Studying the effect of nutritional education intervention on nutrition literacy, blood and anthropometric indices of nutritional status in hemodialysis patients
Determining the effect of nutritional education intervention on nutrition literacy, blood and anthropometric indices of nutritional status in hemodialysis patients
Design
This research will be conducted as a single-arm trial on 84 hemodialysis patients of Ilam. Before starting nutrition intervention, patients will be examined in terms of demographic characteristics and the main variables of the study, including nutritional literacy, blood and anthropometric indices. Educational intervention will be done for two consecutive months for all patients. The primary and secondary outcomes of the study will be measured immediately after the completion of the nutrition education and also three months after the completion of the nutrition education. Nutritional literacy level will be evaluated using DSNLS validated questionnaire. Data will be analyzed by SPSS v.22.
Settings and conduct
Before and After trial
Participants/Inclusion and exclusion criteria
Hemodialysis patients with age range between 18-65 years old
Intervention groups
The intervention will be in the form of nutritional education, which will include all hemodialysis patients of a hospital (90 subjects). Specific nutritional literacy of patients before and after the study will be evaluated and measured using a special questionnaire. Nutritional education related to their nutritional care will be provided in the form of a booklet that includes all relevant topics. At the same time, different parts of the aforementioned booklet will be explained to the patient and their companion in person by the nurse, medical intern student and nutritionist.
Main outcome variables
Nutrition literacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150523022372N2
Registration date:2024-04-29, 1403/02/10
Registration timing:retrospective
Last update:2024-04-29, 1403/02/10
Update count:0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Davoud Vahabzadeh
Name of organization / entity
Urmia university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3225 3307
Email address
dnutrition@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
2023-05-24, 1402/03/03
Actual recruitment end date
2023-06-20, 1402/03/30
Trial completion date
2023-09-23, 1402/07/01
Scientific title
Studying the effect of nutritional education intervention on nutrition literacy, blood and anthropometric indices of nutritional status in hemodialysis patients
Public title
The effect of nutritional education intervention on nutrition literacy of hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being on hemodialysis
being in the study age range
having at least primary literacy or having a literate companion
Exclusion criteria:
Having very old age
Having insufficient literacy
Inability to cooperate due to illness
Death
Participating in educational programs incompletely
Transfer to other dialysis methods or kidney transplant
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
83
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
Ethics committdiee of Ilam University of Medical Sciences
Street address
Pajouhesh Blvd-Ilam University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
6931851147
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.MEDILAM.REC.1401.054
Health conditions studied
1
Description of health condition studied
Hemodialysis patient
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for renal dialysis
Primary outcomes
1
Description
Nutrition literacy
Timepoint
Bimonthly
Method of measurement
Dialysis Specific Nutrition Literacy Scale (DSNLS)
Secondary outcomes
1
Description
Blood indicators
Timepoint
Bimonthly
Method of measurement
Laboratory tests
2
Description
Anthropocentric measurements
Timepoint
Bimonthly
Method of measurement
Measurement equipment such as Scales and gauges
Intervention groups
1
Description
All the patients of one hemodialysis department, which are 90 subjects totally, will be undergone to educational intervention. Nutritional education related to their nutritional care will be provided in the form of a booklet that includes all relevant topics. At the same time, different parts of the aforementioned booklet will be explained to the patient and their companion in person by the nurse, medical intern student and nutritionist. Any ambiguities or problems in understanding will be resolved during face-to-face training. In this way, all the patients will pass the training course for two consecutive months.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mustafa Khomeini Hospital of ILAM
Full name of responsible person
Davoud Vahabzadeh
Street address
Pajouhesh Blvd
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3222 7126
Fax
+98 84 3222 7126
Email
vahabzadeh-d@medilam.ac.ir
Web page address
https://medicine.medilam.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
َAbbas Maleki
Street address
Pajouhesh
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5724
Email
vcr@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Davoud Vahabzadeh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Pajouhesh Blvd
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7126
Email
vahabzadeh-d@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Davoud Vahabzadeh
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Pajouhesh
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7126
Fax
+98 84 3222 7126
Email
vahabzadeh-d@medilam.ac.ir
Web page address
https://medicine.medilam.ac.ir/nut
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Davoud Vahabzadeh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Pajouhesh
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7126
Fax
+98 84 3222 7126
Email
vahabzadeh-d@medilam.ac.ir
Web page address
https://medicine.medilam.ac.ir/nut
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
In Article
When the data will become available and for how long
6 Months after final report of research
To whom data/document is available
Subjects who receive our article
Under which criteria data/document could be used
For directing other researchers And validation of our work
From where data/document is obtainable
Article Publisher
What processes are involved for a request to access data/document