- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544069
The Effect of Health Education on Children's Healthy Lifestyle Skills
The Effect of Health Education on Children's Healthy Lifestyle Skills: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sultan Ayaz Alkaya, Professor, PhD
- Phone Number: +903122162649
- Email: sultan@gazi.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrolled at Şehit Yavuz Başayar Primary School
- Currently attending 2nd, 3rd, or 4th grade
- Willing to participate in the study
- Having parental consent
Exclusion Criteria:
- Refusal to participate in the study
- Lack of parental consent
- Inability to complete the data collection tools
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
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.
|
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.
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre-intervention, immediately after the intervention, and 1-month after the intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026 - 575
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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