Protocol summary

Summary
Aims: Aim of this study is evaluation of the effect of an intervention based on social marketing model on reduction of salt intake. Design: The study population is 103 people of Yasuj that aged between 25 - 50 years old. This people will be allocated to intervention group (52 people) and comparison group (51 people) based on amount of daily salt intake. Method: This study has three phases: design, implementation and evaluation. A formative research is used in designing phase. Data for the quantitative study will be collected using Standard questionnaire based on Knowledge, attitude and practice of salt intake. Intervention programs are developed based on formative research data’s analysis and be conducted for one month. Two months after the intervention among study population, Knowledge, attitude, practice of salt intake and the amount of urinary salt are measured again and will be compared with the comparison group and baseline status. Participants: Study population is Yasuj residents with the age range of 25 - 50 year. People with special diet due to cardiovascular disease, hypertension and diabetes will not be included in the study. Interventions: intervention program will consist of: holding educational classes, providing consultation and distribution of pamphlet among intervention group. The main outcome variables: primary outcome variable are raising awareness and improving the attitude and practice of salt consumption. Secondary outcome variable is measuring the amount of salt in the urine of the intervention group

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042427568N1
Registration date: 2016-12-19, 1395/09/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-19, 1395/09/29
Registrant information
Name
Mehdi Layeghi Asl
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 6850
Email address
mehdi.layeghi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of social marketing model based educational intervention to reduce salt consumption in people aged between 25-50 years old and comparison with people will nor receive the intervention
Public title
The impact of social marketing model to reduce salt consumption
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Yasuj residents with the age range of 25 - 50 year that sign informed consent to participate in the study. Exclusion criteria: People with special diet due to cardiovascular disease, hypertension and diabetes and people who do not complete questionnaire or people who do not give a urine sample or people who do not participate in the study.
Age
From 24 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 103
Randomization (investigator's opinion)
Randomized
Randomization description
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 Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Bolv,
City
Yasuj
Postal code
Approval date
2016-08-15, 1395/05/25
Ethics committee reference number
IR.YUMS.REC.1394.146

Health conditions studied

1

Description of health condition studied
The amount of salt consumption
ICD-10 code
T57.3
ICD-10 code description
Toxic effect: Strychnine and its salts

Primary outcomes

1

Description
Knowledge, Attitude and Practice
Timepoint
Before the intervention and two months after that
Method of measurement
Questionnaire

Secondary outcomes

1

Description
The urinary sodium
Timepoint
Before intervention and two months after that
Method of measurement
The measurement of urinary sodium using Kawasaki test

Intervention groups

1

Description
There is no intervention for comparison group.
Category
Behavior

2

Description
Intervention group will receive below interventions during one month: Five Educational sessions about too much salt intake and it's effect on health and ways to reduce salt intake. Each session lasts 45 minute. Consultation about advantages of salt reduction and distribution of pamphlet.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoghi Health Center
Full name of responsible person
Medli Layeghi Asl
Street address
In front of Bahrestan Bread Complex, Jomhori Blvd
City
Yasuj

2

Recruitment center
Name of recruitment center
Shahid Ashrafi Health Center
Full name of responsible person
Medli Layeghi Asl
Street address
Alley 6, Bahonar Blvd,
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Research, Yasuj University of Medical Sciences
Full name of responsible person
Doctor Abdolmohammad Moosavi
Street address
Vice chancellor for research, Yasuj University of Medical Sciences, Motahari Blvd,
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research, Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Public Health, Yasuj University of Medical Sciences
Full name of responsible person
Mehdi Layeghi asl
Position
Master of Science
Other areas of specialty/work
Street address
Shahid Dastjerdi Street, Emam Hosein Square,
City
Yasuj
Postal code
Phone
+98 74 3322 6850
Fax
Email
m.layeghiasl@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health, Yasuj University of Medical Sciences
Full name of responsible person
Doctor Mohsen Shams
Position
Ph.D in Health Education and Promotion
Other areas of specialty/work
Street address
Shahid Dastjerdi Street, Emam Hosein Square, Yasuj
City
Yasuj
Postal code
Phone
+98 74 3322 6850
Fax
Email
Moshisf@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Public Health, Yasuj University of Medical Sciences
Full name of responsible person
Mehdi Layeghi asl
Position
Master of Science
Other areas of specialty/work
Street address
Shahid Dastjerdi Street, Emam Hosein Square, Yasuj
City
Yasuj
Postal code
Phone
+98 74 3322 6850
Fax
Email
m.layeghiasl@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...