Atherosclerotic Cardiovascular DiseaseBE ACTIVENCT03911141

Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease

A study testing Gamification and Financial in people with Atherosclerotic Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Atherosclerotic Cardiovascular Disease
What is being tested?: Gamification and Financial
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,062 participants
Where: 1 siteUnited States
Study dates: 12 Apr 2019to 27 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Conditions: Atherosclerotic Cardiovascular Disease
Being tested: Gamification, Financial
Medical subject headings: Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GamificationBehavioural
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.
FinancialBehavioural
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.

Study groups in NCT03911141
Study group	Role	What they receive
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. Receives: Behavioral: Gamification
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. Receives: Behavioral: Financial
Gamification and Financial Incentive Intervention	Experimental	Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm. Receives: Behavioral: Gamification; Behavioral: Financial

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Months 1-12

Secondary outcomes (3)

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.
Measured: 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.
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.
Measured: 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.
Measured: Months 1-18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 201927 Jan 2024

First posted10 Apr 2019
Study start12 Apr 2019
Primary completion24 Jul 2023
Study completion27 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 1,062 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03911141
Sponsor's protocol ID: 831230
Acronym: BE ACTIVE
Status last verified: Dec 2024
First submitted: 3 Apr 2019
Last updated: 27 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40525292
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.
PubMed 40380122
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.
PubMed 39182941
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.
PubMed 38583084
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.
PubMed 36870551

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis

All Atherosclerotic Cardiovascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease
ClinicalTrials.gov ID: NCT03911141
Acronym / sponsor ID: BE ACTIVE / 831230
Conditions: Atherosclerotic Cardiovascular Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,062 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 12 Apr 2019 (actual)
Primary completion: 24 Jul 2023 (actual)
Study completion: 27 Jan 2024 (actual)
First posted: 10 Apr 2019 (actual)
Results: Posted 27 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
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	Behavioral: GamificationParticipants 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	Behavioral: FinancialParticipants 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.
Gamification and Financial Incentive Intervention	Experimental	Behavioral: Gamification, Behavioral: FinancialParticipants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GamificationParticipants 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.	Behavioural	Gamification Intervention, Gamification and Financial Incentive Intervention
FinancialParticipants 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.	Behavioural	Financial Incentive Intervention, Gamification and Financial Incentive Intervention

Primary outcome

Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
Time frame: 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.

3 secondary outcomes

Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
Time frame: 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.
Time frame: 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.
Time frame: Months 1-18

Results and safety

Results posted to the registry on 27 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	151	144
Gamification Intervention	304	263
Financial Incentive Intervention	302	286
Gamification and Financial Incentive Intervention	305	280

Primary outcome: Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.

Time frame: Months 1-12. Mean (Standard Deviation). Unit: Step counts

Measure	Control n = 151	Gamification Intervention n = 304	Financial Incentive Intervention n = 302	Gamification and Financial Incentive Intervention n = 305
Value	1418 (1753)	1954 (1706)	1915 (1903)	2297 (1842)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	21 of 151 (13.9%)	80 of 151 (53%)	0 of 151
Gamification Intervention	51 of 304 (16.8%)	180 of 304 (59.2%)	1 of 304
Financial Incentive Intervention	45 of 302 (14.9%)	140 of 302 (46.4%)	0 of 302
Gamification and Financial Incentive Intervention	44 of 305 (14.4%)	171 of 305 (56.1%)	0 of 305

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40525292Russell 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.
Derived from this study: PubMed 40380122Ryu 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.
Derived from this study: PubMed 39182941Fortunato 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.
Derived from this study: PubMed 38583084Fanaroff 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.
Derived from this study: PubMed 36870551Fanaroff 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.

Related trials for Atherosclerotic Cardiovascular Disease

Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mitesh Patel, MD, MBA, MS principal investigator

University of Pennsylvania

Alexander Fanaroff, MD, MHS principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gamification and Financial in people with Atherosclerotic Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count. (time frame: Months 1-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03911141, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.