PreventionNCT04977700
Using Physical Tracking to Predict Sunburn
A study testing Intervention Group in people with Prevention, run by Klein Buendel, Inc. at 1 site in United States.
Trial summary
Recreational UV exposure is associated with every form of skin cancer and individuals who engage in more physical activity have a higher prevalence of sunburn, a proximal biomarker of melanoma risk, perhaps explaining why melanoma is the only cancer with which physical activity is positively correlated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 or older; reside in the United States; read/write in English; upload outdoor activity to Strava ≥3 times per week
Who cannot join
- Younger than 18; reside outside of the United States; read/write in a language other than English; uploads Strava activity less than 3 times per week OR does not use Strava; having a cognitive or visual impairment that would interfere with participating; having another family member participating in the research; having participated in the focus group and usability testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Retrospective and Real-Time Physical Activity Tracking to Predict Risk of Sunburn in Outdoor Exercisers on Strava
Recreational UV exposure is associated with every form of skin cancer and individuals who engage in more physical activity have a higher prevalence of sunburn, a proximal biomarker of melanoma risk, perhaps explaining why melanoma is the only cancer with which physical activity is positively correlated. Mobile technology for tracking physical activity has become increasingly prevalent and Strava, an activity tracking app and social networking site for athletes, is one of the most popular of these technologies. This research will test the feasibility of delivering location-based, ecologically-valid sun safety advice to Strava users at times when they are predicted to be engaged in outdoor physical activity, by utilizing Strava's public open-source Applications Programming Interface.
Read the detailed description
Skin cancer is the most common cancer in the United States. Over 5.4 million cases of keratinocyte cancers (basal and squamous cell) are diagnosed annually and incidence of melanoma has increased 3% each year for the past 30 years. In the 2014 Call to Action to Prevent Skin Cancer, the U. S. Surgeon General included strategies for coordinating messages on sun safety and physical activity, recognizing the need for sun safety among populations that engage in physical activity outdoors. Recreational UV exposure is associated with every form of skin cancer; individuals who engage in more physical activity have a higher prevalence of sunburn. Melanoma is the only cancer with which physical activity is positively correlated. Strava, a tracking app and social networking site for athletes, is one of the most popular of mobile technologies for logging physical activity and providing social feedback on activities by other Strava users. The goal of this R21 research is to test the feasibility of interfacing with the Strava website and its mobile app to develop an algorithm that a) predicts when individuals are likely to be engaged in physical activity outdoors in the sun when ultraviolet radiation is high and b) delivers sun safety advice tailored to the time, location, and personal risk (e.g., skin sun sensitivity) of the Strava users. Concept focus groups with Strava users and non-users will provide input on the feasibility, content, and functions in the Strava Sun (SS) intervention. The algorithm that predicts future outdoor exercise will be developed using machine learning modeling on activity data provided by Strava users. The SS intervention will be programmed to deliver ecologically-valid sun safety advice through Strava's open-source Applications Programming Interface (API) via email and comments in the Strava interface. The sun safety advice will be tailored to location, time, season and user's personal risk, employing advice algorithms we developed for a sun safety mobile app, sunZapp, and a social media message library in our Go Sun Smart intervention for outdoor recreation resorts. SS will be tested for usability prior to conducting a pilot field trial to establish feasibility of SS in practice. The project is significant and innovative. A sun protection interface for the Strava platform will provide individuals who engage in regular physical activity personalized, ecologically-valid advice to help them practice sun safety during outdoor activities. It will contain a novel machine learning algorithm that predicts future high-risk behavior, i.e., outdoor physical activity, to provide precision prevention advice.
