Physical ActivityNCT06572527
Child Health Coordinated Physical Activity Program
A study testing Physical Activity Program in people with Physical Activity and Children, Only, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a non-randomized study to evaluate the effects of physical activity interventions developed with the Nurse-led Child Health Coordinated Physical Activity Program on the physical activity levels of preschool children. Read more about this study
- Who is it for?
- Ages 60 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Children, Only, Nurse's Role
- What is being tested?
- Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 5 Jun 2024
- 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 60 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being 5 years old
- Being a student in kindergarten
- Volunteer for research
- Family consent to participate in the study
- The teacher of the class in which the student is enrolled agrees to participate in the study
Who cannot join
- Physical activity limitations due to medical conditions
- After starting the study
- Absence from the program for at least two weeks
- If a situation arises during implementation that prevents participation in physical activity programs
- Withdrawal of consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Emirdağ Fidan Ali Altıntaş Anaokulu
Afyonkarahisar
About this study
Official title: The Effect of a Nurse-Led, Child Health Coordinated Physical Activity Program on Physical Activity Levels in Preschool Children: A Non-randomized Study
This study was conducted as a non-randomized study to evaluate the effects of physical activity interventions developed with the Nurse-led Child Health Coordinated Physical Activity Program on the physical activity levels of preschool children.
Research hypotheses; H1a: The anthropometric measurements of the group receiving the intervention are different from the control group.
H1b: The physical activity levels of the group receiving intervention according to family reports are different from the control group
Read the detailed description
The study group of the research consisted of 5-year-old students studying in kindergartens. The total number of students in kindergartens is 159 in the research area. Gpower 3.1.9.4 program was used to determine the sample size of the study. The sample size was determined as 42 ( 21 in the experimental and control groups) under a large effect size (0.80), an alpha value of 0.05 and a power level of 80%. It was decided to include a total of 52 students in the study by accepting a loss rate of approximately 20%.
Because it is known that it is important to promote physical activity at an early age, this study implemented interventions developed in accordance with the Coordinated Approach to Child Health Program, a program consisting of classroom, family, and student components. In the classroom component of the program, health education practices were prepared to teach children to identify, practice, and adapt physical activity habits to their lives through the classroom environment. In the family component of the program, there are interventions that ensure the participation of children, parents, and other family members to develop physical activity habits at home. Increasing physical activity in preschool children can be achieved by developing interventions that are fun and encourage children to be physically active in a structured classroom setting that promotes gross motor skills and moderate to vigorous physical activity during kindergarten and recess. In this study, a six-week program consisting of nurse, teacher, and family components developed in accordance with the Coordinated Approach to Child Health in Preschool Children program was implemented twice a week to evaluate its effects on physical activity in preschool children and its effectiveness in increasing physical activity.
The interventions averaged 60 minutes per week. Prior to implementation, school administrators and teachers were interviewed and informed about the purpose of the research and the implementation process. To inform parents and students about the research, the informed consent form and parent questionnaire were sent to parents in a sealed envelope and collected from students by teachers the next day. Informed consent was obtained by explaining the purpose and procedure of the study to the students whose parents had given their consent, and they were asked to complete the data collection instruments through the classroom teacher (pre-test). The post-test was administered 2 weeks after the completion of the study. The pre-test and post-test were administered by the teachers and the height-weight measurements were done by the nurse. No intervention was applied to the control group except for the physical activities they perform in their daily lives. Data collection instruments were administered to the control group in a similar manner and at the same time as the experimental group. The primary outcomes expected from the study are anthropometric measurements and physical activity levels. The research data was collected using the parent questionnaire developed by the researchers based on the literature and anthropometric measurements.
- Conditions
- Physical Activity, Children, Only, Nurse's Role, Body Weight Changes
- Being tested
- Physical Activity Program
- Medical subject headings
- Motor Activity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity ProgramBehavioural
Nurse-Led Coordinated Physical Activity Program for Child Health," developed as part of the Coordinated Approach to Child Health program for preschool children.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Nurse-Led Coordinated Physical Activity Program for Child Health, consisting of nurse, teacher, and family components was implemented by the researcher two days a week for six weeks. The interventions were last an average of 60 minutes each week. During this time, the nurse implemented a program, developed based on expert opinion and various guidelines, that directed students to be more active. Teachers were expected to encourage students and actively participate in the program. Families were regularly informed through the "family bulletin" and it was ensured that the program started at school was continued at home. Receives: Behavioral: Physical Activity Program |
| Control | No intervention | No intervention was applied to the control group except for the regular physical activities they perform in their school life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The parents' evaluation about their child's level of physical activity
This is a survey question. Parents rate their children's level of physical activity compared to their peers. (5-point scale from much more active to much less active)
Measured: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
The duration of watching TV or using a computer (in a day)
Time spent watching TV or using a computer
Measured: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
The status of organized planned physical activity
This question was developed based on the recommendation of at least 60 minutes of moderate-intensity physical activity per day. The status of moderate-intensity physical activity was explained with examples, and information about the child's activity status was obtained from the family for the past week . (Yes/no question) Expert opinion was obtained for the survey questions.
Measured: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
Time of playing outside
Time spent playing outside on weekdays and weekends,
Measured: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
The frequency of some activities
Number of activities per week (ranging from never to more than 3 times per week). This survey question is in accordance with the Department of Health and Human Services recommendation.
