NCT03243929

Brief Summary

The purpose of the Translation of District Sun Safe Policies to Schools study was to test whether schools need assistance to facilitate the implementation of school district board-approved sun safety policies by individual elementary schools. The intervention is expected to produce a change in practices at the school level and to improve the sun safety behavior of children attending the intervention schools compared to control schools. A group of 40 school districts in Southern California that adopted board policy 5141.7 for sun safety provided 118 schools that were randomized to a intervention condition or to an attention control condition. The primary outcome is change in school-level sun safety practices based on 10 Centers for Disease Control and Prevention (CDC) categories for policy change (i.e., sunscreen use, UV protective clothing, hats, student education, teacher education, provision of shade, scheduling to avoid peak UV exposure, parent outreach, resource allocation for sun safety, and an accountability system). This primary outcome was assessed by a survey of the principal and one teacher at each school (N=118 principals and 113 teachers at pretest). Parents (N=1770 at pretest) of children attending the schools completed a self-report measure assessing the secondary outcomes of change in individual-level sun safety behavior of their elementary school aged children and number of communications received from the school regarding sun safety. Assessment of principals, teachers and parents occurred at pretest, just prior to randomization, and at a posttest 20-months after the pretest. One Parent Teacher Association (PTA) representative per school was contacted to assess PTA involvement in intervention activities related to sun safety. The primary hypothesis was stated for the effectiveness of the intervention condition at increasing school-level sun safety practices consistent with the sun safety policies of the school districts and read, H1: At follow-up, a greater percentage of schools in the intervention condition will implement at least one component of the school district sun safety policy compared to schools randomized to the attention-control condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

August 6, 2017

Last Update Submit

July 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure of implementation of sun safety practices and policy at schools

    Change in implementation of sun safety policy after intervention, through survey administration

    20 Months

Secondary Outcomes (1)

  • Students sun protection behavior

    20 Months

Study Arms (2)

Intervention

EXPERIMENTAL

All participants in the Translation of District Sun Safe Policies to Schools arm received 1) initial coaching meeting that guided principals through an evaluation of current sun safety practices, the selection of goals for the implementation of sun safety practices, and guidance on the use of intervention materials to support implementation of sun safety practices in the school, 2) follow-up communications from coaches including email, telephone, and virtual meetings, 3) access to media and online resources to support implementation of sun safety practices, 4) mini-grants to support changes in school sun safety practices.

Behavioral: Translation of District Sun Safe Policies to Schools

Attention Control

OTHER

All participants in the attention control arm received three emails during the 20 month intervention period including (1) NASBE's Fit Healthy and Ready to Learn; A School Health Guide Part II: Policies to Promote Sun Safety and Prevent Skin Cancer, (2) CDC's Guidelines for Sun Safety to Prevent Skin Cancer, and (3) a link to the Surgeon General's 2014 Call to Action to Prevent Skin Cancer. This attention-control treatment will equalize schools on awareness of recommendations to implement school sun safety.

Behavioral: Attention Control

Interventions

Translation of District Sun Safe Policies to Schools intervention was guided by Diffusion of Innovation Theory. Principals and other staff in intervention schools received 1) initial coaching meeting that guided principals through an evaluation of current sun safety practices, the selection of goals for the implementation of sun safety practices, and guidance on the use of intervention materials to support implementation of sun safety practices in the school, 2) follow-up communications from coaches including email, telephone, and virtual meetings, 3) access to media and online resources to support implementation of sun safety practices, 4) mini-grants to support changes in school sun safety practices. These components promoted implementation of the 10 policy components recommended by CDC.

Intervention

Schools in the control condition received three emails during the 20 month intervention period including (1) NASBE's Fit Healthy and Ready to Learn; A School Health Guide Part II: Policies to Promote Sun Safety and Prevent Skin Cancer, (2) CDC's Guidelines for Sun Safety to Prevent Skin Cancer, and (3) a link to the Surgeon General's 2014 Call to Action to Prevent Skin Cancer. This attention-control treatment will equalize schools on awareness of recommendations to implement school sun safety.

Attention Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • School districts in California with school Board Policy 5141.7 available online, and with at least one elementary school.

You may not qualify if:

  • Schools Districts that do not have school Board Policy 5141.7 online, or do not have any elementary schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claremont Graduate University

Claremont, California, 91711, United States

Location

Related Publications (1)

  • Reynolds KD, Buller DB, Buller MK, Massie K, Berteletti J, Ashley J, Meenan R. Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools. Prev Med. 2020 Aug;137:106125. doi: 10.1016/j.ypmed.2020.106125. Epub 2020 May 7.

Study Officials

  • Kim D Reynolds, PhD

    Claremont Graduate University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor

Study Record Dates

First Submitted

August 6, 2017

First Posted

August 9, 2017

Study Start

January 13, 2014

Primary Completion

March 21, 2018

Study Completion

April 10, 2018

Last Updated

July 20, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations