Behavior, ChildNCT05681832
Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency
A study testing Intervention group in people with Behavior, Child and Physical Inactivity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to develop a physical activity program based on behavioral change models for children and to investigate the effectiveness of the physical activity program we have developed for children attending primary school. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Behavior, Child, Physical Inactivity
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Apr 2023
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntarily wanting to join the program
- Not having any chronic diseases
- Be able to read and write
- To have the cognitive skills to understand and answer the questionnaire
- To be a student at primary or secondary school.
Who cannot join
- Having a vision or hearing problem
- Have a diagnosis of chronic cardiac, neurological, or rheumatic disease
- Doing regular exercise/sports for the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency.
The aim of our study is to develop a physical activity program based on behavioral change models for children and to investigate the effectiveness of the physical activity program we have developed for children attending primary school. There is a limited number of studies in the literature on exercise habits in children, and there is no evidence on which model will provide better results when integrated into school or training programs. Although behavioral modification-based physical activity programs for children have been established and their effectiveness has been investigated in many different countries, there are limited randomized controlled studies on this subject. Currently, there are no randomized control studies on the topic in Turkey.
Our study will be the first study in which a school-based physical activity program based on behavioral change models in Turkish children is developed and its effectiveness is investigated. We believe that our study will contribute to the development of new models and protocols to improve the health of children in Turkey and the world and to provide behavior change methods that are research-based to combat physical inactivity.
Read the detailed description
The COVID-19 pandemic, which started in 2019, has negatively affected the lives of all humanity in many ways, especially with the decrease in physical activity. Due to quarantines, schools continued their educational activities online for a long time. While physical inactivity in children was a serious problem even in the pre-pandemic period, the restrictions imposed due to pandemic conditions had a catastrophic effect on the physical inactivity levels of children. It has been reported that children reach the recommended physical activity levels while they are at school. Studies show that the habits we have acquired since childhood are most likely habits that we can have for a lifetime.
The effectiveness of behavior change theories and models has been proven in studies conducted to gain exercise habits in various age groups. In the literature, many theories such as Self-Determination Theory (SDT), Transtheoretical Model, Planned Behavior Theory, and Social Cognitive Theory have been used to help children gain exercise habits. In a cross-sectional study involving 462 children aged 7-11, the effectiveness of the SDT model on children's physical activity motivation was examined. The results showed that there is a positive relationship between children's motivation based on activity enjoyment and satisfaction and physical activity scores. It has been reported that applications based on theory are promising for future interventions aimed at increasing physical activity levels in children.
However, there is a limited number of studies in the literature to gain exercise habits in children, and there is no evidence that which model will provide better results. In a postgraduate thesis done in Turkey in 2021, online exercise training based on behavior change theories and strategies was applied to gain exercise habits in children. They reported limited evidence that they obtained Although very few children participated in the study due to restrictions during the COVID-19 pandemic, they reported limited evidence that children achieved positive changes in health behavior.
For these reasons, the planning of our study is to develop a physical activity program based on behavioral change models for children and to investigate the effectiveness of the physical activity program we have developed in children attending primary school.
- Conditions
- Behavior, Child, Physical Inactivity
- Being tested
- Intervention group
- Keywords
- child, behavior change models, HIIT, Exercise, physical activity, physical inactivity, motivation
- Medical subject headings
- Child Behavior, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
The children in this group will participate in a 15-minute HIIT (High-intensity interval training) program twice a week for eight weeks. Motivational interviewing through presentations and Kahoot for the children and their parents will be done at the program's beginning, middle, and end.
The HIIT program will consist of 2.5 minutes of warm-up 12.5 exercises then a cool-down period of 5 minutes. The intensity of the exercise was increased based on each kid's performance and monitored during the sessions using a smartwatch.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Intervention group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cognitive Behavioral Physical Activity Questionnaire
This questionnaire will test the changes in behavior towards physical activity in children. The scale consists of 3 sub-dimensions, namely self-regulation and personal barriers, and a total of 15 statements. All statements in the scale are scored with a 5-point Likert Type rating as "1. I totally disagree,…, 5. I totally agree".
Measured: Change from baseline to 8 weeks
The physical Activity Stages Of Change Questionnaire
This questionnaire will specifiy which stage of change the child is in according to the transtheoretical model. Transtheoretical Model, explains whether the individual is ready to change their behavior and describes the behavior change process that occurs in stages. This will help us know how to modify the program to work out well for each child.
Measured: Change from baseline to 8 weeks
Motivation Scale For Participation In Physical Activity
This scale will evaluate the level of motivation to participate in physical activity.
Measured: Change from baseline to 8 weeks
The physical activity efficacy scale
This scale consists of 5 dimensions and 26 items (at school: 6 items, transportation: 3 items, indoor: 5 items, leisure and recreation: 6 items, in-school travel and transportation: 6 items). The scale consists of two parts. In the first part, demographic information is asked, and in the second part, how much they trust themselves to take part in physical activities in the five physical activity areas. A 10-point Likert-type range was used to score the items (0= "I am not confident at all" and 100= "I am totally confident"). The overall average score is between 0 and 100. High scores will indicate a high level of physical activity efficacy.
Measured: Change from baseline to 8 weeks
The Physical Activity Questionnaire
It will assess physical activity levels in children. It is is a self-administered, 7-day activity recall tool.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Nov 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mira Amer, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681832
- Sponsor's protocol ID
- E-74555795-050.01.04-567380
- Status last verified
- May 2024
- First submitted
- 28 Dec 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency.
- ClinicalTrials.gov ID
- NCT05681832
- Acronym / sponsor ID
- E-74555795-050.01.04-567380
- Conditions
- Behavior, Child, Physical Inactivity
- Keywords
- child, behavior change models, HIIT, Exercise, physical activity, physical inactivity, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 12 Jan 2023 (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 aim of our study is to develop a physical activity program based on behavioral change models for children and to investigate the effectiveness of the physical activity program we have developed for children attending primary school. There is a limited number of studies in the literature on exercise habits in children, and there is no evidence on which model will provide better results when integrated into school or training programs. Although behavioral modification-based physical activity programs for children have been established and their effectiveness has been investigated in many different countries, there are limited randomized controlled studies on this subject. Currently, there are no randomized control studies on the topic in Turkey.
Our study will be the first study in which a school-based physical activity program based on behavioral change models in Turkish children is developed and its effectiveness is investigated. We believe that our study will contribute to the development of new models and protocols to improve the health of children in Turkey and the world and to provide behavior change methods that are research-based to combat physical inactivity.
Detailed description
The COVID-19 pandemic, which started in 2019, has negatively affected the lives of all humanity in many ways, especially with the decrease in physical activity. Due to quarantines, schools continued their educational activities online for a long time. While physical inactivity in children was a serious problem even in the pre-pandemic period, the restrictions imposed due to pandemic conditions had a catastrophic effect on the physical inactivity levels of children. It has been reported that children reach the recommended physical activity levels while they are at school. Studies show that the habits we have acquired since childhood are most likely habits that we can have for a lifetime.
The effectiveness of behavior change theories and models has been proven in studies conducted to gain exercise habits in various age groups. In the literature, many theories such as Self-Determination Theory (SDT), Transtheoretical Model, Planned Behavior Theory, and Social Cognitive Theory have been used to help children gain exercise habits. In a cross-sectional study involving 462 children aged 7-11, the effectiveness of the SDT model on children's physical activity motivation was examined. The results showed that there is a positive relationship between children's motivation based on activity enjoyment and satisfaction and physical activity scores. It has been reported that applications based on theory are promising for future interventions aimed at increasing physical activity levels in children.
However, there is a limited number of studies in the literature to gain exercise habits in children, and there is no evidence that which model will provide better results. In a postgraduate thesis done in Turkey in 2021, online exercise training based on behavior change theories and strategies was applied to gain exercise habits in children. They reported limited evidence that they obtained Although very few children participated in the study due to restrictions during the COVID-19 pandemic, they reported limited evidence that children achieved positive changes in health behavior.
For these reasons, the planning of our study is to develop a physical activity program based on behavioral change models for children and to investigate the effectiveness of the physical activity program we have developed in children attending primary school.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Voluntarily wanting to join the program
- Not having any chronic diseases
- Be able to read and write
- To have the cognitive skills to understand and answer the questionnaire
- To be a student at primary or secondary school.
Key exclusion criteria (3 listed)
- Having a vision or hearing problem
- Have a diagnosis of chronic cardiac, neurological, or rheumatic disease
- Doing regular exercise/sports for the last 6 months
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 |
|---|---|---|
| Intervention groupThe children in this group will participate in a 15-minute HIIT (High-intensity interval training) program twice a week for eight weeks. Motivational interviewing through presentations and Kahoot for the children and their parents will be done at the program's beginning, middle, and end. The HIIT program will consist of 2.5 minutes of warm-up 12.5 exercises then a cool-down period of 5 minutes. The intensity of the exercise was increased based on each kid's performance and monitored during the sessions using a smartwatch. | Behavioural | Intervention group |
Primary outcome
The Cognitive Behavioral Physical Activity Questionnaire
Time frame: Change from baseline to 8 weeks
This questionnaire will test the changes in behavior towards physical activity in children. The scale consists of 3 sub-dimensions, namely self-regulation and personal barriers, and a total of 15 statements. All statements in the scale are scored with a 5-point Likert Type rating as "1. I totally disagree,…, 5. I totally agree".
The physical Activity Stages Of Change Questionnaire
Time frame: Change from baseline to 8 weeks
This questionnaire will specifiy which stage of change the child is in according to the transtheoretical model. Transtheoretical Model, explains whether the individual is ready to change their behavior and describes the behavior change process that occurs in stages. This will help us know how to modify the program to work out well for each child.
Motivation Scale For Participation In Physical Activity
Time frame: Change from baseline to 8 weeks
This scale will evaluate the level of motivation to participate in physical activity.
The physical activity efficacy scale
Time frame: Change from baseline to 8 weeks
This scale consists of 5 dimensions and 26 items (at school: 6 items, transportation: 3 items, indoor: 5 items, leisure and recreation: 6 items, in-school travel and transportation: 6 items). The scale consists of two parts. In the first part, demographic information is asked, and in the second part, how much they trust themselves to take part in physical activities in the five physical activity areas. A 10-point Likert-type range was used to score the items (0= "I am not confident at all" and 100= "I am totally confident"). The overall average score is between 0 and 100. High scores will indicate a high level of physical activity efficacy.
The Physical Activity Questionnaire
Time frame: Change from baseline to 8 weeks
It will assess physical activity levels in children. It is is a self-administered, 7-day activity recall tool.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Behavior, Child and Physical Inactivity, run by Istanbul University - Cerrahpasa 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 5 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: finished, as of the sponsor's last update on 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Cognitive Behavioral Physical Activity Questionnaire (time frame: Change from baseline to 8 weeks). The study lists 5 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 14 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.