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To examine the association between COVID-19 impact and clinical outcomes of an integrated collaborative care intervention for adults with obesity and comorbid depression.Latent class analysis identified clusters of self-reported COVID-19 impact. Cluster characteristics were examined using Fishers' least significant difference method and canonical discriminant analysis. Intervention vs. usual care effects on primary (body mass index [BMI], depressive symptoms) and secondary (anxiety symptoms and other psychosocial) outcomes stratified by cluster were examined using linear mixed models.Three clusters were identified: mental health and sleep impact (cluster 1, n = 37), economic impact (cluster 2, n = 18), and less overall impact (cluster 3, n = 20). Clusters differed in age, income, diet, and baseline coping skills. The intervention led to improvements across several health outcomes compared with usual care, with medium to large effects on functional impairments (standardized mean difference, -0.7 [95% CI: -1.3, -0.1]) in cluster 1, depressive symptoms (-1.1 [95% CI: -2.0, -0.1]) and obesity-related problems (-1.6 [95% CI: -2.8, -0.4]) in cluster 2, and anxiety (-1.1 [95% CI: -1.9, -0.3]) in cluster 3.People with obesity and comorbid depression may have varied intervention responses based on COVID-19 impact. Interventions tailored to specific COVID-19 impact clusters may restore post-pandemic health.

This study examined whether stressful life events were associated with weight loss, central adiposity, and health behavior changes of African American breast cancer survivors (AABCS) participating in a weight loss intervention. We conducted a secondary-data analyses of Moving Forward, a weight loss efficacy trial for AABCS conducted in 2011–2014. Two-hundred forty-six eligible women were randomized to a 6-month interventionist-guided (IG) or self-guided (SG) weight loss intervention. Data was collected on height, weight, self-reported diet, and self-reported physical activity. Stress (e.g., financial, legal, employment, relationships, safety, prejudice) was measured using an abbreviated version of the Crisis in Family Systems (CRISYS) urban life stress measure. Generalized linear models stratified by group examined the degree to which stress was associated with weight loss or changes in central adiposity, physical activity, and diet during the intervention (Months 1–6) or maintenance (Months 7 to 12) phases. Participants reported a median of 3.0 life stressors (range 0 to 22) mostly relating to relationships, safety concerns, and financial problems. In the IG group during the intervention phase, exposure to life stressors was not associated with weight loss (p = 0.15) or change in central adiposity (p = 0.69), physical activity (p = 0.15), or diet (p = 0.26). We found similar associations for the maintenance phase and in the SG group. Despite facing stress across a myriad of domains (e.g., relationships, safety, finances), AABCS were successful at initiating and maintaining behaviors to achieve weight loss, reductions in central adiposity, and behavioral changes. Future randomized controlled trials are warranted that include more strategies to address the challenges that AABCS face, to determine whether AABCS in particular might benefit from interventions that address barriers (e.g., stress management) to weight loss. Such strategies are critical for improving quality of life and lowering the risk of cancer recurrence.

The cardiovascular disease (CVD) process may begin early in life when accompanied by atherosclerotic risk factors. CVD risk factors in children are associated with stiffening of the large elastic arteries, a reflection of subclinical atherosclerosis. Physical activity is a preventative lifestyle strategy that may benefit arterial stiffness by attenuating the hemodynamic stress on the artery wall. This study examined the relations between physical activity, carotid pulsatile stress, and carotid stiffness in children. One hundred and forty children (9-11 yrs; 50.0% male, 57.9% African-American, 42.10% Caucasian, body mass index (BMI) 20.1 ± 4.7 kg/m2) participated in this study. Physical activity counts were measured using a wrist-worn accelerometer and averaged over 7 days. Carotid artery β-stiffness and pulse pressure (calibrated to brachial mean and diastolic pressure) were assessed as via ultrasound and tonometry, respectively. Pulsatile stress was calculated as the product of carotid pulse pressure and heart rate. Physical activity counts were correlated with pulsatile stress (r = -0.27), and BMI (r = -0.23), but were unrelated to carotid stiffness. In multivariate models, associations between physical activity counts and pulsatile stress remained (B = -1.3 [95%CI, -2.4, -0.2], β = -0.20, p < 0.05) after covariate adjustment for age, race, sex, pubertal stage, and BMI. Carotid pulsatile stress was related to regional carotid stiffness (r = 0.45, p < 0.05). These data suggest that higher levels of physical activity at young age are associated with lower hemodynamic stress in the carotid artery. Findings are discussed in the context of an inverse relationship between hemodynamic pulsatile stress and carotid stiffness in children.

