Protocol summary
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Study aim
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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.
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Design
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A randomized, clinical trial with control group, parallel groups on 180 students. Excel software will be used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Physical activity behavior; Body mass index; Perceived self-efficacy; Social support; Outcome expectations; Self-regulation.
General information
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Reason for update
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The reported value for the achieved sample size was entered incorrectly.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250417065366N1
Registration date:
2025-05-08, 1404/02/18
Registration timing:
retrospective
Last update:
2025-07-09, 1404/04/18
Update count:
1
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Registration date
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2025-05-08, 1404/02/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-09-22, 1403/07/01
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Expected recruitment end date
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2024-10-21, 1403/07/30
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Actual recruitment start date
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2024-09-22, 1403/07/01
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Actual recruitment end date
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2024-10-21, 1403/07/30
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Trial completion date
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2025-01-22, 1403/11/03
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Scientific title
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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
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Public title
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Physical Activity Educational Program in Overweight or Obese Male Students
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 13 years old to 15 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
180
Actual sample size reached:
150
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-03-11, 1402/12/21
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Ethics committee reference number
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IR.BPUMS.REC.1402.303
Health conditions studied
1
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Description of health condition studied
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Physical Activity
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Physical activity Behavior
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Timepoint
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Before intervention, 1 and 3 months after intervention
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Method of measurement
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7-day physical activity questionnaire
2
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Description
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Body mass index
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Timepoint
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Before intervention, 1 and 3 months after intervention
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Method of measurement
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Ratio of weight to squared height
Secondary outcomes
1
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Description
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Perceived self-efficacy
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Timepoint
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Before intervention, 1 and 3 months after intervention
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Method of measurement
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Questionnaire
2
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Description
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Outcome expectations
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Timepoint
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Before intervention, 1 and 3 months after intervention
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Method of measurement
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Questionnaire
3
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Description
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Social support
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Timepoint
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Before intervention, 1 and 3 months after intervention
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Method of measurement
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Questionnaire
4
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Description
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Self-regulation
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Timepoint
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Before intervention, 1 and 3 months after intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group (1) : In this group, students received multimedia educational content based on social cognitive theory in 7 chapters.
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Category
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Behavior
2
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Description
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Intervention group (2) : In this group, the educational intervention was implemented through a dedicated AI chatbot.
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Category
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Behavior
3
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Description
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Control group: This group will not receive any intervention.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Boushehr University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available