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The effect of educational program based on the Health ActionProcess Approach Model on consumption of fruit and vegetable in type 2 diabetes patients in Buin Zahra city.

Protocol summary

Study aim
Design, implementation and evaluation of health approach education that can improve the quality of life of diabetic patients.
Design
From among the centers covered in the city, four centers will be selected by lottery, and in these four centers, after the entry and exit conditions, the participants in the study will be selected by simple randomization and will be divided into two intervention and control groups. This study will be done on 100 people.
Settings and conduct
This study will be conducted in Buin Zahra city of Qazvin province and regarding the consumption of fruits and vegetables in diabetic patients.
Participants/Inclusion and exclusion criteria
Entry requirements: Having type 2 diabetes, being a volunteer. Age between 30 and 60 years. Not having complications of diabetes, having a mobile phone, being literate, suffering from the disease for one year. Exit conditions: Reluctance to participate in the study, having physical and mental disorders, participation in another study, immigration, complications of diabetes, addiction.
Intervention groups
The educational intervention includes a group training program that is presented by the researcher in four sessions for 30-35 minutes. The training will include lectures, slides, film and photo shows, group discussions, brainstorming, and questions and answers. For the control group, after completing the questionnaire In the second stage, a training session will be held and a training package including pamphlets, training videos and posters will be provided to them.
Main outcome variables
Amount of fruit and vegetable consumption

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221224056911N1
Registration date: 2023-09-18, 1402/06/27
Registration timing: retrospective

Last update: 2023-09-18, 1402/06/27
Update count: 0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Yahya Ghasemkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3422 4170
Email address
y.ghasemkhani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program based on the Health ActionProcess Approach Model on consumption of fruit and vegetable in type 2 diabetes patients in Buin Zahra city.
Public title
The effect of educational program based on the Health ActionProcess Approach Model on consumption of fruit and vegetable in type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes. Being a volunteer Being between 30 and 60 years old Not having complications related to diabetes The patient has a smart mobile phone Be literate in reading and writing A history of diabetes for at least one year.
Exclusion criteria:
Suffering from physical and mental illnesses Having severe complications of diabetes Having an addiction to drugs, alcohol, etc.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Buin Zahra city includes 11 comprehensive health service centers, out of which four centers will be selected by lottery, and then the names of the patients will be extracted and a list will be prepared, and those who do not have the conditions to participate in the study will be removed from the list. Among the remaining patients, people will be selected and entered into the study in a simple way (by lottery). Also, 12 people will be allocated to the intervention group and 12 people to the control group from two centers, and 13 people will be allocated to the intervention group and 13 people to the control group from the other two centers.
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 Qazvin University of Medical Sciences
Street address
No. 18, Elaheh Ave.14 , governorship Blvd., Buin Zahra Town
City
Buin Zahra
Province
Qazvin
Postal code
3451746338
Approval date
2023-03-18, 1401/12/27
Ethics committee reference number
IR.QUMS.REC.1401.367

Health conditions studied

1

Description of health condition studied
Status of fruit and vegetable consumption in diabetic patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Amount of fruit and vegetable consumption
Timepoint
Before the educational intervention and one month after the educational intervention
Method of measurement
According to the self-reported questionnaire by the diabetic patients participating in the study

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, after completing the questionnaire and according to the results of the analysis of the path and weight of each structure and according to the standard time of a training session which is 30 to 45 minutes and will be implemented based on the training goals. In these sessions, the food pyramid and Food groups including fruits and vegetables, the benefits of consuming fruits and vegetables, alternative behaviors will be presented through group discussion, existing obstacles will be removed by the method of brainstorming and verbal encouragement of patients, the positive experiences of patients following a diet containing fruits and vegetables It will be discussed in a group, strategies for increasing access to fruits and vegetables, preparing a meal containing fruits and vegetables, and preparing a snack such as a fruit and vegetable salad will be taught. Also, a video on how to clean and disinfect fruits and vegetables will be taught. It will be distributed to patients.
Category
Behavior

2

Description
Control group: For the control group, no special program or intervention will be considered, but in order to comply with the ethics of the research, after the final evaluation (FOLLOW UP), a group training session will be considered for all patients of the control group, and also, the training package developed in The choice of all patients and the control group will be included.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
ComprehensiveRural Urban Service Centers of Buin Zahra City
Full name of responsible person
Yahya Ghasemkhani
Street address
No. 18, Elaheh Ave.14 , governorship Blvd., Buin Zahra Town
City
Buin Zahra
Province
Qazvin
Postal code
3451746338
Phone
+98 28 3422 4170
Fax
+98 28 3422 8406
Email
y.ghasemkhani@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mir Hashemi
Street address
Deputy of Research and Technology Qazvin University of Medical Sciences p. 18، Modt Sub، Shahid Beheshti Blvd، Qazvin city
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Fax
+98 28 3335 0056
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Yahya Ghasemkhani
Position
High school
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 18, Elaheh Ave.14 , governorship Blvd., Buin Zahra Town
City
Buien zahra
Province
Qazvin
Postal code
3451746338
Phone
+98 28 3422 4170
Fax
Email
y.ghasemkhani@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Yahya Ghasemkhani
Position
High school.
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 18, Elaheh Ave.14 , governorship Blvd., Buin Zahra Town
City
Buien zahra
Province
Qazvin
Postal code
3451746338
Phone
+98 28 3422 4170
Fax
Email
y.ghasemkhani@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Yahya Ghasemkhani
Position
High school
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 18, Elaheh Ave.14 , governorship Blvd., Buin Zahra Town
City
Buien zahra
Province
Qazvin
Postal code
3451746338
Phone
+98 28 3422 4170
Fax
Email
y.ghasemkhani@qums.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
All information about the main outcome can be shared.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
All researchers working in academic and industrial institutions can receive it.
Under which criteria data/document could be used
In case of confidentiality, patient information and study results should be used to improve patients' quality of life.
From where data/document is obtainable
Email address:y.ghasemkhani60@gmail.com Phone number:02834224170 Yahya Ghasemkhani
What processes are involved for a request to access data/document
1- Submitting an application on behalf of the applicant. 2- I received the request. 3- Sending documents to the applicant. About 2 weeks.
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