Protocol summary

Study aim
Designing and Evaluating Message and Training Programs for Preventing Cyclists' Risky Behaviors
Design
Isfahan Secondary Secondary Schools were selected by random sampling from two schools (one as intervention group and the other as control group) and then through cyclists at school again using simple intervention and control group random sampling method. They will be selected The sample size was 86 persons in each of the intervention and control groups with a 20% probability of falling.
Settings and conduct
Two schools of Isfahan Secondary School will be selected based on random sampling method . The intervention group will receive the designed training program. The comparison group will not receive the message and the training program. In this study the data analyzer will also be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Cycling2- Ability to express and share risky behavior experiences3 Adolescents age 15 to 19 years exclusion: Not willing to continue cooperation at any stage 2 lack of desire to participate in training sessions over a one meeting
Intervention groups
According to the qualitative study before the intervention, all the determinants of cycling risk behaviors at the individual level will be identified and then educational intervention for the intervention group in the form of training sessions, sending educational messages through social networks and delivery. Targeted training packages will be delivered. The message control and training groups will not be presented in the intervention group and the intervention variables will be measured by a Self-report questionnaire three times before, immediately and two months after the intervention. Finally, after the final evaluation of the group Controls will be trained
Main outcome variables
Reducing show off During Cycling 2 Using safety equipment during cycling

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191218045793N1
Registration date: 2020-02-08, 1398/11/19
Registration timing: prospective

Last update: 2020-02-08, 1398/11/19
Update count: 0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Fatemeh Saber
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4626 5985
Email address
fsaber@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A mixed study of message framing in risky behaviors prevention education program and its evaluation in adolescent boy cyclists
Public title
The effect of educational intervention on cyclists' risky behaviors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
cycling Having experience in risky behavior (performing show off and not using safety equipment) and being able to express and share them Male adolescents in the age group of 15 to 19 years
Exclusion criteria:
Not willing to cooperate at every stage of the research lack of desire to participate in training sessions over a one meeting
Age
From 15 years old to 19 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 172
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization - Randomization Unit - Individual - Randomization Tool: Random Number Table
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants will be divided into case and control groups and each group will be unaware of what the other group received and to which group it is assigned. Also, in order to prevent bias in the data analysis, the data analyzer will be blinded to the type of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی اصفهان
Street address
Azadi Square - Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-09-25, 1398/07/03
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.386

Health conditions studied

1

Description of health condition studied
Risky behaviors of cyclists
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
reduce risky behavior (performing show off and not using safety equipment) of cycling and Improve attitude
Timepoint
Before, immediately and two months after the intervention
Method of measurement
En Self-report questionnaire from qualititative study

Secondary outcomes

1

Description
reducing cycling accidents
Timepoint
Before, immediately and two months after the intervention
Method of measurement
En Self-report questionnaire from qualititative study

Intervention groups

1

Description
According to the qualitative study prior to the intervention, all risk factors, including the reasons for performing show off cycling, and the reasons for not using safety equipment during cycling will be identified at the individual level, followed by the intervention for the intervention group. The format of the training sessions, the sending of educational messages through social networks based on the key ideas extracted from the qualitative study, along with the provision of targeted training packages, will in fact help people become aware of the types of risky behaviors during cycling and its consequences. Then become knowledge of attitude and self-efficacy Will acquire the necessary and many other skills that will be systematically designed for safe behaviors.
Category
Prevention

2

Description
Control group: No control message and training sessions will be provided for the control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
آموزش و پرورش منطقه دو
Full name of responsible person
فرشته زمانی علویجه
Street address
Azadi Square - Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
fe.zamani@hlth.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Azadi Square - Hezar Jerib Street-Isfahan University Of Medical Sciences- bldg NO 4.research and technology
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh saber
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Azadi Square - Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 4626 5985
Email
f_saber1385@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fereshteh zamani-alivijeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Azadi Square - Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
fe.zamani@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh saber
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Azadi Square - Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 4626 5985
Fax
Email
f_saber1385@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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