NCT04396431

Brief Summary

The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group was implemented in February- October 2014 in Turkey. After obtaining the parents' and the children's written consent, data were collected through face-to-face interviews using, the instruments (stages of change, the decisional balance scale, child and parental sun protection behavior form, self-efficacy form) on sun protection based on the transtheoretical model.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Status
completed

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 Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 15, 2020

Last Update Submit

May 18, 2020

Conditions

Keywords

nursingTranstheoretical modelsun protectionself-efficacydecisional balanceprevention

Outcome Measures

Primary Outcomes (1)

  • self-efficacy

    examines self efficacy regarding protection from the sun. It is also scored on a five-point scale (1 - not at all confident, 2 - not very confident, 3 - moderately confident, 4 - very confident, and 5 - extremely confident)

    6 months

Secondary Outcomes (1)

  • sun protection behavior

    6 months

Study Arms (1)

2

OTHER

The intervention group was offered a six-hour training program based on the transtheoretical model in order to promote sun protection behavior and to reinforce self-efficacy.

Behavioral: education

Interventions

educationBEHAVIORAL

The intervention group was offered a six-hour training program based on the transtheoretical model in order to promote sun protection behavior and to reinforce self-efficacy. The program was prepared by the researchers in consideration of the SunSmart Program implemented in Australia, the SunWise School Program developed by the United States Environmental Protection Agency. The program included various educational tools such as a sun protection story, activity book, PowerPoint presentations, cartoons, and puzzles. Refresher training was conducted 15 days, 1 month, and 2 months after the initial training. Sun protection behavior and self-efficacy of the children were evaluated at the beginning of the study and six months after the program. As gifts to support their sun protection behavior, the children were given an FDA-approved sunscreen with 50+ SPF, a white cotton short-sleeved T-shirt as protective clothing, sunglasses with 100% UV protection, and a wide-brimmed hat.

2

Eligibility Criteria

Age8 Years - 9 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsschool-aged children
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age between 8 and 9
  • have the consent of a parent
  • Fitzpatrick skin type between 1 and 3

You may not qualify if:

  • Fitzpatrick skin type between 4 and 6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate prof

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 20, 2020

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2015

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share