Protocol summary

Study aim
The Effect of Lifestyle Modification Training on controlling the Risk Factors of Metabolic Syndrom in Nurses .
Design
Clinicaell trial,control group, blinded to parallel groups,randomiaed
Settings and conduct
This study is a clinical trial intervention with pre- test & post -test with randomized control group with informed consent from participating groups & with the aim of the effectiveness of lifestyle modification training on controlling risk factors of metabolic syndrome in nurses.The hospital is military.
Participants/Inclusion and exclusion criteria
Log in:- Nurses with associate degree and work expreience of at last 6 months in military hospital. NO Login: -Pregnancy..-Having a history of surgery in the last . -Treated with blood pressure control and diabetes medication.
Intervention groups
The intervention group will Parrticipation in 3(60minute)training sessions,incuding famiiiarization with the disease and its effcts;espcially adherence to diet,enhancing phsical activity and promoting lifestyle.Intervention time is 3 months.
Main outcome variables
Fasting Blood Suger,Triglycerid,Gholsterol HDL

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191111045410N1
Registration date: 2019-12-26, 1398/10/05
Registration timing: retrospective

Last update: 2019-12-26, 1398/10/05
Update count: 0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Fatemeh Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3300 0538
Email address
stu.fatemeh.1981@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness Of Lifestyle modification Educationnal Program On Controlling The Risk Factor Of Metabolic Syndrom In Nurses
Public title
The Study of Lifestyle training on Contaoliing Metabolic syndrom
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A high school diploma 6 months working in a military hospital Minimum age 25 &Maximum 50 years
Exclusion criteria:
Pregnat . genetic diseases. Having a history of surgery in the last . treated with blood pressure control and diabetes medication. Treated with similar lifestyle training program
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a simple randomized clinical trial study to achieve the goals of the study by using clinical and laboratory evaluation of people's health monitoring records in people who are diagnosed with metabolic syndrome based on ATPIII criteria. The study population consisted of 200 nurses in two groups of test and control. We assigned 40 patients to each group. Each person was assigned a number between 1 and 200 random numbers. It is generated electronically or from a random number table and assigned to numbers Ignored outside the range of 1 to 80 patients in groups 1 to 40 and 41 to 80 in the control group will be
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 Baghiyatalah University of Medical Sciences
Street address
No.550 ,Rezai st,End 17 South Sharivar st
City
Tehran
Province
Tehran
Postal code
1791685936
Approval date
2019-12-10, 1398/09/19
Ethics committee reference number
IR.BMSU.REC.1398.298

Health conditions studied

1

Description of health condition studied
Metabolic disorder unspecified
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder unspecified

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
0-3 Months After measurement
Method of measurement
Enzymatic assay

2

Description
Triglyceride, Cholesterol HDL
Timepoint
0-3 Months After measurement
Method of measurement
Enzymatic assay

Secondary outcomes

1

Description
Abdominal obesity
Timepoint
0-3 Months after measurement
Method of measurement
Centimeters

2

Description
Blood Perssure
Timepoint
0-3 Months after measurement
Method of measurement
Mm mercury

Intervention groups

1

Description
The intervention group will participate in 3 60- minute training sessions,including familiarization with the disease &its complications;disease control startegies,especially adherence to diet,increased physical activity.and life style enhancement . The intervention time is 3 months
Category
Lifestyle

2

Description
Control group: No Training is given to this group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beast hospital
Full name of responsible person
Habibi,Fatemeh
Street address
No.550 ,Rezai st,End 17 South Sharivar st
City
Tehran
Province
Tehran
Postal code
1791686953
Phone
+98 21 3300 0538
Email
fatemeh.1981@gmail.com

2

Recruitment center
Name of recruitment center
Baghiyatalah haspital
Full name of responsible person
Habibi,Fatemeh
Street address
No.550 ,Rezai st,End 17 South Sharivar st
City
Tehran
Province
Tehran
Postal code
1791686935
Phone
+98 21 3300 0538
Email
fatemeh.1981@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
DR ,Alishiri, Gholam Hossin
Street address
Sheikh BahaiAve,Mulla Sadra Ave
City
Tehran
Province
Tehran
Postal code
1377866479
Phone
+98 21 8755 4428
Email
fatemeh.1981@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Parandeh,Akram
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Sixth floor,Payambar Azam building,Nursing faculty
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5492
Email
Akram.parandeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Parandeh,Akram
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Sixth floor,Payambar Azam building,Nursing faculty
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5492
Email
Akram.parandeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hbibi Fatemeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.550 ,Rezai st,End 17 South Sharivar st
City
Tehran
Province
Tehran
Postal code
1791686953
Phone
+98 21 3300 0538
Email
fatemhe.1981@gmail.com

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
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
Title and more details about the data/document
Article &Thesis
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Research Working in instiitutes, medical centers and research
Under which criteria data/document could be used
Research on the Prevention of Risk Factors for Metabolic Sndrome
From where data/document is obtainable
P.H.D Parande akram akram.parandeh@gmail.com
What processes are involved for a request to access data/document
Submit a requsest by email and confirmation of the request within to 2 to 4 weeks
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