STUDY OBJECTIVES: Text messaging (TM) may provide an inexpensive and convenient method for self-reported sleep assessment. This pilot study evaluated the feasibility of a TM sleep diary among a racial/ethnic minority population with uncontrolled type 2 diabetes. METHODS: A convenience sample of 40 participants with uncontrolled type 2 diabetes was recruited. Participants wore an Actiwatch (Philips Spectrum Plus, Philips Respironics, Murrysville, Pennsylvania) for 7 consecutive days during both wake and sleep intervals and completed a daily TM sleep diary including 10 questions adapted from the Consensus Sleep Diary. The relationships between sleep measures from TMs and actigraphy were explored through Bland-Altman plots and correlations. RESULTS: Of the 40 participants enrolled, 34 were African American and 6 were Latino. The mean age was 52.2 years (standard deviation = 8.2), and the mean hemoglobin A1c was 9.0% (standard deviation = 1.5). All but 1 participant attempted to complete the TM sleep diary. With a maximum of 70 TM replies possible, the median number of responses per participant was 66 (interquartile range = 59.5–69). Actigraphy and TM measures were related for total sleep time (median = 382 vs 393 min, respectively [r = .71; P < .01]), sleep onset latency (median = 31.4 vs 27.5 min [r = .61; P < .01]), time in bed (433.3 vs 489.3 min [r = .74; P < .01]), and sleep efficiency (77% vs 86% [r = .45; P = .005]). The measure of wake after sleep onset was higher from actigraphy than from TM, with a weak relationship between the 2 measures (median 47.9 vs 6.0 min [r = .31; P = .05]). CONCLUSIONS: TM is a novel and feasible method for sleep assessment in racial/ethnic minority adults with uncontrolled type 2 diabetes. CITATION: Biggers A, Henkins J, Barton I, et al. Feasibility of text message sleep assessment in African American and Latino patients with type 2 diabetes. J Clin Sleep Med. 2021;17(1):69–78.

ImportanceWide-spread distribution of diagnostics is an integral part of the United States’ COVID-19 strategy; however, few studies have assessed the effectiveness of this intervention at reducing transmission of community COVID-19.ObjectiveTo assess the impact of the Say Yes! Covid Test (SYCT!) Michigan program, a population-based program that distributed 20,000 free rapid antigen tests within Ann Arbor and Ypsilanti, Michigan in June-August 2021, on community prevalence of SARS-CoV-2.DesignThis ecological study analyzed cases of SARS-CoV-2 from March to October 2021 reported to the Washtenaw County Health Department.SettingWashtenaw County, MichiganParticipantsAll residents of Washtenaw CountyInterventionsCommunity-wide distribution of 500,000 rapid antigen tests for SARS-CoV-2 to residents of Ann Arbor and Ypsilanti, Michigan. Each household was limited to one test kit containing 25 rapid antigen tests.Main Outcome and MeasuresCommunity prevalence of SARS-CoV-2, as measured through 7-day average cases, in Ann Arbor and Ypsilanti was compared to the rest of Washtenaw County. A generalized additive model was fitted with non-parametric trends for control and relative differences of trends in the pre-intervention, intervention, and post-intervention periods to compare intervention municipalities of Ann Arbor and Ypsilanti to the rest of Washtenaw County. Model results were used to calculate average cases prevented in the post-intervention period.ResultsIn the post-intervention period, there were significantly lower standardized average cases in the intervention communities of Ann Arbor/Ypsilanti compared to the rest of Washtenaw County (pConclusions and RelevanceMass distribution of rapid antigen tests may be a useful mitigation strategy to combat community transmission of SARS-CoV-2, especially given the recent relaxation of social distancing and masking requirements.

