School-based Randomized Trial of SunSmart Interventions

Skin Neoplasm Clinical Trial

Official title:

A Novel Intervention to Improve Sun Exposure Awareness and Behavior in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176237
• Other study ID #: HS-11-00677
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: November 30, 2018

Study information

• Verified date: November 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3750
• Est. completion date: November 30, 2018
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Neoplasm
• Skin Neoplasms

Intervention

Other:
• UV Dosimetry Laboratory
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sun exposure behavior	Self reported change in sun exposure behavior using 4 questions in a self-completed questionnaire	One week after completion of education activities