School-based Randomized Trial of SunSmart Interventions

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

3750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-11-30

Brief Summary

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

The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Of Video-based Versus Written Patient Education on Sunscreen

NCT00826306

Dermatology Disease Skin Cancer

COMPLETED NA

Focus Group in Collecting Feedbacks From Indoor Tanning Bed Users for Social Media-Delivered Intervention Development

NCT04179227

Health Status Unknown

TERMINATED

Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

NCT00535769

Skin Cancer

COMPLETED EARLY_PHASE1

Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation

NCT01964222

Cancer

COMPLETED NA

Reducing Delay of Vaccination in Children Study

NCT02665013

Communicable Diseases

COMPLETED NA

Detailed Description

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

Childhood sun exposure not only increases melanoma risk, but may establish lifetime patterns of exposure and protection. Individuals receive a substantial proportion of lifetime exposure to ultraviolet radiation (UVR) during childhood, and severe sunburns before age 20 may increase lifetime risk of developing melanoma. The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure. Building on the previously existing SunSmart program the investigators have been conducting in 20 local Los Angeles schools in partnership with USC's Joint Education Project (JEP), this study will implement a Randomized Controlled Trial among 5th-6th graders (aged 10-14), comparing this new education-feedback approach to the existing SunSmart education-only program, testing knowledge, attitudes and behavior before and after the intervention. In a subset of students, the investigators will collect real time UV exposure data using personal dosimetry as a Gold Standard measure of change in UV exposure behaviors. The study design randomizes at least 18 schools to 9 intervention or 9 non-intervention (control) schools, and students within each school all have pre- and post-tests. The investigators will also select classrooms from each school across conditions to have students wear dosimeters pre- and post- Intervention/Control. Using a hierarchical cluster analysis with the school unit taken as random and students as repeated measures within school, the investigators will test the primary hypothesis that improvements in sun exposure behaviors are significantly higher than baseline at post-test in the Intervention than Control group, and that this may even occur without significant differences in sun exposure knowledge and attitudes between the two groups. The investigators will additionally test the hypothesis that total UV exposures obtained from UV dosimetry are significantly lower than baseline in the Intervention than control group after Intervention.

Conditions

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

Skin Neoplasm

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

Schools are randomized to receive one of three conditions: (1) Intervention (the expanded SunSmart program); (2) Control (regular SunSmart program); (3) Observation only. Schools in groups (2) and (3) receive the expanded SunSmart program at the conclusion of their participation in data collection.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Children in schools do not know which arm they are in. Schools and Investigators do know which arm a school is in.

Study Groups

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

Intervention

Schools receive 3 one hour lessons on sun safety, followed by a 1 hour UV dosimtery laboratory session.

Group Type EXPERIMENTAL

UV Dosimetry Laboratory

Intervention Type OTHER

The UV Dosimetry Laboratory is a one hour lesson that incorporates science and health education - kids hypothesize what UV levels will be around the school yard, go and measure UV, review their results, and then come up with a SunSmart plan for playing in the school yard.

Control

Schools receive 3 one hour lessons on sun safety.

Group Type NO_INTERVENTION

No interventions assigned to this group

Observation

Schools do not receive any lessons.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

UV Dosimetry Laboratory

The UV Dosimetry Laboratory is a one hour lesson that incorporates science and health education - kids hypothesize what UV levels will be around the school yard, go and measure UV, review their results, and then come up with a SunSmart plan for playing in the school yard.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Child in classrooms from selected schools in the Los Angeles metropolitan area.

Exclusion Criteria

* All children will participate in the educational activities, unless they opt out of pre- and post-test questionnaires or are absent from school for any of the education sessions.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes