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Gamification + Financial Incentives for Cardiovascular Disease (BE ACTIVE Trial)

N/A

Waitlist Available

Led By Alexander Fanaroff, MD, MHS

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 1-18

Awards & highlights

BE ACTIVE Trial Summary

This trial will test whether gamification, financial incentives, or both increase physical activity among patients with elevated risk for ASCVD.

Who is the study for?

This trial is for adults over 18 with a high risk of heart disease, specifically those who have or are at risk for atherosclerotic cardiovascular disease. Participants must be able to consent and not already in another exercise study. They need to walk less than 7,500 steps daily and have access to a device that can sync with an activity tracker.Check my eligibility

What is being tested?

The study tests if making physical activity into a game (gamification), offering money rewards, or both can help people at risk for heart disease exercise more. It's random which group participants will join: just gamification, just financial incentives, both, or none.See study design

What are the potential side effects?

Since the interventions involve increasing physical activity through games and potential financial rewards rather than medication or medical procedures, side effects are minimal but may include typical exercise-related issues like muscle soreness.

BE ACTIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 1-18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 1-18

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1-18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in mean daily step counts during the 12 month intervention using a wearable pedometer (Fitbit watch) to measure step count.

Secondary outcome measures

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 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 step counts during the 6 month follow-up using a wearable pedometer (Fitbit watch) to measure step count.

Other outcome measures

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 150 minutes of MVPA during the 6 month follow-up using a wearable device (Fitbit watch) to measure MVPA derived from step counts.

BE ACTIVE Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Gamification and Financial Incentive InterventionExperimental Treatment2 Interventions

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

Group II: Gamification InterventionExperimental Treatment1 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 III: Financial Incentive InterventionExperimental Treatment1 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 IV: ControlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gamification

2019

Completed Phase 3

~2230

Financial

2019

N/A

~1150

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,879,026 Total Patients Enrolled

Alexander Fanaroff, MD, MHSPrincipal InvestigatorUniversity of Pennsylvania

5 Previous Clinical Trials

3,374 Total Patients Enrolled

Mitesh Patel, MD, MBA, MSPrincipal InvestigatorUniversity of Pennsylvania

14 Previous Clinical Trials

133,403 Total Patients Enrolled

Media Library

Financial Incentives Clinical Trial Eligibility Overview. Trial Name: NCT03911141 — N/A

Cardiovascular Disease Research Study Groups: Gamification Intervention, Control, Gamification and Financial Incentive Intervention, Financial Incentive Intervention

Cardiovascular Disease Clinical Trial 2023: Financial Incentives Highlights & Side Effects. Trial Name: NCT03911141 — N/A

Financial Incentives 2023 Treatment Timeline for Medical Study. Trial Name: NCT03911141 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there open slots available for enrolment in this investigation?

"This trial, which was posted on 4/12/2019 and recently updated 6/17/2022 is not presently searching for study participants. However, 511 other trials are actively recruiting patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911141.