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

NCT ID: NCT03911141

Last Updated: 2025-01-27

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1062 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-12

Study Completion Date

2024-01-27

Brief Summary

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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.

Detailed Description

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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

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Atherosclerotic Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Gamification

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Financial

Intervention Type 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.

Gamification and Financial Incentive Intervention

Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.

Group Type EXPERIMENTAL

Gamification

Intervention Type 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.

Financial

Intervention Type 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.

Interventions

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Gamification

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitesh Patel, MD, MBA, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Alexander Fanaroff, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40525292 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40380122 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38583084 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36870551 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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831230

Identifier Type: -

Identifier Source: org_study_id

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