Currently accepted at: JMIR Research Protocols
Date Submitted: Jul 2, 2023
Date Accepted: Apr 26, 2024
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/50378
The final accepted version (not copyedited yet) is in this tab.
Study to Evaluate the Efficacy of a Multimodal Digital Behavior Change Intervention on Lifestyle Behavior, Cardiometabolic Biomarkers, and Medical Expenditure: Protocol of a Randomized Controlled Trial
ABSTRACT
Background:
The US Preventive Services Task Force recommends providers offer individualized healthy behavior interventions for all adults, independent of their risk of cardiovascular disease. While strong evidence exists to support disease-specific programs designed to improve multiple lifestyle behaviors, approaches to adapt these interventions for a broader population are not well-established. Digital Behavior Change Interventions (DBCI) hold promise as a more generalizable and scalable approach to overcome resource and time limitations that traditional behavioral interventions programs face, especially within an occupational setting.
Objective:
We aimed to evaluate the efficacy of a multimodal DBCI on 1) self-reported behaviors of physical activity, nutrition, sleep, and mindfulness, 2) cardiometabolic biomarkers, and 3) chronic disease-related medical expenditure.
Methods:
We conducted a two-arm randomized controlled trial for 12-months among employees of an academic healthcare facility in the US. The intervention arm received a scale, smartphone app, activity tracker, video library for healthy behavior recommendations, and an on-demand health coach. The control arm received standard employer-provided health and wellness benefits. Primary outcomes of the study included changes in self-reported lifestyle behaviors, cardiometabolic biomarkers, and chronic disease-related medical expenditure. We collected health behavior data via baseline and quarterly online-surveys, biometric measures via clinic visits at baseline and 12 months, and identified relevant costs through claims datasets.
Results:
A total of 603 participants were enrolled and randomized to the intervention (n = 300) and control arms (n = 303). The average age was 46.7 years, and participants were majority female (80.3%), White (85.4%) and non-Hispanic (90.7%), with no systematic differences in baseline characteristics observed between the study arms. We observed retention rates 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 to assess impact on behavior, cardiometabolic biomarkers, and medical expenditure. Trial Registration: Clinical Trials Registry (#NCT04712383), Date: January 13, 2021 https://clinicaltrials.gov/ct2/show/NCT04712383
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.