Physical InactivityNCT06408844
Examining the Impact of Behavior Change Intervention
A study testing Physical activity behavior change program implemented with 5A model in people with Physical Inactivity and Behavior, Health, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Behavior, Health, Health Behavior
- What is being tested?
- Physical activity behavior change program implemented with 5A model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Inactivity, Behavior, Health, Health Behavior
- Being tested
- Physical activity behavior change program implemented with 5A model
- Keywords
- 5A Model, child, behaviour change, physical activity, health promotion
- Medical subject headings
- Sedentary Behavior, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity behavior change program implemented with 5A modelBehavioural
According to the 5A model, the personal action plan includes the following items:
- List specific goals by behavioral period
- List obstacles and strategies to address them
- Determine follow-up plan
- Sharing the plan with the child and family In accordance with this plan, it is aimed to increase physical activity behavior in the classroom and during online meetings for 8 weeks. Additionally, after the training, motivational reminders will be held at regular intervals until the 28th week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Training to improve physical activity behavior will be given to the experimental group for 8 weeks, based on the 5A model. Receives: Behavioral: Physical activity behavior change program implemented with 5A model |
| Control group | No intervention | The control group will not receive any intervention and will be asked to continue their routine lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Children's physical activity level will be determined using the Paq-c survey.
Measured: 1 day
Physical health
Children's body composition, aerobic capacity, anaerobic capacity, strength and flexibility will be evaluated.
Measured: 1 day
Psychosocial Health
Children's psychosocial health will be assessed with the CNSVS procedure.
Measured: 1 day
Secondary outcomes (3)
Physical Activity attitude
Their attitudes towards Physical Activity will be evaluated.
Measured: 1 day
Behavior Change Step
It will be questioned whether the physical activity behavior is in the pre-contemplation, contemplation, preparation, action or maintenance periods.
Measured: 1 day
Children's Quality of Life
The impact of education on the quality of life will be evaluated using the "Quality of Life Scale for Children".
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start7 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups in this study: the experimental group and the control group.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Özdemir, Inonu University
- Investigators
- Filiz Özdemir, Ass. Prof., Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408844
- Sponsor's protocol ID
- Inonu-FTR-MHK-01
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Physical Activity Behavior Change Program Implemented With 5A Model on Physical and Psychosocial Health in School Age Children
- ClinicalTrials.gov ID
- NCT06408844
- Acronym / sponsor ID
- Inonu-FTR-MHK-01
- Conditions
- Physical Inactivity, Behavior, Health, Health Behavior
- Keywords
- 5A Model, child, behaviour change, physical activity, health promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups in this study: the experimental group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Physical activity behavior change program implemented with 5A modelTraining to improve physical activity behavior will be given to the experimental group for 8 weeks, based on the 5A model. |
| Control group | No intervention | –The control group will not receive any intervention and will be asked to continue their routine lives. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity behavior change program implemented with 5A modelAccording to the 5A model, the personal action plan includes the following items: 1. List specific goals by behavioral period 2. List obstacles and strategies to address them 3. Determine follow-up plan 4. Sharing the plan with the child and family In accordance with this plan, it is aimed to increase physical activity behavior in the classroom and during online meetings for 8 weeks. Additionally, after the training, motivational reminders will be held at regular intervals until the 28th week. | Behavioural | Experimental group |
Primary outcome
Physical activity level
Time frame: 1 day
Children's physical activity level will be determined using the Paq-c survey.
Physical health
Time frame: 1 day
Children's body composition, aerobic capacity, anaerobic capacity, strength and flexibility will be evaluated.
Psychosocial Health
Time frame: 1 day
Children's psychosocial health will be assessed with the CNSVS procedure.
3 secondary outcomes
Physical Activity attitude
Time frame: 1 day
Behavior Change Step
Time frame: 1 day
Children's Quality of Life
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
Related trials for Physical Inactivity
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Özdemir, Ass. Prof. principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity behavior change program implemented with 5A model in people with Physical Inactivity and Behavior, Health, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.