Investigating the effect of educational intervention based on health literacy on preventive behaviors of cardiovascular diseases in middle-aged people at risk of cardiovascular diseases
Determining the effect of an educational intervention based on health literacy on the adoption of preventive behaviors of cardiovascular diseases among middle-aged people at risk of cardiovascular diseases in Shahrekord city.
Design
The clinical trial encompasses a control group, consisting of 50 individuals in each group - a method of random cluster sampling is employed to select the centers and individuals, utilizing a table of random numbers.
Settings and conduct
In the city of Shahrekord, one center is randomly allocated to the control group and one center to the intervention group from each of the three municipal districts. Within these centers, 17 individuals who are vulnerable to cardiovascular diseases and of middle age are randomly chosen and assigned to either the intervention or control group. Subsequent to obtaining informed consent from these individuals, a pre-test is conducted in both groups simultaneously. The collected data is then analyzed, and based on the findings, educational content is formulated and implemented in the intervention group. Following the educational intervention, a post-test is conducted immediately and then repeated three months later, simultaneously in both groups. This allows for the investigation of the impact of the educational intervention.
Participants/Inclusion and exclusion criteria
Having one of the risk factors of cardiovascular diseases
Middle-aged age group
Absence of cardiovascular diseases
Intervention groups
In the current study, a suitable intervention based on health literacy in the field of risk factors of cardiovascular diseases and prevention of these diseases will be carried out in the intervention group and after the completion of the research, the control group will also receive training.
Main outcome variables
Education intervention ; access to information; understanding information; application of information; health literacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240124060797N1
Registration date:2024-07-15, 1403/04/25
Registration timing:retrospective
Last update:2024-07-15, 1403/04/25
Update count:0
Registration date
2024-07-15, 1403/04/25
Registrant information
Name
Fatemeh Azizi sani dopolani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 4757
Email address
azizi.f@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational intervention based on health literacy on preventive behaviors of cardiovascular diseases in middle-aged people at risk of cardiovascular diseases
Public title
Investigating the effect of educational intervention on preventive behaviors of cardiovascular diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
having one of the risk factors including; High blood pressure and blood fat, family history, overweight and obesity, lack of proper physical activity that puts them in the category of people at risk.
Being Iranian
Living in Shahrekord city
Being literate in reading and writing
Age group 30 to 59 years
Exclusion criteria:
People with cardiovascular diseases
Absence in one of the training sessions
Change of residence from Shahrekord city
Age
From 30 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be carried out utilizing a random cluster approach, wherein one center will be assigned as the intervention group and another as the control group, selected randomly from the encompassing health service centers within each of the three districts in Shahrekord city. A total of 6 centers will be chosen, with 3 designated for sample inclusion in the intervention group and 3 in the control group. From the pool of individuals served by these centers who meet the criteria for participation in the study, 50 individuals will be randomly chosen as the sample for the intervention group, and another 50 for the control group. The selection of participants will be facilitated through the use of a table of random numbers as the randomization tool.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in Tarbiat Modares University research
Street address
No. 30, 32 Alley, Moalem Blvd., Shahr e Kord Town
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814834699
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.MODARES.REC.1402.254
Health conditions studied
1
Description of health condition studied
Prevention of cardiovascular diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of educational intervention on preventive behaviors of cardiovascular diseases
Timepoint
Before the educational intervention, immediately and three months after the educational intervention
Method of measurement
Data collection using valid and validated questionnaires in the field of health literacy and preventive behaviors of cardiovascular diseases.
Secondary outcomes
1
Description
Health literacy score
Timepoint
Before the educational intervention, immediately and three months after the educational intervention
Method of measurement
Collecting information using valid and validated questionnaires in the field of health literacy and preventive behaviors of cardiovascular diseases.
Intervention groups
1
Description
Intervention group: In the intervention group, the educational intervention will begin after obtaining the consent form and conducting the pre-test. After collecting the questionnaires and analyzing the resulting data, taking into account the results of previous studies, the opinion of experts and the use of reliable domestic and foreign scientific sources, a suitable educational program prepared by the researcher is presented. And the intervention group is given the necessary training regarding cardiovascular diseases, ways to prevent these diseases, and information related to improving health literacy. In the continuation of the pre-test, immediately and three months after the educational intervention, to measure the amount of behavior change and the stability of the desired behavior, as well as the final evaluation of the effect of the educational intervention, is performed simultaneously in both the intervention and control groups.
Category
Prevention
2
Description
Control group: In the control group, after receiving the informed consent, the pre-test is presented at the same time as the intervention group, then the questionnaires are collected and the resulting data are analyzed. After that, this control group, unlike the intervention group, is not subjected to any educational intervention, but the post-test questionnaires were also given to this group together with the intervention group, i.e. immediately after providing training to the intervention group and three months after that, and the results It is analyzed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord health centers
Full name of responsible person
Seyyedeh Fatemeh Azizi Sani
Street address
No. 30, 32 Alley, Moalem Blvd., Shahr e Kord Town
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814834699
Phone
+98 38 3333 4757
Email
fatemeazizi1923@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Gholamreza Moussavi
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Street., Tehran Town
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
moussavi@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 Modares 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
Tarbiat Modares University
Full name of responsible person
Fatemeh Azizi sani dopolani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 30, 32 Alley, Moalem Blvd., Shahr e Kord Town
City
Shahr e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814834699
Phone
+98 38 3333 4757
Fax
Email
azizi.f@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Azizi sani dopolani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 30, 32 Alley, Moalem Blvd., Shahr e Kord Town
City
Shahr e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814834699
Phone
+98 38 3333 4757
Fax
Email
azizi.f@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Azizi sani dopolani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 30, 32 Alley, Moalem Blvd., Shahr e Kord Town
City
Shahr e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814834699
Phone
+98 38 3333 4757
Fax
Email
azizi.f@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of educational intervention
The results of the pre-test and post-test
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Information will be accessible to researchers and participants after publication.
Under which criteria data/document could be used
Conditions will be determined based on the type of data and publishable data will be published.
From where data/document is obtainable
Fatemeh Azizi is a master's student at Tarbiat Modares University
Dr. Hassan Shahbazi is an assistant professor at the Faculty of Medical Sciences of Tarbiat Modares University
Address: Tarbiat Modares University, Faculty of Medical Sciences
Email: azizi.f@modares.ac.ir
What processes are involved for a request to access data/document
The request should be sent through the mentioned email address. Response will be made within 8 to 10 days.