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Results From the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation (DIAMANTE) Randomized Clinical Trial

Journal article (2024) - Adrian Aguilera, Marvyn Arévalo Avalos, Lisa Ochoa-Frongia, Urmimala Sarkar, Elad Yom-Tov, Courtney Lyles, Jing Xu, Bibhas Chakraborty, Caroline Figueroa, Faviola Garcia, Karina Rosales, Rosa Hernandez-Ramos, Chris Karr, Joseph Williams
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. ...
Journal article (2023) - Caroline A. Figueroa, Laura Gomez-Pathak, Imran Khan, Joseph Jay Williams, Courtney R. Lyles, Adrian Aguilera
University students have low levels of physical activity and are at risk of mental health disorders. Mobile apps to encourage physical activity can help students, who are frequent smartphone-users, to improve their physical and mental health. Here we report students’ qualitative feedback on a physical activity smartphone app with motivational text messaging. We provide recommendations for the design of future apps. 103 students used the app for 6 weeks in the context of a clinical trial (NCT04440553) and answered open-ended questions before the start of the study and at follow-up. A subsample (n = 39) provided additional feedback via text message, and a phone interview (n = 8). Questions focused on the perceived encouragement and support by the app, text messaging content, and recommendations for future applications. We analyzed all transcripts for emerging themes using qualitative coding in Dedoose. The majority of participants were female (69.9%), Asian or Pacific Islander (53.4%), with a mean age of 20.2 years, and 63% had elevated depressive symptoms. 26% felt encouraged or neutral toward the app motivating them to be more physically active. Participants liked messages on physical activity benefits on (mental) health, encouraging them to complete their goal, and feedback on their activity. Participants disliked messages that did not match their motivations for physical activity and their daily context (e.g., time, weekday, stress). Physical activity apps for students should be adapted to their motivations, changing daily context, and mental health issues. Feedback from this sample suggests a key to effectiveness is finding effective ways to personalize digital interventions. ...
Journal article (2022) - Caroline A. Figueroa, Nina Deliu, Bibhas Chakraborty, Arghavan Modiri, Jing Xu, Jai Aggarwal, Joseph Jay Williams, Courtney Lyles, Adrian Aguilera
Background: Low physical activity is an important risk factor for common physical and mental disorders. Physical activity interventions delivered via smartphones can help users maintain and increase physical activity, but outcomes have been mixed. Purpose: Here we assessed the effects of sending daily motivational and feedback text messages in a microrandomized clinical trial on changes in physical activity from one day to the next in a student population. Methods: We included 93 participants who used a physical activity app, "DIAMANTE"for a period of 6 weeks. Every day, their phone pedometer passively tracked participants' steps. They were microrandomized to receive different types of motivational messages, based on a cognitive-behavioral framework, and feedback on their steps. We used generalized estimation equation models to test the effectiveness of feedback and motivational messages on changes in steps from one day to the next. Results: Sending any versus no text message initially resulted in an increase in daily steps (729 steps, p = .012), but this effect decreased over time. A multivariate analysis evaluating each text message category separately showed that the initial positive effect was driven by the motivational messages though the effect was small and trend-wise significant (717 steps; p = .083), but not the feedback messages (-276 steps, p = .4). Conclusion: Sending motivational physical activity text messages based on a cognitive-behavioral framework may have a positive effect on increasing steps, but this decreases with time. Further work is needed to examine using personalization and contextualization to improve the efficacy of text-messaging interventions on physical activity outcomes. ...
Journal article (2022) - C.A. Figueroa, Hikari Murayama, Claudia von Vacano, Priscila Carcamo Amorim, Alison White, Ashley Quiterio, Tiffany Luo, Adrian Aguilera, Angela D.R. Smith, Courtney Lyles, Victoria Robinson
Journal article (2021) - Laura Elizabeth Pathak, Adrian Aguilera, Joseph Jay Williams, Courtney Rees Lyles, Rosa Hernandez-Ramos, Jose Miramontes, Anupama Gunshekar Cemballi, Caroline Astrid Figueroa
Background: Text messaging interventions can be an effective and efficient way to improve health behavioral changes. However, most texting interventions are neither tested nor designed with diverse end users, which could reduce their impact, and there is limited evidence regarding the optimal design methodology of health text messages tailored to low-income, low-health literacy populations and non-English speakers. Objective: This study aims to combine participant feedback, crowdsourced data, and researcher expertise to develop motivational text messages in English and Spanish that will be used in a smartphone app-based texting intervention that seeks to encourage physical activity in low-income minority patients with diabetes diagnoses and depression symptoms. Methods: The design process consisted of 5 phases and was iterative in nature, given that the findings from each step informed the subsequent steps. First, we designed messages to increase physical activity based on the behavior change theory and knowledge from the available evidence. Second, using user-centered design methods, we refined these messages after a card sorting task and semistructured interviews (N=10) and evaluated their likeability during a usability testing phase of the app prototype (N=8). Third, the messages were tested by English- and Spanish-speaking participants on the Amazon Mechanical Turk (MTurk) crowdsourcing platform (N=134). Participants on MTurk were asked to categorize the messages into overarching theoretical categories based on the capability, opportunity, motivation, and behavior framework. Finally, each coauthor rated the messages for their overall quality from 1 to 5. All messages were written at a sixth-grade or lower reading level and culturally adapted and translated into neutral Spanish by bilingual research staff. Results: A total of 200 messages were iteratively refined according to the feedback from target users gathered through user-centered design methods, crowdsourced results of a categorization test, and an expert review. User feedback was leveraged to discard unappealing messages and edit the thematic aspects of messages that did not resonate well with the target users. Overall, 54 messages were sorted into the correct theoretical categories at least 50% of the time in the MTurk categorization tasks and were rated 3.5 or higher by the research team members. These were included in the final text message bank, resulting in 18 messages per motivational category. Conclusions: By using an iterative process of expert opinion, feedback from participants that were reflective of our target study population, crowdsourcing, and feedback from the research team, we were able to acquire valuable inputs for the design of motivational text messages developed in English and Spanish with a low literacy level to increase physical activity. We describe the design considerations and lessons learned for the text messaging development process and provide a novel, integrative framework for future developers of health text messaging interventions. ...
