Atherosclerotic Cardiovascular Disease
Conditions
Brief 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.
Detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality in the United States (US). Regular physical activity has been demonstrated to reduce the risk of ASCVD and is associated with a number of other health benefits. Yet, less than 50% of adults in the US achieve enough physical activity to actually obtain these benefits. Insights from behavioral economics have been shown to both better reflect the 'predictable irrationality' of humans and to be effective in designing interventions that achieve sustained improvements in health behavior. Our prior work has demonstrated that interventions using financial incentives and gamification can leverage principles from behavioral economics to increase physical activity during 3-month interventions and sustain effects in 3-month follow-up periods. These findings warrant further investigation of longer-term effects. In this study, we conduct a four-arm randomized, controlled trial to evaluate the effectiveness of using behavioral economic approaches including gamification, financial incentives, or both to increase physical activity among patients with elevated risk for atherosclerotic cardiovascular disease during a 12-month intervention with a 6-month follow-up.
Interventions
BEHAVIORALGamification
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals. Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level. In the follow-up period, participants continue to get a daily text stating if they met their step goal.
BEHAVIORALFinancial
Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets. During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | Months 1-12 | Change in mean daily steps counts from baseline to the 12-month intervention period, excluding the 8-week ramp-up phase. This will be measured using the Fitbit Charge wearable device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | Months 1-18 | Change in mean daily steps from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge wearable device. |
| 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. | Months 1-12 | Change in mean daily minutes of MVPA from baseline to the intervention period, excluding the 8-week ramp up phase. This will be measured using the Fitbit Charge wearable device. |
| 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. | Months 1-18 | Change in mean daily minutes of MVPA from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge wearable device. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Weeks That Achieve 150 Minutes of MVPA During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | Months 1-12 | Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the intervention period. The denominator is the total number of weeks all participants in each arm participated in the study and the numerator is the number of weeks all participants had at least 150 minutes of MVPA. This will be measured using the Fitbit Charge wearable device. |
| Proportion of Weeks That Achieve 150 Minutes of MVPA During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | Months 1-18 | Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the follow-up period. The denominator is the total number of weeks all participants in each arm participated in the study and the numerator is the number of weeks all participants had at least 150 minutes of MVPA. This will be measured using the Fitbit Charge wearable device. |
Countries
United States
Participant flow
Pre-assignment details
Before randomization, participants completed a baseline period where they wore a Fitbit for two weeks for the study team to track their average daily step counts. Week two of the baseline period was used to determine eligibility. The average of step counts over 1000 steps per day were taken to calculate the baseline step count. Participants with baseline steps over 7,500 were considered ineligible.
Participants by arm
| Arm | Count |
|---|---|
| Control Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up. | 151 |
| Gamification Intervention Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal. | 304 |
| Financial Incentive Intervention Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day. | 302 |
| Gamification and Financial Incentive Intervention Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm. | 305 |
| Total | 1,062 |
Baseline characteristics
| Characteristic | Total | Control | Gamification Intervention | Financial Incentive Intervention | Gamification and Financial Incentive Intervention |
|---|---|---|---|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 8.1 | 66.6 years STANDARD_DEVIATION 8 | 67.2 years STANDARD_DEVIATION 8 | 66.4 years STANDARD_DEVIATION 8.2 | 66.6 years STANDARD_DEVIATION 8.2 |
| Annual Household Income $50,000 to $100,000 | 373 Participants | 52 Participants | 109 Participants | 106 Participants | 106 Participants |
| Annual Household Income Greater than $100,000 | 446 Participants | 51 Participants | 134 Participants | 123 Participants | 138 Participants |
| Annual Household Income Less than $50,000 | 243 Participants | 48 Participants | 61 Participants | 73 Participants | 61 Participants |
