Sun SafetySSSNCT03243929
Translation of District Sun Safe Policies to Schools
A study testing Translation of District Sun Safe Policies to Schools in people with Sun Safety and Sun Safe Schools, run by Claremont Graduate University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sun Safety, Sun Safe Schools, Prevention of Skin Cancer
- What is being tested?
- Translation of District Sun Safe Policies to Schools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2014to 10 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- School districts in California with school Board Policy 5141.7 available online, and with at least one elementary school.
Who cannot join
- Schools Districts that do not have school Board Policy 5141.7 online, or do not have any elementary schools
Trial locations and contacts
1 site in 1 country.
United States1 site
Claremont Graduate University
Claremont, California, 91711
About this study
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.
- Conditions
- Sun Safety, Sun Safe Schools, Prevention of Skin Cancer
- Being tested
- Translation of District Sun Safe Policies to Schools, Attention Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translation of District Sun Safe Policies to SchoolsBehavioural
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.
Attention ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of implementation of sun safety practices and policy at schools
Change in implementation of sun safety policy after intervention, through survey administration
Measured: 20 Months
Secondary outcomes (1)
Students sun protection behavior
Change in sun safety behaviors after intervention, through survey administration
Measured: 20 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start13 Jan 2014
- Primary completion21 Mar 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sun SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claremont Graduate University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim D. Reynolds, Claremont Graduate University
- Investigators
- Kim D Reynolds, PhD, Principal investigator, Claremont Graduate University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243929
- Sponsor's protocol ID
- 5R01HD074416
- Acronym
- SSS
- Status last verified
- Jul 2018
- First submitted
- 6 Aug 2017
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32389679
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of District Sun Safe Policies to Schools
- ClinicalTrials.gov ID
- NCT03243929
- Acronym / sponsor ID
- SSS / 5R01HD074416
- Conditions
- Sun Safety, Sun Safe Schools, Prevention of Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Claremont Graduate UniversityUniversity, hospital or other
- Study start
- 13 Jan 2014 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Translation of District Sun Safe Policies to SchoolsAll 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. |
| Attention Control | Other | Behavioral: Attention ControlAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- School districts in California with school Board Policy 5141.7 available online, and with at least one elementary school.
Key exclusion criteria (1 listed)
- Schools Districts that do not have school Board Policy 5141.7 online, or do not have any elementary schools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translation of District Sun Safe Policies to SchoolsTranslation 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. | Behavioural | Intervention |
| Attention ControlSchools 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. | Behavioural | Attention Control |
Primary outcome
Measure of implementation of sun safety practices and policy at schools
Time frame: 20 Months
Change in implementation of sun safety policy after intervention, through survey administration
1 secondary outcome
Students sun protection behavior
Time frame: 20 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Derived from this study: PubMed 32389679Reynolds 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.
- Individual participant dataSharing planned: No
Related trials for Sun Safety
Enrolling by invitation
Regional Efforts to Advance School-based Sun Safety Through Collaboration for Skin Health
Skin Cancer Prevention, Sun Safety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim D Reynolds, PhD principal investigator
Claremont Graduate University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Translation of District Sun Safe Policies to Schools in people with Sun Safety and Sun Safe Schools, run by Claremont Graduate University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of implementation of sun safety practices and policy at schools (time frame: 20 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03243929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.