- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06418672
Go Sun Smart Georgia Evaluation (GSSG)
The goal of this clinical trial is to evaluate the dissemination of the Go Sun Smart Georgia (GSSG) program with Georgia worksites and learn whether the intervention changes the employees' sun protection behavior in outdoor workers in Southwest Georgia.
The primary aim is to assess program effectiveness by comparing employee sun protection practices between the employers assigned to the GSSG intervention and the employers assigned to the wait-list control group (delayed intervention). The hypothesis that will be tested is that compared to the delayed intervention group, employees at intervention worksites will practice more sun protection during the post-test.
Worksites will be asked to complete internal coach training and participate in technical assistance around sun safety. Study participants will fill out surveys and participate in interviews
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project builds on the original Go Sun Smart at Work (GSSW) program-a sun safety educational program delivered to worksite leaders, managers, and workers-that was previously shown to be effective for employers adopting sun safety policies and implementing sun safety education and actions, and improved employees' sun protection behavior (e.g., use of protective clothing).
To successfully implement and scale up GSSW with outdoor workers in Southwest Georgia-predominantly African American and Hispanic-this intervention must be systematically adapted to ensure program fit to the population and setting while maintaining core program elements. A well-adapted and tailored occupational sun safety program with high dissemination potential will greatly impact this overlooked employee population, reduce health care costs, improve quality of life, and save lives. The adaptation process took place in 2022-2024, and the adapted Go Sun Smart Georgia (GSSG) program will be evaluated in 2024.
Go Sun Smart Georgia (GSSG) is an educational, train-the-trainer, and technical assistance program for Georgia worksites that employ outdoor workers. It will be implemented with worksites assigned to the intervention group in May-Aug 2024 and with worksites assigned to the comparison (delayed intervention) group in Aug - Dec. 2024. The study team will provide worksites with training for internal worksite coaches (the coach(es) will be employee(s) chosen by the worksite to serve as a champion for the program, not part of the study staff and paid by the worksite), training for other internal educators, technical assistance for conducting the program, and employee educational sessions, as needed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandra Morshed, PhD
- Phone Number: 404-727-1077
- Email: alexandra.morshed@emory.edu
Study Contact Backup
- Name: Radhika Agarwal
- Email: Radhika.agarwal2@emory.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Rollins School of Public Health
-
Contact:
- Alexandra Morshed, PhD
- Phone Number: 404-727-1077
- Email: alexandra.morshed@emory.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Outdoor workers
- Employed at participating worksite
- Works at least 5 hours outdoors per week
- Can read and/or clearly understand English
Managers
- Employed at participating worksite in supervisory position
- Responsible for worksite safety/health policy or training
- Can read and/or clearly understand English
Semi-structured interviews
- Employed by participating worksite
- Closely involved with GSSG implementation
- Can read and/or clearly understand English
Exclusion Criteria:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Cognitively impaired or Individuals with Impaired Decision-Making Capacity
- Individuals who are not able to clearly understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early Intervention
6 worksites will be enrolled.
GSSG implementation in May-August 2024
|
Go Sun Smart Georgia (GSSG) is an educational, train-the-trainer, and technical assistance program for Georgia worksites that employ outdoor workers. GSSG is delivered through personal contacts with senior worksite managers, employee training, and distribution of educational materials. In meetings with managers, trained coaches work to increase perceived need for workplace sun safety, cite advice from national authorities (e.g., CDC and NIOSH), plan for policy implementation, alter policies/education and/or workplace to improve fit, clarify changes to other managers/ employees, and bundle sun safety with worksite safety. The intervention period will last 12-16 weeks in each of the groups. |
Active Comparator: Delayed Intervention
6 worksites will be enrolled.
GSSG implementation in August- December 2024.
|
Go Sun Smart Georgia (GSSG) is an educational, train-the-trainer, and technical assistance program for Georgia worksites that employ outdoor workers. GSSG is delivered through personal contacts with senior worksite managers, employee training, and distribution of educational materials. In meetings with managers, trained coaches work to increase perceived need for workplace sun safety, cite advice from national authorities (e.g., CDC and NIOSH), plan for policy implementation, alter policies/education and/or workplace to improve fit, clarify changes to other managers/ employees, and bundle sun safety with worksite safety. The intervention period will last 12-16 weeks in each of the groups. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in outdoor worker sun safety behaviors
Time Frame: 16 weeks
|
Will be captured through outdoor worker survey (posttest). To evaluate the impact of GSSG on sun safety behaviors (primary outcome), employees will report a) frequency of sun protection at work (i.e., sunscreen with SPF 30+, long-sleeved shirts, long pants, hat with wide-brim, sunglasses, shade use, limit midday sun exposure, and have sunscreen, hat and eye protection at all times [1=never, 5=always]) and b) sunburn in past 3 months on the job (yes/no; number). Surveys will include questions about amount of times respondent works outdoors; the respondent's sun and heat protection behaviors; perceptions of their sun exposure risk and history of sunburn; presence and perception of workplace policies, procedures, standards, resources, and training for sun safety and heat at the organization; experience with the Go Sun Smart Georgia program; and respondent demographics. |
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in worksite policy adoption
Time Frame: Baseline, After 16 weeks
|
Will be captured through manager survey, outdoor worker survey
|
Baseline, After 16 weeks
|
Worksite sun safety education
Time Frame: Baseline, After 16 weeks
|
Will be captured through manager survey, outdoor worker survey
|
Baseline, After 16 weeks
|
Change in worksite sun safety actions
Time Frame: Baseline, After 16 weeks
|
Will be captured through manager survey
|
Baseline, After 16 weeks
|
Appropriateness of program
Time Frame: At 16 weeks
|
Will be captured through manager survey, outdoor worker survey, semi-structured interviews
|
At 16 weeks
|
Feasibility of program
Time Frame: At 16 weeks
|
Will be captured through manager survey, outdoor worker survey, semi-structured interviews
|
At 16 weeks
|
Acceptability of program
Time Frame: At 16 weeks
|
Will be captured through manager survey, outdoor worker survey, semi-structured interviews
|
At 16 weeks
|
Fidelity of implementation
Time Frame: 16 weeks
|
Will be captured through program logs.
|
16 weeks
|
Representativeness of participants
Time Frame: At 16 weeks
|
Will be captured through outdoor worker survey
|
At 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra Morshed, PhD, Rollins School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00007062
- 3U48DP006377-03S4 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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