| Baseline daily steps | 5014 Average daily step counts STANDARD_DEVIATION 1569 | 4980 Average daily step counts STANDARD_DEVIATION 1554 | 4958 Average daily step counts STANDARD_DEVIATION 1556 | 5018 Average daily step counts STANDARD_DEVIATION 1579 | 5081 Average daily step counts STANDARD_DEVIATION 1585 |
| BMI | 31.2 kg/m^2 STANDARD_DEVIATION 6.7 | 31.4 kg/m^2 STANDARD_DEVIATION 7.3 | 31 kg/m^2 STANDARD_DEVIATION 6.3 | 31.5 kg/m^2 STANDARD_DEVIATION 7 | 31.1 kg/m^2 STANDARD_DEVIATION 6.5 |
| Chronic kidney disease | 37 Participants | 4 Participants | 8 Participants | 10 Participants | 15 Participants |
| Chronic obstructive pulmonary disease | 28 Participants | 5 Participants | 4 Participants | 10 Participants | 9 Participants |
| Current smoking | 43 Participants | 11 Participants | 10 Participants | 11 Participants | 11 Participants |
| Diabetes | 244 Participants | 37 Participants | 65 Participants | 66 Participants | 76 Participants |
| Education College graduate | 785 Participants | 105 Participants | 220 Participants | 223 Participants | 237 Participants |
| Education High school graduate | 52 Participants | 13 Participants | 14 Participants | 19 Participants | 6 Participants |
| Education Some college or specialized training | 215 Participants | 31 Participants | 69 Participants | 57 Participants | 58 Participants |
| Education Some high school | 10 Participants | 2 Participants | 1 Participants | 3 Participants | 4 Participants |
| Heart Failure | 20 Participants | 4 Participants | 6 Participants | 5 Participants | 5 Participants |
| Hyperlipidemia | 565 Participants | 77 Participants | 163 Participants | 170 Participants | 155 Participants |
| Hypertension | 657 Participants | 93 Participants | 188 Participants | 192 Participants | 184 Participants |
| Marital Status Married | 664 Participants | 91 Participants | 189 Participants | 189 Participants | 195 Participants |
| Marital Status Other | 239 Participants | 33 Participants | 67 Participants | 73 Participants | 66 Participants |
| Marital Status Single | 159 Participants | 27 Participants | 48 Participants | 40 Participants | 44 Participants |
| Prior myocardial infarction | 25 Participants | 4 Participants | 6 Participants | 8 Participants | 7 Participants |
| Prior wearable device use | 739 Participants | 106 Participants | 213 Participants | 206 Participants | 214 Participants |
| Race/Ethnicity, Customized Asian non-Hispanic | 28 Participants | 7 Participants | 5 Participants | 7 Participants | 9 Participants |
| Race/Ethnicity, Customized Black non-Hispanic | 266 Participants | 40 Participants | 76 Participants | 82 Participants | 68 Participants |
| Race/Ethnicity, Customized Hispanic | 16 Participants | 1 Participants | 4 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 15 Participants | 0 Participants | 5 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 737 Participants | 103 Participants | 214 Participants | 202 Participants | 218 Participants |
| Self reported health status Excellent | 66 Participants | 11 Participants | 23 Participants | 11 Participants | 21 Participants |
| Self reported health status Fair | 152 Participants | 23 Participants | 37 Participants | 45 Participants | 47 Participants |
| Self reported health status Good | 501 Participants | 60 Participants | 145 Participants | 149 Participants | 147 Participants |
| Self reported health status Poor | 8 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants |
| Self reported health status Very Good | 335 Participants | 56 Participants | 96 Participants | 95 Participants | 88 Participants |
| Sex: Female, Male Female | 642 Participants | 97 Participants | 197 Participants | 173 Participants | 175 Participants |
| Sex: Female, Male Male | 420 Participants | 54 Participants | 107 Participants | 129 Participants | 130 Participants |
| Step goal increase from baseline | 1867 step counts STANDARD_DEVIATION 817 | 1855 step counts STANDARD_DEVIATION 867 | 1890 step counts STANDARD_DEVIATION 854 | 1890 step counts STANDARD_DEVIATION 829 | 1826 step counts STANDARD_DEVIATION 742 |
| Step goal selection 33% increase from baseline | 352 Participants | 51 Participants | 92 Participants | 95 Participants | 114 Participants |
| Step goal selection 40% increase from baseline | 164 Participants | 26 Participants | 37 Participants | 45 Participants | 56 Participants |
| Step goal selection 50% increase from baseline | 209 Participants | 21 Participants | 72 Participants | 61 Participants | 55 Participants |
| Step goal selection Custom goal | 337 Participants | 53 Participants | 103 Participants | 101 Participants | 80 Participants |
| Stroke | 18 Participants | 2 Participants | 4 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 1 / 304 | 0 / 302 | 0 / 305 |
| other Total, other adverse events | 80 / 151 | 180 / 304 | 140 / 302 | 171 / 305 |
| serious Total, serious adverse events | 21 / 151 | 51 / 304 | 45 / 302 | 44 / 305 |
Outcome results
Primary
Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
Change in mean daily steps counts from baseline to the 12-month intervention period, excluding the 8-week ramp-up phase. This will be measured using the Fitbit Charge wearable device.
