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IRCT20260825070797N1 IRCT 2026-09-11 Rasht University of Medical Sciences Examining the Effectiveness of the Teach-Back approach on activating self-management behaviors among prediabetic patients Examining the Effectiveness of the Teach-Back approach on activating self-management behaviors among prediabetic patients: A Randomized Control Trial Study 2026-09-23 anticipated 60 Recruiting https://irct.ir/trial/92972 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is a block randomization with blocks of 6; in each block, 3 people are assigned to the control group (A) and 3 people to the intervention group (B), then all possible sequences A and B are prepared and the required number (10 blocks) is selected using a random number table and combined sequentially to create a final sequence of 60 people. The randomization unit is a client with prediabetes. The randomization tool is a random number table and the allocation sequence is prepared by the executive researcher before the patients start arriving. Allocation concealment is done using sealed and numbered envelopes 1 to 60 and each envelope is opened for each person in their presence after meeting the conditions and obtaining informed consent, respectively, to determine the group code; the purpose of this is to prevent bias in allocation. N/A The study is educational and has no application.. Intervention 1: Intervention group: Intervention group: The intervention group included four 20-minute in-person sessions (weeks 1, 4, 8, and 12) of lifestyle modification education with Teach-Back approach, along with sending 24 educational-motivational SMS messages and 8 short animations between sessions, for patients with prediabetes. Intervention 2: Control group: Control group: The control group consists of clients with prediabetes who receive routine medical care (including periodic visits every three months by the treating physician and receiving standard treatment and care recommendations) and will not receive any educational intervention with Teach-Back approach, text messages, or animations. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made on this matter yet.
public Dr. Marzieh Shayestefard
Shahid Beheshti Highway, Daneshjoo Street, Shahid Beheshti School of Nursing and Midwifery, Rasht
Rasht Iran (Islamic Republic of) 41469-39814 +98 13 3255 3202 m.shayestefard@gums.ac.ir Rasht University of Medical Sciences scientific Dr. Marzieh Shayestefard
Shahid Beheshti Highway, Daneshjoo Street, Shahid Beheshti School of Nursing and Midwifery, Rasht
Rasht Iran (Islamic Republic of) 41469-39814 +98 13 3255 3202 m.shayestefard@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) People between the ages of 18 and 65 with prediabetes whose fasting blood sugar level is between 100 and 125. Periodic visits to a specialist every 3 months Literacy Possession of a smartphone and the ability to use it Desire to change and improve Participate in teach-back sessions 18 years 65 years Both Presence of unstable cardiovascular disorders Presence of musculoskeletal disorders Lack of literacy Not having a smartphone Lifestyle Other Intervention group: Intervention group: The intervention group included four 20-minute in-person sessions (weeks 1, 4, 8, and 12) of lifestyle modification education with Teach-Back approach, along with sending 24 educational-motivational SMS messages and 8 short animations between sessions, for patients with prediabetes. Control group: Control group: The control group consists of clients with prediabetes who receive routine medical care (including periodic visits every three months by the treating physician and receiving standard treatment and care recommendations) and will not receive any educational intervention with Teach-Back approach, text messages, or animations. The primary outcome variable is the level of self-management behavior activation in clients with prediabetes, which is assessed using the Patient Activation Questionnaire (PAM) before and three months after the intervention. Timepoint: Measurement of research variables is carried out at two points: at the beginning of the study (before the intervention) and three months after the start of the intervention. Method of measurement: Patient Activation Measure-13. Changes in fasting blood sugar. Timepoint: At the beginning of the study (before the intervention) and at the end of the twelfth week (after the intervention). Method of measurement: Based on laboratory results and information in the patient's file. Weight changes. Timepoint: At the beginning of the study (before the intervention) and at the end of the twelfth week (after the intervention). Method of measurement: Based on case information and direct weight measurement. Body mass index changes. Timepoint: At the beginning of the study (before the intervention) and at the end of the twelfth week (after the intervention). Method of measurement: Based on file information and direct measurement of the patient's weight and height. Rasht University of Medical Sciences Approved 2026-08-19 Research Ethics Committees if Guilan university of medical sciences Shahid Beheshti Highway, Daneshjoo Street, Shahid Beheshti School of Nursing and Midwifery, Rasht Rasht Guilan Iran (Islamic Republic of)