Protocol summary

Study aim
Determining the effect of intervention based on health belief model on behaviors, risk factors and ten-year risk score related to cardiovascular diseases
Design
The clinical trial includes two intervention and control groups, with parallel groups, one blind, randomized on 120 patients. Simple randomization method of lottery type is used.
Settings and conduct
Before and after the intervention, the ten-year risk of cardiovascular disease in people is determined, and demographic questionnaires and constructs of health belief patterns and preventive behaviors are also completed. The place of the intervention is Dorcheh City Health Center and the trainings are face-to-face and group. The study is blinded and the target group does not know whether they are assigned to the control or intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: over 30 years old, no history of smoking, annual risk score of 10-30%, covered by Dorcheh health centers, completing the consent form, not participating in related trainings in the past. Exclusion criteria: not completing the questionnaire, not participating in the training sessions and not responding to the researcher's call
Intervention groups
The educational program includes 10 sessions with educational content based on the source of the Ministry of Health (IRAPEN). The educational content is adjusted according to the constructs of the health belief model based on the preventive behaviors of diet, medication and physical activity and the results of the pre-test. The trainings are done in groups using a combination of lecture, question and answer, brainstorming and discussion. The control group also receives the usual care of health centers.
Main outcome variables
Outcomes include improvement of dietary, medication and physical activity behaviors and reduction of risk factors and ten-year risk score of cardiovascular diseases.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200621047870N2
Registration date: 2023-12-20, 1402/09/29
Registration timing: prospective

Last update: 2023-12-20, 1402/09/29
Update count: 0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
Elham Ebrahimi dorcheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3375 5127
Email address
elhamebrahimi1344@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, implementation and evaluation of an educational intervention based on Health Belief Model on behaviors and risk factors affecting cardiovascular diseases in people over 30 years old with a ten-year risk score of 10-30% of cardiovascular diseases
Public title
Investigating the effect of educational intervention on behaviors and risk factors affecting cardiovascular diseases
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People over 30 years old People with no history of smoking and alcohol consumption People with a ten-year risk score of 10-30% of cardiovascular diseases​
Exclusion criteria:
People who are very old and it is difficult to get information from them​ People who have previously participated in training courses related to the present intervention
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
120 people who are eligible and available to enter the study covered by Dorcheh 1 and Dorcheh 2 health centers (60 people from each center) by simple random sampling method of lottery type by taking names from the box as the target group of the study are selected and according to the homogeneity of the demographics and regional information of Dorcheh 1 and Dorcheh 2 health centers, using a simple random sampling method of lottery type by taking the names of the centers from inside the sealed envelope, 60 people from one center will be assigned to the intervention group and 60 people from the other center will be assigned to the control group. ​
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants, who are the target group of the study, will not know whether they are assigned to the intervention or control group until after receiving secondary information from the individuals and completing the study. The information of each member of the intervention and control group will be kept confidential with the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
The educational intervention of the present study is based on the health belief model in order to change behaviors and risk factors affecting cardiovascular diseases. And the main goal of the current intervention is to change the ten-year risk of cardiovascular diseases in high-risk people.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-12-16, 1402/09/25
Ethics committee reference number
IR.MUI.DHMT.REC.1402.046

Health conditions studied

1

Description of health condition studied
The patients examined in this study include people with a ten-year risk score of 10-30% of cardiovascular diseases. The risk factors that are measured to determine the ten-year risk of cardiovascular diseases include body mass index, waist circumference, blood pressure, fasting blood sugar, and blood fat (total cholesterol).
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease

Primary outcomes

1

Description
Diet, medication and physical activity behaviors
Timepoint
Diet, medication and physical activity behaviors are determined before the intervention and two and six months after the intervention.
Method of measurement
The scores of diet, medication and physical activity behaviors are determined using a questionnaire.

Secondary outcomes

1

Description
Ten-year risk score of cardiovascular diseases
Timepoint
The ten-year risk score of cardiovascular diseases is measured before the intervention and six months after the intervention.​
Method of measurement
The ten-year risk score of cardiovascular diseases is determined based on the risk factors of body mass index, waist circumference, blood pressure, fasting blood sugar, blood fat (total cholesterol). These items are measured using a scale, tape measure, manometer, and blood test, respectively. After entering the information of the risk factors of people in the Sib electronic system, the system determines the ten-year risk score of cardiovascular diseases for each person.

Intervention groups

1

Description
Intervention group:The training program includes 10 sessions and each session lasts 90 minutes for the intervention group. The educational content is presented based on an authentic source from the Ministry of Health under the title of the collection of basic interventions of non-communicable diseases in the primary health care system of Iran and under the title of Irapen book. The content of this book is mainly related to the risk factors of cardiovascular diseases and the necessary training regarding the preventive behaviors of these diseases, including physical activity, diet and medication. In fact, the educational content of the study is determined and adjusted according to the structures of the health belief model based on the mentioned preventive behaviors as well as the results of the pre-test. Trainings are conducted in groups using a combination of lecture, question and answer, brainstorming and group discussion methods in each training session. During the educational classes, media such as pamphlets (distributed among all those present in the class for studying at home), books, posters, videos and educational photos are used to increase learning.
Category
Behavior

2

Description
Control group: The control group will receive only the routine care of health centers.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dorcheh Comprehensive Health Center
Full name of responsible person
Elham ebrahimi dorcheh
Street address
Basij St., Dorcheh city, Esfahan city
City
Esfahan
Province
Isfehan
Postal code
84316-36631
Phone
+98 31 3376 8797
Email
elhamebrahimi1344@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Research and Technology Department, Building number 4, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elham ebrahimi dorcheh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Esfahan University of Medical Sciences, Hazarjarib Street, Shiraz Gate, Esfahan
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
elhamebrahimi1344@gmail.com
Web page address
https://mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham ebrahimi dorcheh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Esfahan University of Medical Sciences, Hazarjarib Street, Shiraz Gate, Esfahan
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
elhamebrahimi1344@gmail.com
Web page address
https://mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham ebrahimi dorcheh
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Esfahan University of Medical Sciences, Hazarjarib Street, Shiraz Gate, Esfahan
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
elhamebrahimi1344@gmail.com
Web page address
https://mui.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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
Start access after printing the results
To whom data/document is available
All people working in academic, scientific and industrial sectors are able to receive data
Under which criteria data/document could be used
1- Using information to conduct scientific and research studies 2- Not changing information and observing ethical standards
From where data/document is obtainable
1- Conductors and authors of the research plan 2- Research assistant of the university and the relevant educational institution (ٍEsfahan University of Medical Sciences). Communication channels of the research plan administrators: 1- Mrs. Elham Ebrahimi, Address: Alley 98, Nabavi Manesh St, Atashgah Street, Esfahan, Contact number: 09133764592, Email address: elhamebrahimi1344@gmail.com. 2-Dear Dr. Hossein Shahnazi, Address: Department of Health Education, Faculty of Health, Esfahan University of Medical Sciences, Hazar Jarib Street, Esfahan, contact number: 09133360148, email address: h_shahnazi@yahoo.com.
What processes are involved for a request to access data/document
After contacting the project managers and checking the applicant's scientific and moral qualifications, the information will be provided to the person in the shortest possible time.
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