Back to resultsSunSmart Intervention in Schools
Primary Purpose
Melanoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Knowledge Assessment
Sponsored by
About this trial
This is an interventional prevention trial for Melanoma focused on measuring Sunscreen, Sun Exposure, Behaviors, Baseline Assessments, Follow-up Assessments, Knowledge
Eligibility Criteria
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.
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Testing
Arm Description
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.
Outcomes
Primary Outcome Measures
Sun Exposure Knowledge
Determining children's knowledge of sun exposure risk through a self-completed questionnaire
Sun Exposure Attitudes
Determining children's attitude toward sun exposure through a self-completed questionnaire
Sun Exposure Behavior
Determining children's behavior toward sun exposure through a self-completed questionnaire
Secondary Outcome Measures
Mediators of Program Effects: Attitudes
Assessing children's attitude toward sun exposure through a self-completed questionnaire
Mediators of Program Effects: Norms
Determining children's understanding of social norms regarding tanning and sun protection through a self-completed questionnaire
Mediators of Program Effects: Personal Agency
Determining children's understanding of behavioral control regarding sun protection through a self-completed questionnaire
Full Information
NCT ID
NCT03745872
First Posted
November 15, 2018
Last Updated
January 3, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03745872
Brief Title
SunSmart Intervention in Schools
Official Title
SunSmart Intervention in Schools
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Sunscreen, Sun Exposure, Behaviors, Baseline Assessments, Follow-up Assessments, Knowledge
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Knowledge Assessment
Intervention Description
Students participating in this study will receive a pre test, instruction regarding sun safety, and a post test.
Primary Outcome Measure Information:
Title
Sun Exposure Knowledge
Description
Determining children's knowledge of sun exposure risk through a self-completed questionnaire
Time Frame
From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Title
Sun Exposure Attitudes
Description
Determining children's attitude toward sun exposure through a self-completed questionnaire
Time Frame
From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Title
Sun Exposure Behavior
Description
Determining children's behavior toward sun exposure through a self-completed questionnaire
Time Frame
From the administration of the questionnaire to the end of the followup questionnaire, up to 3 years
Secondary Outcome Measure Information:
Title
Mediators of Program Effects: Attitudes
Description
Assessing children's attitude toward sun exposure through a self-completed questionnaire
Time Frame
During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Title
Mediators of Program Effects: Norms
Description
Determining children's understanding of social norms regarding tanning and sun protection through a self-completed questionnaire
Time Frame
During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
Title
Mediators of Program Effects: Personal Agency
Description
Determining children's understanding of behavioral control regarding sun protection through a self-completed questionnaire
Time Frame
During the followup questionnaire, which is given 3 to 4 weeks post intervention, up to three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelinn Borrayo, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SunSmart Intervention in Schools
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