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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Gamification Intervention | Experimental | 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. |
|
| Financial Incentive Intervention | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamification | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Months 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Months 1-18 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitesh Patel, MD, MBA, MS | University of Pennsylvania | Principal Investigator |
| Alexander Fanaroff, MD, MHS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40525292 | Derived | Russell LB, Volpp KGM, Patel MS, Chokshi NP, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Klaiman T, Szymczak JE, Small DS, Fanaroff AC. Cost-Effectiveness of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease. Circ Cardiovasc Qual Outcomes. 2025 Jul;18(7):e011839. doi: 10.1161/CIRCOUTCOMES.124.011839. Epub 2025 Jun 17. | |
| 40380122 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Gamification and Financial Incentive Intervention | Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Gamification Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Step counts | Months 1-12 |
|
18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthopedic | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthopedic | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander C. Fanaroff, MD, MHS | Hospital of the University of Pennsylvania | 2156157674 | alexander.fanaroff@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2024 | Oct 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Gamification and Financial Incentive Intervention | Experimental | Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm. |
|
|
| Financial | Behavioral | 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. |
|
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. |
| Months 1-12 |
| 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. | Months 1-18 |
| Months 1-12 |
| 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. | Months 1-18 |
| Derived |
| Ryu E, Farraday D, Fanaroff AC, Coratti S, Chokshi NP, Zhu J, Szymczak JE, Russell LB, Norton L, Small D, Volpp KG, Klaiman T. What motivates participants: a qualitative analysis of gamification and financial incentives to increase physical activity. BMC Public Health. 2025 May 16;25(1):1804. doi: 10.1186/s12889-025-22717-0. |
| 39182941 | Derived | Fortunato MP, Girard A, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Chokshi N, Szymczak JE, Klaiman T, Russell LB, Small DS, Patel MS, Volpp KGM, Fanaroff AC. Investigating racial and gender disparities in virtual randomized clinical trial enrollment: Insights from the BE ACTIVE study. Am Heart J. 2024 Oct;276:120-124. doi: 10.1016/j.ahj.2024.06.003. Epub 2024 Jul 30. |
| 38583084 | Derived | Fanaroff AC, Patel MS, Chokshi N, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Klaiman T, Szymczak JE, Russell LB, Small DS, Volpp KGM. Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial. Circulation. 2024 May 21;149(21):1639-1649. doi: 10.1161/CIRCULATIONAHA.124.069531. Epub 2024 Apr 7. |
| 36870551 | Derived | Fanaroff AC, Patel MS, Chokshi N, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Szymczak JE, Russell LB, Small DS, Volpp KGM. A randomized controlled trial of gamification, financial incentives, or both to increase physical activity among patients with elevated risk for cardiovascular disease: rationale and design of the be active study. Am Heart J. 2023 Jun;260:82-89. doi: 10.1016/j.ahj.2023.02.014. Epub 2023 Mar 2. |
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.
| BG002 | 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. |
| BG003 | Gamification and Financial Incentive Intervention | Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Annual Household Income | Count of Participants | Participants |
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| Self reported health status | Count of Participants | Participants |
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| Prior wearable device use | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Diabetes | Count of Participants | Participants |
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| Hyperlipidemia | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
|
| Current smoking | Count of Participants | Participants |
|
| Prior myocardial infarction | Count of Participants | Participants |
|
| Stroke | Count of Participants | Participants |
|
| Heart Failure | Count of Participants | Participants |
|
| Chronic obstructive pulmonary disease | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| Baseline daily steps | Mean | Standard Deviation | Average daily step counts |
|
| Step goal selection | Count of Participants | Participants |
|
| Step goal increase from baseline | Mean | Standard Deviation | step counts |
|
| OG002 | 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. |
| OG003 | Gamification and Financial Incentive Intervention | Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm. |
|
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| 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. | Posted | Mean | Standard Deviation | Step counts | Months 1-18 |
|
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|
| 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. | Posted | Mean | Standard Deviation | Minutes | Months 1-12 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Minutes | Months 1-18 |
|
|
|
| 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. | Posted | Number | Proportion of weeks | Months 1-12 |
|
|
|
| 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. | Posted | Number | Proportion of weeks | Months 1-18 |
|
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|
| 0 |
| 151 |
| 21 |
| 151 |
| 80 |
| 151 |
| EG001 | 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. | 1 | 304 | 51 | 304 | 180 | 304 |
| EG002 | 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. | 0 | 302 | 45 | 302 | 140 | 302 |
| EG003 | Gamification and Financial Incentive Intervention | Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm. | 0 | 305 | 44 | 305 | 171 | 305 |
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
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| Fitbit-related | Product Issues | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
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| Fitbit-related | Product Issues | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
|
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