Protocol summary
-
Study aim
-
Determining the effect of educational intervention based on the BASNEF model in prevention of osteoporosis in high school students in Ghoochan city, 1965-96
-
Design
-
In this study, 120 students enrolled in high school studying at upper secondary schools are selected. Participants were randomly assigned to two groups of intervention and control and assigned to each participant a code that was written at each test stage of each person's questionnaire. The intervention group received education based on the BASNEF model and then the intervention was measured between the two groups using appropriate statistical software
-
Settings and conduct
-
In this study, the research sample was girl students who studied in two high schools in Quchan in mathematics, physics, humanities and science.
-
Participants/Inclusion and exclusion criteria
-
1.The age group is 15-17 years old.
2. Have the desire to participate in the study.
3. According to them, there is no physical limiting disease such as musculoskeletal disorders, fractures, diabetes or asthma.
-
Intervention groups
-
The intervention group consists of 60 primary school students who receive 4 training sessions based on the BASNEF model and educational pamphlet.
Control group: 60 primary school students who do not receive any interventions, and compare their effectiveness with the intervention group based on the BASNEF model.
-
Main outcome variables
-
BASNEF model structures: knowledge, attitude, abstract norms, behavioral intention, incapacitating factors, behavior. Which are measured immediately and one month after training and are compared together.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20171019036883N3
Registration date:
2018-01-24, 1396/11/04
Registration timing:
retrospective
Last update:
2018-01-24, 1396/11/04
Update count:
1
-
Registration date
-
2018-01-24, 1396/11/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Private
-
Expected recruitment start date
-
2018-01-21, 1396/11/01
-
Expected recruitment end date
-
2018-03-06, 1396/12/15
-
Actual recruitment start date
-
2017-04-14, 1396/01/25
-
Actual recruitment end date
-
2017-05-22, 1396/03/01
-
Trial completion date
-
empty
-
Scientific title
-
The Effect of Education Based on the BASNEF Model on Prevention of Osteoporosis in Girls' High School Students in quchan City, 2017
-
Public title
-
The Effect of Education on Preventive Behaviors of Osteoporosis
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Entry criteria, willingness to participate in research
aged 15 to 17
non-specific diseases, attend training sessions.
Exclusion criteria:
1. Incorrect company at training sessions (at least two training sessions).
-
Age
-
From 15 years old to 17 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
120
Actual sample size reached:
120
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
After selecting two schools from the list of schools in Quchan, using a coin throwing method, a school was selected as the control group and the other as the intervention group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Other
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-03-07, 1395/12/17
-
Ethics committee reference number
-
IR.SBMU.PHNM.1395.635
Health conditions studied
1
-
Description of health condition studied
-
osteoporosis
-
ICD-10 code
-
M80
-
ICD-10 code description
-
Osteoporosis
Primary outcomes
1
-
Description
-
Upgrading the score for the BASNEF model
-
Timepoint
-
Before training and immediately after training and one month after the last training session
-
Method of measurement
-
questionnaire
Secondary outcomes
1
-
Description
-
Preventive behaviors of osteoporosis
-
Timepoint
-
Before the intervention, immediately and one month after the intervention
-
Method of measurement
-
By a researcher-made questionnaire
Intervention groups
1
-
Description
-
In the intervention group, four training sessions on osteoporosis are given based on the BASNEF model, and educational pamphlets are given to students on the same disease
-
Category
-
Prevention
2
-
Description
-
Control group: No intervention is performed in the control group. But ethically, traditional data and pamphlet training will be distributed upon completion of data collection
-
Category
-
Prevention
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Shahid beheshti University of Medical Sciences
-
Proportion provided by this source
-
10
-
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
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