Trial Outcomes & Findings for Using Physical Tracking to Predict Sunburn (NCT NCT04977700)
NCT ID: NCT04977700
Last Updated: 2023-11-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
baseline and four-weeks post intervention
Results posted on
2023-11-13
Participant Flow
n=123 participants were recruited and screened for participation in formative research prior to the pilot study detailed, including focus groups, usability testing, and collection of activity data. None of those participants were randomized. n=41 participants participated in the randomized pilot as described in this entry.
Participant milestones
| Measure |
Intervention Group
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
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 months from randomization.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
10
|
|
Overall Study
COMPLETED
|
31
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Physical Tracking to Predict Sunburn
Baseline characteristics by cohort
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 14.8 • n=99 Participants
|
48.9 years
STANDARD_DEVIATION 17.9 • n=107 Participants
|
43.9 years
STANDARD_DEVIATION 15.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and four-weeks post interventionWhat 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Prevalence of Sun Protection Practices
baseline
|
0.30 proportion of practices/day
Standard Deviation 0.35
|
0.43 proportion of practices/day
Standard Deviation 0.43
|
|
Prevalence of Sun Protection Practices
four week posttest
|
0.35 proportion of practices/day
Standard Deviation 0.37
|
0.41 proportion of practices/day
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: BaselineParticipants 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Prevalence of Sunburn
|
1.0 sunburn
Standard Deviation 2.7
|
0.2 sunburn
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: four-weeks post interventionParticipants 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Prevalence of Sunburn
|
0.3 sunburn
Standard Deviation 0.6
|
0.3 sunburn
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: BaselineDuration 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
|
578.1 minutes
Standard Deviation 603.3
|
465.8 minutes
Standard Deviation 250.4
|
SECONDARY outcome
Timeframe: four-weeks post interventionDuration 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Physical Activity (Godin Leisure-Time Exercise Questionnaire)
|
474.6 minutes
Standard Deviation 238.4
|
657.5 minutes
Standard Deviation 578.0
|
SECONDARY outcome
Timeframe: four weeks post interventionPopulation: Control group participants were not given this item.
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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
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 months from randomization.
|
|---|---|---|
|
Recall of Sun Protection Messages
|
1.9 units on a scale
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: baseline and four-weeks post interventionParticipants 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Self-Efficacy for Sun Protection When Exercising
baseline
|
3.1 units on a scale
Standard Deviation 0.9
|
3.4 units on a scale
Standard Deviation 0.8
|
|
Self-Efficacy for Sun Protection When Exercising
four-week follow-up
|
3.4 units on a scale
Standard Deviation 0.8
|
3.3 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: baselineDuration 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire)
|
578.1 minutes
Interval 36.0 to 2580.0
|
465.8 minutes
Interval 138.0 to 960.0
|
SECONDARY outcome
Timeframe: four weeks post-interventionDuration 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.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
Participants will be enrolled on a rolling basis and participate in SS for 4 months in the intervention condition. After pretesting, participants will receive sun protection messages from SS through emails/comments based on algorithm results from their profile and activity data. All participants will complete posttest survey 4 months from randomization.
Intervention Group: 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.
|
Control Group
n=10 Participants
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 months from randomization.
|
|---|---|---|
|
Range of Physical Activity (Godin Leisure-Time Exercise Questionnaire)
|
474.6 minutes
Interval 0.0 to 1020.0
|
657.5 minutes
Interval 285.0 to 2220.0
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place