]>
IRCT20260413069068N1 IRCT 2026-06-18 Semnan University of Medical Sciences Effect of a self-management program on improving lifestyle and self-efficacy Effect of a self-management program based on the 5A model on improving lifestyle and self-efficacy in older adults with metabolic syndrome: a randomized controlled trial 2026-08-06 anticipated 60 Recruiting https://irct.ir/trial/89785 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be allocated to the intervention (A) and comparison (B) groups using the permuted block randomization method. In this approach, six possible arrangements of blocks with a block size of four (AABB, BBAA, ABBA, BAAB, ABAB, and BABA) will be generated and predefined. Using a random number table, numbers 1 to 6 will correspond to one of the six block arrangements, whereas 0 and 7 to 9 will be discarded. Participants will then be sequentially assigned to groups A and B according to the order of the selected blocks. N/A Metabolic syndrome. Intervention 1: Based on the pretest results and needs assessment, educational content and materials (booklets, pamphlets, and educational files) will be developed. The intervention group will participate in eight weekly 60-minute sessions based on the 5A self-management model. Educational sessions will be delivered through lectures, group discussions, question-and-answer activities, practical exercises, and written materials. To accommodate participants with limited literacy, the content will be presented in simple language, primarily through verbal and practical methods. For illiterate participants, questionnaires will be completed through interviewer administration. Each session will incorporate the five components of the 5A model (Assess, Advise, Agree, Assist, and Arrange). Participants will be asked to perform daily home-based exercises (15–30 minutes), and weekly telephone or text-message follow-ups will be conducted to monitor adherence, provide feedback, and address potential barriers. Self-efficacy will be enhanced using Bandura’s strategies, including mastery experiences, vicarious learning, and verbal persuasion. The control group will receive routine care only. Intervention adherence will be assessed based on session attendance, completion of home exercises, and responsiveness to follow-up contacts, with adherence above 75% considered satisfactory. All screening, data collection, physical measurements, and follow-up procedures will be thoroughly documented. Intervention 2: Control Group: No educational intervention will be performed for the control group, and they will only receive routine health care. 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 There is no further information.
public Elahe Bahrami
Health and Treatment Network, Basij Square, Meyami
Meyami Iran (Islamic Republic of) 3613969111 0098 32624601 elahebah@gmail.com Semnan University of Medical Sciences scientific Dr. Tahereh Ramezani
Geriatric Health Department, School of Rehabilitation Sciences, Semnan University of Medical Sciences Campus, Kilometer 5 of Damghan Road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 t_ramezani533@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Metabolic syndrome according to IDF criteria Age 60 and above Having the ability and willingness to participate in training sessions Obtaining a score of 7 or higher on the short cognitive status test Informed consent to participate in research 60 years 90 years Both Presence of an acute illness or clinical instability at the time of enrollment Presence of an acute psychiatric disorder Severe hearing or visual impairment that prevents participation in educational sessions Any medical condition that makes participation in the study inappropriate or unsafe E88.81 Metabolic syndrome Lifestyle N/A Based on the pretest results and needs assessment, educational content and materials (booklets, pamphlets, and educational files) will be developed. The intervention group will participate in eight weekly 60-minute sessions based on the 5A self-management model. Educational sessions will be delivered through lectures, group discussions, question-and-answer activities, practical exercises, and written materials. To accommodate participants with limited literacy, the content will be presented in simple language, primarily through verbal and practical methods. For illiterate participants, questionnaires will be completed through interviewer administration. Each session will incorporate the five components of the 5A model (Assess, Advise, Agree, Assist, and Arrange). Participants will be asked to perform daily home-based exercises (15–30 minutes), and weekly telephone or text-message follow-ups will be conducted to monitor adherence, provide feedback, and address potential barriers. Self-efficacy will be enhanced using Bandura’s strategies, including mastery experiences, vicarious learning, and verbal persuasion. The control group will receive routine care only. Intervention adherence will be assessed based on session attendance, completion of home exercises, and responsiveness to follow-up contacts, with adherence above 75% considered satisfactory. All screening, data collection, physical measurements, and follow-up procedures will be thoroughly documented. Control Group: No educational intervention will be performed for the control group, and they will only receive routine health care. Health-Promoting Lifestyle. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Walker’s Health-Promoting Lifestyle Profile (HPLP-II). Self-Efficacy. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Self-Efficacy Questionnaire SRAHPS. Waist Circumference. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Non-stretchable Cloth Measuring Tape (cm). Fasting Blood Sugar (FBS). Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Blood Test (Glucose Oxidase Enzymatic Method). Triglycerides (TG). Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Blood Test. High-Density Lipoprotein (HDL). Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Blood Test. Systolic blood pressure. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: OMRON Blood Pressure Monitor. Diastolic blood pressure. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: OMRON Blood Pressure Monitor. Body Mass Index (BMI). Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: ECA Calibrated Scale and Stadiometer. Semnan University of Medical Sciences Approved 2026-05-21 Ethics committee of Semnan University of Medical Sciences Research and Technology Deputy, Central Headquarters Building, Semnan University of Medical Sciences, Basij Service Road, Basij Blvd., Modiran Town, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)