Physical ActivityNCT06623604
The Effect of the Physical Activity Program Developed According to the Precede-Proceed Model on the Physical Activity Level and Physical Activity Behavior of Elementary School Students
A study testing Experimental: Physical activity program in people with Physical Activity and Physical Activity Levels, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The present study aims to investigate the effect of the physical activity program developed according to the Precede-Proceed Model on children\'s physical activity level and physical activity self-efficacy, attitude, enjoyment level, and exercise change behaviors. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Physical Activity Levels, Physical Activity Behavior
- What is being tested?
- Experimental: Physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2021to 30 Jun 2022
- 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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in the fourth grade at the designated schools
- Could read and write
- Families agreed to participate and gave their consent
Who cannot join
- Have chronic and metabolic diseases or disabilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University
Fethiye, Muğla, 48300
About this study
The present study aims to investigate the effect of the physical activity program developed according to the Precede-Proceed Model on children\'s physical activity level and physical activity self-efficacy, attitude, enjoyment level, and exercise change behaviors. This study was conducted in an experimental design with a pretest-posttest control group. Considering the possibility of data loss during the research, 178 students between the ages of 9 and 11 were included in the study, 89 in the intervention group and 89 in the control group. The exercises were carried out three days a week for 30 minutes in the school garden and gym, and the training was carried out in the classrooms one day a week.
- Being tested
- Experimental: Physical activity program
- Keywords
- Precede-proceed model, school nursing, physical activity, child
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Physical activity programBehavioural
In consultation with school administrators and classroom teachers, a physical activity program was implemented so that students\' classes would not be disrupted.
The exercises were carried out three days a week for 30 minutes in the school garden and gym by the same researcher, and the education was carried out in the classrooms one day a week.
During the program, students did a total of 180 hours of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Program | Experimental | The physical activity program consists of two parts: exercise and education. Exercises in the program include light and moderate movements that may be performed by a healthy student between the ages of 9 and 11. The exercises were carried out three days a week for 30 minutes in the school garden and gym by the same researcher, and the education was carried out in the classrooms one day a week. During the program, students did a total of 180 hours of physical activity. In addition, the students' teachers also participated in the program and did exercises with their students. Throughout the program, exercises included 'belly and abdominal movement sets' in the first four weeks, 'leg and hip movement sets' in the following four weeks, and 'arms, shoulder, and chest movement sets' in the final four weeks, as well as yoga movements. Receives: Behavioral: Experimental: Physical activity program |
| Control Group | No intervention | Measurements and questionnaires were applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Self-Efficacy Scale (PASS)
Physical Activity Self-Efficacy Scale (PASS) was used to measure the physical self-efficacy of children.
Measured: 0-6 months
Attitude toward Physical Activity Scale (APAS)
Attitude toward Physical Activity Scale (APAS) was used to measure the physical activity attitude of children.
Measured: 0-6 months
Physical Activity Levels
The Physical Activity Questionnaire for Older Children (PAQ-C) was used to measure the physical activity level of children.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start24 Oct 2021
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In consultation with school administrators and classroom teachers, a physical activity program was implemented so that students\' classes would not be disrupted. Exercises in the program include light and moderate movements that may be performed by a healthy student between the ages of 9 and 11. Sport physicians have advised that there is no need for any health screening, as children\'s hearts, pulses, and muscles are not affected by light and moderate exercises. The exercises were carried out three days a week for 30 minutes in the school garden and gym by the same researcher, and the education was carried out in the classrooms one day a week. The researcher performing the exercises received education in an earlier study that included physical exercises and yoga movements. During the program, students did a total of 180 hours of physical activity.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Recep Kara, Muğla Sıtkı Koçman University
- Investigators
- Recep KARA, Ph.D, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623604
- Sponsor's protocol ID
- MuglaSKURK
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 2 Oct 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Physical Activity Program Developed According to the Precede-Proceed Model on the Physical Activity Level and Physical Activity Behavior of Elementary School Students
- ClinicalTrials.gov ID
- NCT06623604
- Acronym / sponsor ID
- MuglaSKURK
- Keywords
- Precede-proceed model, school nursing, physical activity, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 24 Oct 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Oct 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 present study aims to investigate the effect of the physical activity program developed according to the Precede-Proceed Model on children\'s physical activity level and physical activity self-efficacy, attitude, enjoyment level, and exercise change behaviors. This study was conducted in an experimental design with a pretest-posttest control group. Considering the possibility of data loss during the research, 178 students between the ages of 9 and 11 were included in the study, 89 in the intervention group and 89 in the control group. The exercises were carried out three days a week for 30 minutes in the school garden and gym, and the training was carried out in the classrooms one day a week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In consultation with school administrators and classroom teachers, a physical activity program was implemented so that students\' classes would not be disrupted. Exercises in the program include light and moderate movements that may be performed by a healthy student between the ages of 9 and 11. Sport physicians have advised that there is no need for any health screening, as children\'s hearts, pulses, and muscles are not affected by light and moderate exercises. The exercises were carried out three days a week for 30 minutes in the school garden and gym by the same researcher, and the education was carried out in the classrooms one day a week. The researcher performing the exercises received education in an earlier study that included physical exercises and yoga movements. During the program, students did a total of 180 hours of physical activity.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Program | Experimental | Behavioral: Experimental: Physical activity programThe physical activity program consists of two parts: exercise and education. Exercises in the program include light and moderate movements that may be performed by a healthy student between the ages of 9 and 11. The exercises were carried out three days a week for 30 minutes in the school garden and gym by the same researcher, and the education was carried out in the classrooms one day a week. During the program, students did a total of 180 hours of physical activity. In addition, the students' teachers also participated in the program and did exercises with their students. Throughout the program, exercises included 'belly and abdominal movement sets' in the first four weeks, 'leg and hip movement sets' in the following four weeks, and 'arms, shoulder, and chest movement sets' in the final four weeks, as well as yoga movements. |
| Control Group | No intervention | –Measurements and questionnaires were applied to the control group. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in the fourth grade at the designated schools
- Could read and write
- Families agreed to participate and gave their consent
Key exclusion criteria (1 listed)
- Have chronic and metabolic diseases or disabilities
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 |
|---|---|---|
| Experimental: Physical activity programIn consultation with school administrators and classroom teachers, a physical activity program was implemented so that students\' classes would not be disrupted. The exercises were carried out three days a week for 30 minutes in the school garden and gym by the same researcher, and the education was carried out in the classrooms one day a week. During the program, students did a total of 180 hours of physical activity. | Behavioural | Physical Activity Program |
Primary outcome
Physical Activity Self-Efficacy Scale (PASS)
Time frame: 0-6 months
Physical Activity Self-Efficacy Scale (PASS) was used to measure the physical self-efficacy of children.
Attitude toward Physical Activity Scale (APAS)
Time frame: 0-6 months
Attitude toward Physical Activity Scale (APAS) was used to measure the physical activity attitude of children.
Physical Activity Levels
Time frame: 0-6 months
The Physical Activity Questionnaire for Older Children (PAQ-C) was used to measure the physical activity level of children.
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 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Recep KARA, Ph.D principal investigator
Muğla Sıtkı Koçman 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 Experimental: Physical activity program in people with Physical Activity and Physical Activity Levels, run by Muğla Sıtkı Koçman 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 1 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 2 Oct 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?
Physical Activity Self-Efficacy Scale (PASS) (time frame: 0-6 months). 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 2 Oct 2024.