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IRCT20200621047870N2 IRCT 2023-12-20 Esfahan University of Medical Sciences Investigating the effect of educational intervention on behaviors and risk factors affecting cardiovascular diseases 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 2024-04-03 anticipated 120 Complete https://irct.ir/trial/74458 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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 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. N/A 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).. Intervention 1: 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. Intervention 2: Control group: The control group will receive only the routine care of health centers. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: Start access after printing the results To whom: All people working in academic, scientific and industrial sectors are able to receive data Conditions: 1- Using information to conduct scientific and research studies 2- Not changing information and observing ethical standards Where to obtain: 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. How to obtain: 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. Comments:
public Elham ebrahimi dorcheh
Esfahan University of Medical Sciences, Hazarjarib Street, Shiraz Gate, Esfahan
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 elhamebrahimi1344@gmail.com Esfahan University of Medical Sciences scientific Elham ebrahimi dorcheh
Esfahan University of Medical Sciences, Hazarjarib Street, Shiraz Gate, Esfahan
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 elhamebrahimi1344@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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​ 30 years no limit Both 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 I25 Chronic ischemic heart disease Behavior N/A 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. Control group: The control group will receive only the routine care of health centers. 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. 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. Esfahan University of Medical Sciences Approved 2023-12-16 Ethics Committee of Isfahan University of Medical Sciences Esfahan University of Medical Sciences, Hezar Jarib St., Esfahan Esfahan Isfehan Iran (Islamic Republic of)