Protocol summary
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Study aim
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The purpose of this study is" Designing an educational program based on theory and its impact on healthy spine- related behavior in female fifth grade elementary school in capital Tehran`s region 22".
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Design
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The study population included 102 public elementary schools fifth grade girls, Tehran 22nd District, has inclusion criteria,with the pre and post-test in the academic year 97-98. At first, two similar schools were selected and are randomly assigned to control and test group. Then in each school, two classes are randomly selected and in each group, 51 eligible people are enrolled in the study.
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Settings and conduct
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Before intervention, a localized questionnaire based on the four constructs of social cognitive theory (behavioral capability, self-efficacy, beliefs and behavior), validity and reliability of which were previously measured, will be completed by the two groups.After performing 6 educational intervention sessions in the test group,Immediately, three and six months after the intervention, the questionnaire will again be filled in by the two groups.The effects of the intervention are compared with control group.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Fifth grade female student; parental written consent for student participation in the study; informed consent and voluntary; participation of the student in the study; ability to attend training sessions; no training in this area.
Exclusion Criteria: having pain or disorder in the student's spine; disapproval of student's spine health by physiotherapist.
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Intervention groups
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Intervention group: Includes 51 people who receive instructional education based on 4 construct of social cognitive theory. The control group also includes 51 people who will not receive any intervention.
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Main outcome variables
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Healthy spine-related behavior
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180528039885N1
Registration date:
2018-10-30, 1397/08/08
Registration timing:
registered_while_recruiting
Last update:
2019-06-17, 1398/03/27
Update count:
1
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Registration date
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2018-10-30, 1397/08/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-22, 1397/06/31
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Expected recruitment end date
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2019-09-21, 1398/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of a theory-based educational program on healthy spine-related behavior among female fifth grade elementary school - Randomized Community Trial
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Public title
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Effectiveness of a theory-based educational program on healthy spine-related behavior
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Female fifth grade elementary school
Parents informed consent
Student informed consent and voluntary participation
Ability to attend training sessions
No training in this area
Exclusion criteria:
Receive back pain prevention programs before or outside of this study
Any reports of pain or disorder in the student's spine by him or her, parents or school officials
Report of student's spine unhealthy by physiotherapist
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Age
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From 11 years old to 11 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
102
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Because the trial is done on the group and the community ,in the first stage of the sampling process, a list of schools in the study location was prepared which included nine schools in the study location.
As the second step, two schools of 9 schools -which is similar In terms of social class and the number of students in the class- are randomly assigned to the intervention and control groups using the simple random sampling technique .
As the final step, two classes of fifth grade in each school - 51 students regarding the inclusion and exclusion criteria - are randomly selected to enter the study .
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-03-17, 1396/12/26
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Ethics committee reference number
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IR.TMU.REC.1396.727
Health conditions studied
1
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Description of health condition studied
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back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Healthy spine-related behavior
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Timepoint
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before, Immediate, three and six months after the intervention
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Method of measurement
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Using a questionnaire
Secondary outcomes
1
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Description
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Knowledge, Skill, Self-efficacy and Belief.
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Timepoint
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before, Immediate, three and six months after the intervention
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Method of measurement
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Using a performance checklist
Intervention groups
1
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Description
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Intervention group: Includes 51 people who receive 6 sessions of instructional education program based on social cognitive theory. Two strategies( 3 sessions) are used to increase the behavioral capability(knowledge and skills):- Provide required knowledge to conduct recommended behavior using lecture, slide show and brain storm 2- Teaching essential skills for accepting the behavior and keeping it using the direct and vicarious experience and demonstration- re demonstration method In order to increase self-efficacy are used (2 sessions) , methods of mastering the practice, observing others' performance, receiving suggestions from others, and confronting emotions arising from thoughts of change . To enhance the fear-avoidance beliefs (1 sessions) are used the methods of discussing about benefit, brainstorm , and role playing .
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Category
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Prevention
2
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Description
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Control group: Includes 51 people (two classes) who are in the same school as the intervention group and do not receive any training.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Deputy of Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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When the data will become available and for how long
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31/ 09/2020
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To whom data/document is available
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The person who evaluates the outcome - Analytic person - Journal Reviewer - executor of plan
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Under which criteria data/document could be used
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To evaluate the outcome, data analysis and validation of data - Under the conditions of the triple-blind
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From where data/document is obtainable
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executor of plan
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What processes are involved for a request to access data/document
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It is requested by e-mail to the project implementer with the address: tavafian@modares.ac.ir
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Comments
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