Protocol summary

Summary
General goal: the effect of implementation of Pender's health promotion model on preventive behaviors of osteoporosis in premenopausal employed women in central building of shiraz university of medical sciences in 2014-15. inclusion criteria: women aged 35-45 years old who worked at shiraz university of medical science and were not menopaused; women who do not have menopausal symptoms in 6 months ago(Menstrual disorders-hot flashes and ...); women who do not have a history of long-term use of corticosteroids; having informed consent and willingness to participate in research. Exclusion criteria: women who do not take more than one session of classes; women who did not complete the questionnaire; having ovarian resection surgery. Sample size: 65 patients in each group. Intervention: initially, 130 of the women working in the central building of Shiraz University of Medical Sciences who qualify for the study will be randomly selected And then with blocking method size 4 divided into control and experimental groups.Then preventive behaviors of osteoporosis questionnaire based on health promotion model by both experimental and control groups completed. Continuing education intervention and preventive behaviors of osteoporosis based on health promotion model in 4 sessions, and each session 2 hours for experimental group in conference room at central building of shiraz university will be held. Then questionnaire for both groups 3 months after the intervention will be completed. And at the end of a 2-hour sessions will be held for the control group. Primary outcome: increased knowledge and awareness about osteoporosis preventive behaviors and use these behaviors in daily life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405267531N9
Registration date: 2015-07-22, 1394/04/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-22, 1394/04/31
Registrant information
Name
Iran Jahanbin
Name of organization / entity
University of Medical Sciences Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 917 313 7399
Email address
jahanbii@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementation of Pender's health promotion model on preventive behaviors of osteoporosis in premenopausal employed women in central building of shiraz university of medical sciences in 2014-15.
Public title
The effect of Pender's health promotion model on preventive behaviors of osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: women aged 35-45 years old who worked at shiraz university of medical science and were not menopaused; women who do not have menopausal symptoms in 6 months ago(Menstrual disorders-hot flashes and ...); women who do not have a history of long-term use of corticosteroids; having informed consent and willingness to participate in research. Exclusion criteria: women who do not take more than one session of classes; women who did not complete the questionnaire; having ovarian resection surgery.
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
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 Science
Street address
Central Building of Shiraz University of Medical Science, Zand street,shiraz
City
Shiraz
Postal code
71348-14336
Approval date
2015-03-07, 1393/12/16
Ethics committee reference number
CT-9376-7416

Health conditions studied

1

Description of health condition studied
Osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Postmenopausal osteoporosis

Primary outcomes

1

Description
Nutrition
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire osteoporosis preventive behaviors based on Pender's Model

2

Description
Physical activity
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire osteoporosis preventive behaviors based on Pender's Model

3

Description
Sunlight
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire osteoporosis preventive behaviors based on Pender's Model

Secondary outcomes

empty

Intervention groups

1

Description
Intervention experimental group: hold classes preventive behaviors of osteoporosis based on the Pender's health promotion model that includes nutrition education, physical activity and exposure to direct sunlight is. This class of 4 sessions, each session is 2 hours.
Category
Prevention

2

Description
Intervention control group: Holding Class osteoporosis preventive behaviors based on the Pender's health promotion model , including education, nutrition, physical activity and exposure to direct sunlight is. This class is in the form of one 2-hour sessions.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Central Building of Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Askarian
Street address
Central Building of Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Central Building of Shiraz University of Medical Science, Zand Street, shiraz
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 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
Fatemeh School of Nursing and Midwifery
Full name of responsible person
Mahsa Askarian
Position
Master student of Nursing
Other areas of specialty/work
Street address
College of Nursing and Midwifery , Namazi square,shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs-midwif@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemeh School of Nursing and Midwifery
Full name of responsible person
Iran Jahanbin
Position
Instructor, Faculty member
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Namazi square, shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs-midwif@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Fatemeh School of Nursing and Midwifery
Full name of responsible person
Mahsa Askarian
Position
Master student of nursing
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Namazi square,shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs-midwif@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir

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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