The effect of salt intake reduction and socioeconomic determinants on cardiovascular diseases and hypertension in the Shahrekord PERSIAN cohort in Chaharmahal and Bakhtiari province, Iran
Determining the effectiveness of educational intervention to reduce salt intake on systolic and diastolic blood pressure
Design
a community trial.
Settings and conduct
A village-based cluster randomized controlled trial will be conducted in the first part of the study. Villages in Ardal County, Chaharmahal and Bakhtiari Province will be randomly selected. Out of the 20 target villages, the villages will be divided into two intervention and control groups. Ten villages will be randomly selected as the intervention group to reduce salt consumption and ten villages as the control group. The interventions will occur over 2 months (8 weeks, one 1.5-hour session each week, and a total of 8 group discussion sessions with the village people and a team of nutritionists, health educators, cardiologists, and epidemiologists).
Participants/Inclusion and exclusion criteria
People who participated in the Shahrekord Cohort Study and have a registration code.
Intervention groups
Among the 20 target villages of the cohort study in Ardal County, Chaharmahal and Bakhtiari Province, the villages will be divided into two intervention and control groups. Ten villages will be randomly selected as the intervention group to reduce salt consumption and ten villages as the control group.
Main outcome variables
The primary outcome will be the change in the proportion of people with controlled blood pressure (BP <140/90 mmHg) from baseline. BP outcomes include changes in systolic blood pressure (SBP), diastolic blood pressure (DBP)
General information
Reason for update
Acronym
SH
IRCT registration information
IRCT registration number:IRCT20140901019002N2
Registration date:2025-05-18, 1404/02/28
Registration timing:registered_while_recruiting
Last update:2025-05-18, 1404/02/28
Update count:0
Registration date
2025-05-18, 1404/02/28
Registrant information
Name
Ali Ahmadi
Name of organization / entity
SKUMS
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 0065
Email address
ahmadi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-30, 1404/02/10
Expected recruitment end date
2025-05-31, 1404/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of salt intake reduction and socioeconomic determinants on cardiovascular diseases and hypertension in the Shahrekord PERSIAN cohort in Chaharmahal and Bakhtiari province, Iran
Public title
Salt and hypertention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The rural community of Ardel County, which is part of the Persian Shahrekord Future Cohort Study population, registered in the enrollment phase.
Exclusion criteria:
Not being a member of the Shahrekord group
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
340
Randomization (investigator's opinion)
Randomized
Randomization description
Among the 20 target villages of the cohort study in Ardal County, Chaharmahal and Bakhtiari Province, the villages will be randomly divided into two intervention and control groups. Ten villages will be randomly selected as the intervention group (receiving education and information) to reduce salt consumption and ten villages will be selected as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
During the study, none of the participants, evaluators, interventionists, or health staff involved in the trial knew who was in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی شهرکرد
Street address
17 سعدی
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815918459
Approval date
2022-04-19, 1401/01/30
Ethics committee reference number
IR.SKUMS.REC.1401.015
Health conditions studied
1
Description of health condition studied
hupertention
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
Before and after the intervention (8 weeks after the intervention)
Method of measurement
Blood pressure monitor
Secondary outcomes
1
Description
Lipids and salt intake
Timepoint
Before and after the intervention
Method of measurement
Laboratory and food frequency and cohort study
Intervention groups
1
Description
Intervention group:
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rural health homes and comprehensive health centers in Ardal
Full name of responsible person
Ali Ahmadi
Street address
17 sadi
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815918459
Phone
+98 38 3333 3448
Email
aliahmadi2007@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Omrani
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874119
Phone
+98 38 3333 0062
Email
omranism@skums.ac.ir
Web page address
https://research.skums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
50
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Ahmadi
Position
Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
17 Sadi
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815918459
Phone
+98 38 3333 3448
Email
ahmadi@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Arsalan Khaledifar
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815874119
Phone
+98 38 3333 0064
Email
khaledifar@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Ahmadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
17 Sadi
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815918459
Phone
+98 38 3333 3448
Email
ahmadi@skums.ac.ir
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
Not applicable
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
After the work is completed, except for identity information, the rest of the data can be shared.
When the data will become available and for how long
after one year
To whom data/document is available
There is no limit.
Under which criteria data/document could be used
For joint work and scientific collaboration with other researchers
From where data/document is obtainable
Executive and office
What processes are involved for a request to access data/document
Responses will be made within two months of receiving the email and request for collaboration.