NCT03745872

Brief Summary

A prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 26, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

3.9 years

First QC Date

November 15, 2018

Last Update Submit

January 3, 2022

Conditions

Keywords

SunscreenSun ExposureBehaviorsBaseline AssessmentsFollow-up AssessmentsKnowledge

Outcome Measures

Primary Outcomes (3)

  • Sun Exposure Knowledge

    Determining children's knowledge of sun exposure risk through a self-completed questionnaire

    From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years

  • Sun Exposure Attitudes

    Determining children's attitude toward sun exposure through a self-completed questionnaire

    From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years

  • Sun Exposure Behavior

    Determining children's behavior toward sun exposure through a self-completed questionnaire

    From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years

Secondary Outcomes (3)

  • Mediators of Program Effects: Attitudes

    During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years

  • Mediators of Program Effects: Norms

    During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years

  • Mediators of Program Effects: Personal Agency

    During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years

Study Arms (1)

Testing

EXPERIMENTAL

This is a preventative study model. All students who choose to participate will receive a pre and post test regarding their sun exposure behaviors and knowledge on sun exposure risk.

Behavioral: Knowledge Assessment

Interventions

Students participating in this study will receive a pre test, instruction regarding sun safety, and a post test.

Testing

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any children between grades 4 and 8 enrolled in one of the participating schools.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

MelanomaBehavior

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Evelinn Borrayo, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participant names will be written on pre and post test to enable matching purposes, but once this has been completed, only the study ID will be used.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All students who participate in this study will be given a pre test, instruction regarding sun exposure and a post test to determine their sun exposure behaviors and knowledge of sun exposure risks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

September 26, 2017

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations