Optimizing accelerometer implementation in a gerotherapeutic trial: Feasibility, adherence, and operational insights...

The use of wearable technology for digital phenotyping has been limited in gerotherapeutic trials. Thus, it is important to identify insights into the operational feasibility of adopting accelerometers for digital phenotyping in gerotherapeutic trials, participant adherence to device and intervention, and study dropout risk, particularly in middle-aged adults. This exploratory analysis utilized data from 120 generally healthy, middle-aged adults participating in the Alpha-ketoglutarate (AKG) supplementation and BiologicaL agE in middle-aged adults (ABLE) double-blind, randomized, placebo-controlled trial (ClinicalTrials.gov identifier: NCT05706389). Participants were instructed to wear an ActiGraph wGT3X-BT accelerometer for seven days at four study visits, adhering to a six-month 1 g/day oral AKG supplement regimen with a three-month follow up. Device operational concerns, accelerometer wear behaviour, device wear and supplement use adherence, and study dropouts were evaluated. Associations between device wear (time or adherence) and dropout were analysed using Cox proportional hazards models using study visit as the time scale to account for when participants dropped out from the study. Participants (mean age 50.6 ± 6.0 years, 50% female, n = 59 AKG, n = 61 placebo) showed high adherence: median accelerometer wear was 24 hours per day, > 80% achieved ≥ 4 valid days per visit, and supplement use adherence >90%, with minimal device-related operational concerns across all four visits. Overall study dropout was 17%. In Cox models across study visits, one minute higher in wearing time (hazard ratio (HR): 0.998; 95% confidence interval (CI): 0.997-0.999) and being male (HR: 0.208; CI: 0.065-0.663) were significantly associated with lower dropout risk. Accelerometer deployment proved highly feasible in this gerotherapeutic trial with middle-aged adults. Higher device wearing time and being male were significantly associated with lower study dropout, informing strategies to enhance future trial success.