Protocol summary

Study aim
Determining the Effect of Educational Intervention Based on Health Belief Model in improving metabolic indices of type2 diabetic patients
Design
In this study, patients Will be selected randomly from one or two villages (as needed) and the patients of the one or two other villages as a control group are selected. then, 50 patients with type 2 diabetes are included in the study.
Settings and conduct
the programmed educational intervention will be conducted a session in a week, during 6 sessions (60 minutes), the program is according to the Health Belief Model. this study will be done at Shamshir Comprehensive Rural Health Service Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: at least one year have passed from a definitive diagnosis of type 2 diabetes, being in the age group of 30 to 65 years old, the HbA1c test is equal or higher than 7% and no perceptual problem. exclusion criteria include: patients who do not attend more than one session in the educational intervention, patients who do not perform the required tests completely and Patients who are not willing to cooperate in the study anyway.
Intervention groups
Intervention group: educational intervention will be conducted a session weekly, during 6 sessions (60 minutes) with a designed program according to the Health Belief Model. this intervention will be implemented in three stages. the first stage consists of one session, the goal of this stage is to increase the susceptibility to diabetes complications. topics to be considered at this meeting including the acquaintance of patients with the nature of diabetes and its complications, the definition of diabetes control and the importance of monitoring blood glucose. the second stage consists of three sessions, the goal of this stage is to increase perceptions to pros and cons of the adhering to diet, drug orders and physical activity. the third stage consists of two sessions with the goal of facilitating and encouraging patients to perform their intended behavioral goals and enhancing their self-efficacy by inviting a successful diabetic patient and an active family member. control group: The control group receives only routine training during this time.
Main outcome variables
1. Age 2. Sex 3. Education level 4. Employment status 5. marital status 6. A history of diabetes 7. Number of family members 8. Educational intervention 9. Perceived Susceptibility 10. Perceived Severity 11. Perceived Benefits 12. Perceived Barriers 13. Cues to action 14. Self-efficacy 15. body mass index (BMI) 16. Fasting blood sugar (FBS) 17. glycated haemoglobin (HbA1c) 18. Cholesterol 19. Triglyceride (TG) 20. High-density lipoprotein (HDL) 21. Low-density lipoprotein (LDL)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170619034641N2
Registration date: 2017-12-28, 1396/10/07
Registration timing: registered_while_recruiting

Last update: 2017-12-28, 1396/10/07
Update count: 0
Registration date
2017-12-28, 1396/10/07
Registrant information
Name
Alireza Abdi
Name of organization / entity
nursing and midwifery school, Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3725 0111
Email address
arabdi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Effect of Educational Intervention Based on Health Belief Model in improving metabolic indices of type2 diabetic patients
Public title
Assessing the Effect of Educational Intervention in metabolic indices of diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include: at least one year have passed from a definitive diagnosis of type 2 diabetes, being in the age group of 30 to 65 years old, their HbA1c test is equal or higher than 7% and no perceptual problem.
Exclusion criteria:
Exclusion criteria include: patients who do not attend more than one session in the educational intervention, patients who do not perform the required tests completely and Patients who are not willing to cooperate in the study anyway.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients Will be selected randomly from one or two villages (as needed) and the patients of the one or two other villages are considered as the control group randomly.
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshty BLV., Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR.KUMS.RES.1396.387

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Glycated haemoglobin (HbA1c)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
A1C care device

2

Description
Fasting blood sugar (FBS)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
AutoAnalyzer

3

Description
Triglyceride (TG)
Timepoint
AutoAnalyzer
Method of measurement
AutoAnalyzer

4

Description
Cholesterol
Timepoint
Before the intervention and three months after the intervention
Method of measurement
AutoAnalyzer

5

Description
High-density lipoprotein (HDL)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
AutoAnalyzer

6

Description
Low-density lipoprotein (LDL)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
AutoAnalyzer

7

Description
Perceived Susceptibility
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health belief model researcher-made questionnaire

8

Description
Perceived Severity
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health belief model researcher-made questionnaire

9

Description
Perceived Barriers
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health belief model researcher-made questionnaire

10

Description
Perceived Benefits
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health belief model researcher-made questionnaire

11

Description
Cues to action
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health belief model researcher-made questionnaire

12

Description
Self-efficacy
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health belief model researcher-made questionnaire

13

Description
body mass index (BMI)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
DETECTO-MEDIC Height and Weight Measurement Device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: educational intervention will be conducted weekly during 6 sessions (60 minutes) with a designed program according to the Health Belief Model. this intervention will be implemented in three stages. the first stage consists of one session, the goal of this stage is to increase the susceptibility to diabetes complications. topics to be considered at this meeting including the acquaintance of patients with the nature of diabetes and its complications, the definition of diabetes control and the importance of monitoring blood glucose. the second stage consists of three sessions, the goal of this stage is to increase perceptions of the benefits and obstacles, adhering to diet, drug orders and physical activity. the third stage consists of two sessions with the goal of facilitating and encouraging patients to perform their intended behavioral goals and enhancing their self-efficacy by inviting a successful diabetic patient and an active family member.
Category
Lifestyle

2

Description
Control group: The control group receives only routine training during this time.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shamshir Comprehensive Rural Health Service Center
Full name of responsible person
alireza abdi
Street address
Paveh Shamshir Rural
City
Paveh
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
arabdi@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمانشاه
Full name of responsible person
Behrooz Hamzeh
Street address
Vice Chancellor for Research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
arabdi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمانشاه
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
Kermanshah School of Nursing and Midwifery
Full name of responsible person
alireza abdi
Position
PhD in Nursing Education-Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
arabdi@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
alireza abdi
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
arabdi@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Abdi
Position
PhD in Nursing Education, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
arabdi@kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
if the desired journal or research deputy will request the data, the file will be in their disposal.
When the data will become available and for how long
after two years from data collection
To whom data/document is available
research deputy of KUMS, and editor in chief of the raised journal
Under which criteria data/document could be used
to publish the paper and offering the final report of the project
From where data/document is obtainable
contact to corresponding author
What processes are involved for a request to access data/document
request via email
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