Protocol summary

Summary
The aim of this randomized controlled trial is to determine the effect of educational short message based on health belief model on osteoporosis preventive behaviors in reproductive age women. This study will be carried out on 126 women in reproductive ages who refer to Shabestar city health centers 1 and 2. After obtaining written informed consent, the researcher will request all the participating women to complete a questionnaire containing demographic information, Health Belief Model about osteoporosis (OHBS) questionnaire, a Food Frequency Questionnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ). Then, using a computer software and the blocking system of four and six, the participants were randomly allocated into an intervention group and a control group. The intervention group will receive education about osteoporosis and the control group will receive education about common cancers in women via SMS. After holding a training session for intervention group with slides, text messages, maximum of 4 message per day for intervention group and 2 message per day for control group, will be sent for a month. After two months, the questionnaires will be again completed by the participants. In the end, changes in the mean scores of nutrition performance, physical activity and health belief model structures will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201605313027N37
Registration date: 2016-07-22, 1395/05/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-22, 1395/05/01
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Nursing and Midwifery Faculty, Tabriz University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational short message based on health belief model on osteoporosis preventive behaviors in reproductive age women: a single blind randomized controlled clinical trial
Public title
The effect of educational short message based on health belief model on osteoporosis preventive behaviors in reproductive age women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women of 30- 45 years old who have health records in Shabestar city health centers; having a mobile phone; enabled SMS receiving system; the absence of disease or infirmity which prevents the study; at least having guidance school degree; willing to participate in the study. Exclusion criteria: pregnant women and lactating women because of their particular lifestyle that requires larger amounts of calcium than normal people. Simultaneous participation in educational courses related to the research; early menopause under 40 years old; having osteoporosis diagnosed by a physician; having physical activity-limiting diseases such as heart disease, arthritis, diabetes, etc, with medical diagnosis; having diseases that impair absorption and reabsorption of calcium, such as parathyroid disease, calcium supplementation and consumption of other effective drugs on osteoporosis such as steroids, licorice and etc.
Age
From 30 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht streetncellor
City
Tabriz
Postal code
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
IR.TBZMED.REC.1395.291

Health conditions studied

1

Description of health condition studied
Diseases of the musculoskeletal system and connective tissue
ICD-10 code
M80
ICD-10 code description
Disorders of bone density and structure

Primary outcomes

1

Description
Physical Activity Performance
Timepoint
Before and two months after intervention
Method of measurement
International Physical Activity Questionnaire (IPAQ)

2

Description
Nutrition Performance
Timepoint
Before and two months after intervention
Method of measurement
Food Frequency Questionnaire (FFQ)

Secondary outcomes

1

Description
Knowledge and health belief model structures About Osteoporosis
Timepoint
Before and two months after intervention
Method of measurement
Osteoporosis Health Belief Scale

Intervention groups

1

Description
The control group will receive education about common cancers in women via SMS. In this way that maximum of 2 message per day for control group, will be sent for a month.
Category
Prevention

2

Description
The intervention group will receive education about osteoporosis via SMS. In this way that after holding a training session for intervention group with slides, text messages, maximum of 4 message per day will be sent for a month.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shabestar`s health Centers 1 and 2
Full name of responsible person
Fahimeh Sehhatie Shafaie
Street address
Tabriz, Sharieati street, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
City
Shabestar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Nursing and Midwifery Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Hossein Namdar
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Nursing and Midwifery Faculty of Tabriz 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
Faculty of Nursing and Midwifery of Tabriz
Full name of responsible person
Leila Parandeh
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Sharieati street
City
Tabriz
Postal code
Phone
+98 41 4242 2052
Fax
Email
leilaparandeh82@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery of Tabriz
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Sharieati street
City
Tabriz
Postal code
Phone
Fax
Email
sehhatief@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery of Tabriz
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Sharieati street
City
Tabriz
Postal code
Phone
Fax
Email
sehhatief@tbzmed.ac.ir
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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