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IRCT20260213068844N1 IRCT 2026-06-25 Semnan University of Medical Sciences Effect of Lifestyle Education and Mindfulness on Self-Neglect Effect of Health-Promoting Lifestyle and Positive Mindfulness Training on Reducing Self-Neglect in Older Adults with Type 2 Diabetes: A Randomized Controlled Trial 2026-07-06 anticipated 60 Recruiting https://irct.ir/trial/89607 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be randomly assigned to either the intervention group (A) or the comparison group (B) using the permuted block randomization method. The randomization procedure will be conducted using six predefined four-person blocks, including AABB, BBAA, ABBA, BAAB, ABAB, and BABA. A random number table will be used to select the corresponding block arrangements for numbers 1 to 6, while numbers 0 and 7–9 will be disregarded. Participants will subsequently be assigned sequentially to groups A and B according to the order of the selected block sequences. N/A Diabetes mellitus due to underlying condition. Intervention 1: Intervention Group: The intervention will be delivered as a group-based healthy lifestyle and positive mindfulness training program for older adults with type 2 diabetes. The educational content will be developed based on needs assessment findings, diabetes self-care principles, healthy lifestyle recommendations, and mindfulness and positive psychology approaches. Participants will attend eight weekly sessions lasting 45–60 minutes each. Session contents include: (1) introduction to the program, goal setting, and education on diabetes and self-care; (2) healthy nutrition and basic mindfulness training; (3) physical activity and self-compassion; (4) sleep hygiene, positive emotions, and gratitude practice; (5) social skills and autonomy; (6) stress management, acceptance, and mindful breathing; (7) values, positive relationships, and meaning in later life; and (8) review and consolidation of learned skills and development of a home follow-up plan. Sessions will be conducted using lectures, group discussions, question-and-answer activities, and practical exercises. Educational materials include booklets, pamphlets, guided meditation audio/video files, and home practice logs. Participants will be asked to perform mindfulness and healthy lifestyle-related home exercises for 15–30 minutes daily. Weekly follow-up will be conducted through telephone calls or text messages. Adherence to the intervention will be assessed based on session attendance, completion of home exercises, and responsiveness to follow-up contacts. Adherence rates above 75% will be considered satisfactory. Intervention 2: Control Group: No educational intervention will be performed for the control group, and they will only receive routine health care. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Akram Esrafili Bisheh
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 A.esrafili77@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) Being +60 years old At least elementary literacy or presence of a literate caregiver to complete questionnaires and follow up on exercises Definite medical diagnosis of type 2 diabetes based on medical records Having moderate to severe self-neglect based on a standardized questionnaire or primary caregiver report Score 7 or higher on the Abbreviated Mental Test (AMT) Ability to perform basic activities of daily living Ability to understand and implement educational intervention instructions 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 E08 Diabetes mellitus due to underlying condition Lifestyle N/A Intervention Group: The intervention will be delivered as a group-based healthy lifestyle and positive mindfulness training program for older adults with type 2 diabetes. The educational content will be developed based on needs assessment findings, diabetes self-care principles, healthy lifestyle recommendations, and mindfulness and positive psychology approaches. Participants will attend eight weekly sessions lasting 45–60 minutes each. Session contents include: (1) introduction to the program, goal setting, and education on diabetes and self-care; (2) healthy nutrition and basic mindfulness training; (3) physical activity and self-compassion; (4) sleep hygiene, positive emotions, and gratitude practice; (5) social skills and autonomy; (6) stress management, acceptance, and mindful breathing; (7) values, positive relationships, and meaning in later life; and (8) review and consolidation of learned skills and development of a home follow-up plan. Sessions will be conducted using lectures, group discussions, question-and-answer activities, and practical exercises. Educational materials include booklets, pamphlets, guided meditation audio/video files, and home practice logs. Participants will be asked to perform mindfulness and healthy lifestyle-related home exercises for 15–30 minutes daily. Weekly follow-up will be conducted through telephone calls or text messages. Adherence to the intervention will be assessed based on session attendance, completion of home exercises, and responsiveness to follow-up contacts. Adherence rates above 75% will be considered satisfactory. Control Group: No educational intervention will be performed for the control group, and they will only receive routine health care. Self-neglect. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Elder Self‑Neglect Scale. 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-Compassion. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Self-Compassion Scale Short Form (SCS-SF). Fasting Blood Suger. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: CareSens Glucometer. Glycated Hemoglobin (HbA1c). Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: Infopia HbA1c Analyzer. Systolic 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: SECA Calibrated Scale and Stadiometer. Diastolic blood pressure. Timepoint: Before, immediately after, 3 months after the educational intervention. Method of measurement: OMRON Blood Pressure Monitor. Semnan University of Medical Sciences Approved 2026-02-16 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)