Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-01-01 @ 3:21 PM
Study NCT ID:
NCT01804595
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2013-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Control Trial of Sun Protection Interventions for Operating Engineers
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
A Randomized Control Trial of Sun Protection Interventions for Operating Engineers
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled trial testing the efficacy of 4 sun protection interventions--education only; education and mailed sunscreen; education and text message reminders; and education, mailed sunscreen, and text message reminders--among Michigan Operating Engineers. Pre- and post-intervention surveys will be collected to determine changes in sunscreen use and sun burning, the primary outcome variables. The investigators hypothesize that all interventions will increase sunscreen use and reduce burning and that the education-only intervention will have the least effect of the 4 interventions while the education, mailed sunscreen, and text messaging arm will have the greatest effect.
Detailed Description:
The education intervention will be provided during regularly scheduled safety training sessions, and the text messages and mailed sun screen (SPF30)interventions will be offered during the summer when UV rays are at their highest. Inclusion criteria are Operating Engineers who:1)are greater than 18 years of age; 2) are interested in enrolling in the sun protection study; 3) own a cell-phone that accepts text messages; and 4) are willing to share their phone number with the study team. Based on power analysis, 256 subjects are needed to have 80% power to detect medium sized effects on primary outcomes. Accounting for a 20% attrition rate, 320 subjects will be recruited. The analyses will include: a) paired t-tests to determine changes over time (from pre-intervention to post-intervention) in outcome variables (sunscreen use and burning) separately in the 4 intervention groups, b) Repeated Measures Analysis of Variance (RM-ANOVA) to compare the changes in outcomes across the 4 groups, and c) t-tests on change scores as follow-ups to the RM-ANOVA to determine exactly which groups differ from each other. Sub-analyses will explore if particular subgroups of Operating Engineers (e.g., demographic, heath behavior, and job type subgroups) differ in sunscreen use and sun burning pre-and post-intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: