Protocol summary

Summary
The aim of this study is to improve the quality of life and healthy nutrition pattern in cardiac patients. This study will be conducted on cardiovascular patients who admitted to the Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute between (2008-2013). Three days dietary records that the completion of them is trained by expert dietitian are given for each patient in the beginning of the cardiac rehabilitation. Patients will be asked to complete the dietary record for three days, including Two days a week and a holiday. After the dietary records are completed by subjects, dietary recommendation will be done based on dietary pattern and individual statues according to ATPIII guideline. Subjects who completed dietary record before cardiac rehabilitation will be asked to complete dietary record after cardiac rehabilitation too. All patients who referred to this center by cardiologist or Cardiac surgeon and completing the cardiac rehabilitation program and 2 dietary records (before and after cardiac rehabilitation) will be enrolled to this study based on all people counting method. Dietary quality index including dietary diversity score, healthy eating index, dietary energy density and dietary approach to stop hypertension will be calculated and compared based on three days dietary records before and after dietary consultation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090923957N1
Registration date: 2015-10-14, 1394/07/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-14, 1394/07/22
Registrant information
Name
Sayyed Morteza Safavi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3168
Email address
safavimorteza@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of nutrition counseling on dietary quality index among cardiac patients referred to Cardiac Rehabilitation Research Center Isfahan Cardiovascular Research Institute during 2008-2013
Public title
Comparison of diet quality before and after the dietary consultation in cardiac patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Coronary heart disease patients which had a heart attack at least 4 weeks ago; 6-8 weeks after Open heart surgery; 6-8 weeks after angioplasty; immediately after percutaneous coronary intervention; coronary artery disease that was diagnosed by angiography; subjects were referred to this center by cardiologist or Cardiac surgeon; subjects who participated in the rehabilitation program and completed nutritional information. Exclusion criteria: Subjects with unstable angina; acute phase of myocardial infarction; unstable arrhythmia
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
Hezarjerib street, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
81745319
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.MUI.REC.1394.3.141

Health conditions studied

1

Description of health condition studied
Coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Dietary diversity score
Timepoint
Two times, before and after dietary consultation
Method of measurement
Analysis of three days dietary record will be conducted and score of 0-10 will be allocated to dietary diversity factors

2

Description
Healthy eating index score
Timepoint
Two times, before and after dietary consultation
Method of measurement
Analysis of three days dietary record will be conducted and the quartiles of healthy eating index scores will be compared

3

Description
Dietary energy density score
Timepoint
Two times, before and after dietary consultation
Method of measurement
Analysis of three days dietary record will be conducted and the quartiles of dietary energy density scores will be compared

4

Description
Dietary approach to stop hypertension score
Timepoint
Two times, before and after dietary consultation
Method of measurement
Analysis of three days dietary record will be conducted and the quartiles of DASH scores will be compared

Secondary outcomes

empty

Intervention groups

1

Description
dietary consultation
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Noushin Mohammadifard
Street address
Jomhori eslami st, khoram st, Isfahan Cardiovascular Research institute, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Food Security Research Center
Full name of responsible person
Dr Leila Azadbakht
Street address
Hezar Jarib Avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Food Security Research Center
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences, School of Nutrition and Food Science
Full name of responsible person
Sepideh Mehrabani
Position
MSc student of health Sciences in Nutrition
Other areas of specialty/work
Street address
Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3435 9511
Fax
Email
sepideh_mehr65@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Noushin Mohammadifard
Position
PhD candidate in nutrition
Other areas of specialty/work
Street address
Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3337 7883
Fax
Email
nmohammadifard@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Sepideh Mehrabani
Position
MSc student of health Sciences in Nutrition
Other areas of specialty/work
Street address
Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3435 9511
Fax
Email
sepideh_mehr65@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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