Investigating the sustainable effect of self-care educational intervention on diet quality to reduce the risk of cardiovascular diseases in chronic patients.
Determination the sustainable effect of self-care educational intervention on diet quality to reduce the risk of cardiovascular diseases in chronic patients of Saravan city in 2023.
Design
Among the 4 comprehensive urban health service centers in Saravan, 2 centers will be selected as intervention centers and 2 centers will be selected as controls. Then, 57 people from each center will be randomly selected from the list of chronic blood pressure patients (19 people), diabetes (19 people) and obesity (19 people) and will be included in the study.
Settings and conduct
Treatment of Saravan city, comprehensive urban health service centers
Participants/Inclusion and exclusion criteria
People must be 18 years old or older. Participants should be able to read and write. Participants must be residents of Saravan city. People in comprehensive health service centers should have health records. Participants should not have cardiovascular disease
Intervention groups
Holding training sessions to strengthen self-care in food quality
Main outcome variables
Increasing the quality of the diet
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230612058460N1
Registration date:2023-06-21, 1402/03/31
Registration timing:registered_while_recruiting
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Hossien Izadirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3372 5403
Email address
izadi111389@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-21, 1402/03/31
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the sustainable effect of self-care educational intervention on diet quality to reduce the risk of cardiovascular diseases in chronic patients.
Public title
the sustainable effect of self-care educational intervention on diet quality to reduce the risk of cardiovascular diseases in chronic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People must be 18 years old or older.
Participants should be able to read and write.
Participants must be residents of Saravan city.
People in comprehensive health service centers should have health records.
Participants should not have cardiovascular diseases.
Exclusion criteria:
People with mental and psychological problems
People with less than 6 months of residence in Saravan
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
230
Randomization (investigator's opinion)
Randomized
Randomization description
Among the 4 comprehensive urban health service centers in Saravan, 2 centers will be selected as intervention centers and 2 centers will be selected as controls. Then 57 people from each center will be randomly selected from the list of chronic blood pressure patients (19 people), diabetes (19 people) and obesity (19 people) and will be included in the study.
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 zahedan University of Medical Sciences
In the intervention group, the educational content will be prepared based on the guidelines of the Ministry of Health, articles and authentic books and educational booklets. The subjects of the educational sessions will include the recognition of chronic diseases, the importance of diet and self-care in preventing chronic diseases, adherence and following dietary guidelines, developing a low-salt diet, limiting alcohol consumption, maintaining a low-fat diet. In this research, visual educational materials including videos, photos, and illustrated pamphlets will be used, as well as interactive exercises where participants can share their experiences and learn how to act by observing others. The face validity of the educational materials will be determined in a review by a panel of ten experts consisting of doctors, nutritionists, nurses, health educators and patients. Training sessions will be held by health experts in comprehensive health service centers. The time of each session is approximately between 50 and 60 minutes, and each time groups of up to 10 people will participate in it. At the beginning of the study, control group patients will receive four training sessions on four consecutive days. Then, a one-hour training session will be held every 3 months until the end of the study in order to follow up and strengthen nutritional self-care behaviors, which will be a total of six training sessions during the project period
Category
Prevention
2
Description
Control group: no intervention is done in the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Saravan
Full name of responsible person
Hossien Izadirad
Street address
Azadi St. - Health and treatment network
City
Saravan
Province
Sistan-va-Balouchestan
Postal code
9891915399
Phone
+98 54 3372 5403
Email
izadi111389@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nur Mohammad Bakhshani
Street address
Dr. Hasabi Square - Zahedan University of Medical Sciences campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2117
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hossien Izadirad
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Dr. Hasabi Square - Zahedan University of Medical Sciences campus
City
ZAHEDAN
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3372 5403
Email
izadi111389@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hossien Izadirad
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Dr. Hasabi Square - Zahedan University of Medical Sciences campus
City
ZAHEDAN
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3372 5403
Email
izadi111389@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hossien Izadirad
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Dr. Hasabi Square - Zahedan University of Medical Sciences campus
City
ZAHEDAN
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3372 5403
Email
izadi111389@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available