The largest-ever study testing the effectiveness of an evidence-based approach to increasing physical activity using smartphone fitness trackers gamification to reduce the risk of cardiovascular disease will launch at the Perelman School of Medicine at the University of Pennsylvania and Ascension, one of the nation's leading non-profit health systems , thanks to a $25 million award. The six-year study, funded by the Patient-Centered Outcomes Research Institute (PCORI), will build on the highly successful BE ACTIVE trial, published in 2024, which demonstrated sustained increases in daily step counts using a behavioral economics based approach to gamification to enhance ongoing engagement, where participants were awarded points for meeting daily step goals and progress through levels based on accumulated points.
Doctors often tell patients to exercise more to improve heart health, but until now, large controlled trials like this one have been missing to prove that physical activity truly prevents heart events. "We're testing whether a fairly simple points system, coupled with ongoing behavioral reinforcement to encourage participants, achieves sustained increases in physical activity to a sufficient degree to prevent heart attacks and save lives," said Alexander C. Fanaroff, MD, an assistant professor of Cardiovascular Medicine at Penn Medicine and a core faculty member in the Penn Center for Health Incentives and Behavioral Economics (CHIBE). "Despite overwhelming observational evidence that higher physical activity is associated with better cardiovascular health, no prior randomized trial has been large enough to prove that increasing activity actually prevents heart attacks and strokes and to quantify the magnitude of these effects."
Targeting those at higher risk
This new study will enroll 18,000 adults with at least a 1-in-10 chance of having a heart attack, stroke, hospitalization for heart failure, or dying from heart disease within the next decade, as calculated by the American Heart Association PREVENT equations.
Those taking part in the trial will establish a baseline step count over two weeks and then set a goal to increase their daily step count by 33-50% above their own baseline. They will then be entered into a game designed using principles from behavioral economics, in which they receive points each week and lose points on days they miss their goal. Participants get a text message each day letting them know if they met their goal or not. As they earn or lose points, they move up and down to different levels of the game. A support partner, identified by each participant, will receive weekly updates on how the participant is doing.
A nationwide, remote study
The study is made possible through systemwide partnership with Ascension. Ascension will offer the trial to patients in communities they serve across 15 states and the District of Columbia. "We are excited to partner with Penn Medicine on this innovative clinical trial to help support our patients and their health at scale", Mitesh Patel, MD, MBA, Chief Clinical Transformation Officer and National Vice President at Ascension. Patel is also the former director of the Penn Medicine Nudge Unit, and an adjunct professor at the Wharton School.
"Because of its size and scope, this trial tests whether behavioral economics applied in practice can act as the missing bridge between encouraging patients to move and actually preventing heart attacks and strokes," added Kevin Volpp, MD, PhD, Director of the Penn Center for Health Incentives and Behavioral Economics, and Mark V. Pauly President's Distinguished Professor.
The trial is fully remote from start to finish and requires no office visits. Participants simply use the technology that already exists in nearly every smartphone; a tiny sensor called an accelerometer that measures movement and motion.
"Results from this landmark trial have the potential to transform cardiovascular prevention guidelines, reduce mortality, improve quality of life, and dramatically lower healthcare costs," said Fanaroff.
