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临床试验/NCT05367180
NCT05367180已完成不适用

Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 2 个国家目标入组 1,452 人开始时间: 2022年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,452
试验地点
2
主要终点
Effectiveness of 3 programs of awareness of the risks related to sun exposure, delivered in primary school classes in Reunion Island, on students' knowledge of sun prevention

研究概览

简要总结

Sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.The worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. The country with the highest age-standardized incidence rate is Australia, where 40.4 cases per 100,000 men and 27.5 cases per 100,000 women were reported in 2018. Since 2008, however, this incidence has decreased by 11% in the 14-49 age group following the implementation of effective sun safety campaigns. In the French overseas department of Reunion Island, which is characterized by a great diversity of skin phototypes due to multiple migratory flows, the ultraviolet (UV) index is very high - equivalent to that in Australia. The age-standardized incidence rate of melanoma Reunion Island increased fourfold between 1995 and 2015. In 2015, it was estimated at nearly 30.0 new cases per 100,000 inhabitants in people with skin phototypes I-III, compared to 13.5 in metropolitan France.

Over the course of a lifetime, 80% of exposure to UV radiation and 50% of skin damage occur before the age of 21, mainly in the school environment. In spite of this, knowledge of the risks associated with sun exposure remains insufficient among children and adolescents. Similar quantitative data have been reported for Reunion Island by the local association MiSolRé (Mission Soleil Réunion), which has been running sun safety campaigns in elementary schools since 2017. However, methodological limitations compromise the validity and extrapolation of the results. And the question arises as to the type of programme to be implemented: strengthening individual skills through health education methods? Community reinforcement through training activities involving peers? Improving access to prevention? Thus, it seems necessary to rigorously evaluate the effectiveness of different actions such as the educational programme "Vivre avec le soleil" alone or associated with the visit of professionals in the field with or without distribution of photoprotection material. The aim of this randomized controlled trial is to evaluate the effectiveness of three awareness-raising programmes on the risks linked to sun exposure, delivered in primary school classes in Reunion Island, on the pupils' knowledge of sun prevention.

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
None

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • students in a primary school in Reunion Island, drawn by lot for the study and whose school director agrees to participate in the program
  • in a primary school with more than 10 classes
  • within a class from the second and the third cycle: CE (elementary course) 1, CE2, CM (average course) 1 or CM2
  • whose 2 parents have given their consent

排除标准

  • in a school that has already benefited from the awareness program by the MiSolRé association in 2016/2017, 2017/2018, 2019/2020, 2020/2021
  • in CP (preparatory course) class
  • in a multi-level class

研究组 & 干预措施

Reference Arm

No Intervention

no preventive action

Vivre avec le Soleil

Experimental

Use of existing validated program "vivre avec le soleil"

干预措施: "Vivre avec le Soleil" prevention program on sun risks (Other)

Vivre avec le Soleil + program of MISOLRE association

Experimental

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association

干预措施: MISOLRE prevention program on sun risks (Other)

Vivre avec le Soleil + program of MISOLRE association

Experimental

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association

干预措施: "Vivre avec le Soleil" prevention program on sun risks (Other)

Vivre avec le Soleil + program of MISOLRE association + sun protections

Experimental

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association and with the distribution of caps, sunscreens and sunglasses

干预措施: MISOLRE prevention program on sun risks (Other)

Vivre avec le Soleil + program of MISOLRE association + sun protections

Experimental

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association and with the distribution of caps, sunscreens and sunglasses

干预措施: "Vivre avec le Soleil" prevention program on sun risks (Other)

Vivre avec le Soleil + program of MISOLRE association + sun protections

Experimental

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association and with the distribution of caps, sunscreens and sunglasses

干预措施: Sun protection equipment (Other)

结局指标

主要结局

Effectiveness of 3 programs of awareness of the risks related to sun exposure, delivered in primary school classes in Reunion Island, on students' knowledge of sun prevention

时间窗: 6 months after inclusion

self questionnaire completed by the students. Comparison of pourcentage of good response to knowledge questionnaire in the 4 arms. No minimum or maximum score.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

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