School-based Randomized Trial of SunSmart Interventions
Primary Purpose
Skin Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UV Dosimetry Laboratory
Sponsored by
About this trial
This is an interventional prevention trial for Skin Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Child in classrooms from selected schools in the Los Angeles metropolitan area.
Exclusion Criteria:
- All children will participate in the educational activities, unless they opt out of pre- and post-test questionnaires or are absent from school for any of the education sessions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Intervention
Control
Observation
Arm Description
Schools receive 3 one hour lessons on sun safety, followed by a 1 hour UV dosimtery laboratory session.
Schools receive 3 one hour lessons on sun safety.
Schools do not receive any lessons.
Outcomes
Primary Outcome Measures
Change in sun exposure behavior
Self reported change in sun exposure behavior using 4 questions in a self-completed questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT04176237
First Posted
November 21, 2019
Last Updated
November 25, 2019
Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04176237
Brief Title
School-based Randomized Trial of SunSmart Interventions
Official Title
A Novel Intervention to Improve Sun Exposure Awareness and Behavior in Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
January 10, 2017 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure.
Detailed Description
Childhood sun exposure not only increases melanoma risk, but may establish lifetime patterns of exposure and protection. Individuals receive a substantial proportion of lifetime exposure to ultraviolet radiation (UVR) during childhood, and severe sunburns before age 20 may increase lifetime risk of developing melanoma. The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure. Building on the previously existing SunSmart program the investigators have been conducting in 20 local Los Angeles schools in partnership with USC's Joint Education Project (JEP), this study will implement a Randomized Controlled Trial among 5th-6th graders (aged 10-14), comparing this new education-feedback approach to the existing SunSmart education-only program, testing knowledge, attitudes and behavior before and after the intervention. In a subset of students, the investigators will collect real time UV exposure data using personal dosimetry as a Gold Standard measure of change in UV exposure behaviors. The study design randomizes at least 18 schools to 9 intervention or 9 non-intervention (control) schools, and students within each school all have pre- and post-tests. The investigators will also select classrooms from each school across conditions to have students wear dosimeters pre- and post- Intervention/Control. Using a hierarchical cluster analysis with the school unit taken as random and students as repeated measures within school, the investigators will test the primary hypothesis that improvements in sun exposure behaviors are significantly higher than baseline at post-test in the Intervention than Control group, and that this may even occur without significant differences in sun exposure knowledge and attitudes between the two groups. The investigators will additionally test the hypothesis that total UV exposures obtained from UV dosimetry are significantly lower than baseline in the Intervention than control group after Intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Neoplasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Schools are randomized to receive one of three conditions: (1) Intervention (the expanded SunSmart program); (2) Control (regular SunSmart program); (3) Observation only. Schools in groups (2) and (3) receive the expanded SunSmart program at the conclusion of their participation in data collection.
Masking
Participant
Masking Description
Children in schools do not know which arm they are in. Schools and Investigators do know which arm a school is in.
Allocation
Randomized
Enrollment
3750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Schools receive 3 one hour lessons on sun safety, followed by a 1 hour UV dosimtery laboratory session.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Schools receive 3 one hour lessons on sun safety.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Schools do not receive any lessons.
Intervention Type
Other
Intervention Name(s)
UV Dosimetry Laboratory
Intervention Description
The UV Dosimetry Laboratory is a one hour lesson that incorporates science and health education - kids hypothesize what UV levels will be around the school yard, go and measure UV, review their results, and then come up with a SunSmart plan for playing in the school yard.
Primary Outcome Measure Information:
Title
Change in sun exposure behavior
Description
Self reported change in sun exposure behavior using 4 questions in a self-completed questionnaire
Time Frame
One week after completion of education activities
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Child in classrooms from selected schools in the Los Angeles metropolitan area.
Exclusion Criteria:
All children will participate in the educational activities, unless they opt out of pre- and post-test questionnaires or are absent from school for any of the education sessions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myles G Cockburn, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33971211
Citation
Miller KA, Huh J, Piombo SE, Richardson JL, Harris SC, Peng DH, Cockburn MG. Sun protection changes among diverse elementary schoolchildren participating in a sun safety intervention: A latent transition analysis of a randomized controlled trial. Prev Med. 2021 Aug;149:106601. doi: 10.1016/j.ypmed.2021.106601. Epub 2021 May 7.
Results Reference
derived
Learn more about this trial
School-based Randomized Trial of SunSmart Interventions
We'll reach out to this number within 24 hrs