Rural Adult and Youth Sun Protection Study (RAYS)

August 6, 2026 updated by: Yelena Wu, University of Utah

Rural Adult and Youth Sun Protection Study - Rural Baseball R01

The purpose of this study is to help prevent skin cancer by improving the use of sun protective behaviors among youths living in rural communities in Utah and West Virginia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Children living in rural and under-served communities are at high risk for skin cancer; however, there are no evidence-based sun safety interventions showing durable effects for this vulnerable pediatric population. The objective of this proposal is to rigorously test a novel, multi-level approach to skin cancer prevention among young rural children that is delivered through developmental baseball leagues. To attain this objective, the investigators will conduct a two-arm cluster-randomized trial with the primary outcome being multi-behavior sun protection change among children.

Study Type

Interventional

Enrollment (Estimated)

843

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yelena P Wu, PhD
    • West Virginia
      • Morgantown, West Virginia, United States, 26501
        • Not yet recruiting
        • West Virginia University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dannell Boatman, EdD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Parent inclusion criteria:

i. Adults who currently have children ages 3 and older years of age playing on participating sports teams in leagues serving rural areas in Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)

ii. Live and/or work in rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems)

Coach/leader inclusion criteria:

i. Adults who serve as coaches or leaders of recreational sports (i.e. baseball/softball, soccer, flag football, etc.) teams or developmental programs serving children ages 3 and older

ii. Live and/or work in rural areas of Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)

Participant inclusion criteria for minor participants (ages 3 and older) are as follows:

i. Live in rural communities and/or participate in sports leagues serving rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems).

Participant inclusion criteria for key informant interviews are as follows:

i. Adults who serve as leaders or who are affiliated with sports leagues or community groups serving rural youths and/or adults who currently have minor children 3 years of age or older playing on participating sports teams and/or adults who live and/or work in rural communities in Utah or West Virginia ((≥4 as defined by the RUCA or RUCC systems)

Local sports leagues will be eligible to participate if they convene recreational sports (i.e. baseball/softball) teams or developmental programs (i.e. T-ball and coach pitch) for children ages 3 and older.

Exclusion Criteria:

  • Adults and children who do not speak or read English will be excluded.
  • For individuals asked to complete surveys, individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of these surveys will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAYS Intervention
The RAYS arm is the intervention being tested, which will include skin cancer prevention education and providing participants with sun-safety supplies.
Behavioral: RAYS Intervention
Developmental baseball leagues will be randomly assigned to RAYS vs. control. Outcomes include directly-observed child sun safety behaviors after controlling for environmental ultra-violet radiation (UVR), with parent-reported child sun protection and other related endpoints at 1 year.
No Intervention: Control
The Control arm of the study will not receive any skin cancer prevention information or sun-safety materials but will only receive general injury prevention information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Directly observed child sunscreen application
Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)

Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who applied sunscreen at any time during the practice or game. This tallied number will create a percentage of the team that applied sunscreen. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.

"How many wearing sunscreen?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.
At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Directly observed child hat wearing
Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)

Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who wore a hat at any time during the practice or game. This tallied number will create a percentage of the team that wore a hat. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.

"How many wore a hat?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.
At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Directly observed child wearing long sleeves
Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)

Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who wore a long-sleeved shirt at any time during the practice or game. This tallied number will create a percentage of the team that wore protective long-sleeved shirts. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.

"How many wore long sleeves?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.
At baseline and post-intervention (3-6 weeks after intervention has been delivered)
Directly observed child shade seeking
Time Frame: At baseline and post-intervention (3-6 weeks after intervention has been delivered)

Teams and their players will be observed once at the beginning and once at the end of the baseball season. A trained research assistant will tally the total number of children who spent time in shade or under an umbrella at any time during the practice or game. This tallied number will create a percentage of the team that spent time in shade/under umbrella. The percentages from the beginning and end of the season will be compared to determine the effectiveness of the intervention.

"How many in shade/under umbrella?" Higher percentages indicate higher proportion of players on the team who engaged in that sun protective behavior.
At baseline and post-intervention (3-6 weeks after intervention has been delivered)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported child sun protection behaviors
Time Frame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline

A random sample of parents will report on their child's use of sun protection using the Sun Habits Survey, a well-established and valid measure. These same parents will be asked to complete questionnaires at baseline, end-of-season, and at 1 year follow-up.

"On a warm and sunny day, how often did your child...Use sunscreen with a sun protective factor (SPF) of 30+?" All parent-reported items will be assessed on a 5-point Likert-type scale ("Never" to "Always").
At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline
Parent-report child sunburn
Time Frame: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline

Parents will report on the number of sunburns their child experienced during baseball and not during baseball at baseline, post-intervention and one-year post-baseline. Parents will report on child behaviors using items from the Sun Habits Survey.

"How many times did your child have a red OR painful sunburn that lasted a day or more? In the past month? In the past 12 months?" Minimum value = 0, maximum value = 5 or more.

A low number indicates a better outcome.
At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Georgetown University
West Virginia University

Investigators

  • Principal Investigator: Yelena P Wu, PhD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00173007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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