Protocol summary

Study aim
Determination of the effect of BASNEF model educational intervention on health promotion behaviors for prevention of osteoporosis in women member of health centers of Tehran University of Medical Sciences
Design
In this research, 162 eligible women aged 30 to 49 years old referring to the health centers of the Tehran University of Medical Sciences were chosen purposefully and a code was allocated to each one of them Then, women were randomly divided into two control and intervention groups.
Settings and conduct
Study population includes women aged 30 to 49 years old attending the health centers in south of Tehran. sample size is 162(81 participants intervention group and 81 participants in control group). In this study there has been employed BASNEF questionnaire including demographic information, the structures of BASNEF model, HPLPII question. Pre-test is taken from both groups. Intervention program will take place over a month of training sessions (four weeks with one session weekly) in form of blended education training (lecture ,question and answer). Every session will take 30 to 45 minutes. In these sessions, the attempt is sharing necessary information to Prevent osteoporosis preventive behaviors . Six months later, in order to assess the interventional program effects, the questionnaire will be completed again for both groups. The study not blinded
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Women aged 30 to 49 years old who go to the health centers of southern Tehran and who have not been postmenopausal and have the consent to participate in the study. Non-inclusion criteria: Specific disease, menopause, unwillingness to participate in the study.
Intervention groups
The study consists of 162 women aged 30 to 49 who are not specific illnesses and are not suffering from postmenopausal women.The 162 patients included 81 in the intervention group and 81 in the control group.The tool of this study is a questionnaire based on the BASNEF model. we are taken pre-test from each of them.then For the intervention group, one-month training sessions (4weeks and each week one session) are conducted as a combined intervention (lecture, question and answer) intervention.Each training session is 30 to 45 minutes. During these sessions, provide information on the prevention of osteoporosis and preventive measures.
Main outcome variables
The training with the BASNEF model, according to the structures that this model has, can enhance the preventive behaviors of osteoporosis.

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20130213012460N15
Registration date: 2018-03-07, 1396/12/16
Registration timing: registered_while_recruiting

Last update: 2018-03-07, 1396/12/16
Update count: 0
Registration date
2018-03-07, 1396/12/16
Registrant information
Name
Roya Sadedgi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 327 5692
Email address
sadeghir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Educational intervention program based on BASNEF Model on preventing Osteoporosis among women refereed to health center affiliated to TUMS
Public title
Educational intervention program for preventing Osteoporosis among women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for entering the study : women aged 30 to 49 years old who go to the health centers of southern Tehran. Women who have not been postmenopausal. Women who are willing to participate in the study.
Exclusion criteria:
Specific illness during the study start menopause during the study unwillingness to continue cooperation Absence of more than two out of five sessions of educational classes
Age
From 30 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 162
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method will be done by simple random method. In this way, after the list of health centers in south Tehran, randomly selected four centers, then the two groups will be placed in the group and two centers will be placed in the comparison group. Finally, by referring to each center and coordinating with the responsible, the samples will be selected by simple random sampling with a coupled number to reach the desired sample size. These samples come together on special days at the health center, and they are invited to participate in the study by familiarizing them with the subjects and expressing the research goals.
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, School of Public Health, Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14155-6446
Approval date
2017-08-09, 1396/05/18
Ethics committee reference number
IR.TUMS.SPH.REC.1396.3.137

Health conditions studied

1

Description of health condition studied
Preventive behaviors of osteoporosis .
ICD-10 code
M81.8
ICD-10 code description
Other osteoporosis without current pathological fracture

Primary outcomes

1

Description
Preventive behaviors of osteoporosis.
Timepoint
Before and six months after the intervention.
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Health promotion behaviors
Timepoint
Before and six months after intervention
Method of measurement
Questionnaire

2

Description
BASNEF theory constructs
Timepoint
Before and six months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group:Using lectures, pamphlets, booklets, posters, educational videos and questions and answers discussions (30-45 minutes)
Category
Behavior

2

Description
Control group: For this group, a preliminary test will be performed at the beginning.no intervention was done
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
South health centers of Tehran University of Medical Sciences
Full name of responsible person
Mrs.Akram-o-Sadat Mohseni Tekye
Street address
No. , Shafiee Alley , Ghods St.
City
Tehran
Province
Tehran
Postal code
1417863181
Phone
+98 21 6697 8200
Email
sthn@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Blvd, Poursinia Street ,vice chancellor for research of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
Msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Email
sadeghir@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Email
sadeghir@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Keshavarz Blvd, Poursina St., School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 4293 3210
Email
Sadeghir@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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