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Investigating the effect of blended learning based on the Theory of Planned Behavior on adopting health-promoting lifestyle and self-efficacy in patients with type 2 diabetes

Protocol summary

Study aim
Determining the effect of blended learning on a health-promoting lifestyle and self-efficacy in patients with type 2 diabetes
Design
Clinical trial with control group on 80 patients
Settings and conduct
Patients with type 2 diabetes who are referred to the diabetes clinic in Hamadan will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using a randomized block design. The study is unblinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of type 2 diabetes by an internal medicine specialist, at least 6 months since the onset of the disease, age between 18 and 70 years, access to a smartphone by the patient or their caregiver, literacy. Exclusion criteria: Presence of a specific underlying disease that makes participation in the study impossible.
Intervention groups
Intervention group: In the intervention group, in addition to receiving routine services, a three-component educational intervention (face-to-face, virtual, and reminder) is also provided. Face-to-face education is provided for four weeks (one 45-60 minute session each week) using lectures. Face-to-face education includes familiarization with diabetes, complications, the importance of self-care, physical activity, and adherence to health guidelines. Virtual education is provided using the "Diabetes Assistant" application, which has sections for individual profiles, educational content, reminders for medication use, and complications of the disease, and is available to patients for 6 weeks. Reminders are also provided by sending health messages via daily text messages. Control group: The control group uses routine education.
Main outcome variables
health-promoting lifestyle؛ self efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180421039371N1
Registration date: 2025-04-28, 1404/02/08
Registration timing: prospective

Last update: 2025-04-28, 1404/02/08
Update count: 0
Registration date
2025-04-28, 1404/02/08
Registrant information
Name
Sahar khoshravesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0360
Email address
s.khoshravesh@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-10, 1404/02/20
Expected recruitment end date
2025-10-12, 1404/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of blended learning based on the Theory of Planned Behavior on adopting health-promoting lifestyle and self-efficacy in patients with type 2 diabetes
Public title
Investigating the effect of blended learning on adopting health-promoting lifestyle and self-efficacy in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of type 2 diabetes by an internal medicine specialist At least 6 months have passed since the onset of the disease Absence of specific complications of diabetes Age between 18 and 70 years Absence of pregnancy and acute heart disease Access to a smartphone by the patient or their caregiver Being literate
Exclusion criteria:
The presence of a specific underlying condition that makes participation in the study impossible.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
First, convenience sampling will be performed among patients with type 2 diabetes who meet the study inclusion criteria. Then, participants will be randomly assigned to blocks of four using the random block method. For this purpose, 20 blocks of four will be prepared. Each block will be placed in an envelope and the envelopes will be opened randomly by an independent person from the research team.
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
Research Ethics Committees of Hamadan University of Medical Scieneces
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2025-04-13, 1404/01/24
Ethics committee reference number
IR.UMSHA.REC.1404.029

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11.00
ICD-10 code description
Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)

Primary outcomes

1

Description
Adopting health-promoting lifestyle
Timepoint
Before and three months after the intervention
Method of measurement
Walker Health Promoting Lifestyle Questionnaire: This questionnaire was psychometrically validated in Iran by Zaidi et al. The questionnaire consists of 49 questions that measure 6 dimensions of self-actualization, responsibility, interpersonal relationships, stress management, physical activity, and nutritional behaviors using a four-point Likert scale (never, sometimes, often, and usually).

2

Description
Self-efficacy
Timepoint
Before and three months after the intervention
Method of measurement
Diabetic Self-Efficacy Questionnaire (DSES): This questionnaire was designed by the Stanford University Research Center in the United States to measure the self-efficacy of people with diabetes. It has 8 questions with a score range from 1 to 10 on a Likert scale, and the answers are categorized as 1 (not at all sure) to 10 (completely sure). The questionnaire was psychometrically validated by Bastani et al. in Iran.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, in addition to receiving routine services, an educational intervention with three components (face-to-face, virtual, and reminder) is also provided. Face-to-face training is provided for four weeks (one 45-60 minute session each week) using lectures and showing educational clips. During these four sessions, educational content is presented as follows: Session 1: Introduction to the goals and framework of the training course, definition of diabetes, Session 2: Importance of self-care behaviors in improving lifestyle, Session 3: Recommendations for physical activity, Session 4: Emphasis on adhering to health guidelines. Virtual training is provided using the "Diabetes Assistant" application. This application is designed by an experienced team and has sections for individual profiles, educational content, reminders for medication use, complications of the disease, conversation, and support, which are available to patients for 6 weeks. Reminders are also provided by sending health messages via SMS daily for one month simultaneously with face-to-face training.
Category
Lifestyle

2

Description
Control group:The control group will receive routine education. This means that they will visit the clinic if needed and receive routine health and medical services for type 2 diabetes patients. In order to comply with ethical principles, all educational content will be made available to the control group at the end of the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Research Center in Hamedan city
Full name of responsible person
Leila Jamali Fashi
Street address
Mahdieh No. 4, Khedrian Ave., Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3264 6702
Email
leilajamali6464@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Fourth floor, Headquarters, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 4042
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Leila Jamali Fashi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Community Health Nursing Department, Faculty of Nursing and Midwifery, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
38380150 081 0098
Email
leilajamali6464@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Khoshravesh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Community Health Nursing Department, Faculty of Nursing and Midwifery, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
38380150 081 0098
Email
khoshraveshsahar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Leila Jamali Fashi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Community Health Nursing Department, Faculty of Nursing and Midwifery, Shahid Fahmideh Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
38380150 081 0098
Email
leilajamali6464@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Requires approval from the research team.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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