An Early-Stage Digital Therapeutic Intervention to Enhance Affective Response During Physical Activity Among Adults With Overweight or Obesity: Benchmark-Driven Formative Testing Study

BACKGROUND: Mobile device-enabled interventions known as digital therapeutics (DTx) are increasingly used to prevent chronic disease by targeting psychological and behavioral processes. Individuals' unique experiences while receiving DTx comprise real-world evidence (RWE) for evaluating DTx performance. An emerging strategy for early-stage DTx formative work uses small sample sizes, which facilitate efficient iteration and agile learning, while evaluating performance against descriptive benchmarks defined a priori, therefore minimizing the risk for confirmation bias. This study test benchmarks from the DTx RWE framework to formatively evaluate a novel DTx (the eMOTION study) to enhance affective response (ie, how people feel) during physical activity (PA). OBJECTIVE: This study aimed to determine whether the eMOTION DTx met a priori benchmarks for safety (