Rural Adult and Youth Sun Protection Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-7
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
RAYS Intervention
BehavioralDevelopmental 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.
Treatment groups
843 Participants
are divided into 2 treatment groupsGroup A: RAYS InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Directly observed child sunscreen application
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.
Time frame
At baseline and post-intervention (3-6 weeks after intervention has been delivered)2
Directly observed child hat wearing
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.
Time frame
At baseline and post-intervention (3-6 weeks after intervention has been delivered)3
Directly observed child wearing long sleeves
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.
Time frame
At baseline and post-intervention (3-6 weeks after intervention has been delivered)4
Directly observed child shade seeking
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.
Time frame
At baseline and post-intervention (3-6 weeks after intervention has been delivered)Secondary outcomes
1
Parent-reported child sun protection behaviors
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").
Time frame
At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline2
Parent-report child sunburn
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.
Time frame
At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baselineSponsors and contacts
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Source ClinicalTrials.gov