Clinical trial NCT03911141: Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease
Official title: Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerotic Cardiovascular Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 1062
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
timeFrame: Months 1-12
Secondary outcomes:
measure: Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
timeFrame: Months 1-18
measure: 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.
timeFrame: Months 1-12
measure: 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.
timeFrame: Months 1-18
Other outcomes:
measure: 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.
timeFrame: Months 1-12
measure: 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.
timeFrame: Months 1-18
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Alexander Fanaroff, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: