- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06408844
Examining the Impact of Behavior Change Intervention
May 9, 2024 updated by: Filiz Özdemir, Inonu University
The Effects of Physical Activity Behavior Change Program Implemented With 5A Model on Physical and Psychosocial Health in School Age Children
The health-related benefits of physical activity are well established for all age groups.
It also has positive effects on memory, executive function and school performance in children and adolescents.
However, it is known that 81% of individuals between the ages of 11-17 live a life that is not physically active enough.
The World Health Organization recommends interventions to increase physical activity.
In this study, 48 students from 5th, 6th and 7th grades will be selected from randomly selected secondary schools in Karaman central district and will be divided into experimental and control groups.
In this randomized controlled study, behavior change intervention with the 5A model will be applied to the experimental group, and no intervention will be applied to the control group.
Physical activity levels, physical and psychosocial health of children in both groups will be evaluated at the beginning of the intervention, at Week 8 and at Week 28.
Physical activity diary, "Physical activity scale for 4-8 Grades" scale will be used to measure children's physical activity levels.
For their physical health, body composition, strength, flexibility and functional capacity will be evaluated.
Quality of life with the "Pediatric Quality of Life 4.0 Inventory" for psychosocial health; Cognitive functions will be evaluated with "CNS Vital Signs Cognitive Performance and Attention Tests".
This study aims to evaluate the sustainability effect of the 5A intervention on physical activity and its impact on physical health and psychosocial health.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Behavioral interventions for health promotion are widely used for preventive health practices.
There are many studies on topics such as smoking, diet, obesity and oral care.
However, we see that studies improving physical activity behavior in children are limited.
Considering that physical activity is an important health-related behavior that should be acquired from childhood, we predict that studies on this subject will have an important place in the literature.
In addition, it is stated in the guidelines that while the effect of physical activity behavior on health-related parameters in children is clear, more evidence is still needed on its effect on cognitive functions.
With our study, we aim to examine the sustainability, physical and psychosocial effects of developing physical activity behavior in children using the 5A model and contribute to the literature.
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karaman, Turkey
- Alparslan Ortaokulu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being a middle school student
- Being between the ages of 10-12
- Getting <3.16 points from the "Physical activity scale for grades 4-8"
Exclusion Criteria:
- Having a condition where exercise is contraindicated
- Families or children do not give consent to participate in the study.
- Having a psychosocial problem that prevents adaptation to work
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Training to improve physical activity behavior will be given to the experimental group for 8 weeks, based on the 5A model.
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According to the 5A model, the personal action plan includes the following items:
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No Intervention: Control group
The control group will not receive any intervention and will be asked to continue their routine lives.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity level
Time Frame: 1 day
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Children's physical activity level will be determined using the Paq-c survey.
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1 day
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Physical health
Time Frame: 1 day
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Children's body composition, aerobic capacity, anaerobic capacity, strength and flexibility will be evaluated.
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1 day
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Psychosocial Health
Time Frame: 1 day
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Children's psychosocial health will be assessed with the CNSVS procedure.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity attitude
Time Frame: 1 day
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Their attitudes towards Physical Activity will be evaluated.
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1 day
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Behavior Change Step
Time Frame: 1 day
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It will be questioned whether the physical activity behavior is in the pre-contemplation, contemplation, preparation, action or maintenance periods.
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1 day
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Children's Quality of Life
Time Frame: 1 day
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The impact of education on the quality of life will be evaluated using the "Quality of Life Scale for Children".
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Filiz Özdemir, Ass. Prof., Inonu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
May 7, 2024
First Submitted That Met QC Criteria
May 9, 2024
First Posted (Actual)
May 10, 2024
Study Record Updates
Last Update Posted (Actual)
May 10, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Inonu-FTR-MHK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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