- Conditions
- Prevention
- Being tested
- Intervention Group
- Keywords
- skin cancer, physical activity
- Medical subject headings
- Skin Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Test the developed algorithm that delivers location-based, tailored sun safety advice to Strava users through Strava comments for acceptability, ways of interacting with it, and barriers/willingness to allowing access.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will be enrolled on a rolling basis and participate in SS for 4 weeks in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on results from their activity data. All participants will complete posttest survey 4 weeks from randomization. Receives: Behavioral: Intervention Group |
| Control Group | No intervention | A small control group will be included to see if a no-treatment control condition is acceptable to users and estimate follow-up rates for planning a randomized trial. Participants will be enrolled on a rolling basis and will complete a pretest at randomization. All participants will complete a posttest survey 4 weeks from randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sun Protection Practices
What proportion of 8 sun protection practices did participants do on reported days of exercise. Participants responded to 8 potential sun protection practices and provided the number of days they did each practice within the timeframe provided (3 months at baseline; 4 weeks at posttest). Participants also provided number of days of outdoor exercises within timeframe. Proportion was calculated by dividing the frequency of each sun protection practice by the number of days of outdoor exercise within the timeframe. Mean score of all sun protection practices per day of outdoor exercise is reported. Range = 0-1, where a higher number indicates more sun safety practices performed. A proportion was used to account for different timeframes at baseline and posttest.
Measured: baseline and four-weeks post intervention
Prevalence of Sunburn
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past three months, and if so, how many times.
Measured: Baseline
Prevalence of Sunburn
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past four weeks, and if so, how many times.
Measured: four-weeks post intervention
Secondary outcomes (6)
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported.
Measured: Baseline
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported.
Measured: four-weeks post intervention
Recall of Sun Protection Messages
Participants in intervention only were asked about how many messages they read. Scale ranges from 0 - 3. 0 = none of the messages; 1 = some of the messages; 2 = most of the messages; 3 = all of the messages. Higher score indicates higher message recall.
Measured: four weeks post intervention
Self-Efficacy for Sun Protection When Exercising
Participants were asked: how confident are you that you can practice sun safety next time that you exercise. 1 = not confident; 2 = a little confident; 3 = somewhat confident; 4 = very confident. Higher scores indicates more self-efficacy for sun safety.
Measured: baseline and four-weeks post intervention
Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported.
Measured: baseline
Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Duration in minutes of exercise multiplied by number of times per week, in the past 7 days. Total minutes per week calculated; mean per treatment group reported.
Measured: four weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Colorado State University
- Responsible party
- Sponsor
- Investigators
- Julia Berteletti, MSW, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977700
- Sponsor's protocol ID
- 0328
- Other IDs
- 1R21CA241637-01A1
- Status last verified
- Nov 2023
- First submitted
- 2 Jul 2021
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Retrospective and Real-Time Physical Activity Tracking to Predict Risk of Sunburn in Outdoor Exercisers on Strava
- ClinicalTrials.gov ID
- NCT04977700
- Acronym / sponsor ID
- 0328
- Conditions
- Prevention
- Keywords
- skin cancer, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Colorado State University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 18 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recreational UV exposure is associated with every form of skin cancer and individuals who engage in more physical activity have a higher prevalence of sunburn, a proximal biomarker of melanoma risk, perhaps explaining why melanoma is the only cancer with which physical activity is positively correlated. Mobile technology for tracking physical activity has become increasingly prevalent and Strava, an activity tracking app and social networking site for athletes, is one of the most popular of these technologies. This research will test the feasibility of delivering location-based, ecologically-valid sun safety advice to Strava users at times when they are predicted to be engaged in outdoor physical activity, by utilizing Strava's public open-source Applications Programming Interface.
