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
Determining the effect of a 5A‑based self‑management program on improving lifestyle and self‑efficacy in older adults with metabolic syndrome
Design
This is a non-blinded randomized controlled trial with two parallel groups (intervention and control) including 60 older adults with metabolic syndrome. Participants will be allocated using permuted block randomization.
Settings and conduct
Older adults attending the health centers of Meyami 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: Age 60 years or older; diagnosis of metabolic syndrome according to the IDF criteria; ability and willingness to participate in educational sessions; provision of informed consent; and a score of 7 or higher on the Abbreviated Mental Test (AMT). Exclusion criteria: Presence of an acute or unstable medical condition, acute psychiatric disorders, or any condition that would make participation unsafe or impossible.
Intervention groups
Intervention group: Following the needs assessment, participants will attend eight weekly 60-minute sessions based on the 5A model. They will perform daily home-based activities (15–30 minutes) and receive weekly telephone or text-message follow-up. Self-efficacy will be enhanced using Bandura-based strategies, and adherence will be monitored through attendance, home activity completion, and follow-up responses. Control group: Participants will receive routine care only, with no educational intervention.
Main outcome variables
Health-Promoting Lifestyle, Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260413069068N1
Registration date:2026-06-18, 1405/03/28
Registration timing:prospective
Last update:2026-06-18, 1405/03/28
Update count:0
Registration date
2026-06-18, 1405/03/28
Registrant information
Name
Elahe Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 375 1957
Email address
elahebah@irct.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-06, 1405/05/15
Expected recruitment end date
2026-12-06, 1405/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of a self-management program on improving lifestyle and self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
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 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.
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
2026-05-21, 1405/02/31
Ethics committee reference number
IR.SEMUMS.REC.1405.021
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary 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-Efficacy Questionnaire SRAHPS
Secondary outcomes
1
Description
Waist Circumference
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
Non-stretchable Cloth Measuring Tape (cm)
2
Description
Fasting Blood Sugar (FBS)
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
Blood Test (Glucose Oxidase Enzymatic Method)
3
Description
Triglycerides (TG)
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
Blood Test
4
Description
High-Density Lipoprotein (HDL)
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
Blood Test
5
Description
Systolic blood pressure
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
OMRON Blood Pressure Monitor
6
Description
Diastolic blood pressure
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
OMRON Blood Pressure Monitor
7
Description
Body Mass Index (BMI)
Timepoint
Before, immediately after, 3 months after the educational intervention
Method of measurement
ECA Calibrated Scale and Stadiometer
Intervention groups
1
Description
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.
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
Meyami County Health and Treatment Network
Full name of responsible person
Dr. Alireza Mesri Pour Alavijeh
Street address
Health and Treatment Network, Basij Square, Miami
City
Meyami
Province
Semnan
Postal code
3631969111
Phone
+98 23 3262 4601
Fax
+98 23 3262 4604
Email
info@shmu.ac.ir
Web page address
https://shmu.ac.ir/mayamey/fa
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
سمنان
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
Elahe Bahrami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Health and Treatment Network, Basij Square, Meyami
City
Meyami
Province
Semnan
Postal code
3613969111
Phone
0098 32624601
Email
elahebah@gmail.com
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
Elahe Bahrami
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Health and Treatment Network, Basij Square, Meyami
City
Meyami
Province
Semnan
Postal code
3631969111
Phone
+98 23 3262 4601
Email
elahebah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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