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

Atherosclerotic Cardiovascular Disease Clinical Trial

— BE ACTIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911141
• Other study ID #: 831230
• Status: Completed
• Phase: N/A
• Start date: April 12, 2019
• Est. completion date: January 27, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1062
• Est. completion date: January 27, 2024
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 the intervention period. This will be measured using the Fitbit Charge 3 wearable device.	Months 1-12
Other	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. This will be measured using the Fitbit Charge 3 wearable device.	Months 1-18
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 3 wearable device.	Months 1-12
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 3 wearable device.	Months 1-18
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 3 wearable device.	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 3 wearable device.	Months 1-18