Introduction:
Reunion Island, a French overseas department, is located in the southern hemisphere, close to the Capricorn tropic in the same range of latitudes as Australia. This island has a multi-cultural and multi-ethnicpopulation of 860,000 inhabitants, a quarter of whom are at high risk of developing skin cancer due to intense ultraviolet radiation. Melanoma is responsible for the majority of skin cancer deaths. The early prevention of melanoma is based on sun protection in childhood, but Reunion Island complies with the regulations of mainland France, which are not adapted to the environmental conditions of this tropical region.
Objective:
The main objective of our study is to evaluate the effectiveness of three sun protection programs conducted in Reunionese primary schools through a pupil knowledge questionnaire.
Trial design:
PRESOLRE is an interventional, open-label, cluster-randomised controlled trial, in 4 parallel arms, that is being conducted throughout 2022-2023 on Reunion Island. The trial design assumes an escalation interventional effect using: first, a control arm without proposed intervention (arm 1); second, an arm whose classes of pupils are encouraged to use the validated educational program ‘Living with the sun’ (arm 2); third, an arm whose classes of pupils are encouraged to use both ‘Living with the sun’ combined with MiSolRé's sun protection awareness program (arm 3); fourth, an arm whose classes of pupils are encouraged to use ‘Living with the sun’ combined with MiSolRé's sun protection awareness program, and who receive a distribution of hats, sunglasses and sun creams (arm 4). In all, 1,780 pupils from eighty classes of 20 pupils, on average, will be included. Randomisation applies to the classes of pupils (so defined as clusters). The analysis of the primary outcome is based on the proportion of correct answers to the knowledge questions after the awareness program, compared between the 4 arms using a linear mixed model with random intercept.
Implications for public health:
The public health perspective of this interventional research protocol is to scale up the best sun protection programs for both the entire Reunion Island territory and the other tropical French overseas departments.
Trial registration number: ID: NCT05367180