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Effect of lifestyle educational program on health promoting behaviors and menopausal symptoms among 45-60-year-old women

Protocol summary

Summary
This study is an experimental, pretest-posttest method controlled, that will be done on 200, 45-60 years old postmenopausal women, in Ramjerd, Marvdasht in 2014. The samples with simple random sampling among qualified women and based on inclusion and exclusion criteria are selected. In this study, postmenopausal status was considered as cessation of menstruation without use of medications for at least 12 months. The data collection tool is demographic information questionnaire, Menopause Rating Scale (MRS), and Walker’s health-promoting lifestyle profile (HPLPII). Post-test will be done two months after the pre-test. In this study, educational intervention on health-promoting lifestyle was conducted for postmenopausal women in 4 sessions by researcher. In the any four sessions, a specified educational content and different educational methods, including interactive lecture, group discussion, and media, such as booklet, picture, and slideshow, will be used to enhance the participants’ learning and participation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509237816N7
Registration date: 2016-02-22, 1394/12/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-22, 1394/12/03
Registrant information
Name
Mahin Nazari
Name of organization / entity
School of health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
manazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences,The Research Vice-chancellor
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lifestyle educational program on health promoting behaviors and menopausal symptoms among 45-60-year-old women
Public title
Effect of lifestyle educational program on health promoting behaviors and menopausal symptoms
Purpose
Health service research
Inclusion/Exclusion criteria
The inclusion criteria: 45-60 years old women who have physiological menopause; passage of at least one year and at most 10 years from cessation of menstrual cycle; being physically and mentally healthy; being willing to participate in the study The exclusion criteria: having a history of hormone therapy within the past 6 months ; having a history of hysterectomy;radiation therapy; use of drugs that reduce menopause symptoms
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: 200
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shiraz University of Medical Sciences, The Research Vice-chancellor
Street address
Shiraz,Zand Street
City
Shiraz
Postal code
Approval date
2015-07-12, 1394/04/21
Ethics committee reference number
94-7536 / IR.SUMS.REC.1394.67

Health conditions studied

1

Description of health condition studied
health-promoting behaviors and menopausal symptoms
ICD-10 code
Z72.9
ICD-10 code description
Problem related to lifestyle, unspecified

Primary outcomes

1

Description
health-promoting behaviors
Timepoint
Before intervention and two months after intervention
Method of measurement
Walker’s Health Promoting Lifestyle Profile

Secondary outcomes

1

Description
menopausal symptoms
Timepoint
Before intervention and two months after intervention
Method of measurement
questionnaire of Menopause Rating Scale (MRS)

Intervention groups

1

Description
In the control group no intervention was done.
Category
N/A

2

Description
In this study, educational intervention on health-promoting lifestyles was conducted for postmenopausal women in 4 sessions, each having a specified educational content. Additionally, different educational methods, including interactive lecture and group discussion, and media, such as booklet, poster, picture, and slideshow, were used to enhance the participants’ learning and participation.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ramjerd rural health center in Marvdasht
Full name of responsible person
Nasrin Bahmani
Street address
Marvdasht Health Center
City
Marvdash

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Poost Froush
Street address
Shiraz, Shiraz University of Medical Sciences,Research Vice-chancellor
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences , School of Health
Full name of responsible person
Dr. Mahin Nazari
Position
Assistant Professor in Department of Health Education and Health Promotion
Other areas of specialty/work
Street address
Shiraz, School of Health, Street Alzahra
City
Shiraz
Postal code
Phone
+98 71372510003
Fax
+98 71 3726 0225
Email
manazari2sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences,Faculty of Health
Full name of responsible person
Dr. Mahin Nazari
Position
Assistant Professor in Department of Health Education and Health Promotion
Other areas of specialty/work
Street address
Shiraz, Faculty of Health, Alzahra Street
City
Shiraz
Postal code
Phone
+98 71372510005
Fax
Email
manazari@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Health
Full name of responsible person
Samaneh Farmani
Position
MSc student in the Faculty of Health, Department of Health Education and Health Promotion
Other areas of specialty/work
Street address
Shiraz, Faculty of Health, Alzahra Street
City
Shiraz
Postal code
Phone
+98 71372510002
Fax
Email
s_farmani@sums.ac.ir
Web page address

Sharing plan

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