update count:0
Registration date
2023-08-13, 1402/05/22
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-21, 1402/05/30
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multimodal nutrition intervention on glucose and lipid parameters of Arfa iron and steel company workers
Public title
The effect of multimodal nutrition intervention on workers
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Be employed in Arfa iron and steel company in Yazd
Exclusion criteria:
Having any type of cancer
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
1100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.SSU.SPH.REC.1402.042
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
I25.0
ICD-10 code description
Cardiovascular disease, unspecified
Primary outcomes
1
Description
fast blood sugar
Timepoint
Before and after intervention
Method of measurement
Standards of medical diagnostic laboratories
2
Description
cholesterol(lipid profile index)
Timepoint
Before and after intervention
Method of measurement
Standards of medical diagnostic laboratories
3
Description
TG (lipid profile index)
Timepoint
Before and after intervention
Method of measurement
Standards of medical diagnostic laboratories
4
Description
liver enzymes (AST, ALT)
Timepoint
Before and after intervention
Method of measurement
Standards of medical diagnostic laboratories
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive nutritional education
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Arfa steel company
Full name of responsible person
Azadeh Nadjarzadeh
Street address
Ardakan
City
Ardakan
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2239
Email
azadehnajarzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh nadjarzadeh
Street address
Yazd University of Medical Sciences, Alem sq.,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2239
Email
azadehnajarzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr.Azadeh Nadjarzadeh
Position
Associate Professor, nutrition specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2239
Email
azadnajarzadeh@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Azadeh Nadjarzadeh
Position
Associate Professor, nutrition specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2239
Email
azadnajarzadeh@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azade Najarzadeh
Position
Associate Professor, nutrition specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Saddughi University, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 1624 0691
Fax
Email
azadnajarzadeh@ssu.ac.ir
Web page address
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
data report will be shared after publishing the paper.
When the data will become available and for how long
Six months after publish
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Using for Meta-analysis
From where data/document is obtainable
Center nutrition, public health, univercity of medical
sciencies yazd Tel: 009835 31492239 Email:
azadehnajarzadeh@gmail.com Azadenadjarzadeh
What processes are involved for a request to access data/document
It will be sent two weeks after the receipt of the email
with the consent of the co-workers