The present research aimed to explore the effectiveness of a health intervention in the light of WHO five-keys in FCHVs’ knowledge, attitude and behavior.
Design
The present empirical research was conducted as a census on all health volunteers in the target health centers. Health volunteers of three centers were taken as the experiment group (n=65) and the other two as the control (n=60).Due to the intervention nature of the study, no blinding study was performed.
Settings and conduct
This study was performed on all volunteer health care volunteers in health centers by census method.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: work as health volunteer in the target health center, consent to participate in the research and active participation in educational program. The exclusion criterion was a volunteer’s unwillingness to continue with the research for any reason.
Intervention groups
The intervention group is a group that receives educational interventions to promote food safety.
Main outcome variables
Determining the mean score of knowledge, attitude and practice towards food safety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160822029485N4
Registration date:2020-03-16, 1398/12/26
Registration timing:retrospective
Last update:2020-03-16, 1398/12/26
Update count:0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
Ali Safari
Name of organization / entity
School of public health, Shahid beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3275 5043
Email address
alisafari_31@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-30, 1398/01/10
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-04-04, 1398/01/15
Actual recruitment end date
2019-07-16, 1398/04/25
Trial completion date
2019-08-01, 1398/05/10
Scientific title
Effectiveness of a health intervention based on WHO food safety manual in Iran
Public title
The Effectiveness of Health Intervention on Food Safety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Work as health volunteer in the target health centre
Consent to participate in the research and active participation in educational program
Exclusion criteria:
volunteer’s unwillingness to continue with the research for any reason
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Of the six health care centers in the damavand city, three center were randomly assigned to the experimental group and the other three to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Shahriari Square, Velenak
City
Tehran
Province
Tehran
Postal code
6831197193
Approval date
2014-02-23, 1392/12/04
Ethics committee reference number
SBMU.REC.1392.700
Health conditions studied
1
Description of health condition studied
Food safety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Awareness
Timepoint
The effect of educational intervention was evaluated before and two months after the intervention.
Method of measurement
WHO Questionnaire related to food safety
2
Description
Attitude
Timepoint
The effect of educational intervention was evaluated before and two months after the intervention.
Method of measurement
WHO Questionnaire related to food safety
3
Description
behaviour
Timepoint
The effect of educational intervention was evaluated before and two months after the intervention.
Method of measurement
WHO Questionnaire related to food safety
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The instructional content of each session was presented in accordance with learners’ learning power using reliable scientific sources and experts’ comments. To ensure of the correspondence between the educational content with participants’ level of understanding, this content was provided to 10 health volunteers similar to those in the main research, as a pilot test. The intervention ran for one month in five 90-minute sessions in the form of lecture and PowerPoint presentation. Question and answer sessions were also held. Educational pamphlets were developed. Group discussions were held for the experiment group.
Category
Behavior
2
Description
Control group: This group will not receive any educational intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Damavand health center
Full name of responsible person
Mohtasham Ghaffari
Street address
Shahriari Square, Velenak
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 2041
Email
mohtashamghaffari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yadollah Mehrabi
Street address
Shahriari Square, Velenak
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 2041
Email
mehrabi@sbmu.ac.ir
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyede Zenab Jafarian
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shahriari Squareو Velenak
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 2040
Email
jafarian.zenab@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohtasham Ghaffari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahriari Squareو Velenak
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 2040
Email
mohtashamghaffari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyede Zenab Jafarian
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shahriari Square, Velenak
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 2041
Email
jafarian.zenab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is accessible.
When the data will become available and for how long
Available immediately after publish.
To whom data/document is available
Policy makers, decision makers, and academics have access.
Under which criteria data/document could be used
Use of statistical data in accordance with ethical principles
From where data/document is obtainable
Refer to Scientific Response for documentation.
What processes are involved for a request to access data/document
Individuals should receive the documentation with a full explanation of the research and having the necessary documentation to conduct the research related to the data.