Journal article (2021) - Rosa Hernandez-Ramos, Adrian Aguilera, Faviola Garcia, Jose Miramontes-Gomez, Laura Elizabeth Pathak, Caroline Astrid Figueroa, Courtney Rees Lyles
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. ...
Review (2021) - Caroline A. Figueroa, Tiffany Luo, Adrian Aguilera, Courtney R. Lyles
Digital health, including the use of mobile health apps, telemedicine, and data analytics to improve health systems, has surged during the COVID-19 pandemic. The social and economic fallout from COVID-19 has further exacerbated gender inequities, through increased domestic violence against women, soaring unemployment rates in women, and increased unpaid familial care taken up by women—all factors that can worsen women's health. Digital health can bolster gender equity through increased access to health care, empowerment of one's own health data, and reduced burden of unpaid care work. Yet, digital health is rarely designed from a gender equity perspective. In this Viewpoint, we show that because of lower access and exclusion from app design, gender imbalance in digital health leadership, and harmful gender stereotypes, digital health is disadvantaging women—especially women with racial or ethnic minority backgrounds. Tackling digital health's gender inequities is more crucial than ever. We explain our feminist intersectionality framework to tackle digital health's gender inequities and provide recommendations for future research. ...
Journal article (2021) - Caroline A. Figueroa, Adrian Aguilera, Bibhas Chakraborty, Arghavan Modiri, Jai Aggarwal, Nina Deliu, Urmimala Sarkar, Joseph Jay Williams, Courtney R. Lyles
Objective: Providing behavioral health interventions via smartphones allows these interventions to be adapted to the changing behavior, preferences, and needs of individuals. This can be achieved through reinforcement learning (RL), a sub-area of machine learning. However, many challenges could affect the effectiveness of these algorithms in the real world. We provide guidelines for decision-making. Materials and Methods: Using thematic analysis, we describe challenges, considerations, and solutions for algorithm design decisions in a collaboration between health services researchers, clinicians, and data scientists. We use the design process of an RL algorithm for a mobile health study "DIAMANTE"for increasing physical activity in underserved patients with diabetes and depression. Over the 1.5-year project, we kept track of the research process using collaborative cloud Google Documents, Whatsapp messenger, and video teleconferencing. We discussed, categorized, and coded critical challenges. We grouped challenges to create thematic topic process domains. Results: Nine challenges emerged, which we divided into 3 major themes: 1. Choosing the model for decision-making, including appropriate contextual and reward variables; 2. Data handling/collection, such as how to deal with missing or incorrect data in real-time; 3. Weighing the algorithm performance vs effectiveness/implementation in real-world settings. Conclusion: The creation of effective behavioral health interventions does not depend only on final algorithm performance. Many decisions in the real world are necessary to formulate the design of problem parameters to which an algorithm is applied. Researchers must document and evaulate these considerations and decisions before and during the intervention period, to increase transparency, accountability, and reproducibility. ...
Review (2021) - Tiffany Christina Luo, Adrian Aguilera, Courtney Rees Lyles, Caroline Astrid Figueroa
Background: Regular physical activity (PA) is crucial for well-being; however, healthy habits are difficult to create and maintain. Interventions delivered via conversational agents (eg, chatbots or virtual agents) are a novel and potentially accessible way to promote PA. Thus, it is important to understand the evolving landscape of research that uses conversational agents. Objective: This mixed methods systematic review aims to summarize the usability and effectiveness of conversational agents in promoting PA, describe common theories and intervention components used, and identify areas for further development. Methods: We conducted a mixed methods systematic review. We searched seven electronic databases (PsycINFO, PubMed, Embase, CINAHL, ACM Digital Library, Scopus, and Web of Science) for quantitative, qualitative, and mixed methods studies that conveyed primary research on automated conversational agents designed to increase PA. The studies were independently screened, and their methodological quality was assessed using the Mixed Methods Appraisal Tool by 2 reviewers. Data on intervention impact and effectiveness, treatment characteristics, and challenges were extracted and analyzed using parallel-results convergent synthesis and narrative summary. Results: In total, 255 studies were identified, 7.8% (20) of which met our inclusion criteria. The methodological quality of the studies was varied. Overall, conversational agents had moderate usability and feasibility. Those that were evaluated through randomized controlled trials were found to be effective in promoting PA. Common challenges facing interventions were repetitive program content, high attrition, technical issues, and safety and privacy concerns. Conclusions: Conversational agents hold promise for PA interventions. However, there is a lack of rigorous research on long-term intervention effectiveness and patient safety. Future interventions should be based on evidence-informed theories and treatment approaches and should address users' desires for program variety, natural language processing, delivery via mobile devices, and safety and privacy concerns. ...