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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
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

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

    First Posted
    November 21, 2019
    Last Updated
    November 25, 2019
    Sponsor
    University of Southern California
    Collaborators
    National Institutes of Health (NIH)
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    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

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