Protocol summary

Study aim
Determining the effect of program intervention (educational-implementation-environmental) based on PRECEDE-PROCEED model to promoting the preventive behavior of leishmaniasis in households with children under 10 years old
Design
Among villages in Jajarm city, 5 villages will be randomly selected as intervention group and 5 similar villages of cultural and geographical location will be selected as the control group. Then from the villages of the intervention group 84 and from the control group villages 84 families will be randomly selected.
Settings and conduct
Educational intervention is done with an emphasis on the patterns of PRECEDE-PROCEED , for a maximum of 3 month.
Participants/Inclusion and exclusion criteria
Having a child under 10 years of old Residence is at least 6 months in the Sankhast district of Jajarm city
Intervention groups
Intervention group: Educational intervention is done with an emphasis on the patterns of PRECEDE-PROCEED , for a maximum of 3 month. Control group: There will be no intervention on the control group
Main outcome variables
preventive behavior of leishmaniasis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160619028529N8
Registration date: 2018-04-28, 1397/02/08
Registration timing: prospective

Last update: 2018-04-28, 1397/02/08
Update count: 0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Hadi Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 8530
Email address
tehranih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of program intervention (educational-implementation-environmental) based on PRECEDE-PROCEED model to promoting the preventive behavior of Leishmaniasis in households with children under 10 years old of jajarm 2016-2017
Public title
The effect of intervention to promoting the preventive behavior of Leishmaniasis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child under 10 years of old Residence is at least 6 months in the Sankhast district of Jajarm city
Exclusion criteria:
One of the children of the family has the leishmaniasis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
221.IR.MUMS.REC.1396

Health conditions studied

1

Description of health condition studied
Leishmaniasis
ICD-10 code
B55
ICD-10 code description
Leishmaniasis

Primary outcomes

1

Description
preventive behavior of Leishmaniasis
Timepoint
before the intervention, immediately and, three months after the intervention
Method of measurement
Questionnaire, Behavioral View Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Educational intervention is done with an emphasis on the patterns of PRECEDE-PROCEED , for a maximum of 3 month.
Category
Lifestyle

2

Description
Control group: There will be no intervention on the control group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Villages in Jajarm city
Full name of responsible person
Hosein Jajarmi
Street address
Beheshti Street
City
Jajarm
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3222 1910
Email
jajarmi20@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice President of Research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Fax
Email
tehranih@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Tehrani
Position
استادیار گروه آموزش بهداشت و ارتقای سلامت
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
خیابان دانشگاه، بین دانشگاه 16 و 18، دانشکده بهداشت
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Fax
Email
tehranih@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Fax
Email
tehranih@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
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
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Hadi Tehrani: tehranih@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email
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