Protocol summary

Study aim
Design and evaluation of theory-based educational intervention on the safety behavior of pedestrians in yazd city
Design
six health centers and 2 blocks of them are selected by random numbers table. 3 centers and their blocks are as intervention groups and the others are control groups. then, 17 individual are selected of each block, randomly. after searching their eligibility, questionnaire is distributed to all subjects.
Settings and conduct
in the study ,we use of double blinding. The participants and analyst is not aware of the intervention and control groups.
Participants/Inclusion and exclusion criteria
204 people(18 to 35 years old) are hired in the study with the following criterias: Interest in participating in the study • Visit his/her social network maximum every three days • crossing the street once a week • Lack of linguistic or communication problems
Intervention groups
Intervention is educational clips that upload in the social network. 3 months after the intervention, the effectiveness of the educational clips is evaluated. In the control group, clips are downloaded about drivers' behavior in terms of speed and priority.
Main outcome variables
intention and safe crossing of road

General information

Reason for update
Acronym
TEI
IRCT registration information
IRCT registration number: IRCT20180228038896N1
Registration date: 2018-06-21, 1397/03/31
Registration timing: prospective

Last update: 2018-06-21, 1397/03/31
Update count: 0
Registration date
2018-06-21, 1397/03/31
Registrant information
Name
Fateme Zare harofteh
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3569
Email address
fzare@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of theory-based educational intervention on the safety behavior of pedestrians in yazd city
Public title
The effect of educational intervention on the pedestrian behaviors of Yazd city
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 35 years Interest in participating in the study The ability to use virtual social networks the use of virtual social networks visit of his or her virtual social networks maximume every three days at a time Crossing the street in the last week
Exclusion criteria:
Not use of virtual social networks or Not visiting of them for more than three days Language disorders or problems in communication Lack of interest in continuing the study not responding to questionnaire 20% of the total or any part of the questionnaire
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 204
Randomization (investigator's opinion)
Randomized
Randomization description
First, six comprehensive health centers (2 centers from each 3 areas in Yazd) is selected by randomized sampling method . Then, 2 blocks of each center is selected by the random method. tool for randomization is statistical software. 3 centers and their selected blocks of that are control group and 3 other centers and their selected blocks are the intervention group. In fact, the centers are our block randomization unit (to prevent contamination, block randomization is done based on the telephone number of the people, so that the exchange of intervention and information decrease to the minimum).
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding is performed . The clusters and blocks are coded. The training packages are also coded. Participants are unaware of a variety of educational package. Interrogators and analyst are not aware of type of educational package of each cluster / block and control and intervention group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee in Biomedical Researchs of Tarbiat Modares University
Street address
nasr bridge, Jalal-e-Al-e-Ahmad Hwy, Tehran
City
tehran
Province
Tehran
Postal code
P.O.Box: 14115-111
Approval date
2017-04-07, 1396/01/18
Ethics committee reference number
IR.TMU.REC.1396.556

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
ICD-10 code description
کد ندارد

Primary outcomes

1

Description
the mean of intent to doing safe behavior
Timepoint
before of intervention and Three months after the intervention
Method of measurement
Self-report questionnaire

Secondary outcomes

1

Description
the mean of safe crossing of road
Timepoint
before of intervention and Three months after the intervention
Method of measurement
self report questionnaire

Intervention groups

1

Description
Intervention group:we Provide educational clips according to the results of pretest . so put the chips on the virtual network
Category
Behavior

2

Description
Control group:This group does not receive intervention. After finishing the study, the video clips will be loaded into their virtual group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Health Center
Full name of responsible person
Fateme Zare Harefteh
Street address
Daneshjo Blvd, Imam Reza Complex, Department of Health, Yazd University of Medical Sciences & Health Services
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3628 8113
Email
fzare87@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Dr Yaghob Fatholahi Nnanah Karan
Street address
No 7, Nasr Bridge, Jalal AleAhmad Street,Tehran.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
fatolahi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modarres University
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
Tarbiyat Modares University
Full name of responsible person
Fateme Zare Harofteh
Position
Candidat for Ph.D
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No.7, Nasr Bridge,Jalal AleAhmad ,Tehran.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3569
Email
fzare@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiyat Modares University
Full name of responsible person
Alireza Hidarnia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No7, Nasr Beridge, Jalal AleAhmad Street, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 982182883569
Email
hidarnia@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiyat Modares University
Full name of responsible person
Fateme Zare Harofteh
Position
Candidat for ph.D
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No 7, Nasr Beidge, Jalal AleAhmad Street, tehran.
City
Tehran
Province
Tehran
Postal code
111-1141
Phone
+98 21 8882 4745
Email
fzare@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I have not decided yet.
When the data will become available and for how long
I have not decided yet.
To whom data/document is available
I have not decided yet.
Under which criteria data/document could be used
I have not decided yet.
From where data/document is obtainable
I have not decided yet.
What processes are involved for a request to access data/document
I have not decided yet.
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