N/A
N=1,062
Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease
Atherosclerotic Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT03911141 ↗Enrolled (actual)
1,062
Serious AEs
15.2%
Results posted
Jan 2025
Primary outcome: Primary: Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. — 1418; 1954; 1915; 2297 Step counts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gamification (Behavioral); Financial (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. |
1418; 1954; 1915; 2297 | — |
| SECONDARY Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. |
1245; 1708; 1576; 1831 | — |
| SECONDARY Change in Mean Daily Minutes of Moderate to Vigorous Physical Activity (MVPA) During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. |
5.3; 7.4; 7.8; 9 | — |
| SECONDARY Change in Mean Daily Minutes of Moderate to Vigorous Physical Activity (MVPA) During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. |
4.7; 5.4; 5.3; 5.5 | — |
Summary
The objective of this study is to use a randomized, controlled trial to test the effectiveness of using gamification, financial incentives, or both to increase physical activity among patients with elevated risk for atherosclerotic cardiovascular disease (ASCVD). ASCVD is the leading cause of morbidity and mortality in the United States. Regular physical activity has been shown to reduce the risk of ASCVD, but less than 50% of US adults achieve enough physical activity to obtain these benefits.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Have a 10-year ASCVD risk score of 7.5% or greater (including those with existing ASCVD)
- Are able to provide informed consent
Exclusion Criteria
- Are already participating in another physical activity study
- An 18-month physical activity program is infeasible (e.g. metastatic cancer; unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise)
- They do not have a device (e.g. smartphone, tablet, or computer) to transmit data from the wearable activity tracker
- Baseline step count is 7, 500 or greater
- They do not have a primary care physician in the University of Pennsylvania Health System.
Data sourced from ClinicalTrials.gov (NCT03911141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.