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

NCT ID: NCT05367180

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reference Arm

no preventive action

Group Type NO_INTERVENTION

No interventions assigned to this group

Vivre avec le Soleil

Use of existing validated program "vivre avec le soleil"

Group Type EXPERIMENTAL

"Vivre avec le Soleil" prevention program on sun risks

Intervention Type OTHER

Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months

Vivre avec le Soleil + program of MISOLRE association

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

Group Type EXPERIMENTAL

MISOLRE prevention program on sun risks

Intervention Type OTHER

Training of an ambassador class by a field coordinator Dissemination of the information by the ambassador class to the other classes of the school drawn by lot Transmission of an information document to parents on photoprotection to make them aware of the actions to adopt

"Vivre avec le Soleil" prevention program on sun risks

Intervention Type OTHER

Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months

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

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

Group Type EXPERIMENTAL

MISOLRE prevention program on sun risks

Intervention Type OTHER

Training of an ambassador class by a field coordinator Dissemination of the information by the ambassador class to the other classes of the school drawn by lot Transmission of an information document to parents on photoprotection to make them aware of the actions to adopt

"Vivre avec le Soleil" prevention program on sun risks

Intervention Type OTHER

Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months

Sun protection equipment

Intervention Type OTHER

Distribution of sunscreen, caps and sunglasses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MISOLRE prevention program on sun risks

Training of an ambassador class by a field coordinator Dissemination of the information by the ambassador class to the other classes of the school drawn by lot Transmission of an information document to parents on photoprotection to make them aware of the actions to adopt

Intervention Type OTHER

"Vivre avec le Soleil" prevention program on sun risks

Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months

Intervention Type OTHER

Sun protection equipment

Distribution of sunscreen, caps and sunglasses

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoine BERTOLOTTI

Role: PRINCIPAL_INVESTIGATOR

CHU de La Réunion

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de La Réunion

Saint-Pierre, , Reunion

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Reunion

References

Explore related publications, articles, or registry entries linked to this study.

Dugast C, Bruneau L, Fianu A, Ferdynus C, Boussaid K, Vuichard J, Duloutre F, Dumez J, Sultan-Bichat N, Bertolotti A. PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island. BMJ Open. 2024 May 15;14(5):e082045. doi: 10.1136/bmjopen-2023-082045.

Reference Type DERIVED
PMID: 38754877 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022/CHU/09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MoleGazer Development Feasibility Study
NCT05015816 ACTIVE_NOT_RECRUITING NA