School-based Randomized Trial of SunSmart Interventions

NCT04176237 | Completed

• 1 other identifier: HS-11-00677
• Study Type: interventional
• Target: 3,750
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Intervention

EXPERIMENTAL

Schools receive 3 one hour lessons on sun safety, followed by a 1 hour UV dosimtery laboratory session.

Other: UV Dosimetry Laboratory

Control

NO INTERVENTION

Schools receive 3 one hour lessons on sun safety.

Observation

NO INTERVENTION

Schools do not receive any lessons.

Interventions

UV Dosimetry Laboratory OTHER

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Child in classrooms from selected schools in the Los Angeles metropolitan area.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Institutes of Health (NIH): collaborator

Related Publications (1)

• 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.

  PMID: 33971211 DERIVED

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Myles G Cockburn, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Children in schools do not know which arm they are in. Schools and Investigators do know which arm a school is in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: January 1, 2014
• Primary Completion: January 10, 2017
• Study Completion: November 30, 2018
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share