The aim of this study is to determine the effectiveness of a health coaching approach on lifestyle enhancement and the improvement of clinical indicators in clients with prediabetes.
Design
A parallel-group randomized clinical trial with intervention and control groups (sample size of 31 per group) is being conducted using block randomization and a random number table to assign treatment codes A and B.
Settings and conduct
This randomized trial is being conducted at the specialized clinic of Imam Khomeini Hospital in Sowme'eh Sara on pre-diabetic patients who, following informed consent, are assigned to either an intervention group or a control group using block randomization; although the participants and intervention providers are not blinded, the assessor and the statistical analyst remain blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 18–65 with prediabetes (fasting blood glucose 100–125 mg/dL), literacy, a smartphone, ability to attend regular visits, and willingness to participate. Exclusion criteria: Presence of cardiovascular or musculoskeletal disorders, illiteracy, and lack of a smartphone.
Intervention groups
This study aims to evaluate the effectiveness of health coaching in improving the lifestyle of pre-diabetic patients; the intervention group receives coaching sessions—both in-person and virtually—over a 12-week period, whereas the control group receives only routine care and physician-prescribed pharmacological treatments.
Main outcome variables
Total score of the integrated health and wellness assessment tool
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260825070797N2
Registration date:2026-09-22, 1405/06/31
Registration timing:prospective
Last update:2026-09-22, 1405/06/31
Update count:0
Registration date
2026-09-22, 1405/06/31
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
Not yet recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the Effectiveness of health coaching approach in promotion of lifestyle of pre diabetic patients: A Randomized Control Trial Study
Public title
Examining the Effectiveness of health coaching approach in promotion of lifestyle of pre diabetic patients: A Randomized Control Trial Study
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 18 to 65 with prediabetes who have a fasting blood sugar level between 100 and 125.
Periodic visits to a specialist every three months.
Reading and writing literacy
Possessing a smartphone and the ability to use it.
Willingness to change, improvement
Participating in health coaching 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:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is performed using a block design with blocks of six (three in the control group and three in the intervention group); the unit of randomization is the individual, and no stratification is specified. The allocation sequence is generated by preparing all possible sequences and randomly selecting ten of them using a random number table; to ensure allocation concealment, the codes are placed in sequentially numbered envelopes that are opened in order as each patient is enrolled.
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.1405.242
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 study's primary outcome variable is lifestyle improvement, measured by an integrated health and wellness score.
Timepoint
The primary outcome is measured at two time points: before the start of the intervention (pre-test) and at the end of week 12, immediately after the intervention concludes (post-test).
Method of measurement
Integrated Health and Wellness Questionnaire
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Before the intervention (pre-test) and at the end of week 12, after the completion of the intervention (post-test).
Method of measurement
Patient's file
2
Description
Weight
Timepoint
Before the intervention (pre-test) and at the end of week 12, after the completion of the intervention (post-test).
Method of measurement
Patient's file
3
Description
Body Mass Index
Timepoint
Before the intervention (pre-test) and at the end of week 12, after the completion of the intervention (post-test).
Method of measurement
Patient's file
Intervention groups
1
Description
Intervention group: In addition to standard care, the intervention group receives health coaching sessions based on the GROW model over a 12-week period, delivered both in-person and virtually (via video calls or educational and motivational text messages).
Category
Behavior
2
Description
Control group: During the study, the control group receives only routine care and pharmacological treatments prescribed by the attending physician.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sowme'eh Sara
Full name of responsible person
Dr. Hossein Ronaghi
Street address
Sowme'eh Sara – Khorramshahr Boulevard – Next to Abrisham Park
City
Sowme'eh Sara
Province
Guilan
Postal code
4361996186
Phone
+98 13 4432 3041
Email
imamh@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 Shayesteh Fard
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 Shayesteh Fard
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 Shayesteh-Fard
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