Atherosclerotic Cardiovascular Disease
Conditions
Keywords
Physical Activity, Goal-Setting, Gamification
Brief summary
To use a randomized controlled trial to test the effectiveness of four goal-setting strategies within a gamification intervention to increase physical activity among adults at elevated risk for ASCVD.
Detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the United States. While increased physical activity can reduce this risk, less than half of adults in the United States meet the minimum recommendation guidelines for physical activity. Gamification, or the application of game design elements to non-game settings, has demonstrated promise in increasing physical activity when designed using insights from behavioral economics. However, the best way to design goal-setting within these interventions has not been well-examined. In this randomized controlled trial, the investigators will evaluate the effectiveness of four different goal-setting strategies within a gamification intervention to increase physical activity among adults with elevated risk for ASCVD. The trial will include a 2-week run-in period to estimate a baseline, followed by an 8-week introductory phase, an 8-week maintenance phase, and then after the intervention is completed an 8-week follow-up period.
Interventions
BEHAVIORALChoice + Immediate
Participants in the choice + immediate goal arm will choose a step goal and must attempt to achieve this new step goal immediately at the start of the study.
BEHAVIORALChoice + Gradual
Participants in the choice + gradual goal arm will choose a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
BEHAVIORALAssigned + Immediate
Participants in the assigned + immediate goal arm will be assigned a step goal and must attempt to achieve this new step goal immediately at the start of the study.
BEHAVIORALAssigned + Gradual
Participants in the assigned + gradual goal arm will be assigned a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
BEHAVIORALDaily performance feedback
Participants will receive daily performance feedback on their daily step count.
BEHAVIORALGamification
All participants in the intervention arms will be entered into a gamification platform that has points and levels designed to incorporate insights from behavioral economics.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older; * ability to read and provide informed consent to participate in the study; * diagnosis of clinical ASCVD or a 10-year ASCVD risk score ≥ 7.5% calculated according to the 2013 ACC/AHA guidelines; * Smartphone or tablet compatible with application for the wearable activity tracking device.
Exclusion criteria
* Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English; * conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise; * already enrolled in another study targeting physical activity; * any other medical conditions or reasons he or she is unable to participate in a physical activity study for 24 weeks; * baseline step count of 10,000 steps or greater.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean daily steps from baseline to maintenance period. | Baseline to weeks 9-16 | The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean daily steps from baseline to follow-up period. | Baseline to the weeks 17 to 24 | The secondary outcome is change in mean daily steps from baseline to the weeks 17 to 24 (follow-up period). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in minutes of MVPA from baseline to maintenance and follow-up periods. | Baseline to weeks 9-16 and weeks 17-24 | An exploratory outcome is change in minutes of moderate-to-vigorous physical activity (MVPA) from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period). |
| Change in minutes of sleep from baseline to maintenance and follow-up periods. | Baseline to weeks 9-16 and weeks 17-24 | An exploratory outcome is change in minutes of sleep from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period). |
Countries
United States
Outcome results
None listed