Comparison of nutritional behaviors in two groups of testing and control before and after intervention , comparison of perceived self - efficacy in the two groups , comparing the interests and perceived obstacles perceived in healthy eating behaviors in two groups , Comparison of sentiment related to healthy eating behaviors in two groups , compared to the situation of healthy eating behaviors in two groups , compared to the level of commitment to healthy eating behaviors in two groups , comparison of the commitment to healthy eating behaviors in two groups , comparing the previous related behavior in two groups .
Design
Clinical trials with control groupcommunity oriented and pragmatic with parallel random groups
Settings and conduct
The four - minute training sessions two sessions per week will be onsidered for the test group . the control group also receivesTraining is performed at Imam and Golestan Hospital .
Participants/Inclusion and exclusion criteria
Medical diagnosis recording of acute coronary unknown sandrom mplications arising from coronary artery disease such as acute lung failure and congestive heart failure The ability to participate in training sessions Having read and rite literacy Ahvaz settlement Adult patients with acute coronary artery syndrome and heart are released from the CCU and emergency departments of Imam Khomeini 's hospitals andGolestan
Intervention groups
The four - minute training sessions two sessions per week will be onsidered for the test group . the control group also receives
Main outcome variables
keywords education health promotion model nutritional behavior training program heart disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190108042298N1
Registration date:2019-02-28, 1397/12/09
Registration timing:registered_while_recruiting
Last update:2019-02-28, 1397/12/09
Update count:0
Registration date
2019-02-28, 1397/12/09
Registrant information
Name
marzieh shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8394
Email address
shafiei.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-26, 1397/11/06
Expected recruitment end date
2019-04-26, 1398/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on health promotion model on nutritional behaviors of patients with acute coronary syndrome
Public title
The effect of educational intervention based on health promotion model on nutritional behaviors of patients with acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Medical diagnosis recording of acute coronary
unknown complications arising from coronary artery disease such as acute lung failure and congestive heart failure
The ability to participate in training sessions
Having read and write literacy
Adult patients with acute coronary artery syndrome and heart انفارکتوس are released from the CCU and emergency departments of Imam Khomeini 's hospitals andGolestan
Ahvaz settlement
Exclusion criteria:
affection complications such as acute and intense chest pain , uncontrolled arrhythmia s acute lung failure and congestive heart failure during the study .
Lack of participation in more than one training session
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
More than 1 sample in each individual
Number of samples in each individual:
70
The patients with acute coronary artery Syndrome are released from qualified heart and emergency medical wards to the number of 140 patients , and are driven by the method of the random permutation blocks with the size of Block 4 to the two groups of intervention and control control groups .
Randomization (investigator's opinion)
Randomized
Randomization description
according to the permutation block method , which is the size of block 4
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 Ahvaz University of Medical Sciences
Street address
Golestan University of Medical Sciences of Nursing School
City
Ahvaz
Province
Khouzestan
Postal code
6373135981
Approval date
2018-07-20, 1397/04/29
Ethics committee reference number
IR.AJUMS.REC.1397.747
2
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Highway, Ahvaz University of Medical Sciences, Faculty of Nursing and Midwifery
City
AHWAZ
Province
Khouzestan
Postal code
6373135981
Approval date
2019-01-04, 1397/10/14
Ethics committee reference number
IR.AJUMS.REC.1397.747
Health conditions studied
1
Description of health condition studied
patients with acute coronary artery syndromes
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
Primary outcomes
1
Description
Perceived self-efficacy
Timepoint
Three months after the intervention
Method of measurement
questionnaire
2
Description
Perceived benefits
Timepoint
Three months after the intervention
Method of measurement
questionnaire
3
Description
Perceived barriers
Timepoint
Three months after the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Economic situation
Timepoint
quarter
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: 4 45-minute training sessions in the form of face-to-face training, lectures, presentation of video tutorials, education on the promotion of lifestyle and nutrition in patients with heart disease and coronary syndrome.
Category
Lifestyle
2
Description
Control group: Routine Clinic Training
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospitals , Gulistan
Full name of responsible person
Mahin Gheibizadeh
Street address
Golestan College of Nursing and Midwifery
City
AHWAZ
Province
Khouzestan
Postal code
6373135981
Phone
+98 61 5262 1220
Email
shafiei.m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Golestan College of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6373135981
Phone
+98 61 5262 1220
Email
shafiei.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Gheibizadeh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan College of Nursing
City
Ahvaz
Province
Khouzestan
Postal code
6373135981
Phone
+98 61 5262 1220
Email
Gheibizadeh-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Gheibizadeh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan University of Medical Sciences Ahvaz College of Nursing and Nursing
City
Ahvaz
Province
Khouzestan
Postal code
6373135981
Phone
+98 61 5262 1220
Email
shafiei.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Gheibizadeh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan University of Medical Sciences Ahvaz College of Nursing and Nursing
City
Ahvaz
Province
Khouzestan
Postal code
6373135981
Phone
+98 61 5262 1220
Email
shafiei.m@ajums.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 total of the potential data is beyond the unstoppable of individuals .
When the data will become available and for how long
Starting accession period 6 months after the results are published
To whom data/document is available
Data will be available only for practitioners working in academic and academic institutions
Under which criteria data/document could be used
Use in scientific researchshafiei79@
From where data/document is obtainable
shafiei79@gmail.com
What processes are involved for a request to access data/document
Send e - mail immediately after receiving e - mail