Rural Adult and Youth Sun Protection Study

Официальное название

Rural Adult and Youth Sun Protection Study - Rural Baseball R01

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Directly observed child sunscreen application [Срок оценки: At baseline and post-intervention (3-6 weeks after intervention has been delivered)]
• Directly observed child hat wearing [Срок оценки: At baseline and post-intervention (3-6 weeks after intervention has been delivered)]
• Directly observed child wearing long sleeves [Срок оценки: At baseline and post-intervention (3-6 weeks after intervention has been delivered)]
• Directly observed child shade seeking [Срок оценки: At baseline and post-intervention (3-6 weeks after intervention has been delivered)]

Вторичные конечные точки (2)

• Parent-reported child sun protection behaviors [Срок оценки: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline]
• Parent-report child sunburn [Срок оценки: At baseline, post-intervention (3-6 weeks after intervention has been delivered), and one year post-baseline]

Критерии участия

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• University of Utah — Salt Lake City
• West Virginia University — Morgantown

Публикации

• Wu YP, Chipman J, Boatman D, Welch K, Sleiman MM Jr, Moyano J, Jarrett Z, Statman MR, Braun E, Balls N, Grossman D, Abildso CG, Dzewaltowski D, VoPham T, Schlechter C, Wetter DW, Tercyak KP. The Rural Adult and Youth Skin protection study (RAYS): Protocol for a sun protection intervention trial in rural Utah and West Virginia sports programs. Contemp Clin Trials. 2026 Jul 31:108417. doi: 10.1016/j PMID 42537926

Идентификаторы

NCT: NCT06439979 · 00173007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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