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

NCT03911141 | Completed Results DMC

• 1 other identifier: 831230
• Study Type: interventional
• Target: 1,062
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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

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.

  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.

  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.

  Months 1-18

Other Outcomes (2)

• 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 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

Study Arms (4)

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.

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.

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.

Behavioral: Gamification; Behavioral: Financial

Interventions

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.

Gamification Intervention; Gamification and Financial Incentive Intervention

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.

Financial Incentive Intervention; Gamification and Financial Incentive Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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.

  PMID: 40525292 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.

  PMID: 40380122 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.

  PMID: 38583084 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.

  PMID: 36870551 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Alexander C. Fanaroff, MD, MHS
• Organization: Hospital of the University of Pennsylvania

alexander.fanaroff@pennmedicine.upenn.edu

2156157674

Study Officials

• Mitesh Patel, MD, MBA, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Alexander Fanaroff, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 10, 2019
• Study Start: April 12, 2019
• Primary Completion: July 24, 2023
• Study Completion: January 27, 2024
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2024-12

Locations

US (1)