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Examining the Effectiveness of the Teach-Back approach on activating self-management behaviors among prediabetic patients: A Randomized Control Trial Study

Protocol summary

Study aim
The aim is to determine the effectiveness of the educational feedback approach on activating self-management behavior and improving health-related indicators in clients with prediabetes and helping prevent its progression to type 2 diabetes.
Design
A randomized, controlled clinical trial with a parallel design and two intervention and control groups, pre-test-post-test, was conducted on 60 clients with prediabetes; randomization was performed using a block method with blocks of 6 (3 people in each group) and using a random number table, and sealed and numbered envelopes were used to conceal allocation.
Settings and conduct
This study is conducted in the field of prevention and self-management of prediabetes at Razi Subspecialty Clinic. As a randomized, controlled clinical trial, eligible individuals are randomly assigned to two intervention and control groups, and the effectiveness of the educational feedback approach on activating their self-management behavior is evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 18–65 with prediabetes (fasting blood sugar 100–125), literate, with a smartphone, regular visits, and willingness to participate. Exclusion criteria: Diabetes, lack of cooperation or responsiveness, absence from two consecutive sessions, failure to respond to two consecutive text messages, withdrawal, and incomplete completion of the questionnaire.
Intervention groups
In the intervention group, the educational feedback approach is presented in the form of short, interactive sessions to teach and reinforce self-management and lifestyle modification, while the control group receives usual care.
Main outcome variables
Self-management score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260825070797N1
Registration date: 2026-09-11, 1405/06/20
Registration timing: prospective

Last update: 2026-09-11, 1405/06/20
Update count: 0
Registration date
2026-09-11, 1405/06/20
Registrant information
Name
Marzieh Shayestehfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3255 5056
Email address
m.shayestefard@gums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the Effectiveness of the Teach-Back approach on activating self-management behaviors among prediabetic patients: A Randomized Control Trial Study
Public title
Examining the Effectiveness of the Teach-Back approach on activating self-management behaviors among prediabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Presence of unstable cardiovascular disorders Presence of musculoskeletal disorders Lack of literacy Not having a smartphone
Age
From 18 years old to 65 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
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.
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
Research Ethics Committees if Guilan university of medical sciences
Street address
Shahid Beheshti Highway, Daneshjoo Street, Shahid Beheshti School of Nursing and Midwifery, Rasht
City
Rasht
Province
Guilan
Postal code
41469-39814
Approval date
2026-08-19, 1405/05/28
Ethics committee reference number
IR.GUMS.REC.1405.237

Health conditions studied

1

Description of health condition studied
The study is educational and has no application.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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

Intervention groups

1

Description
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.
Category
Lifestyle

2

Description
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.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Rasht Specialized and Subspecialized Polyclinic
Full name of responsible person
Kamran Pouryousef
Street address
Shahid Beheshti Boulevard - Bilalzadeh Street
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 3354 1001
Email
m.shayestefard@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Alavi
Street address
Nurse Street - Head Office Building of Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3332 6061
Email
riasat@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr. Marzieh Shayestefard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Highway, Daneshjoo Street, Shahid Beheshti School of Nursing and Midwifery, Rasht
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 3255 3202
Email
m.shayestefard@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Marzieh Shayestefard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Highway, Daneshjoo Street, Shahid Beheshti School of Nursing and Midwifery, Rasht
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 3255 3202
Email
m.shayestefard@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Marzieh Shayestefard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Highway, Daneshjoo Street, Shahid Beheshti School of Nursing and Midwifery, Rasht
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 3255 3202
Email
m.shayestefard@gums.ac.ir

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
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