Healthy Lifestyle BehaviorsNCT07544069
The Effect of Health Education on Children's Healthy Lifestyle Skills
A study testing Healthy Lifestyle Education in people with Healthy Lifestyle Behaviors, run by Gazi University.
Trial summary
Childhood is a critical period for the development of lifelong health behaviors, and early interventions play an essential role in promoting long-term health and preventing future health problems. This study is planned to evaluate the effect of health education on children's healthy lifestyle skills. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle Behaviors
- What is being tested?
- Healthy Lifestyle Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled at Şehit Yavuz Başayar Primary School
- Currently attending 2nd, 3rd, or 4th grade
- Willing to participate in the study
- Having parental consent
Who cannot join
- Refusal to participate in the study
- Lack of parental consent
- Inability to complete the data collection tools
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Health Education on Children's Healthy Lifestyle Skills: A Randomized Controlled Trial
Childhood is a critical period for the development of lifelong health behaviors, and early interventions play an essential role in promoting long-term health and preventing future health problems. This study is planned to evaluate the effect of health education on children's healthy lifestyle skills.
Read the detailed description
This study is designed as a randomized controlled trial to evaluate the effectiveness of a structured health education program on healthy lifestyle skills among primary school children aged 8-10 years. The study will be conducted in a public primary school in Ankara, Türkiye, during the 2025-2026 academic year. The study population will consist of students enrolled in the 2nd, 3rd, and 4th grades. Participants who meet the inclusion criteria and provide parental consent will be included in the study. Data will be collected using a Descriptive Characteristics Form and the Healthy Lifestyle Skills Scale for Children Aged 8-10, which assesses health protection, hygiene, physical activity, and nutrition behaviors. Following baseline data collection (pre-test), participants will be randomly assigned to either the experimental group or the control group. The experimental group will receive a structured healthy lifestyle education program, while the control group will receive no intervention during the study period.
The intervention will be implemented over a two-week period and will consist of two sessions. Each session will last approximately 45 minutes, including 30 minutes of theoretical instruction and 15 minutes of interactive activities. The education program will include topics such as personal hygiene, cleanliness habits, health protection, regular physical activity, and healthy nutrition. Educational materials such as brochures and visual presentations will be used to support learning and enhance engagement. After the completion of the intervention, both groups will undergo a post-test assessment using the same measurement tools. Additionally, a follow-up assessment will be conducted one month after the completion of the intervention to evaluate the sustainability of the effects of the education program. No intervention will be applied to the control group during the study period; however, after the post-test assessment, the same education program will be provided to the control group for ethical considerations.
- Conditions
- Healthy Lifestyle Behaviors
- Being tested
- Healthy Lifestyle Education
- Keywords
- Health Education, Child, Primary School, Health Behavior, Nursing
- Medical subject headings
- Health Education, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyle EducationBehavioural
A healthy lifestyle education program consisting of two sessions over a two-week period will be implemented for children. The program includes topics such as hygiene, nutrition, physical activity, and health protection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The healthy lifestyle education program prepared by the researcher will be given to the students in the initiative group in two sessions. Each session is planned to be 40 minutes in total. In each session, 30 minutes will be education and 15 minutes will be spent on classroom activities to encourage active student participation. The education sessions will cover health protection, personal hygiene, regular physical activity, and healthy eating. To reinforce the educational content and support students in applying what they have learned to their daily lives, brochures will be distributed at the end of the training program. Receives: Behavioral: Healthy Lifestyle Education |
| Control group | No intervention | No intervention will be applied to the control group during the study period. After the post-test, the same education program will be provided to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy lifestyle skills level
The Healthy Lifestyle Skills Scale for Children Aged 8-10 is a validated instrument developed to assess healthy lifestyle skills among primary school children aged 8-10 years. The scale consists of 22 items and four subdimensions: health protection (7 items), cleaning and hygiene (8 items), sports and physical activity (4 items), and proper nutrition (3 items). All items are rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("always"). The total score ranges from 22 to 110, with higher scores indicating better healthy lifestyle skills. Based on score ranges, scores between 22-69 indicate low, 70-89 moderate, and 90-110 high levels of healthy lifestyle skills. The scale can be administered individually or in groups and takes approximately 15-20 minutes to complete. It is self-reported and will be completed by the students under researcher supervision.
Measured: Pre-intervention, immediately after the intervention, and 1-month after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Lifestyle BehaviorsStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Ayaz Alkaya, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544069
- Sponsor's protocol ID
- 2026 - 575
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education on Children's Healthy Lifestyle Skills: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07544069
- Acronym / sponsor ID
- 2026 - 575
- Conditions
- Healthy Lifestyle Behaviors
- Keywords
- Health Education, Child, Primary School, Health Behavior, Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Apr 2026 (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.
Childhood is a critical period for the development of lifelong health behaviors, and early interventions play an essential role in promoting long-term health and preventing future health problems. This study is planned to evaluate the effect of health education on children's healthy lifestyle skills.
Detailed description
This study is designed as a randomized controlled trial to evaluate the effectiveness of a structured health education program on healthy lifestyle skills among primary school children aged 8-10 years. The study will be conducted in a public primary school in Ankara, Türkiye, during the 2025-2026 academic year. The study population will consist of students enrolled in the 2nd, 3rd, and 4th grades. Participants who meet the inclusion criteria and provide parental consent will be included in the study. Data will be collected using a Descriptive Characteristics Form and the Healthy Lifestyle Skills Scale for Children Aged 8-10, which assesses health protection, hygiene, physical activity, and nutrition behaviors. Following baseline data collection (pre-test), participants will be randomly assigned to either the experimental group or the control group. The experimental group will receive a structured healthy lifestyle education program, while the control group will receive no intervention during the study period.
The intervention will be implemented over a two-week period and will consist of two sessions. Each session will last approximately 45 minutes, including 30 minutes of theoretical instruction and 15 minutes of interactive activities. The education program will include topics such as personal hygiene, cleanliness habits, health protection, regular physical activity, and healthy nutrition. Educational materials such as brochures and visual presentations will be used to support learning and enhance engagement. After the completion of the intervention, both groups will undergo a post-test assessment using the same measurement tools. Additionally, a follow-up assessment will be conducted one month after the completion of the intervention to evaluate the sustainability of the effects of the education program. No intervention will be applied to the control group during the study period; however, after the post-test assessment, the same education program will be provided to the control group for ethical considerations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Healthy Lifestyle EducationThe healthy lifestyle education program prepared by the researcher will be given to the students in the initiative group in two sessions. Each session is planned to be 40 minutes in total. In each session, 30 minutes will be education and 15 minutes will be spent on classroom activities to encourage active student participation. The education sessions will cover health protection, personal hygiene, regular physical activity, and healthy eating. To reinforce the educational content and support students in applying what they have learned to their daily lives, brochures will be distributed at the end of the training program. |
| Control group | No intervention | –No intervention will be applied to the control group during the study period. After the post-test, the same education program will be provided to the control group. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Enrolled at Şehit Yavuz Başayar Primary School
- Currently attending 2nd, 3rd, or 4th grade
- Willing to participate in the study
- Having parental consent
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Lack of parental consent
- Inability to complete the data collection tools
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 |
|---|---|---|
| Healthy Lifestyle EducationA healthy lifestyle education program consisting of two sessions over a two-week period will be implemented for children. The program includes topics such as hygiene, nutrition, physical activity, and health protection. | Behavioural | Experimental Group |
Primary outcome
Healthy lifestyle skills level
Time frame: Pre-intervention, immediately after the intervention, and 1-month after the intervention.
The Healthy Lifestyle Skills Scale for Children Aged 8-10 is a validated instrument developed to assess healthy lifestyle skills among primary school children aged 8-10 years. The scale consists of 22 items and four subdimensions: health protection (7 items), cleaning and hygiene (8 items), sports and physical activity (4 items), and proper nutrition (3 items). All items are rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("always"). The total score ranges from 22 to 110, with higher scores indicating better healthy lifestyle skills. Based on score ranges, scores between 22-69 indicate low, 70-89 moderate, and 90-110 high levels of healthy lifestyle skills. The scale can be administered individually or in groups and takes approximately 15-20 minutes to complete. It is self-reported and will be completed by the students under researcher supervision.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle Education in people with Healthy Lifestyle Behaviors, run by Gazi University.
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 4 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sultan Ayaz Alkaya, Professor, PhD (+903122162649, sultan@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy lifestyle skills level (time frame: Pre-intervention, immediately after the intervention, and 1-month after the intervention.). 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 22 Apr 2026.