Mobile Sun Health Intervention EnabLing Daily Protection (mSHIELD)

September 23, 2026 updated by: University of Utah

mSHIELD (Mobile Sun Health Intervention EnabLing Daily Protection)

The overall purpose of this proposal is to refine a mobile-health (mHealth) system to reduce excessive unprotected sun exposure among young adults.

Participants will complete a 4-week intervention with all intervention components delivered through the mHealth application. Intervention components include Text Message Reminders, Sun Protection Education Modules, Action Planning Module, and UV Radiation (UVR) Weather Information.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

mHealth tools provide an ideal opportunity for reducing young adults' UVR exposure. mSHIELD intervention components were selected to target key constructs (e.g., self-efficacy, barrier reduction) within Social Cognitive Theory (SCT) which are associated with sun protection behaviors. The initial concept for the mSHIELD intervention includes the following four components: real-time UVR alerts and feedback; UVR weather forecasts; text messages; and action planning. Although these components provide a good fit with SCT constructs and utilize evidence-based behavior change strategies, they have rarely been used in the context of mHealth for sun protection, and this will be the first mHealth intervention for sun protection to apply all four of these components simultaneously. Therefore, prior to testing mSHIELD in a large study, it will be important to refine components based on user preferences and pilot tests.

To test the pilot intervention, participants will complete a 4-week intervention with all intervention components delivered through the study application. Intervention components will include: text messages, sun protection education modules, an action planning module, and UVR/weather information. The modules/components are used for the entire 4-week intervention period. Immediately following the 4-week intervention, participants will be asked to complete a post-intervention survey and study interview. Participants will also be asked to complete a survey one month post-intervention. Participants will receive up to 5 reminders to complete each study activity through each of their approved communication methods (e.g., email).

Data collected at the one-month post-intervention surveys will be analyzed and compared to baseline values. For this study, the criteria for a clinically significant impact will be that a participant reports no sunburns and now frequently uses sunscreen and at least one other sun protection method during outdoor time; a priori, a benchmark of at least 50% of participants reaching this criteria is set to indicate whether the intervention can proceed to larger-scale testing or if further refinements are needed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Tammy Stump
        • Contact:
        • Principal Investigator:
          • Tammy Stump, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individual is at least 18 years old; AND
  • Individual reports having at least one sunburn in the last year; AND/OR
  • Individual reports using sunscreen plus one or more other sun protection behavior (protective clothing, shade, etc.) infrequently (i.e. never/seldom/sometimes)

Exclusion Criteria:

  • Individual does not speak/read English; AND/OR
  • Individual reports a personal history of skin cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: mSHIELD (mobile Sun Health Intervention EnabLing Daily Protection)

Participants will complete a 4-week intervention with all intervention components delivered through the study application. Intervention components will include: text messages, sun protection education modules, an action planning module, and ultraviolet radiation (UVR)/weather information. The modules/components are used for the entire 4-week intervention period.
Behavioral: Text Message Reminders

Participants will receive text message reminders twice a week. These messages will remind participants to use sunscreen or other forms of sun protection and will include brief facts about sun safety and environmental risks.

Behavioral: Sun Protection Education Modules

The education section consists of 5 modules on sun protection basics, ultraviolet (UV) exposure, skin health, sunscreen use, and tanning. Each module takes about 5 to 10 minutes to read.

Behavioral: Action Planning Module

The app will guide participants through creating a specific plan for using sun protection during a routine outdoor activity. Completing an action plan takes about 5 minutes. Participants will be asked to complete two action plans during the study and prompted to review these plans weekly.

Behavioral: UV Radiation (UVR) Weather Information

The UVR Weather feature displays information similar to what is available in many weather apps, with a focus on the sunburn risk hours. The display also shows different levels of UV risk throughout the day and indicates the current UV risk based on real-time UV Index. Participants will receive a daily notification summarizing the UV information for that day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants with a Clinically Significant Impact
Time Frame: up to 2 months from baseline

To determine whether a prototype mHealth system improves use of sun protection strategies among young adults.

Data at the one-month post-intervention surveys will be analyzed and compared to baseline values. For this study, the criteria for a clinically significant impact will be that a participant reports no sunburns and now frequently uses sunscreen and at least one other sun protection method during outdoor time. This outcome measure will report the proportion of participants with a clinically significant impact.
up to 2 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tammy Stump, PhD, Huntsman Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 191461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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