Protocol summary

Study aim
develop, implement, and evaluate the impact of lifestyle education package in order to control metabolic syndrome components
Design
The intervention group received educational package consists of a three months’ schedul schedule ( First month: face- to- face and pamphlets education program .Second month: 14 educational message ,Third month: Educational film ). The control group received usual care by a physician in each visit, and fasting blood glucose will be assessed at baseline and after 3month.
Settings and conduct
from two health centers
Participants/Inclusion and exclusion criteria
72 women and men aged over 18 years with MetS
Intervention groups
enrolled through randomized sampling to either intervention group who take usual care plus a 3-month lifestyle modification intervention or control group.
Main outcome variables
Anthropometric indices, blood pressure, lipid profiles, and fasting blood glucose will be assessed at baseline and after 3 month.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200212046470N1
Registration date: 2020-02-23, 1398/12/04
Registration timing: retrospective

Last update: 2020-02-23, 1398/12/04
Update count: 0
Registration date
2020-02-23, 1398/12/04
Registrant information
Name
Shahed Samat
Name of organization / entity
Faculty of Medical Sciences, University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9686
Email address
sdrmed1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation and Evaluation of Lifestyle Modification Packages Based on Family Medicine Approach to Controlling Metabolic Syndrome Components
Public title
Assessing the effectiveness of Educational Package for Controlling Metabolic Syndrome Components
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
minimum age of 18 years old The inclusion criteria were as follows: existence of ≥3/5 elements for metabolic syndrome including: central obesity (men: ≥94 cm, women: ≥80 cm waist circumference); hypertension (systolic ≥130 mmHg, diastolic ≥85 mmHg and/or anti-hypertensive treatment); diabetes (fasting blood sugar (FBS) ≥100 mg/dL and/or anti-diabetic treatment); elevated triglycerides(TG) (≥150 mg/dL); low high-density lipoprotein (HDL) (men: <40 mg/dL, women: <50 mg/dL) and/or cholesterol-lowering treatment
Exclusion criteria:
level of education less than fifth grade hepatic diseases, hematologic diseases, renal failure (GFR <30), Secondary causes of dyslipidemia, such as hypothyroidism and taking oral contraceptives, severe psychological illness, physical disability, known Cancer and treated type 1 diabetes, Alzheimer's and dementia Active TB disease, HIV
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Not randomized
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
National Committee on Ethics in Biomedical Research
Street address
pursina
City
Tehran
Province
Tehran
Postal code
1411846877
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3071

Health conditions studied

1

Description of health condition studied
metabolic syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anthropometric indices, blood pressure, lipid profiles, and fasting blood glucose
Timepoint
before intervention and after 3 month of intervention.
Method of measurement
clinical Anthropometric measurement- Laboratory measurement- Clinical mercury manometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: received educational package consists of a three months’ schedul schedule ( First month: face- to- face and pamphlets education program .Second month: 14 educational message ,Third month: Educational film )
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
health center Shah Abadi
Full name of responsible person
shahed samat
Street address
Shahid Rajaii Third Street,, No. 13, FLOOR. 2
City
Lahijan
Province
Guilan
Postal code
4415763391
Phone
+98 21 8802 9686
Email
sdrmed1@yahoo.com

2

Recruitment center
Name of recruitment center
health center Imam Sadiq
Full name of responsible person
shahed samat
Street address
Shahid Rajaii Third Street, FLOOR. 2, No. 1
City
Lahijan
Province
Guilan
Postal code
4415763391
Phone
+98 21 8802 9686
Email
sdrmed1@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahed samat
Street address
pursina
City
Tehran
Province
Tehran
Postal code
4415763391
Phone
+98 21 8802 9686
Email
sdrmed1@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
shahed samat
Position
family medicine
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Shahid Rajaii Third Street, No. 13, floor. 2
City
Lahijan
Province
Guilan
Postal code
4415763391
Phone
+98 21 8802 9686
Email
sdrmed1@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
negar omidi
Position
Assistant Professor of Cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
north karghar
City
Tehran
Province
Tehran
Postal code
4415763319
Phone
+98 21 8802 9686
Email
negar.omidi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahed samat
Position
family medicine
Latest degree
Medical doctor
Other areas of specialty/work
Family Health
Street address
Shahid Rajaee Third Street, No. 13, floor. 1
City
lahijan
Province
Guilan
Postal code
4415763319
Phone
+98 21 8802 9686
Email
sdrmed1@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For Prevention Studies with permission of Supervisor
From where data/document is obtainable
sdrmed1@yahoo.com
What processes are involved for a request to access data/document
An email send to the Trial  Scientific responsible Dr. Negar Omidi And receive them within a month
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