## Protocol Section
### Identification Module
**NCT ID:** NCT06418672

**Acronym:** GSSG

**Brief Title:** Go Sun Smart Georgia Evaluation

**Official Title:** Go Sun Smart Georgia Evaluation

#### Organization Study ID Info
**ID:** STUDY00007062
#### Organization
**Class:** OTHER
**Full Name:** Emory University
#### Secondary ID Infos
**ID:** 3U48DP006377-03S4
**Link:** https://reporter.nih.gov/quickSearch/3U48DP006377-03S4
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** Centers for Disease Control and Prevention

**Class:** INDUSTRY

**Name:** Klein Buendel, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Emory University

#### Responsible Party

**Investigator Affiliation:** Emory University

**Investigator Full Name:** Alexandra Morshed

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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

**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.

### Conditions Module

**Conditions:**

- Sun Safety

**Keywords:**

- Sun Protection Behavior

- Sun Safety Education

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 312

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 6 worksites will be enrolled. GSSG implementation in May-August 2024

**Intervention Names:**

- Behavioral: Go Sun Smart Georgia (GSSG)

**Label:** Early Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 6 worksites will be enrolled. GSSG implementation in August- December 2024.

**Intervention Names:**

- Behavioral: Go Sun Smart Georgia (GSSG)

**Label:** Delayed Intervention

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Delayed Intervention

- Early Intervention

**Description:** 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.

**Name:** Go Sun Smart Georgia (GSSG)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in outdoor worker sun safety behaviors

**Time Frame:** 16 weeks

#### Secondary Outcomes

**Description:** Will be captured through manager survey, outdoor worker survey

**Measure:** Change in worksite policy adoption

**Time Frame:** Baseline, After 16 weeks

**Description:** Will be captured through manager survey, outdoor worker survey

**Measure:** Worksite sun safety education

**Time Frame:** Baseline, After 16 weeks

**Description:** Will be captured through manager survey

**Measure:** Change in worksite sun safety actions

**Time Frame:** Baseline, After 16 weeks

**Description:** Will be captured through manager survey, outdoor worker survey, semi-structured interviews

**Measure:** Appropriateness of program

**Time Frame:** At 16 weeks

**Description:** Will be captured through manager survey, outdoor worker survey, semi-structured interviews

**Measure:** Feasibility of program

**Time Frame:** At 16 weeks

**Description:** Will be captured through manager survey, outdoor worker survey, semi-structured interviews

**Measure:** Acceptability of program

**Time Frame:** At 16 weeks

**Description:** Will be captured through program logs.

**Measure:** Fidelity of implementation

**Time Frame:** 16 weeks

**Description:** Will be captured through outdoor worker survey

**Measure:** Representativeness of participants

**Time Frame:** At 16 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alexandra.morshed@emory.edu

**Name:** Alexandra Morshed, PhD

**Phone:** 404-727-1077

**Role:** CONTACT

**Contact 2:**

**Email:** Radhika.agarwal2@emory.edu

**Name:** Radhika Agarwal

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Atlanta

**Country:** United States

**Facility:** Rollins School of Public Health

**State:** Georgia

**Zip:** 30322

#### Overall Officials

**Official 1:**

**Affiliation:** Rollins School of Public Health

**Name:** Alexandra Morshed, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Scientific data will be preserved and shared using the Emory Dataverse Repository, sco.library.emory.edu/dataverse, where they will be publicly available to those interested in using them.

**Description:** To enable interoperability of datasets and resources, we will provide a data codebook/dictionary for all variables included per dataset and documentation with the following elements: information about how the data were collected, sampling details, data cleaning details, related publications, and grant information. The team will make available platform-independent, character-based formats of datasets (e.g., CSV) that retain full detail and precision

**Info Types:**

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** Data will be made available no later than the time of an associated publication or the end of the performance period of the SIP award that funds this project. Data will be made available for at least 5 years.

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
