Determining the effect of education based on health belief model on behavior and nutritional indicators in patients with myocardial infarction
Design
A clinical trial study with intervention and control groups on 72 patients was randomized. A table of random numbers is used for randomization.
Settings and conduct
This study is a prospective clinical trial that will be performed on 72 patients with myocardial infarction referred to the Rehabilitation Clinic of the Rehabilitation Research Center, Cardiovascular Research Institute. patient will be divided into two groups of intervention and control using a table of random numbers, and patients in the intervention group will receive educational content related to proper nutrition based on the health belief model during 4 sessions. Data will be collected and analyzed using questionnaires measuring the structures of the Health Belief Model, three-day food registration and demographic characteristics before, one and three months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria included all patients with myocardial infarction and exclusion criteria included low literacy and unwillingness to participate in the study.
Intervention groups
The intervention will be done by holding training classes for the intervention group in 4 sessions over 4 weeks using educational methods (lectures, questions and answers and using PowerPoint). The control group will also receive only the usual training of the rehabilitation center.
Main outcome variables
total cholesterol, HDL, LDL, blood sugar and body mass index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210609051528N1
Registration date:2021-07-05, 1400/04/14
Registration timing:registered_while_recruiting
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Fatemeh Fatahian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5231 4027
Email address
fatemehfatahian@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-28, 1400/04/07
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Education Based On Health Belief Model On Behavior And Nutritional Indicators Of Patients With Myocardial Infarction
Public title
The Effect Of Education On Behavior And Nutritional Indicators Of Patients With Myocardial Infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
literacy
ability to communicate
having myocardial infarction
complete health of sight and hearing
lack of a special diet
Exclusion criteria:
Existence of severe disease conditions that prevent the patient from participating in education and learning
participation in educational programs similar to the present study
cancellation of cooperation
non-participation in at least two training sessions
the existence of underlying disease that interferes with the counseling program
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Persons will be divided into two groups of intervention and control based on a simple randomization method using a random number table. In this method, we put a set of numbers in the table without a specific pattern and order and completely randomly. To use a table of random numbers, we first specify the table numbers to read (for example, up, down, left, or right), then assume specific numbers for each group: We consider even numbers for the intervention group and odd numbers for the control group. Then we touch one of the numbers and move in one of the predetermined directions and record the numbers and assign them to the intervention and control groups.
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 Isfahan University of Medical Sciences
Street address
Faculty of Health, Isfahan University of Medical Sciences, Hazar Jerib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.144
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
total cholesterol
Timepoint
before and three month after the start of the study
Method of measurement
measurement through experiments
2
Description
HDL
Timepoint
before and three month after the start of the study
Method of measurement
measurement through experiments
3
Description
LDL
Timepoint
before and three month after the start of the study
Method of measurement
measurement through experiments
4
Description
FBS
Timepoint
before and three month after the start of the study
Method of measurement
measurement through experiments
5
Description
BMI
Timepoint
before and three month after the start of the study
Method of measurement
weight/〖hight〗^2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with myocardial infarction in the intervention group, nutrition training intervention based on the structures of the Health Belief Model by holding 4 sessions of 60 minutes (Within a month, one session per week) using the methods Lectures, questions and answers, and slide shows will be held, and patients will be followed up by telephone during this time. The educational content has been prepared by the research team and it has been tried to make all the contents simple and understandable for all patients. The nutritional educational content is adjusted based on the economic situation of the people and includes: correcting the type and amount of oil consumed, correct cooking method and not using frying Increase consumption of vegetables and fruits to at least 5 units per day, replace low-fat dairy products with high-fat ones, reduce salt consumption, remove salt shakers from the table and avoid salty foods, eat lean meats, separate chicken skin before cooking, replace Vegetable protein instead of animal, eat fish 1 to 2 times a week, eat oily nuts 5 times a week, do not eat sweets and fatty foods. To measure the effect of the intervention, one and three months after the end of the training program, the data will be collected again. Also, three months after the intervention, blood sugar, total cholesterol, HDL, LDL, BMI will be measured.
Category
Behavior
2
Description
Control group: The control group did not receive any educational intervention and used only the routine training of the rehabilitation center. It should be noted that at the end of the study, in order to observe ethics in research, all trainings will be provided to the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Clinic Rehabilitation Research Center, Cardiovascular Research Institute
Full name of responsible person
Masoumeh Sadeghi
Street address
Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Therapeutic Training Center, after Shahrestan Bridge, Mushtaq 3rd St, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3611 5209
Email
crc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Hagh Jooi Javanmard
Street address
Faculty of Health, Isfahan University of Medical Sciences, Hazar Jerib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 6836 4800
Email
sh_haghjo@med.ac.ir
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
Hossein Shahnazi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Isfahan, Hezar Jerib St., Isfahan University of Medical Sciences, Faculty of Health
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Health, Isfahan University of Medical Sciences, Hazar Jerib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Health, Isfahan University of Medical Sciences, Hazar Jerib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD