NCT07544069

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 13, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

Health Education, Child, Primary School, Health Behavior, Nursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-intervention, immediately after the intervention, and 1-month after the intervention.

Study Arms (2)

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.

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.

Interventions

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.

Experimental Group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled at Şehit Yavuz Başayar Primary School
  • Currently attending 2nd, 3rd, or 4th grade
  • Willing to participate in the study
  • Having parental consent

You may not qualify if:

  • Refusal to participate in the study
  • Lack of parental consent
  • Inability to complete the data collection tools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health EducationHealth Behavior

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Central Study Contacts

Sultan Ayaz Alkaya, Professor, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr., Faculty of nursing

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 22, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04