History
# Registration date Revision Id
2 2025-07-07, 1404/04/16 346713
1 2025-05-08, 1404/02/18 339130
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Comparing the Impact of Social Cognitive Theory-Based Educational Interventions Using Multimedia and AI Chatbot on Physical Activity in Overweight or Obese Male Secondary School Students in Bushehr City.
Design
A randomized, clinical trial with control group, parallel groups on 180 students. Excel software will be used for randomization.
Settings and conduct
This study will compare the effect of educational intervention using multimedia and AI chatbot on the physical activity behavior in overweight or obese male students in selected Secondary School in Bushehr City.
Participants/Inclusion and exclusion criteria
Study inclusion criteria: 1- Body mass index of 25 or higher 2- Willingness to participate in the study 3- Access to internet and electronic devices Study exclusion criteria: 4- Having physical activity disincentive issues 5- Failure to complete study questionnaires 6- Participation in professional sports classes
Intervention groups
Intervention group (1) : In this group, students will receive multimedia educational content based on social cognitive theory in 7 chapters. Intervention group (2) : In this group, the educational intervention will be implemented through a dedicated AI chatbot. Control group: This group will not receive any intervention.
Main outcome variables
Physical activity behavior; Body mass index; Perceived self-efficacy; Social support; Outcome expectations; Self-regulation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250417065366N1
Registration date: 2025-05-08, 1404/02/18
Registration timing: retrospective

Last update: 2025-05-08, 1404/02/18
Update count: 1
Registration date
2025-05-08, 1404/02/18
Registrant information
Name
Mahan Razeghipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3354 1526
Email address
mahan9877@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
2024-09-22, 1403/07/01
Actual recruitment end date
2024-10-21, 1403/07/30
Trial completion date
2025-01-22, 1403/11/03
Scientific title
A Comparative Study of the Impact of Social Cognitive Theory-Based Educational Interventions Using Multimedia and AI Chatbot on Physical Activity in Overweight or Obese Male Secondary School Students
Public title
Physical Activity Educational Program in Overweight or Obese Male Students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Having a body mass index of 25 or higher Access to internet Access to electronic devices such as a computer, laptop or smartphone
Exclusion criteria:
Failure to complete study questionnaires Having Physical activity disincentive issues Participation in professional sports classes
Age
From 13 years old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Actual sample size reached: 153
Randomization (investigator's opinion)
N/A
Randomization description
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 Bushehr University of Medical Sciences
Street address
Bahmani St, Salman Farsi St, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759338
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.BPUMS.REC.1402.303

Health conditions studied

1

Description of health condition studied
Physical Activity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Physical activity Behavior
Timepoint
Before intervention, 1 and 3 months after intervention
Method of measurement
7-day physical activity questionnaire

2

Description
Body mass index
Timepoint
Before intervention, 1 and 3 months after intervention
Method of measurement
Ratio of weight to squared height

Secondary outcomes

1

Description
Perceived self-efficacy
Timepoint
Before intervention, 1 and 3 months after intervention
Method of measurement
Questionnaire

2

Description
Outcome expectations
Timepoint
Before intervention, 1 and 3 months after intervention
Method of measurement
Questionnaire

3

Description
Social support
Timepoint
Before intervention, 1 and 3 months after intervention
Method of measurement
Questionnaire

4

Description
Self-regulation
Timepoint
Before intervention, 1 and 3 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group (1) : In this group, students received multimedia educational content based on social cognitive theory in 7 chapters.
Category
Behavior

2

Description
Intervention group (2) : In this group, the educational intervention was implemented through a dedicated AI chatbot.
Category
Behavior

3

Description
Control group: This group will not receive any intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti High School
Full name of responsible person
Milad Habibinia
Street address
Bahmani St, Salman Farsi St, Shahid Beheshti High School
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3344 9855
Email
bushehr@medu.gov.ir

2

Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini School
Full name of responsible person
Hossein Rabiei Motlagh
Street address
Valiasr Blvd, Moalem St, Shahid Mostafa Khomeini School
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3333 1859
Fax
Email
bushehr@medu.gov.ir

3

Recruitment center
Name of recruitment center
Javadalaemeh High School
Full name of responsible person
Alireza Mashayekhi
Street address
Ayatollah Taleghani Blvd, Hamoor 34 St, Javadalaemeh High School
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3333 2928
Fax
Email
bushehr@medu.gov.ir

4

Recruitment center
Name of recruitment center
Moslehiyan High School
Full name of responsible person
Bahram Behnamnia
Street address
Imam Reza Blvd, Moslehiyan High School
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3353 4644
Fax
Email
bushehr@medu.gov.ir

5

Recruitment center
Name of recruitment center
22 Bahman High School
Full name of responsible person
Safar Jafari
Street address
Sangi St, Tohid St, 22 Bahman High School
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3352 2583
Fax
Email
bushehr@medu.gov.ir

6

Recruitment center
Name of recruitment center
Shahid Majid Boshkoh High School
Full name of responsible person
Ali Keshtkar
Street address
Chamran St, Shahid Majid Boshkoh High School
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3332 2064
Fax
Email
bushehr@medu.gov.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Bahmani St, Salman Farsi St, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3323 1802
Email
khamisipoor@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Homamodin Javadzade
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Bahmani St, Salman Farsi St, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0084
Email
sh.javadzadeh@bpums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Homamodin Javadzade
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Bahmani St, Salman Farsi St, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0084
Email
sh.javadzadeh@bpums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mahan Razeghipour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Bahmani St, Salman Farsi St, Bushehr University of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7516699918
Phone
+98 77 3354 1526
Email
mahan9877@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
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