The aim of this study, is to design and evaluate an educational intervention to empower female students in preventive selfcare for osteoporosis. Study population includes female students of Islamic Azad University Shahrekord Branch. This is a controlled before-and-after study with two experimental and control groups. There will be no intervention in the control group. The sample size has been calculated in this study150 people, including 75 people in the intervention group and 75 people in the control group. Sampling method in this study is a multi-stage stratified random sampling. The intervention group and the control group will be randomly selected between two distinct colleges. The intervention group, will receive training program. There will be no intervention in the control group. This study consists of five stages: designing questionnaires and assessing its validity and reliability; completing Demographic Information, Empowerment and Self-care Questionnaires by students; educational intervention; The students will complete the Empowerment for the Prevention of Osteoporosis Questionnaire three months after the completion of intervention; The students will complete the Self Care for the Prevention of Osteoporosis based on Orem Self Care Model Questionnaire six months after the completion of intervention.
Primary outcomes include Empowerment and Self-care structures and lifestyle modification is a secondary consequence. Inclusion criteria: students aged 18 to 30 years; at least 5 semesters left to finish their education. Exclusion criteria: the lack of consent to participate in the study; people with osteoporosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510028742N8
Registration date:2015-12-15, 1394/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-15, 1394/09/24
Registrant information
Name
Fereshteh Majlessi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9134
Email address
majlesif@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-10-24, 1394/08/02
Expected recruitment end date
2015-10-29, 1394/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of an educational intervention on the empowerment of female students for preventive selfcare for osteoporosis
Public title
empowerment of females for selfcare of osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: students aged from 18 to 30 years; at least five semesters left to finish their education
Exclusion criteria: the lack of consent to participate in the study: those who intend to transfer to other universities or are likely to dropout of school; students with osteoporosis
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Not 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
Ethics Committee of Tehran University of Medical Sciences
Street address
Ethics Committee of Tehran University of Medical Sciences, Research and Technology Management, Tehran University of Medical Sciences, Qouds Ave, Keshavarz Boulvar, Tehran
City
Tehran
Postal code
Approval date
2015-09-05, 1394/06/14
Ethics committee reference number
IR.TUMS.REC.1394.691
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M80, M81,
ICD-10 code description
Disorders of bone density and structure
Primary outcomes
1
Description
Empowerment
Timepoint
Before the intervention, three months after the completion of intervention
Method of measurement
Empowerment For The Prevention of Osteoporosis Questionnaire
2
Description
Selfefficacy
Timepoint
Before the intervention, three months after the completion of intervention
Method of measurement
Empowerment For The Prevention of Osteoporosis Questionnaire
3
Description
Knowledge
Timepoint
Before the intervention, three months after the completion of intervention
Method of measurement
Empowerment For The Prevention of Osteoporosis Questionnaire
4
Description
Attitude
Timepoint
Before the intervention, three months after the completion of intervention
Method of measurement
Empowerment For The Prevention of Osteoporosis Questionnaire
5
Description
life skills
Timepoint
Before the intervention, three months after the completion of intervention
Method of measurement
Empowerment For The Prevention of Osteoporosis Questionnaire
6
Description
Self care
Timepoint
Before the intervention, six months after the completion of intervention
Method of measurement
Self Care for The Prevention Of Osteoporosis Based On Orem Self Care Model Questionnaire
7
Description
Self-care demand
Timepoint
Before the intervention, six months after the completion of intervention
Method of measurement
Self Care for The Prevention Of Osteoporosis Based On Orem Self Care Model Questionnaire
8
Description
Self-care agency
Timepoint
Before the intervention, six months after the completion of intervention
Method of measurement
Self Care for The Prevention Of Osteoporosis Based On Orem Self Care Model Questionnaire
9
Description
Self-care operation
Timepoint
Before the intervention, six months after the completion of intervention
Method of measurement
Self Care for The Prevention Of Osteoporosis Based On Orem Self Care Model Questionnaire
Secondary outcomes
1
Description
Lifestyle modification
Timepoint
Before the intervention, six months after the completion of intervention
Method of measurement
Self Care for The Prevention Of Osteoporosis Based On Orem Self Care Model Questionnaire
Intervention groups
1
Description
Intervention group: Educational intervention in the intervention group includes lectures, brainstorming, modeling and distribution package. Intervention for two months during eight sessions on a weekly basis.
Category
Prevention
2
Description
Control group: there is no intervention in control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University Shahrekord Branch
Full name of responsible person
Nader Sharifi
Street address
Islamic Azad University Shahrekord Branch, Rahmatieh, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Professor Masud Yunesian
Street address
Tehran University of Medical Sciences ,Qouds Ave, Keshavarz Boulvar, Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Majlessi
Position
Professor
Other areas of specialty/work
Street address
Department of Health Education and Promotion, School of Public Health,Tehran University of Medical Sciences, Poursina
City
Tehran
Postal code
Phone
+98 21 8898 9134
Fax
Email
dr_f_majlessi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sience
Full name of responsible person
Dr Fereshteh Majlessi
Position
MD
Other areas of specialty/work
Street address
Department of Health Education and Promotion, School of Public Health,Tehran University of Medical Sciences, Poursina
City
Tehran
Postal code
Phone
+98 21 8898 9134
Fax
Email
dr_f_majlessi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sience
Full name of responsible person
Dr. Fereshteh Majlessi
Position
MD
Other areas of specialty/work
Street address
Department of Health Education and Promotion, School of Public Health,Tehran University of Medical Sciences, Poursina
City
Tehran
Postal code
Phone
+98 21 8898 9134
Fax
Email
dr_f_majlessi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)