Effect of Health-Promoting Lifestyle and Positive Mindfulness Training on Reducing Self-Neglect in Older Adults with Type 2 Diabetes: A Randomized Controlled Trial
Determining the effect of health-promoting lifestyle education and positive mindfulness on reducing self-neglect in older adults with type 2 diabetes
Design
This is a non-blinded randomized controlled trial with two parallel groups (intervention and control) including 60 older adults with type 2 diabetes mellitus. Participants will be allocated using permuted block randomization.
Settings and conduct
Older adults attending the health centers of Mobarakeh County who meet the eligibility criteria will be enrolled in the study and randomly assigned to either the intervention or control group. This study will be conducted without blinding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Older adults aged 60 years and above with a confirmed diagnosis of type 2 diabetes who are able to perform daily activities and understand the educational intervention.
Exclusion Criteria:
Acute or unstable medical conditions, acute psychiatric disorders, or any condition that would make participation unsafe or not feasible.
Intervention groups
Intervention Group:
A group-based education program will be delivered to older adults with type 2 diabetes, focusing on health-promoting lifestyle and positive mindfulness. It will include 8 weekly sessions (45–60 minutes) covering diabetes self-care, healthy behaviors, and mindfulness practices, supported by educational materials. Participants will perform daily home exercises (15–30 minutes) with weekly phone or text follow-ups.
Control Group:
The control group will receive routine care only without any educational intervention.
Main outcome variables
Self-Neglect, Health-Promoting Lifestyle, Self-Compassion, Fasting Blood Glucose (FBG), Glycated Hemoglobin (HbA1c), Systolic Blood Pressure, Diastolic Blood Pressure, and Body Mass Index (BMI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260213068844N1
Registration date:2026-06-25, 1405/04/04
Registration timing:prospective
Last update:2026-06-25, 1405/04/04
Update count:0
Registration date
2026-06-25, 1405/04/04
Registrant information
Name
Akram Esrafili Bishe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5246 0422
Email address
a.esrafili77@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-06, 1405/04/15
Expected recruitment end date
2026-11-06, 1405/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Health-Promoting Lifestyle and Positive Mindfulness Training on Reducing Self-Neglect in Older Adults with Type 2 Diabetes: A Randomized Controlled Trial
Public title
Effect of Lifestyle Education and Mindfulness on Self-Neglect
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
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
Ethics committee of Semnan University of Medical Sciences
Street address
Research and Technology Deputy, Central Headquarters Building, Semnan University of Medical Sciences, Basij Service Road, Basij Blvd., Modiran Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2026-02-16, 1404/11/27
Ethics committee reference number
IR.SEMUMS.REC.1404.322
Health conditions studied
1
Description of health condition studied
Diabetes mellitus due to underlying condition
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Self-neglect
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
Elder Self‑Neglect Scale
Secondary outcomes
1
Description
Health-Promoting Lifestyle
Timepoint
Before, immediately after, 3 months after the educational intervention
Before, immediately after, 3 months after the educational intervention
Method of measurement
Self-Compassion Scale Short Form (SCS-SF)
3
Description
Fasting Blood Suger
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
CareSens Glucometer
4
Description
Glycated Hemoglobin (HbA1c)
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
Infopia HbA1c Analyzer
5
Description
Systolic blood pressure
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
OMRON Blood Pressure Monitor
6
Description
Body Mass Index (BMI)
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
SECA Calibrated Scale and Stadiometer
7
Description
Diastolic blood pressure
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
OMRON Blood Pressure Monitor
Intervention groups
1
Description
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.
Category
Lifestyle
2
Description
Control Group: No educational intervention will be performed for the control group, and they will only receive routine health care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobarakeh County Health and Treatment Network
Full name of responsible person
Dr. Ali Parsa
Street address
Central Headquarters Building, Mobarakeh County Health and Treatment Network, Adjacent to Hazrat Mohammad Rasool Allah Hospital, Parastar Blvd., Safaieh, Mobarakeh, Isfahan, Iran
City
Mobarakeh
Province
Isfehan
Postal code
8494143111
Phone
+98 31 5267 4001
Fax
Email
health@mui.ac.ir
Web page address
https://mobarakeh.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Eslami
Street address
Research and Technology Deputy, Central Headquarters Building, Semnan University of Medical Sciences, Basij Service Road, Basij Blvd., Modiran Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
rds@semums.ac.ir
Web page address
https://rtvc.semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Akram Esrafili Bisheh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Geriatric Health Department, School of Rehabilitation Sciences, Semnan University of Medical Sciences Campus, Kilometer 5 of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
+98 23 3365 4209
Email
A.esrafili77@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Tahereh Ramezani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Geriatric Health Department, School of Rehabilitation Sciences, Semnan University of Medical Sciences Campus, Kilometer 5 of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
+98 23 3365 4209
Email
t_ramezani533@yahoo.com
Web page address
https://rehab.semums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Akram Esrafili Bisheh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Geriatric Health Department, School of Rehabilitation Sciences, Semnan University of Medical Sciences Campus, Kilometer 5 of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
A.esrafili77@gmail.com
Web page address
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
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available