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

backgroundMobile 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).

objectiveThis study aimed to determine whether the eMOTION DTx met a priori benchmarks for safety (<1% of participants report an adverse event), plausibility (≥51% of participants experience increased enjoyment in PA), usability (eg, ≥51% of participants report adequate usability), sustainability, feasibility (eg, <70% of participants report dissatisfaction), and equity (equity and accessibility are approximately equal across subgroups).

methodsParticipants (N=36; mean age 46, SD 14 years; 20/37, 54% female) underwent stratified random assignment to test one of four DTx versions for 14 days (n=9 each): (1) intensity PA goals, (2) affect PA goals with type and context recommendations, (3) affect PA goals with savoring exercises, and (4) affect PA goals with type, context, and savoring. Participants completed daily intervention sessions, asking them to focus on achieving a target heart rate (intensity) or feeling good (affect) during PA. Smartwatches were used to track PA and answer ecological momentary assessment (EMA) questions about how they felt during PA. Performance toward benchmarks was primarily assessed via official Institutional Review Board reporting channels (safety), interviews (plausibility, accessibility, and usability), and questionnaires (System Usability Scale [usability], Delighted-Terrible Scale [sustainability and feasibility], and equity).

resultsThe eMOTION DTx versions exceeded all a priori safety, plausibility, accessibility, usability, sustainability, feasibility, and equity thresholds. For safety, no adverse events were reported. Regarding plausibility, more than half of the participants who received affect goals reported increased PA enjoyment at the end of the study. Moreover, 64%-72% (23-26 out of 36) of participants rated the DTx at or above the standard System Usability Scale cutoff point for acceptable usability. More than 60% (22/36) of participants reported satisfaction with all DTx components, supporting DTx sustainability and feasibility. Finally, there was evidence for equity, with plausibility and accessibility comparable across sex, race, ethnicity, income, age, BMI, mobility, and physical constraint subgroups.

conclusionsSince DTx RWE Framework benchmarks for safety, plausibility, accessibility, usability, sustainability, feasibility, and equity were largely met, the eMOTION Study DTx is ready for a full-scale efficacy trial to refine the DTx and optimize efficiency and feasibility. Our approach incorporated transparent decision-making to generate results that are more readily translatable, easily replicable, and reflect current best practices in the field of DTx.

trial registrationClinicalTrials.gov NCT06125964; https://clinicaltrials.gov/study/NCT06125964.