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IRCT20180421039371N1 IRCT 2025-04-28 Hamedan University of Medical Sciences Investigating the effect of blended learning on adopting health-promoting lifestyle and self-efficacy in patients with type 2 diabetes 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 2025-05-10 anticipated 80 Complete https://irct.ir/trial/82865 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Diabetes Mellitus. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Requires approval from the research team.
public Leila Jamali Fashi
Community Health Nursing Department, Faculty of Nursing and Midwifery, Shahid Fahmideh Blvd., Hamedan
Hamedan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ 38380150 081 0098 leilajamali6464@gmail.com Hamedan University of Medical Sciences scientific Sahar Khoshravesh
Community Health Nursing Department, Faculty of Nursing and Midwifery, Shahid Fahmideh Blvd., Hamedan
Hamedan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ 38380150 081 0098 khoshraveshsahar@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both The presence of a specific underlying condition that makes participation in the study impossible. E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) Lifestyle N/A 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. 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. 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). 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. Hamedan University of Medical Sciences Approved 2025-04-13 Research Ethics Committees of Hamadan University of Medical Scieneces Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Hamedan Hamadan Hamadan Iran (Islamic Republic of)