BACKGROUND
The US Preventive Services Task Force recommends providers individualize healthy behavior interventions for all adults, independent of their risk of cardiovascular disease.
OBJECTIVE
We describe the protocol of randomized controlled trial to evaluate the efficacy of a multimodal Digital Behavior Change Intervention (DBCI) on 1) self-reported behaviors of physical activity, nutrition, sleep, and mindfulness, 2) cardiometabolic biomarkers, and 3) chronic disease-related medical expenditure.
METHODS
A two-arm randomized controlled trial for 12-months among employees of an academic healthcare facility in the US. Intervention arm received an activity tracker, a scale, a smartphone app, a video library for healthy behavior recommendations, and an on-demand health coach. Data was collected through smartphone apps, online-surveys, and in-person visits for collection of biometrics. Data from medical claims was electronically abstracted. Comparative efficacy is assessed using intent-to-treat analysis. Descriptive statistics was used to describe the cohort and their follow-up.
RESULTS
A total of 603 participants consented to participate in the study and attended the entrance visit where they were randomized to intervention (n = 300) and control arm (n = 303). No systematic differences in baseline characteristics were observed. We observed a retention rate of 83.7% for completing the final survey and 75.7% for attending the exit visit.
CONCLUSIONS
This study represents the largest and most comprehensive evaluation of DBCI among participants who were not selected based on their underlying condition and that assesses impact of the intervention on behavior, cardiometabolic biomarkers, and medical expenditure.
CLINICALTRIAL
Clinical Trials Registry (#NCT04712383), Date: January 13, 2021 https://clinicaltrials.gov/ct2/show/NCT04712383