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The effect of an educational program on controlling the related risk factors of Metabolic Syndrome and oxidative Stress Markers: a clinical trial study

Protocol summary

Summary
This proposed clinical trial is aimed to evaluate whether nutritional interventions and physical activities enhance the life style and reduce the related risk factors to the Metabolic Syndrome (METS) and Oxidative Stress Markers. In this regard, 180 individuals with METS within the personnel of SHMU will be selected. To form the study group, our objectives will be discussed with the personnel; and then, the interested ones to participate will be required to give their consent and fill a form. The form is intended to collect specific data, including name, age, sex, weight, height, waist, medical history (i. e. Using antihypertensive and cholesterol lowering drugs, and history of diabetes), telephone number and work address. Then, the individuals with said disease will be selected by an initial evaluation. Using Simple Randomly method, the participants will be divided into two groups (i. e. control and intervention). All the participants will receive an educational brochure about the subjects of healthy diet, physical activity, and dietary antioxidants. The intervention group, in addition to this, will be asked to attend an educational class in which METS and its effects, and the ways of controlling it via following a healthy diet, increasing physical activities, and improving the life style will be discussed. Several tests, including HDL-C, LDL-C, Triglyceride, FBS, Total Antioxidant Capacity, Malondialdehyde , Catalase, Superoxide Dismutase Activity, CRP and Anthropometric Index (Weight, Waist, BMI, and BP) will be taken before and three months after starting the study.

General information

Acronym
Metabolic Syndrome
IRCT registration information
IRCT registration number: IRCT2015041821813N1
Registration date: 2015-06-08, 1394/03/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Maryam Abbasian
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
abbasian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University Of Medical Science
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational program on controlling the related risk factors of Metabolic Syndrome and oxidative Stress Markers: a clinical trial study
Public title
The effect of educational program on controlling the related risk factors of Metabolic Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The satisfaction from parpicipation in the study,Metabolic syndrome was diagnosed using Adult Treatment Panel-III (ATP-III) guidelines when any three of the following were present: raised triglycerides ≥ 150mg/dl,HDL-C<40mg/d in men and 50mg/dl in woman ,blood pressure≥ 130 / 85 mm Hg,FBS ≥100mg/dl. Abdominal obesity≥ 102 cm in men and≥ 88 cm in women). Exclusion criteria:,Pregnancy and lactation
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahroud University Of Medical Science
Street address
Shahroud- 7Tir SQ- Shahroud University Of Medical Science
City
Shahroud
Postal code
3624773955
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
940.02

Health conditions studied

1

Description of health condition studied
Patients with metabolic syndrome
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Zero -3 months after baseline measurements
Method of measurement
Enzymatic colorimetric method

2

Description
Oxidative Stress markers
Timepoint
Zero -3 months after baseline measurements
Method of measurement
Enzymatic colorimetric method

3

Description
HDL-C, Triglyceride
Timepoint
ero -3 months after baseline measurements
Method of measurement
Enzymatic colorimetric method

Secondary outcomes

1

Description
Waist
Timepoint
Zero -3 months after baseline measurements
Method of measurement
Centimeter

2

Description
Blood pressure
Timepoint
Zero -3 months after baseline measurements
Method of measurement
mmHg

Intervention groups

1

Description
The intervention group will participate in a 60 minute classes( three week: a session per week) learning how to approach with disease, its complications and ways to control disease especially dietary containing antioxidants, increases physical activity and improving the life style .The intervention period will take 3 months
Category
Lifestyle

2

Description
The control group will receive an educational brochure about how to approach with disease, its complications and ways to control disease especially dietary containing antioxidants, increases physical activity and improving the life style
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahroud University Of Medical Science
Full name of responsible person
Maryam Abbasian
Street address
Shahroud- 7Tir SQ- Shahroud University Of Medical Science
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Assistance Research Information Technology Shahroud University Of Medical Science
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud - 7Tir SQ Shahroud University Of Medical Science
City
Shahroud - 7Tir SQ Shahroud University Of Medical Science
Grant name
2
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Assistance Research Information Technology Shahroud University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahroud University Of Medical Science
Full name of responsible person
Mehrei Delvarianzadeh
Position
Masters /Faculty Member
Other areas of specialty/work
Street address
School of Medicine, Shahroud University of Medical Sciences,Shahroud
City
Shahroud
Postal code
36247-73955
Phone
+98 23 3239 5054
Fax
+98 32394800
Email
Delvarianzadeh@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University Of Medical Science
Full name of responsible person
Dr. Hossein Ebrahimi
Position
PhD,Nursing Education
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahroud University of Medical Sciences
City
Shahroud
Postal code
36247-73955
Phone
+98 23 3239 3811
Fax
+98 32394800
Email
Ebrahimi @ shmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University Of Medical Science
Full name of responsible person
Maryam Abbasian
Position
Masters /Faculty Member
Other areas of specialty/work
Street address
Shahroud - 7Tir SQ . School of Medicine, Shahroud University of Medical Sciences
City
Shahroud
Postal code
36247-73955
Phone
+98 23 3239 5054
Fax
+98 32394800
Email
Abbasian@shmu.ac.ir
Web page address
http://shmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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