Protocol summary

Summary
The Purpose Of This Study Was To Investigate The Effect Of Educational Program Based On Planned Behavior On The Prevention Of Osteoporosis In Middle Aged Children Referring To Kermanshah Health Centers. The Research Population Of All Middle Aged People Is In The Range Of 30 To 59 Years Old. The Research Environment Will Be Kermanshah Health Centers. Blocks Randomization Method Is Used To Assign Samples To Each Test And Control Group. Initially, The Size Of The Blocks Is 4, Depending On The Number Of Samples That Are 68, 17 Blocks Are Selected Based On The Random Number Table And Individuals Are Assigned To The Groups Based On The Position Of The Blocks. The Intervention Is Designed To Provide A Curriculum Based On Planned Behavioral Model Constructs, With Six Sessions Per Hour, Two Sessions Per Week In Health Centers. Educational Materials Include: Education To Enhance The Knowledge About Osteoporosis, Its Complications, The Prevalence Of Osteoporosis And Factors That Contribute To Osteoporosis, Are The Prevention Of Osteoporosis, With Emphasis On The Role Of Lifestyle And More. Also, In The Training Sessions, We Will Discuss The Components Of The Planned Behavioral Model. The Control Group And The Researcher Completed The Questionnaire Before And 8 Weeks After The Intervention, And The Results Will Be Compared With The Goals Of The Study.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2017081735647N2
Registration date: 2017-10-11, 1396/07/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-11, 1396/07/19
Registrant information
Name
Sarieh Poortaghi
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4209
Email address
s-poortaghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Resources Are Provided By The Tehran Nursing And Midwifery Faculty
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Training Program Based On The Theory Of Planned Behavior On The Prevention Of Osteoporosis Behaviors In Middle Aged Referred To Health Centers In Kermanshah
Public title
The Effect Of Training Program Based On The Theory Of Planned Behavior On The Prevention Of Osteoporosis Behaviors In Middle Aged Referred To Health Centers In Kermanshah
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Individuals Aged 30 To 59 Years Old Who Are Able To Speak And Understand And Learn ; Have A Health Record At The Health Center And Have Not Been Diagnosed With Osteoporosis ; Previously In Educational Classes Have Not Participated In The Same. Exclusion Criteria: Participants Will Have More Than Two Sessions Absent From Classrooms And Cancels The Study.
Age
From 66 years old to 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Faculty Of Nursing And Midwifery, Tehran University Of Medical Sciences
Street address
Tehran University Of Medical Sciences, Faculty Of Nursing And Midwifery, Tohid Avenue, Tehran
City
Tehran
Postal code
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2693

Health conditions studied

1

Description of health condition studied
Osteoporosis
ICD-10 code
M80, M81,
ICD-10 code description
Osteoporosis With Pathological Fracture, Osteoporosis Without Pathological Fracture, Osteoporosis In Diseases Classified Elsewhere, Adult Osteomalacia, Disorders Of Continuity Of Bone, Other Disorders Of Bone Density And Structure

Primary outcomes

1

Description
Preventing Behavior
Timepoint
Before And After Intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The Intervention In The Test Group Will Be A Curriculum Based On The Planned Pattern Of Behavior In 6 Sessions
Category
Prevention

2

Description
The Control Group Does Not Intervene.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers In Kermanshah
Full name of responsible person
Nasim Pakyar
Street address
Plaque 36, Alley Golbarg1, Station No. 9, Farhangian Phase 2, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty Of Nursing, Tehran University Of Medical Sciences
Full name of responsible person
Dr. Ziba Taghi Zadeh
Street address
Tehran University Of Medical Sciences, Faculty Of Nursing And Midwifery, Tohid Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty Of Nursing, 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
Nasim Pakyar
Position
Master Of Nursing
Other areas of specialty/work
Street address
Tehran University Of Medical Sciences, Faculty Of Nursing And Midwifery, Tohid Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4209
Fax
Email
s-poortaghi@sina.tums.ac.irnpakyar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty Of Nursing And Midwifery, Tehran University Of Medical Sciences
Full name of responsible person
Sarieh Poortaghi
Position
Ph.D. In Nursing
Other areas of specialty/work
Street address
Tehran University Of Medical Sciences, Faculty Of Nursing And Midwifery, Tohid Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4209
Fax
Email
s-poortaghi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Nasim Pakyar
Position
Master Of Nursing
Other areas of specialty/work
Street address
Tehran University Of Medical Sciences, Faculty Of Nursing And Midwifery, Tohid Avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4209
Fax
Email
s-poortaghi@sina.tums.ac.irnpakyar@yahoo.com
Web page address

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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