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Clinical Trials/NCT03911141
NCT03911141
Completed
Not Applicable

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

University of Pennsylvania1 site in 1 country1,062 target enrollmentApril 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerotic Cardiovascular Disease
Sponsor
University of Pennsylvania
Enrollment
1062
Locations
1
Primary Endpoint
Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2019
End Date
January 27, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.

Time Frame: Months 1-12

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.

Secondary Outcomes

  • 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)

Study Sites (1)

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