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Comparison of the effect of two types of SMS-based interventions (in the gain frame and the loss frame) on osteoporosis preventive nutritional behaviors in female students

Protocol summary

Study aim
To determine and compare the effectiveness of two types of SMS based- education interventions (in the gain frame and loss frame) on osteoporosis preventive nutritional behaviors in female students
Design
The list of 345 students at the moment of the study is available to the researchers. The subjects will be randomly assigned to one of the three study groups (intervention group 1, intervention group 2, and control group).
Settings and conduct
Setting: Two female high schools in Semnan. Conduct: 350 female students from two high schools will be selected and randomly assigned either to three groups (two intervention groups and one control group). According to pre-test results, two categories of messages gain frame and loss frame will be designed. Developed gain frame messages will be sent to students in the first intervention group. Developed loss frame messages will be sent to students in the first intervention group.Two groups will be followed one month after the intervention. Finally, data will be analyzed.
Participants/Inclusion and exclusion criteria
The main of inclusion criteria: - Having a private cell phone - Being female student The main of exclusion criteria: -Diseases that limit calcium absorption - Consumption of drugs that limit calcium absorption
Intervention groups
Intervention group: Approximately 20-30 massages in the gain frame (focused on the positive outcome) and 20-30 messages in the loss frame (focused on the costs or the loss) regarding knowledge, attitude and osteoporosis preventive nutritional behaviors will be designed. Gain frame messages will be sent to participants in the first intervention group during 4 weeks. Loss frame messages will be sent to participants in the second intervention group during 4 weeks. Control group: No intervention.
Main outcome variables
Osteoporosis preventive nutritional behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110727007132N18
Registration date: 2018-06-20, 1397/03/30
Registration timing: retrospective

Last update: 2018-06-20, 1397/03/30
Update count: 0
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Tahereh Dehdari
Name of organization / entity
Iran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 2188779118263
Email address
t-dehdari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two types of SMS-based interventions (in the gain frame and the loss frame) on osteoporosis preventive nutritional behaviors in female students
Public title
Comparison of the effect of two types of SMS-based interventions (in the gain frame and the loss frame) on osteoporosis preventive nutritional behaviors in female students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
-Having a private cell phone -Being female student
Exclusion criteria:
-History of diseases that limit calcium absorption (such as Rickets, Hemophilia, Thalassemia, Yuri hypercalcemia, Vitamin D deficiency in the Blood, Cushing's Syndrome, Chronic liver Diseases, Malabsorption Syndromes, Type 1 Diabetes, Hyperthyroidism, Para Thyroid, Lymphoma, Leukemia, Rheumatoid Arthritis and Chronic Renal Diseases) -History of consumption of drugs that limit calcium absorption (such as Thyroxine, َAnticonvulsants, Glucocorticoids, Anticoagulants and Immunosuppressants)
Age
From 11 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 345
More than 1 sample in each individual
Number of samples in each individual: 115
115 female students who are studying in high school in Seman, Iran
Actual sample size reached: 350
More than 1 sample in each individual
Actual sample size in each individual:
Randomization (investigator's opinion)
Randomized
Randomization description
The list of 345 students at the moment of the study is available to the researchers. The subjects will be randomly assigned to one of the three study groups (intervention group 1, intervention group 2, and control group). The first person in the list will be randomly assigned to a group. The second person will be randomly assigned to one of the remained two groups. The third person well be assigned to the third group.Similarly, the allocation of the remaining subjects will be continued in three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There is no special characteristic in this study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences and Health Services Ethics ComComittee of Ir
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511107006

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
Nutritional behaviors condition regarding prevention of osteoporosis
Timepoint
Before and one month after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Sending developed SMSs related to osteoporosis in the gain frame (focused on the positive outcome) during 4 weeks
Category
Prevention

2

Description
Intervention group 2: Sending developed SMSs related to osteoporosis in the loss frame (focused on the loss or costs) during 4 weeks
Category
Prevention

3

Description
Control group: Not received any educational messages related to osteoporosis
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Rahe Zeynab Female High School
Full name of responsible person
Tahere Tarahomi
Street address
Motahari Square, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3512844541
Phone
+98 23 3343 9609
Email
tarahomit96@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Shahid akrami Female High School
Full name of responsible person
Maryam Farzane
Street address
Etehad town ship
City
Semnan
Province
Semnan
Postal code
3514973773
Phone
+98 23 3343 5720
Email
farzanem6162@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Tahereh Dehdari
Position
Ph.D in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4625
Email
dehdarit@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Dehdari
Position
Ph.D in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4625
Email
dehdarit@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahereh Dehdari
Position
Ph.D in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4625
Email
dehdarit@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The results only will be published in the article
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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