This study was conducted to evaluate the effect of education on lifestyle modification associated with osteoporosis in female students of Islamic Azad University Kazeroon.The samples are selected based on the criteria of being a student, being female, age 18-25 years. The sample size was determined based on consultation with experts 68 cases for the intervention group and 68 cases to the control group. Samples randomly selected from two colleges in Kazerun Azad University and further four groups are randomly selected from different educational groups, including at least a class of 30 subjects randomly recruited in each group . Data collection is carried out using reliable questionnaires as to determine the demographic information and the level of awareness. After obtaining the written consent from the subjects, the educational intervention in case group is done using lecture method within two months, including two sessions of 40 minutes in a week in each domain (education in domains of nutrition, physical activity, responsibility with regard to health and self-efficacy by related experts), group discussions and the distribution of educational package. At the end of the intervention, data collection is also carried out using questionnaires (as to determine the change in awareness and attitude). In order to specify the behavior change, the same questionnaires applied in the survey are re-administrated to both case and control groups after two months. Primary outcome measures are changes in knowledge, attitude and behavior modification is secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103030588N1
Registration date:2017-01-20, 1395/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
nader sharifi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9128
Email address
sharifi-n@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kazerun Islamic Azad University
Expected recruitment start date
2016-09-05, 1395/06/15
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on lifestyle modification associated with osteoporosis in female students
Public title
Effect of education on lifestyle modification associated with osteoporosis in female students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: being a student, not the final term, being female, age 18-25 years,filling in the questionnaire,participate in classes
Exclusion criteria: failure to complete the questionnaire,interrupted study
Age
From 18 years old to 25 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The sample size was determined based on consultation with experts 68 cases for the intervention group and 68 cases to the control group. Samples randomly selected from two colleges in Kazerun Azad University and further four groups are randomly selected from different educational groups, including at least a class of 30 subjects randomly recruited in each group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences.
Street address
University of Medical Sciences , end of Motahari street, jahrom
City
Jahrom
Postal code
Approval date
2016-11-16, 1395/08/26
Ethics committee reference number
IR.JUMS.REC.1395.089
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M80-M85
ICD-10 code description
Disorders of bone density and structure
Primary outcomes
1
Description
attitudes
Timepoint
Before intervention and immediately after the intervention
Method of measurement
Lifestyle questionnaire Walker
2
Description
awareness
Timepoint
Before intervention and immediately after the intervention
Method of measurement
Lifestyle questionnaire Walker
Secondary outcomes
1
Description
Behavior
Timepoint
Before intervention and two months after the intervention
Method of measurement
Lifestyle questionnaire Walker
Intervention groups
1
Description
Control group: intervention does not take place
Category
N/A
2
Description
Intervention group: training in the form of speech for two months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kazerun Islamic Azad University
Full name of responsible person
farangis sharifi
Street address
Islamic Azad University of Kazerun, kilometer five of Kazerun Bushehr road, Kazerun
City
Kazerun
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kazerun Islamic Azad University
Full name of responsible person
Marhematizade mohammad Hosein
Street address
Vice chancellor for research,Islamic Azad University of Kazerun, kilometerfive of road Kazerun Bushehr, Kazerun
City
Kazerun
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, Kazerun Islamic Azad University
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
Kazerun Islamic Azad University
Full name of responsible person
sharifi farangis
Position
Master/Academic staff
Other areas of specialty/work
Street address
Department of Midwifery,Islamic Azad University of Kazerun, kilometer five of Kazerun Bushehr road, Kazerun
City
Kazerun
Postal code
Phone
+98 71 3630 3975
Fax
Email
f_sharifi44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Midwifery, Kazerun Branch, Islamic Azad University, Kazerun, Iran
Full name of responsible person
sharifi farangis
Position
Master of Midwifery
Other areas of specialty/work
Street address
Department of Midwifery,Islamic Azad University of Kazerun, kilometer five of Kazerun Bushehr road, Kazerun
City
Kazerun Islamic Azad University
Postal code
Phone
+98 71 3630 3975
Fax
Email
f_sharifi44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kazerun Islamic Azad University
Full name of responsible person
sharifi farangis
Position
Master/Academic staff
Other areas of specialty/work
Street address
Department of Midwifery,Islamic Azad University of Kazerun, kilometer five of Kazerun Bushehr road, Kazerun
City
Kazerun
Postal code
Phone
00
Fax
Email
f_sharifi44@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)