Protocol summary

Summary
Osteoporosis is a health priority in Iran and the world. Recently, the prevention of osteoporosis, has been the target of many health professionals. Behavior change is one of the powerful strategies for the prevention of osteoporosis. This study aimed to determine the effect of the trans-theoretical model in the prevention of osteoporosis in women 30-50 years of Khorramabad behaviors has been designed. A clinical trial on 136 eligible women in the intervention and control groups, using multistage cluster sampling will be conducted. Both groups valid and reliable questionnaires of stage of change, self-efficacy and decision balance of trans theoretical model on calcium intake and physical activity are examined.Then training program will be held for calcium intake and physical activity intervention group. Learning to control group action dose not take place. Both groups of three stages: before, after and three months after intervention again the questionnaire evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014021416577N1
Registration date: 2015-03-07, 1393/12/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-07, 1393/12/16
Registrant information
Name
Farideh Malekshahi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3585
Email address
f.malekshahi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2014-02-14, 1392/11/25
Expected recruitment end date
2014-07-20, 1393/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Theory-Based educational intervention on osteoporosis preventive behaviors in women 2013
Public title
Effect of Theory-Based educational on osteoporosis preventive
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: All women 30-50 years of the Khorramabad; at least a fifth-grade education; covered by centers Khorramabd. Exclusion: Unwillingness to participate in the study; rheumatic diseases; mental diseases; fractures, pregnancy; menopause and breast-feeding.
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 136
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
Tarbiat Modares University
Street address
P.O.Box:14115-111, Jalal Ale Ahmad Highway,Tarbiat Modares University, Tehran, Iran
City
Tehran
Postal code
14115111
Approval date
2013-04-26, 1392/02/06
Ethics committee reference number
d/52/605

Health conditions studied

1

Description of health condition studied
Osteoporosis
ICD-10 code
M81.9
ICD-10 code description
Osteoporosis, unspecified

Primary outcomes

1

Description
Physical activity
Timepoint
Before of intervention, after of intervention, later 3 months intervention
Method of measurement
Questionnaire

2

Description
Stage of Physical activity change
Timepoint
Before intervention, after intervention, after 3 months intervention
Method of measurement
Questionnaire

3

Description
Stage of calcium intake change
Timepoint
Before intervention, after intervention, after 3 months intervention
Method of measurement
Questionnaire

4

Description
Calcium intake self efficacy
Timepoint
Before intervention, after intervention, after 3 months intervention
Method of measurement
Questionnaire

5

Description
Physical activity self efficacy
Timepoint
Before intervention, after intervention, after 3 months intervention
Method of measurement
Questionnaire

6

Description
Physical activity decision balance
Timepoint
Before intervention, after intervention, after 3 months intervention
Method of measurement
Questionnaire

7

Description
Calcium intake decision balance
Timepoint
Before intervention, after intervention, after 3 months intervention
Method of measurement
Questionnaire

8

Description
Calcium intake
Timepoint
Before intervention, after intervention, after 3 months intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
[Physical activity:The intervention group are trained on trans- theoretical model in the form of lectures , group discussions , film screenings for stage of change and decision balance structural. Use of persons with previous experience in the field , Verbal reinforcements for self-efficacy structure in 5 sessions of 120 minutes for 6 weeks . A public rally for the intervention group runs. Also be given a booklet and Pam Felt.
Category
Prevention

2

Description
For control group without intervention
Category
Prevention

3

Description
Calcium intake: The intervention group are trained on trans- theoretical model in the form of lectures , group discussions , film screenings for stage of change and decision balance structural. Use of persons with previous experience in the field , Verbal reinforcements for self-efficacy structure in 5 sessions of 120 minutes for 6 weeks . Also be given a booklet and Pam Felt.
Category
Prevention

4

Description
For control group without intercention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center 9
Full name of responsible person
Farideh Malekshahi
Street address
Health center 9, St. Khatamolanbia, St. Enghelab, Khoramabad, Iran
City
Khorramabad

2

Recruitment center
Name of recruitment center
health center somaye
Full name of responsible person
Farideh Malekshahi
Street address
Somaye health center, Alley Haj Mohamad Reza, Emam Khomaini Spuar, St. Alavi
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Modares university
Full name of responsible person
mansoreh movahedin
Street address
P.O.Box 14115-111, Room 121, frist upstair, Departman 1 ,Medical university, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Modares 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
Tarbiat Modares University
Full name of responsible person
Farideh malekshahi
Position
Student of health education and health promotion PhD
Other areas of specialty/work
Street address
P.O.Box: 14115-111, Jalale Ale Ahmad Highway,Tehran, Iran
City
Tehran
Postal code
141151111
Phone
+98 66 3312 0140
Fax
+98 66 3312 0140
Email
f.malekshahi@modares.ac.ir; malekshahif@yahoo.com
Web page address
http://www.modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farideh Malekshahi
Position
Student of Health Education and Health Promotion phD
Other areas of specialty/work
Street address
Iran, Tehran, Jalale Ale Ahmad Highway, P.O.Box: 14115-111
City
Tehran
Postal code
14115111
Phone
+98 21 8288 3585
Fax
+98 21 8800 6544
Email
f.malekshahi@modares.ac.ir malekshahif@yahoo.com
Web page address
http://www.modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farideh Malekshahi
Position
Student of health education &health promotion phD
Other areas of specialty/work
Street address
Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
14115111
Phone
+98 66 3312 0140
Fax
+98 66 3312 0140
Email
f.malekshahi@modares.ac.ir malekshahif@yahoo.com
Web page address
http://www.modares.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
Loading...