Measured: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
Anthropometric measurements
Change in body mass index, height and weight
Measured: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start15 Mar 2024
- Primary completion20 May 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized, parallel assignment (1:1)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Kocoglu-Tanyer, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572527
- Sponsor's protocol ID
- 2023/75
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 27 Aug 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-Led, Child Health Coordinated Physical Activity Program on Physical Activity Levels in Preschool Children: A Non-randomized Study
- ClinicalTrials.gov ID
- NCT06572527
- Acronym / sponsor ID
- 2023/75
- Conditions
- Physical Activity, Children, Only, Nurse's Role, Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 27 Aug 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.
This study was conducted as a non-randomized study to evaluate the effects of physical activity interventions developed with the Nurse-led Child Health Coordinated Physical Activity Program on the physical activity levels of preschool children.
Research hypotheses; H1a: The anthropometric measurements of the group receiving the intervention are different from the control group.
H1b: The physical activity levels of the group receiving intervention according to family reports are different from the control group
Detailed description
The study group of the research consisted of 5-year-old students studying in kindergartens. The total number of students in kindergartens is 159 in the research area. Gpower 3.1.9.4 program was used to determine the sample size of the study. The sample size was determined as 42 ( 21 in the experimental and control groups) under a large effect size (0.80), an alpha value of 0.05 and a power level of 80%. It was decided to include a total of 52 students in the study by accepting a loss rate of approximately 20%.
Because it is known that it is important to promote physical activity at an early age, this study implemented interventions developed in accordance with the Coordinated Approach to Child Health Program, a program consisting of classroom, family, and student components. In the classroom component of the program, health education practices were prepared to teach children to identify, practice, and adapt physical activity habits to their lives through the classroom environment. In the family component of the program, there are interventions that ensure the participation of children, parents, and other family members to develop physical activity habits at home. Increasing physical activity in preschool children can be achieved by developing interventions that are fun and encourage children to be physically active in a structured classroom setting that promotes gross motor skills and moderate to vigorous physical activity during kindergarten and recess. In this study, a six-week program consisting of nurse, teacher, and family components developed in accordance with the Coordinated Approach to Child Health in Preschool Children program was implemented twice a week to evaluate its effects on physical activity in preschool children and its effectiveness in increasing physical activity.
The interventions averaged 60 minutes per week. Prior to implementation, school administrators and teachers were interviewed and informed about the purpose of the research and the implementation process. To inform parents and students about the research, the informed consent form and parent questionnaire were sent to parents in a sealed envelope and collected from students by teachers the next day. Informed consent was obtained by explaining the purpose and procedure of the study to the students whose parents had given their consent, and they were asked to complete the data collection instruments through the classroom teacher (pre-test). The post-test was administered 2 weeks after the completion of the study. The pre-test and post-test were administered by the teachers and the height-weight measurements were done by the nurse. No intervention was applied to the control group except for the physical activities they perform in their daily lives. Data collection instruments were administered to the control group in a similar manner and at the same time as the experimental group. The primary outcomes expected from the study are anthropometric measurements and physical activity levels. The research data was collected using the parent questionnaire developed by the researchers based on the literature and anthropometric measurements.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-randomized, parallel assignment (1:1)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical Activity ProgramNurse-Led Coordinated Physical Activity Program for Child Health, consisting of nurse, teacher, and family components was implemented by the researcher two days a week for six weeks. The interventions were last an average of 60 minutes each week. During this time, the nurse implemented a program, developed based on expert opinion and various guidelines, that directed students to be more active. Teachers were expected to encourage students and actively participate in the program. Families were regularly informed through the "family bulletin" and it was ensured that the program started at school was continued at home. |
| Control | No intervention | –No intervention was applied to the control group except for the regular physical activities they perform in their school life. |
Who may qualify
- Ages
- 60 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being 5 years old
- Being a student in kindergarten
- Volunteer for research
- Family consent to participate in the study
- The teacher of the class in which the student is enrolled agrees to participate in the study
Key exclusion criteria (5 listed)
- Physical activity limitations due to medical conditions
- After starting the study
- Absence from the program for at least two weeks
- If a situation arises during implementation that prevents participation in physical activity programs
- Withdrawal of consent.
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 ProgramNurse-Led Coordinated Physical Activity Program for Child Health," developed as part of the Coordinated Approach to Child Health program for preschool children. | Behavioural | Intervention |
Primary outcome
The parents' evaluation about their child's level of physical activity
Time frame: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
This is a survey question. Parents rate their children's level of physical activity compared to their peers. (5-point scale from much more active to much less active)
The duration of watching TV or using a computer (in a day)
Time frame: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
Time spent watching TV or using a computer
The status of organized planned physical activity
Time frame: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
This question was developed based on the recommendation of at least 60 minutes of moderate-intensity physical activity per day. The status of moderate-intensity physical activity was explained with examples, and information about the child's activity status was obtained from the family for the past week . (Yes/no question) Expert opinion was obtained for the survey questions.
Time of playing outside
Time frame: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
Time spent playing outside on weekdays and weekends,
The frequency of some activities
Time frame: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
Number of activities per week (ranging from never to more than 3 times per week). This survey question is in accordance with the Department of Health and Human Services recommendation.
Anthropometric measurements
Time frame: Pre-intervention (T0) Two weeks after the end of the intervention (T1)
Change in body mass index, height and weight
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 27 Aug 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 Physical Activity Program in people with Physical Activity and Children, Only, run by Selcuk 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 5 inclusion and 5 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 27 Aug 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 parents' evaluation about their child's level of physical activity (time frame: Pre-intervention (T0) Two weeks after the end of the intervention (T1)). The study lists 6 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 27 Aug 2024.