The present study was an educational randomized control trial investigated the effect of an empowerment program based on Transtheoretical model to obtain osteoporosis preventive lifestyle on female students of Shiraz University of Medical Sciences. 152 female students who are in second year of Shiraz University of Medical Sciences were participated in two groups: experimental (n=76) and control groups (n=76). In this investigation which lasted 6 weeks, was surveyed the effect of Independent variable (empowerment program) on dependent variables ( structures of TTM model and lifestyle factors). Pre and post intervention data (1 and 6 weeks after intervention) were collected by using: the SECQ, the process of change, the self-efficacy and the decisional balance questionnaires both in calcium intake and physical activity behaviors. It should be noted that the Students who had one absence session in training period and those who participated in the pre-test and post-test but did not participate were excluded.
General information
Acronym
empowerment
IRCT registration information
IRCT registration number:IRCT201212016261N2
Registration date:2014-01-21, 1392/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-21, 1392/11/01
Registrant information
Name
Mohammad Hussein Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
kaveh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences- Ali Poost Froush
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an empowerment program on prevention of osteoporosis in female students of Shiraz university of medical sciences
Public title
Effect of an empowerment program on prevention of osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
Entrance requirements: The students of Shiraz University of Medical Sciences; University student studying in the second year; People are willing to cooperate; the continuous and sequential training program participants.
Exclusion criteria: Students in training sessions have been held for more than one session may be absent; Students who have participated in the pre-test and post-test, but do not attend; Exclusion reason of such transfer, cancel or migrate from Shiraz.
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:
152
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
Street address
Fars
City
Shiraz
Postal code
0098
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
CT-91-6345
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M81
ICD-10 code description
Osteoporosis without pathological fracture
Primary outcomes
1
Description
TTM structures
Timepoint
1 week after educational intervention
Method of measurement
Self-reported questionnaire based on Marcus's stages of change; process of change, self-efficacy and decisional balance
Secondary outcomes
1
Description
Lifestyle factors
Timepoint
6 weeks after educational intervention
Method of measurement
self- reported questionnaire
Intervention groups
1
Description
perform educational intervention in experimental group through 4 sessions (8 hours) with interactive methods
Category
Lifestyle
2
Description
Distribute educational booklets and Cd among students in the control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hussein Kave
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Poost Froosh
Street address
Shiraz, Fars , Shiraz University of Medical Sciences, School of Public Health and nutrition,department of health education and promotion
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Kaveh
Position
PHD of health education and promotion
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, school of public health and nutrition, Department of health education and promotion
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
kave@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Kaveh
Position
PHD of health education and promotion
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, school of public health, department of health education and promotion
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
kave@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)