NCT04829942

Brief Summary

It is very important for children to take their own health responsibilities in giving them positive health behavior. The rapid advancement of technology, cultural differences, changing living conditions, and increasing chronic diseases show us that people should have the authority to make decisions about their own health, starting from primary school and childhood. All these bring the concept of health literacy to the fore. According to WHO, the concept of health literacy is the cognitive and social skills about individuals' ability to access, understand and use information and their desires in order to protect and improve well-being in health. Providing appropriate health education for age groups is very important for the development of health literacy in children. School-based health education is necessary for health promotion in the 21st century. Studies show that children's health literacy levels are low. There are very few scales that measure health literacy in children. Although there are no school health nursing practices in Northern Cyprus, there are no training programs to develop positive health behaviors. With this study we have planned, it is aimed to implement a training program within the scope of the "School Health Nursing Program" in primary schools selected as a pilot in Northern Cyprus and to form the foundations of School health nursing in our country in line with its results. In addition, measurement tools specific to age groups are needed to measure the level of health literacy, especially in school-age children. Therefore, another purpose of this study is to evaluate the effectiveness of this program on children by implementing an education program within the scope of the "School Health Nursing Program", which will be a first in our country, and to develop the "Child Health Literacy Scale" and to make it a significant contribution to science with this scale.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

March 22, 2021

Last Update Submit

August 17, 2021

Conditions

Keywords

school healthnursingleadershiphealth literacy

Outcome Measures

Primary Outcomes (4)

  • With the school health nursing program to be implemented within 6 months, a moderate increase in physical activity, nutrition and health perception and behavior scale scores of students is expected.

    power analyze

    6 month

  • Nutrition Behavior Scale

    The scale was developed to determine the nutritional consumption of children. It consists of 14 items. High scores on the scale indicate that the children are healthy.

    6 mounth

  • Health Perceptions and Health Behaviors Scale in Children

    This scale was developed by Walker Sechrst and Pender to evaluate children's health perceptions and health behaviors

    6 Mounth

  • Physical Activity Self-Efficacy Scale for Children

    This scale was developed to evaluate the physical activity and self-efficacy levels of primary school students

    6 Mounth

Study Arms (2)

experimental

EXPERIMENTAL

A 12-week training program will be applied to the experimental group. Pre-tests will be applied before the trainings begin, and height and weight measurement, nutrition, health perception and behavior scale and physical activity scale will be applied to the experimental group and the control group within the 3rd and 6th month after the training program begins. Scale applications will be applied within 2 days, taking into account the attention span of the students.

Behavioral: positive health behavior

no intervention

NO INTERVENTION

Power point presentations will be given to the control group

Interventions

Training on nutrition, physical activity, first aid, individual hygiene, violence and bullying will be provided to the initiative group.

experimental

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All male and female students in the 9-11 age group in the two primary schools where the study will be conducted.

You may not qualify if:

  • All male and female students except 9-11 age group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Location

Related Publications (5)

  • Edmundson E, Parcel GS, Perry CL, Feldman HA, Smyth M, Johnson CC, Layman A, Bachman K, Perkins T, Smith K, Stone E. The effects of the child and adolescent trial for cardiovascular health intervention on psychosocial determinants of cardiovascular disease risk behavior among third-grade students. Am J Health Promot. 1996 Jan-Feb;10(3):217-25. doi: 10.4278/0890-1171-10.3.217.

    PMID: 10163302BACKGROUND
  • Liu Y, Tang Y, Cao ZB, Zhuang J, Zhu Z, Wu XP, Wang LJ, Cai YJ, Zhang JL, Chen PJ. Results from the China 2018 Report Card on physical activity for children and youth. J Exerc Sci Fit. 2019 Jan;17(1):3-7. doi: 10.1016/j.jesf.2018.10.002. Epub 2018 Nov 26. No abstract available.

    PMID: 30662507BACKGROUND
  • Chen P. Physical activity, physical fitness, and body mass index in the Chinese child and adolescent populations: An update from the 2016 Physical Activity and Fitness in China-The Youth Study. J Sport Health Sci. 2017 Dec;6(4):381-383. doi: 10.1016/j.jshs.2017.09.011. Epub 2017 Sep 29. No abstract available.

    PMID: 30356661BACKGROUND
  • Knisel E, Rupprich H, Wunram A, Bremer M, Desaive C. Promotion of Elementary School Students' Health Literacy. Int J Environ Res Public Health. 2020 Dec 21;17(24):9560. doi: 10.3390/ijerph17249560.

    PMID: 33371224BACKGROUND
  • Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.

Central Study Contacts

RASİHA GÜLER, 1

CONTACT

HÜLYA FIRAT KILIÇ, 2

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There will be 4th grade students of two primary schools in the Kyrenia region. In the study, it is expected that there will be a moderate increase in the scale scores of the experimental group children after the education.Similarly, 30 people will be taken for the control group, and the sample size is 60 people, 30 being experimental and 30 control groups.In the second stage, the development of the "Child Health-Literacy Scale" will be carried out with 6458 students in the 9-11 age group attending 4th and 5th grades of primary schools.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: "School Health Nursing Application Program", which is included in the first stage of the research, will be applied. Similarly, 30 people will be taken for the control group, and the sample size is 60 people, 30 being experimental and 30 control groups. In the second stage, the development of the "Child Health-Literacy Scale" will be carried out with 6458 students in the 9-11 age group who attend 4th and 5th grades of primary schools. Students will be determined by simple random sampling method among 4th and 5th grade students of primary schools in Kyrenia, Nicosia, Güzelyurt, Famagusta and İskele districts.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 2, 2021

Study Start

April 1, 2022

Primary Completion

April 1, 2022

Study Completion

October 15, 2022

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

statistical analyze

Shared Documents
SAP, CSR

Locations