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The Effect of self-care program education on anthropometric indicators in postmenopausal women with metabolic syndrome.

Protocol summary

Summary
Objectives: Determination of the effect of self-care program education on anthropometric indicators in postmenopausal women with metabolic syndrome. Design: This study will be performed in cluster randomized controlled trial in both the experimental and the control groups consisting of 120 postmenopausal women aged 45-60 years old that are presented with metabolic syndrome to the 8 of the 15 healthcare centers in 22 districts of Tehran municipality. The study will be carried out in the second half of 1395. Setting and Conduct: In this study, 8 healthcare centers will be randomly selected and allocated in two experimental and control groups. The sampling will be performed as targeted and accessible after the participants that meet the inclusion criteria give written consent. Data collection will be done through demographic information, anthropometric indicators questionnaire and Orem needs assessment form. Inclusion criteria: Postmenopausal women aged between 45 to 60 years old; Approval of developing metabolic syndrome by physician; Approved mental, emotional and cognitive health by self-reporting; The absence of cardiovascular disease, diabetes, cancer and hypothyroidism; Not being on hormone therapy. Exclusion criteria: Perform a total hysterectomy and oophorectomy during the study; Not attending the entire training sessions. Intervention: The self- care program in this research, will be in the form of an Orem conceptual model that will depend on the training needs of patients participating in the program. Each experimental group, which will contain 5 to 7 participants, will receive a training program that consists of five sessions( 45- minutes each ) for 5 weeks. Main outcome measures( variables ): The anthropometric indicators of ( weight, body mass index, waist and hip circumference, waist- to- hip ratio, waist to height ratio and middle arm circumference ) in both the intervention and the control groups; will be measured before any intervention and 8 weeks after training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050333803N1
Registration date: 2017-06-26, 1396/04/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Sahab Badizadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5575 0653
Email address
karimmohamadi353@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice ‌Chancellor for research, Iran University of Medical Sciences.
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of self-care program education on anthropometric indicators in postmenopausal women with metabolic syndrome.
Public title
The Effect of education on metabolic syndrome.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Postmenopausal women aged between 45 to 60 years old; Approval of developing metabolic syndrome by physician; Approved mental, emotional and cognitive health by self-reporting; The absence of cardiovascular disease, diabetes, cancer and hypothyroidism; Not being on hormone therapy. Exclusion criteria: Perform a total hysterectomy and oophorectomy during study; Not attending the entire training sessions.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized by colored bullets.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commmittee of Iran University of Medical Science
Street address
Iran University of Medical Science, Hemmat Highway, Tehran.
City
Tehran
Postal code
1449614535
Approval date
2016-09-25, 1395/07/04
Ethics committee reference number
REC.1395.IR.IUMS.9313676006

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E70-E90
ICD-10 code description
Metabolic disorderes

Primary outcomes

1

Description
Weight
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Using a digital scale Seca and with an accuracy of 0.1 kg

2

Description
Body mass index
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Weight by the square of height in metric units

3

Description
Waist circomference
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Using plastic meters and with an accuracy of 0.1 cm

Secondary outcomes

1

Description
Waist-to-hip ratio
Timepoint
Before and 8 weeks after the intervention
Method of measurement
By dividing the waist measurement by the hip measurement unit cm

2

Description
Waist to Height Ratio
Timepoint
Before and 8 weeks after the intervention
Method of measurement
By dividing the waist measurement units cm in height per cm

3

Description
The middle arm circomference
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Using plastic meters per cm