Detailed description
Skin cancer is the most common cancer in the United States. Over 5.4 million cases of keratinocyte cancers (basal and squamous cell) are diagnosed annually and incidence of melanoma has increased 3% each year for the past 30 years. In the 2014 Call to Action to Prevent Skin Cancer, the U. S. Surgeon General included strategies for coordinating messages on sun safety and physical activity, recognizing the need for sun safety among populations that engage in physical activity outdoors. Recreational UV exposure is associated with every form of skin cancer; individuals who engage in more physical activity have a higher prevalence of sunburn. Melanoma is the only cancer with which physical activity is positively correlated. Strava, a tracking app and social networking site for athletes, is one of the most popular of mobile technologies for logging physical activity and providing social feedback on activities by other Strava users. The goal of this R21 research is to test the feasibility of interfacing with the Strava website and its mobile app to develop an algorithm that a) predicts when individuals are likely to be engaged in physical activity outdoors in the sun when ultraviolet radiation is high and b) delivers sun safety advice tailored to the time, location, and personal risk (e.g., skin sun sensitivity) of the Strava users. Concept focus groups with Strava users and non-users will provide input on the feasibility, content, and functions in the Strava Sun (SS) intervention. The algorithm that predicts future outdoor exercise will be developed using machine learning modeling on activity data provided by Strava users. The SS intervention will be programmed to deliver ecologically-valid sun safety advice through Strava's open-source Applications Programming Interface (API) via email and comments in the Strava interface. The sun safety advice will be tailored to location, time, season and user's personal risk, employing advice algorithms we developed for a sun safety mobile app, sunZapp, and a social media message library in our Go Sun Smart intervention for outdoor recreation resorts. SS will be tested for usability prior to conducting a pilot field trial to establish feasibility of SS in practice. The project is significant and innovative. A sun protection interface for the Strava platform will provide individuals who engage in regular physical activity personalized, ecologically-valid advice to help them practice sun safety during outdoor activities. It will contain a novel machine learning algorithm that predicts future high-risk behavior, i.e., outdoor physical activity, to provide precision prevention advice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupParticipants will be enrolled on a rolling basis and participate in SS for 4 weeks in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on results from their activity data. All participants will complete posttest survey 4 weeks from randomization. |
| Control Group | No intervention | –A small control group will be included to see if a no-treatment control condition is acceptable to users and estimate follow-up rates for planning a randomized trial. Participants will be enrolled on a rolling basis and will complete a pretest at randomization. All participants will complete a posttest survey 4 weeks from randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 or older; reside in the United States; read/write in English; upload outdoor activity to Strava ≥3 times per week
Key exclusion criteria (1 listed)
- Younger than 18; reside outside of the United States; read/write in a language other than English; uploads Strava activity less than 3 times per week OR does not use Strava; having a cognitive or visual impairment that would interfere with participating; having another family member participating in the research; having participated in the focus group and usability testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupTest the developed algorithm that delivers location-based, tailored sun safety advice to Strava users through Strava comments for acceptability, ways of interacting with it, and barriers/willingness to allowing access. | Behavioural | Intervention Group |
Primary outcome
Prevalence of Sun Protection Practices
Time frame: baseline and four-weeks post intervention
What proportion of 8 sun protection practices did participants do on reported days of exercise. Participants responded to 8 potential sun protection practices and provided the number of days they did each practice within the timeframe provided (3 months at baseline; 4 weeks at posttest). Participants also provided number of days of outdoor exercises within timeframe. Proportion was calculated by dividing the frequency of each sun protection practice by the number of days of outdoor exercise within the timeframe. Mean score of all sun protection practices per day of outdoor exercise is reported. Range = 0-1, where a higher number indicates more sun safety practices performed. A proportion was used to account for different timeframes at baseline and posttest.
Prevalence of Sunburn
Time frame: Baseline
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past three months, and if so, how many times.
Prevalence of Sunburn
Time frame: four-weeks post intervention
Participants were asked if their skin was sunburned (described as being red and/or painful from exposure to the sun) in the past four weeks, and if so, how many times.
6 secondary outcomes
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Time frame: Baseline
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Time frame: four-weeks post intervention
Recall of Sun Protection Messages
Time frame: four weeks post intervention
Self-Efficacy for Sun Protection When Exercising
Time frame: baseline and four-weeks post intervention
Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Time frame: baseline
Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire)
Time frame: four weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Berteletti, MSW principal investigator
Klein Buendel, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Prevention, run by Klein Buendel, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Sun Protection Practices (time frame: baseline and four-weeks post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.