Protocol summary

Study aim
Determining the effect of educational intervention based on health belief model on nutritional behavior of patients with myocardial infarction
Design
A clinical trial with two intervention and control groups, a sample size based on previous studies of 86 patients and randomly.
Settings and conduct
The study entry was admitted to all of the patients referring to Heshmat Rasht Medical Education Center and Lahijan's 22th Aban hospital on the basis of having clinical symptoms and conducting cardiac tests and changing the electrocardiographic pathway of the diagnosis of cerebral infections and in the CCU department.
Participants/Inclusion and exclusion criteria
Entry Requirement: Patients with Myocardial Infarction Non-compliance condition: 1. Problem remembering nutritional behavior due to self-reported nutritional behavior. Patients' dissatisfaction with attending classes old age inability of patients to read and write
Intervention groups
The intervention was conducted in three sessions and during three weeks in the intervention group based on health belief model constructs and using educational materials (PowerPoint, video instruction, lecture and question and answer).Educational pamphlets and CD were given to patients. The control group received only traditional hospital education.
Main outcome variables
Nutritional Behavior and Status of Structures of the Health Belief Model

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080825001087N11
Registration date: 2018-08-25, 1397/06/03
Registration timing: retrospective

Last update: 2018-08-25, 1397/06/03
Update count: 0
Registration date
2018-08-25, 1397/06/03
Registrant information
Name
Rabiollah Farmanbar
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 0149
Email address
farmanbar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-08, 1395/10/19
Expected recruitment end date
2017-06-09, 1396/03/19
Actual recruitment start date
2017-02-07, 1395/11/19
Actual recruitment end date
2017-07-05, 1396/04/14
Trial completion date
empty
Scientific title
The effect of the theory-based educational intervention on nutritional behavior of patients with myocardial infarction
Public title
The effect of education on behavioral behavior in patients with myocardial infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with myocardial infarction
Exclusion criteria:
Old age and inability of patients to read and write Dissatisfaction of patients with attending classes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
Actual sample size reached: 86
Randomization (investigator's opinion)
Not randomized
Randomization description
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 on Biomedical Research, Science and Research Unit
Street address
University University of Science and Research, Shaheed Sattari Highway, University of Mashhad-e-Hesarak Blvd
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2017-05-09, 1396/02/19
Ethics committee reference number
IR.IAU.SRB.REC.1396.32

Health conditions studied

1

Description of health condition studied
Nutritional Behavior of Patients with Myocardial Infarction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
nutrition behavior of myocardial infarction patients
Timepoint
pre intervention and 1 month post intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
construct of health behavior model
Timepoint
pre intervention and 1 month post intervention
Method of measurement
construct of health behavior model questionnaire

Intervention groups

1

Description
In the intervention group, the training was conducted in three sessions and during three weeks, each session lasted about one hour. The intervention was conducted in the form of training classes, lectures, group discussions, and the delivery of educational pamphlets and printed materials to the patients.
Category
Behavior

2

Description
Control group: No intervention was conducted in the control group. Patients only received routine hospital training.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmat Hospital،Rasht and 22 Aban، Lahijan
Full name of responsible person
Shahin Moghoul
Street address
15 Khordad Avenue، Rasht-Imam Khomeini stree ، Lahijan
City
Rasht and Lahijan
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Fax
+98 13 3366 8718
Email
enasiri@gums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahin Maghoul
Street address
Shahdai Hesarak Blvd.University Square،End of Shahid Sattari Highway،Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4484 5147
Email
enasiri@gums.ac.ir
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
ShahinMaghoul
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Square Rasht, Beginning
City
rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9065
Email
shmaghoul2011@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Jalili
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran - End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 214486517982
Email
Zahra.jalili@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Jalili
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
End of Shahid Sattari Highway - University Square - Shahdia Hesarak Blvd - Islamic Azad University of Science and Research Branch
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
Zahra.Jalili@gmail.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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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