Intervention groups

1

Description
Intervention group: Intervention will be based on a self-care education program. This program will be designed and implemented based on Orem's supportive-educative system; which will include a collection of self-care training programs that assist patients to identify and investigate their needs. This education package will include training the subjects to improve their understanding and awareness of metabolic syndrome and menopause, nutrient regimen, medication regimen, physical activity, and weight loss.This program will be conducted in 5 sessions of 45 minutes duration, of which 30 minutes will include oral presentation and 15 minutes for questions and answers. The program will run over 5 weeks (one session per week), in groups of 5 to 7 people. The training, will start and end at a certain date and will be provided by 5 research assistants. These training programs will be conducted in the morning shift and in the selected healthcare centers of Tehran municipality. The training will contain providing information to the participants regarding metabolic syndrome and its relationship to menopause, complications of the disease, dietary( use of fresh vegetables and fruit, low salt and carbohydrate diet, reduced consumption of saturated fatty acids and their importance and a variety of foods that can be used), medication regimen ( the importance of taking them on time, dosage and their effects ), weight loss and physical activity ( aerobic sports, type of physical activity and its role in health ). The training program will also include educating the participants on how to measure their blood pressure, weight and blood sugar levels. At the end of each session, the subjects will be given educational pamphlets of that. The final educational material will be in the form of a booklet with 5 chapters, which will include: metabolic syndrome and menopause( chapter I ), diet and metabolic syndrome ( chapter II ), medication regimen and metabolic syndrome ( chapter III ), physical activity, weight loss and metabolic syndrome ( chapter IV ), and how to measure blood pressure, body weight and blood sugar ( chapter V ). The content of this booklet will be reviewed and approved by 10 medical and surgical scholars. To evaluate the efficiency of training, the participants will be asked two questions at the beginning of each session about the previous session and how they incorporated that at home. It is worth noting that the trainers will be available to answer any questions raised by participants via phone, if needed. At the end of this study the subjects will be rewarded for their participation.
Category
Lifestyle

2

Description
Control group: In this group there, will not be any intervention and they will continue to have their usual lifestyle as before. At the end of this investigation they will be provided with the educational material and also will be rewarded as their other counterparts for their participation in this program.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
District 1 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate Student of Medicial & Surgical
Street address
Next to the Gas Station, Bahonar Street, Tajrish Square
City
Tehran

2

Recruitment center
Name of recruitment center
District 3 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate Student of Medicial & Surgical
Street address
Before the Hemmat Highway, Lower than Husseinya Ershad, Shariati Street
City
Tehran

3

Recruitment center
Name of recruitment center
District 5 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate student of Medicial & Surgical
Street address
Next to Shahid Shali Street, The bigining of the Ashrafi Esfahani Highway, Higher than the Second Square of Sadeghieh
City
Tehran

4

Recruitment center
Name of recruitment center
Disrict 6 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate Student of Medicial & Surgical
Street address
NO.19, Shahid Farhang Hosseini Alley, Higher than the Taleghani, Valiasr Street
City
Tehran

5

Recruitment center
Name of recruitment center
Disrict 8 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate student of Medicial & Surgical
Street address
NO. 218, Crossroad Kamyab, Dardasht Street, Narmak Street, Resalat Highway
City
Tehran

6

Recruitment center
Name of recruitment center
District 12 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate student of Medicial & Surgical
Street address
Estenkafi Alley, Mojahedin Islam Street, Shohada Square
City
Tehran

7

Recruitment center
Name of recruitment center
Disrict 17 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate student of Medicial& Surgical
Street address
NO.33, Infront of the shihadaye Gomnam Park, Shahid Firoozi Street, Abozar Street
City
Tehran

8

Recruitment center
Name of recruitment center
Disrict 19 of Tehran Municipality Health Center
Full name of responsible person
Sahab badizadeh, Graduate student of Medicial & Surgical
Street address
NO.240, Corner of 16. Alley, Misag Street, Shahid Latifi Street, Khaniabadno
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Iran University of Medical Science
Full name of responsible person
Morteza naserbakht
Street address
Fifh floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Daryadokht masror rodsari
Position
The coach, Masteres of Medical Surgical
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Rashid Yasemi Street, Valiasr Street, Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 4365 1709
Fax
+98 21 8820 1978
Email
Daryadokht_Masros@yahoo.com
Web page address
http//fnm.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Daryadokht Masror rodsari
Position
The coach, Masters Medical Surgiacal
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Rashid Yasemi Street, Valiasr Street, Tehran.
City
Tehran
Postal code
1996713883
Phone
+98 21 4365 1709
Fax
+98 21 8820 1978
Email
Daryadokht_Masror@yahoo.com
Web page address
http//fnm.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sahab badizadeh
Position
Graduate student of Medical Surgiacal
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Rashid Yasemi Street, Valiasr Street, Tehran.
City
Tehran
Postal code
1996713883
Phone
+98 21 5575 0653
Fax
+98 21 8820 1978
Email
pbadizadeh@yahoo.com
Web page address
http//fnm.iums.ac.ir

Sharing plan

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