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School-based Randomized Trial of SunSmart Interventions

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University of Southern California

Status

Completed

Conditions

Skin Neoplasm

Treatments

Other: UV Dosimetry Laboratory

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04176237
HS-11-00677

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,750 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

3,750 participants in 3 patient groups

Intervention
Experimental group
Description:
Schools receive 3 one hour lessons on sun safety, followed by a 1 hour UV dosimtery laboratory session.
Treatment:
Other: UV Dosimetry Laboratory
Control
No Intervention group
Description:
Schools receive 3 one hour lessons on sun safety.
Observation
No Intervention group
Description:
Schools do not receive any lessons.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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