Clinical trial NCT01804595: A Randomized Control Trial of Sun Protection Interventions for Operating Engineers
Official title: A Randomized Control Trial of Sun Protection Interventions for Operating Engineers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Skin Cancer Prevention
Keywords: Worksite intervention
Sun protection intervention
Operating Engineers
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2013-03-05
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* greater than 18 years of age
* interested in enrolling in the sun protection study
* owning a cell-phone that accepts text messages
* willing to share their phone number with the study team

Primary outcomes:
measure: Sunscreen use
timeFrame: Baseline
measure: Sun Burning
timeFrame: Baseline
measure: Sunscreen use
timeFrame: Post-intervention
measure: Sun Burning
timeFrame: Post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sonia A Duffy, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walkosz BJ, Buller DB, Andersen PA, Scott MD, Dignan MB, Cutter GR, Maloy JA. Increasing sun protection in winter outdoor recreation a theory-based health communication program. Am J Prev Med. 2008 Jun;34(6):502-9. doi: 10.1016/j.amepre.2008.02.011.
citation: Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.
citation: Duffy SA, Ronis DL, Waltje AH, Choi SH. Protocol of a randomized controlled trial of sun protection interventions for operating engineers. BMC Public Health. 2013 Mar 26;13:273. doi: 10.1186/1471-2458-13-273.