Rural Adult and Youth Sun Protection Study - Rural Baseball R01
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 843
- 试验地点
- 2
- 主要终点
- Directly observed child sunscreen application
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Masking will only be used for participants in the study. Investigators will know which arm of the study each participant has been randomized to.
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
RAYS Intervention
The RAYS arm is the intervention being tested, which will include skin cancer prevention education and providing participants with sun-safety supplies.
干预措施: RAYS Intervention (Behavioral)
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.
结局指标
主要结局
Directly observed child sunscreen application
时间窗: 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.
Directly observed child hat wearing
时间窗: 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.
Directly observed child shade seeking
时间窗: 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.
Directly observed child wearing long sleeves
时间窗: 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.
次要结局
- Parent-reported child sun protection behaviors(At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline)
- Parent-report child sunburn(At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline)
研究者
Yelena Wu
Associate Professor, Department of Dermatology; Investigator
University of Utah