Background: Digital and mobile health interventions using personalization via reinforcement learning algorithms have the potential to reach large number of people to support physical activity and help manage diabetes and depression in daily life. Objective: The Diabetes and Mental Health Adaptive Notification and Tracking Evaluation (DIAMANTE) study tested whether a digital physical activity intervention using personalized text messaging via reinforcement learning algorithms could increase step counts in a diverse, multilingual sample of people with diabetes and depression symptoms. Methods: From January 2020 to June 2022, participants were recruited from 4 San Francisco, California–based public primary care clinics and through web-based platforms to participate in the 24-week randomized controlled trial. Eligibility criteria included English or Spanish language preference and a documented diagnosis of diabetes and elevated depression symptoms. The trial had 3 arms: a Control group receiving a weekly mood monitoring message, a Random messaging group receiving randomly selected feedback and motivational text messages daily, and an Adaptive messaging group receiving text messages selected by a reinforcement learning algorithm daily. Randomization was performed with a 1:1:1 allocation. The primary outcome, changes in daily step counts, was passively collected via a mobile app. The primary analysis assessed changes in daily step count using a linear mixed-effects model. An a priori subanalysis compared the primary step count outcome within recruitment samples. Results: In total, 168 participants were analyzed, including those with 24% (40/168) Spanish language preference and 37.5% (63/168) from clinic-based recruitment. The results of the linear mixed-effects model indicated that participants in the Adaptive arm cumulatively gained an average of 3.6 steps each day (95% CI 2.45-4.78; P<.001) over the 24-week intervention (average of 608 total steps), whereas both the Control and Random arm participants had significantly decreased rates of change. Postintervention estimates suggest that participants in the Adaptive messaging arm showed a significant step count increase of 19% (606/3197; P<.001), in contrast to 1.6% (59/3698) and 3.9% (136/3480) step count increase in the Random and Control arms, respectively. Intervention effectiveness differences were observed between participants recruited from the San Francisco clinics and those recruited via web-based platforms, with the significant step count trend persisting across both samples for participants in the Adaptive group. Conclusions: Our study supports the use of reinforcement learning algorithms for personalizing text messaging interventions to increase physical activity in a diverse sample of people with diabetes and depression. It is the first to test this approach in a large, diverse, and multilingual sample.

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Background: The COVID-19 pandemic has propelled patient-facing research to shift to digital and telehealth strategies. If these strategies are not adapted for minority patients of lower socioeconomic status, health inequality will further increase. Patient-centered models of care can successfully improve access and experience for minority patients. Objective: This study aims to present the development process and preliminary acceptability of altering in-person onboarding procedures into internet-based, remote procedures for a mobile health (mHealth) intervention in a population with limited digital literacy. Methods: We actively recruited safety-net patients (English- and Spanish-speaking adults with diabetes and depression who were receiving care at a public health care delivery system in San Francisco, United States) into a randomized controlled trial of text messaging support for physical activity. Because of the COVID-19 pandemic, we modified the in-person recruitment and onboarding procedures to internet-based, remote processes with human support. We conducted a preliminary evaluation of how the composition of the recruited cohort might have changed from the pre-COVID-19 period to the COVID-19 enrollment period. First, we analyzed the digital profiles of patients (n=32) who had participated in previous in-person onboarding sessions prior to the COVID-19 pandemic. Next, we documented all changes made to our onboarding processes to account for remote recruitment, especially those needed to support patients who were not very familiar with downloading apps onto their mobile phones on their own. Finally, we used the new study procedures to recruit patients (n=11) during the COVID-19 social distancing period. These patients were also asked about their experience enrolling into a fully digitized mHealth intervention. Results: Recruitment across both pre-COVID-19 and COVID-19 periods (N=43) demonstrated relatively high rates of smartphone ownership but lower self-reported digital literacy, with 32.6% (14/43) of all patients reporting they needed help with using their smartphone and installing apps. Significant changes were made to the onboarding procedures, including facilitating app download via Zoom video call and/or a standard phone call and implementing brief, one-on-one staff-patient interactions to provide technical assistance personalized to each patient's digital literacy skills. Comparing recruitment during pre-COVID-19 and COVID-19 periods, the proportion of patients with digital literacy barriers reduced from 34.4% (11/32) in the pre-COVID-19 cohort to 27.3% (3/11) in the COVID-19 cohort. Differences in digital literacy scores between both cohorts were not significant (P=.49). Conclusions: Patients of lower socioeconomic status have high interest in using digital platforms to manage their health, but they may require additional upfront human support to gain access. One-on-one staff-patient partnerships allowed us to provide unique technical assistance personalized to each patient's digital literacy skills, with simple strategies to troubleshoot patient barriers upfront. These additional remote onboarding strategies can mitigate but not eliminate digital barriers for patients without extensive technology experience.@en