Time frame: Months 1-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 1418 Step counts | Standard Deviation 1753 |
| Gamification Intervention | Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 1954 Step counts | Standard Deviation 1706 |
| Financial Incentive Intervention | Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 1915 Step counts | Standard Deviation 1903 |
| Gamification and Financial Incentive Intervention | Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 2297 Step counts | Standard Deviation 1842 |
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.
Change in mean daily minutes of MVPA from baseline to the intervention period, excluding the 8-week ramp up phase. This will be measured using the Fitbit Charge wearable device.
Time frame: Months 1-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 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 Minutes | Standard Deviation 9.5 |
| Gamification Intervention | 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. | 7.4 Minutes | Standard Deviation 10.6 |
| Financial Incentive Intervention | 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. | 7.8 Minutes | Standard Deviation 11.1 |
| Gamification and Financial Incentive Intervention | 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. | 9 Minutes | Standard Deviation 10.5 |
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.
Change in mean daily minutes of MVPA from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge wearable device.
Time frame: Months 1-18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 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 Minutes | Standard Deviation 10.2 |
| Gamification Intervention | 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. | 5.4 Minutes | Standard Deviation 11.2 |
| Financial Incentive Intervention | 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. | 5.3 Minutes | Standard Deviation 10.9 |
| Gamification and Financial Incentive Intervention | 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. | 5.5 Minutes | Standard Deviation 10.4 |
Secondary
Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
Change in mean daily steps from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge wearable device.
Time frame: Months 1-18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 1245 Step counts | Standard Deviation 1879 |
| Gamification Intervention | Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 1708 Step counts | Standard Deviation 1882 |
| Financial Incentive Intervention | Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 1576 Step counts | Standard Deviation 2062 |
| Gamification and Financial Incentive Intervention | Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. | 1831 Step counts | Standard Deviation 1891 |
Other Pre-specified
Proportion of Weeks That Achieve 150 Minutes of MVPA During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts.
Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the intervention period. The denominator is the total number of weeks all participants in each arm participated in the study and the numerator is the number of weeks all participants had at least 150 minutes of MVPA. This will be measured using the Fitbit Charge wearable device.
Time frame: Months 1-12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .16 Proportion of weeks |
| Gamification Intervention | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .23 Proportion of weeks |
| Financial Incentive Intervention | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .24 Proportion of weeks |
| Gamification and Financial Incentive Intervention | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .27 Proportion of weeks |
Other Pre-specified
Proportion of Weeks That Achieve 150 Minutes of MVPA During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts.
Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the follow-up period. The denominator is the total number of weeks all participants in each arm participated in the study and the numerator is the number of weeks all participants had at least 150 minutes of MVPA. This will be measured using the Fitbit Charge wearable device.
Time frame: Months 1-18
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .14 Proportion of weeks |
| Gamification Intervention | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .18 Proportion of weeks |
| Financial Incentive Intervention | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .18 Proportion of weeks |
| Gamification and Financial Incentive Intervention | Proportion of Weeks That Achieve 150 Minutes of MVPA During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts. | .20 Proportion of weeks |