- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03745872
SunSmart Intervention in Schools
January 3, 2022 updated by: University of Colorado, Denver
A prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention.
Study Overview
Detailed Description
This study aims to demonstrate that learning about sun exposure using a more classroom-based intervention will motivate classroom students to reduce exposure at a critical life period and will create lifetime learned sun exposure behaviors.
Students' sun exposure behaviors will be assessed prior to the educational intervention.
The educational intervention consists of three educational sessions and one lab lesson.
At the conclusion of the intervention, students' sun exposure behaviors will be assessed again via a post-intervention questionnaire.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any children between grades 4 and 8 enrolled in one of the participating schools.
Exclusion Criteria:
- No exclusions, but children or their parents may opt out of participating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Testing
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.
|
Students participating in this study will receive a pre test, instruction regarding sun safety, and a post test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sun Exposure Knowledge
Time Frame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
|
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
Time Frame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
|
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
Time Frame: From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mediators of Program Effects: Attitudes
Time Frame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
|
Assessing children's attitude toward sun exposure through a self-completed questionnaire
|
During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
|
|
Mediators of Program Effects: Norms
Time Frame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
|
Determining children's understanding of social norms regarding tanning and sun protection through a self-completed questionnaire
|
During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
|
|
Mediators of Program Effects: Personal Agency
Time Frame: During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
|
Determining children's understanding of behavioral control regarding sun protection through a self-completed questionnaire
|
During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evelinn Borrayo, PhD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2017
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
November 15, 2018
First Submitted That Met QC Criteria
November 15, 2018
First Posted (Actual)
November 19, 2018
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
January 3, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0667.cc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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