Recent evidence suggests that diabetic retinopathy (DR) is associated with abnormal melatonin regulation, possibly related to dysfunction of the melanopsin-expressing intrinsically photosensitive retinal ganglion cells. This study explored melatonin regulation in type 2 diabetes (T2D) patients with DR and its relation to sleep and circadian functioning. Thirty-five participants (10 non-diabetic controls, 10 T2D without DR, and 15 T2D with DR) were recruited. Overnight urine 6-sulfatoxymelatonin (aMT6s) and objective sleep and wrist activity (7-day actigraphy) were obtained. After adjusting for covariates, having T2D with DR was significantly associated with lower urinary aMT6s (β = − 1.369, p = 0.004) compared with controls, while having T2D without DR was not (p = 0.418). T2D patients with DR reported poorer sleep quality (p = 0.014) and had greater variability of sleep duration (p = 0.017) than others, while no differences were found in sleep duration, efficiency, and rest-activity rhythm. After adjusting for covariates, lower nocturnal aMT6s was significantly associated with greater sleep variability. T2D patients with DR exhibited low overnight production of aMT6s which likely contributed to sleep irregularities possibly due to weak circadian signaling. Whether or not melatonin supplementation could improve health in T2D patients with DR remains to be explored.

Objective Clinical pharmacist support for patients with type 2 diabetes mellitus (T2DM) can optimize patient outcomes and medication adherence. However, there is limited understanding of what pharmacist roles patients perceive as most helpful in T2DM management interventions. This study describes experiences of minority patients with uncontrolled T2DM in terms of perceived pharmacist helpfulness and specific roles found to be most helpful within diabetes management. Design A secondary analysis of a 2-year randomized, crossover trial was conducted. Setting and participants This study included 244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model. Outcome measures The patients completed a mixed-methods survey regarding their experience with the intervention that included a general helpfulness rating on a 10-point unipolar Likert scale and described the support qualitatively, including their perception of the pharmacist roles. Thematic analysis guided coding of the responses. Results One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist. Of these, 108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women. The median rating of clinical pharmacist helpfulness was 10 (very helpful). Only 10 (7%) participants rated pharmacist helpfulness as 1 (not at all helpful). “Medication education and management” was the most frequently perceived supportive role of the clinical pharmacists, followed by “non–medication-related patient education,” “social support,” and “care coordination.” Miscommunication related to scheduling was the most common reason cited for not meeting with the clinical pharmacist. Conclusion This sample of minority patients with uncontrolled T2DM recognized many roles outlined within the American Pharmacists Association Medication Therapy Management framework. Patient experiences with clinical pharmacist T2DM support are crucial for developing effective programs, maximizing patient engagement, satisfying patient needs, and ensuring that a program’s intended purpose aligns with the patient perspective.

BACKGROUND After hospital discharge, patients with acute coronary syndrome (ACS) often experience symptoms that prompt them to seek acute medical attention. Early evaluation of postdischarge symptoms by health care providers may reduce unnecessary acute care utilization. However, hospital-initiated follow-up encounters are insufficient for timely detection and assessment of symptoms. While digital health tools can help address this issue, little is known about the intention to use such tools in ACS patients. OBJECTIVE This study aimed to assess ACS patients’ intention to use digital health apps that support postdischarge symptom monitoring by health care providers and identify patient-perceived facilitators and barriers to app use. METHODS Using email invitations or phone calls, we recruited ACS patients discharged from a central Massachusetts health care system between December 2020 and April 2021, to participate in the study. Surveys were delivered online or via phone to individual participants. Demographics and access to technology were assessed. The intention to use a symptom monitoring app was assessed using 5-point Likert-type (from strongly agree to strongly disagree) items, such as “If this app were available to me, I would use it.” Responses were compared across demographic subgroups and survey delivery methods. Two open-ended questions assessed perceived facilitators and barriers to app use, with responses analyzed using qualitative content analysis. RESULTS Among 100 respondents (response rate 8.1%), 45 (45%) completed the survey by phone. The respondents were on average 68 years old (SD 13 years), with 90% (90/100) White, 39% (39/100) women, and 88% (88/100) having access to the internet or a mobile phone. Most participants (65/100, 65%) agreed or strongly agreed that they would use the app, among which 53 (82%) would use the app as often as possible. The percentage of participants with the intention to use the app was 75% among those aged 65-74 years and dropped to 44% among those older than 75 years. The intention to use was higher in online survey respondents (vs phone survey respondents; odds ratio 3.07, 95% CI 1.20-7.88) after adjusting for age and access to technology. The analysis of open-ended questions identified the following 4 main facilitators (motivations): (1) easily reaching providers, (2) accessing or providing information, (3) quickly reaching providers, and (4) consulting providers for symptoms, and the following 4 main barriers: (1) privacy/security concerns, (2) uncomfortable using technology, (3) user-unfriendly app interface, and (4) preference for in-person/phone care. CONCLUSIONS There was a strong intention to use a symptom monitoring app postdischarge among ACS patients. However, this intent decreased in patients older than 75 years. The survey identified barriers related to technology use, privacy/security, and the care delivery mode. Further research is warranted to determine if such intent translates into app use, and better symptom management and health care quality.

Background After hospital discharge, patients with acute coronary syndrome (ACS) often experience symptoms that prompt them to seek acute medical attention. Early evaluation of postdischarge symptoms by health care providers may reduce unnecessary acute care utilization. However, hospital-initiated follow-up encounters are insufficient for timely detection and assessment of symptoms. While digital health tools can help address this issue, little is known about the intention to use such tools in ACS patients. Objective This study aimed to assess ACS patients’ intention to use digital health apps that support postdischarge symptom monitoring by health care providers and identify patient-perceived facilitators and barriers to app use. Methods Using email invitations or phone calls, we recruited ACS patients discharged from a central Massachusetts health care system between December 2020 and April 2021, to participate in the study. Surveys were delivered online or via phone to individual participants. Demographics and access to technology were assessed. The intention to use a symptom monitoring app was assessed using 5-point Likert-type (from strongly agree to strongly disagree) items, such as “If this app were available to me, I would use it.” Responses were compared across demographic subgroups and survey delivery methods. Two open-ended questions assessed perceived facilitators and barriers to app use, with responses analyzed using qualitative content analysis. Results Among 100 respondents (response rate 8.1%), 45 (45%) completed the survey by phone. The respondents were on average 68 years old (SD 13 years), with 90% (90/100) White, 39% (39/100) women, and 88% (88/100) having access to the internet or a mobile phone. Most participants (65/100, 65%) agreed or strongly agreed that they would use the app, among which 53 (82%) would use the app as often as possible. The percentage of participants with the intention to use the app was 75% among those aged 65-74 years and dropped to 44% among those older than 75 years. The intention to use was higher in online survey respondents (vs phone survey respondents; odds ratio 3.07, 95% CI 1.20-7.88) after adjusting for age and access to technology. The analysis of open-ended questions identified the following 4 main facilitators (motivations): (1) easily reaching providers, (2) accessing or providing information, (3) quickly reaching providers, and (4) consulting providers for symptoms, and the following 4 main barriers: (1) privacy/security concerns, (2) uncomfortable using technology, (3) user-unfriendly app interface, and (4) preference for in-person/phone care. Conclusions There was a strong intention to use a symptom monitoring app postdischarge among ACS patients. However, this intent decreased in patients older than 75 years. The survey identified barriers related to technology use, privacy/security, and the care delivery mode. Further research is warranted to determine if such intent translates into app use, and better symptom management and health care quality.

Older Latinxs engage in lower levels of leisure-time physical activity (PA) compared with non-Latinx Whites. Latin dance is a culturally relevant type of leisure-time PA that may engage older Latinx populations, particularly when coupled with mobile health technologies (mHealth). This single group pre–post feasibility study described the PA and health outcomes of middle-aged and older Latinxs participating in BAILA TECH—an intervention that combines the BAILAMOS Latin dance program with mHealth (Fitbit Charge 2, Fitbit app, and motivational text messages). Participants ( n = 20, Mage = 67 ± 7.1, female n = 15, 75%) were enrolled in the 16-week BAILA TECH intervention held twice a week. Participants received a Fitbit Charge 2 to assess PA at baseline, during the intervention, and postintervention. An mHealth platform (iCardia) collected Fitbit data and staff delivered weekly motivational and informational text messages. Participants completed questionnaires about PA, sedentary behavior, cardiorespiratory fitness, social support, quality of life, and cognitive function at baseline and postintervention. Paired t tests evaluated change in pre–post measures. There was a significant increase in device-assessed moderate-to-vigorous PA ( d = 0.69), self-reported light-leisure ( d = 1.91) and moderate-to-vigorous PA ( d = 1.05), moderate-to-vigorous leisure PA ( d = 1.55), predicted cardiorespiratory fitness ( d = 1.10), and PA social support ( d = 0.81 [family]; d = 0.95 [friends]) from baseline to postintervention. Although nonsignificant, there was a small effect on physical health–related quality of life ( d = 0.32) and executive function ( d = 0.29). These data describe an increase in PA levels and health-related outcomes of middle-aged and older Latinxs from participation in an mHealth-infused Latin dance intervention. An adequately powered trial is necessary to establish efficacy.

The objective of this study was to present lessons learned about engagement, delivery modality and pandemic impact while delivering a collaborative care intervention with a socioeconomically, racially and ethnically diverse sample. Participants completed a post-intervention survey (n = 41) on experiences and preferred intervention delivery modality, coronavirus 2019 (COVID-19) Impact Survey (n = 50) and provided open-ended feedback about the intervention (n = 27). Intervention process data included attendance, modality, and withdrawals. Data were analyzed using descriptive statistics and inductive content analyses. Of 71 intervention participants, 6 (8%) withdrew before session 1. Completers adhered to intervention timeline better than withdrawals. Participants liked the in-person interaction, efficient coach support, accountability of in-person and Zoom vs. phone sessions and the flexibility and convenience of phone and Zoom vs. in-person sessions. A majority of participants reported experiencing pandemic impacts such as heightened emotional distress, decreased activity engagement, poorer eating behaviors and being unable to meet basic needs. Participants deviating from intervention timelines may be re-engaged by targeted outreach attempts. Videoconference has the potential for providing as-needed coaching. Future interventions may be optimized to account for and address areas impacted by the pandemic. Findings revealed specific strategies that can be implemented in future interventions to improve emotional and physical health among diverse populations.

BACKGROUND Over half of US adults have at least one chronic disease, including obesity. Although physical activity is an important component of chronic disease self-management, few reach the recommended physical activity goals. Individuals who identify as racial and ethnic minorities are disproportionally affected by chronic diseases and physical inactivity. Interventions using consumer-based wearable devices have shown promise for increasing physical activity among patients with chronic diseases; however, populations with the most to gain, such as minorities, have been poorly represented to date. OBJECTIVE This study aims to assess the feasibility, acceptability, and preliminary outcomes of an 8-week text-based coaching and Fitbit program aimed at increasing the number of steps in a predominantly overweight ethnic minority population. METHODS Overweight patients (BMI >25 kg/m2) were recruited from an internal medicine clinic located in an inner-city academic medical center. Fitbit devices were provided. Using 2-way SMS text messaging, health coaches (HCs) guided patients to establish weekly step goals that were specific, measurable, attainable, realistic, and time-bound. SMS text messaging and Fitbit activities were managed using a custom-designed app. Program feasibility was assessed via the recruitment rate, retention rate (the proportion of eligible participants completing the 8-week program), and patient engagement (based on the number of weekly text message goals set with the HC across the 8-week period). Acceptability was assessed using a qualitative, summative evaluation. Exploratory statistical analysis included evaluating the average weekly steps in week 1 compared with week 8 using a paired t test (2-tailed) and modeling daily steps over time using a linear mixed model. RESULTS Of the 33 patients initially screened; 30 (91%) patients were enrolled in the study. At baseline, the average BMI was 39.3 (SD 9.3) kg/m2, with 70% (23/33) of participants presenting as obese. A total of 30% (9/30) of participants self-rated their health as either fair or poor, and 73% (22/30) of participants set up ≥6 weekly goals across the 8-week program. In total, 93% (28/30) of participants completed a qualitative summative evaluation, and 10 themes emerged from the evaluation: patient motivation, convenient SMS text messaging experience, social support, supportive accountability, technology support, self-determined goals, achievable goals, feedback from Fitbit, challenges, and habit formation. There was no significant group change in the average weekly steps for week 1 compared with week 8 (mean difference 7.26, SD 6209.3; P=.99). However, 17% (5/30) of participants showed a significant increase in their daily steps. CONCLUSIONS Overall, the results demonstrate the feasibility and acceptability of a remotely delivered walking study that included an HC; SMS text messaging; a wearable device (Fitbit); and specific, measurable, attainable, realistic, and time-bound goals within an ethnic minority patient population. Results support further development and testing in larger samples to explore efficacy.

Background Over half of US adults have at least one chronic disease, including obesity. Although physical activity is an important component of chronic disease self-management, few reach the recommended physical activity goals. Individuals who identify as racial and ethnic minorities are disproportionally affected by chronic diseases and physical inactivity. Interventions using consumer-based wearable devices have shown promise for increasing physical activity among patients with chronic diseases; however, populations with the most to gain, such as minorities, have been poorly represented to date. Objective This study aims to assess the feasibility, acceptability, and preliminary outcomes of an 8-week text-based coaching and Fitbit program aimed at increasing the number of steps in a predominantly overweight ethnic minority population. Methods Overweight patients (BMI >25 kg/m2) were recruited from an internal medicine clinic located in an inner-city academic medical center. Fitbit devices were provided. Using 2-way SMS text messaging, health coaches (HCs) guided patients to establish weekly step goals that were specific, measurable, attainable, realistic, and time-bound. SMS text messaging and Fitbit activities were managed using a custom-designed app. Program feasibility was assessed via the recruitment rate, retention rate (the proportion of eligible participants completing the 8-week program), and patient engagement (based on the number of weekly text message goals set with the HC across the 8-week period). Acceptability was assessed using a qualitative, summative evaluation. Exploratory statistical analysis included evaluating the average weekly steps in week 1 compared with week 8 using a paired t test (2-tailed) and modeling daily steps over time using a linear mixed model. Results Of the 33 patients initially screened; 30 (91%) patients were enrolled in the study. At baseline, the average BMI was 39.3 (SD 9.3) kg/m2, with 70% (23/33) of participants presenting as obese. A total of 30% (9/30) of participants self-rated their health as either fair or poor, and 73% (22/30) of participants set up ≥6 weekly goals across the 8-week program. In total, 93% (28/30) of participants completed a qualitative summative evaluation, and 10 themes emerged from the evaluation: patient motivation, convenient SMS text messaging experience, social support, supportive accountability, technology support, self-determined goals, achievable goals, feedback from Fitbit, challenges, and habit formation. There was no significant group change in the average weekly steps for week 1 compared with week 8 (mean difference 7.26, SD 6209.3; P=.99). However, 17% (5/30) of participants showed a significant increase in their daily steps. Conclusions Overall, the results demonstrate the feasibility and acceptability of a remotely delivered walking study that included an HC; SMS text messaging; a wearable device (Fitbit); and specific, measurable, attainable, realistic, and time-bound goals within an ethnic minority patient population. Results support further development and testing in larger samples to explore efficacy.

BACKGROUND Heart failure (HF) is a highly prevalent chronic condition that places a substantial burden on patients, families, and health care systems worldwide. Recent advances in mobile health (mHealth) technologies offer great opportunities for supporting many aspects of HF self-care. There is a need to better understand patients’ adoption of and interest in using mHealth for self-monitoring and management of HF symptoms. OBJECTIVE The purpose of this study is to assess smartphone ownership and patient attitudes toward using mHealth technologies for HF self-care in a predominantly minority population in an urban clinical setting. METHODS We conducted a cross-sectional survey of adult outpatients (aged ≥18 years) at an academic outpatient HF clinic in the Midwest. The survey comprised 34 questions assessing patient demographics, ownership of smartphones and other mHealth devices, frequently used smartphone features, use of mHealth apps, and interest in using mHealth technologies for vital sign and HF symptom self-monitoring and management. RESULTS A total of 144 patients were approached, of which 100 (69.4%) participated in the study (63/100, 63% women). The participants had a mean age of 61.3 (SD 12.25) years and were predominantly Black or African American (61/100, 61%) and Hispanic or Latino (18/100, 18%). Almost all participants (93/100, 93%) owned a cell phone. The share of patients who owned a smartphone was 68% (68/100). Racial and ethnic minorities that identified as Black or African American or Hispanic or Latino reported higher smartphone ownership rates compared with White patients with HF (45/61, 74% Black or African American and 11/18, 61% Hispanic or Latino vs 9/17, 53% White). There was a moderate and statistically significant association between smartphone ownership and age (Cramér V [ΦC]=0.35; PC=0.29; P=.001), and employment status (ΦC=0.3; P=.01). The most common smartphone features used by the participants were SMS text messaging (51/68, 75%), internet browsing (43/68, 63%), and mobile apps (41/68, 60%). The use of mHealth apps and wearable activity trackers (eg, Fitbits) for self-monitoring of HF-related parameters was low (15/68, 22% and 15/100, 15%, respectively). The most popular HF-related self-care measures participants would like to monitor using mHealth technologies were physical activity (46/68, 68%), blood pressure (44/68, 65%), and medication use (40/68, 59%). CONCLUSIONS Most patients with HF have smartphones and are interested in using commercial mHealth apps and connected health devices to self-monitor their condition. Thus, there is a great opportunity to capitalize on the high smartphone ownership among racial and ethnic minority patients to increase reach and enhance HF self-management through mHealth interventions.

Background Artificial intelligence has provided new opportunities for human interactions with technology for the practice of medicine. Among the recent artificial intelligence innovations, personal voice assistants have been broadly adopted. This highlights their potential for health care–related applications such as behavioral counseling to promote healthy lifestyle habits and emotional well-being. However, the use of voice-based applications for behavioral therapy has not been previously evaluated. Objective This study aimed to conduct a formative user evaluation of Lumen, a virtual voice-based coach developed as an Alexa skill that delivers evidence-based, problem-solving treatment for patients with mild to moderate depression and/or anxiety. Methods A total of 26 participants completed 2 therapy sessions—an introductory (session 1) and a problem-solving (session 2)—with Lumen. Following each session with Lumen, participants completed user experience, task-related workload, and work alliance surveys. They also participated in semistructured interviews addressing the benefits, challenges and barriers to Lumen use, and design recommendations. We evaluated the differences in user experience, task load, and work alliance between sessions using 2-tailed paired t tests. Interview transcripts were coded using an inductive thematic analysis to characterize the participants’ perspectives regarding Lumen use. Results Participants found Lumen to provide high pragmatic usability and favorable user experience, with marginal task load during interactions for both Lumen sessions. However, participants experienced a higher temporal workload during the problem-solving session, suggesting a feeling of being rushed during their communicative interactions. On the basis of the qualitative analysis, the following themes were identified: Lumen’s on-demand accessibility and the delivery of a complex problem-solving treatment task with a simplistic structure for achieving therapy goals; themes related to Lumen improvements included streamlining and improved personalization of conversations, slower pacing of conversations, and providing additional context during therapy sessions. Conclusions On the basis of an in-depth formative evaluation, we found that Lumen supported the ability to conduct cognitively plausible interactions for the delivery of behavioral therapy. Several design suggestions identified from the study including reducing temporal and cognitive load during conversational interactions, developing more natural conversations, and expanding privacy and security features were incorporated in the revised version of Lumen. Although further research is needed, the promising findings from this study highlight the potential for using Lumen to deliver personalized and accessible mental health care, filling a gap in traditional mental health services.

Background Patients with poorly controlled type 2 diabetes (T2D) experience increased morbidity, increased mortality, and higher cost of care. Self-monitoring of blood glucose (SMBG) is a critical component of diabetes self-management with established diabetes outcome benefits. Technological advancements in blood glucose meters, including cellular-connected devices that automatically upload SMBG data to secure cloud-based databases, allow for improved sharing and monitoring of SMBG data. Real-time monitoring of SMBG data presents opportunities to provide timely support to patients that is responsive to abnormal SMBG recordings. Such diabetes remote monitoring programs can provide patients with poorly controlled T2D additional support needed to improve critical outcomes. Objective To evaluate 6 months of a diabetes remote monitoring program facilitated by cellular-connected glucose meter, access to a diabetes coach, and support responsive to abnormal blood glucose recordings greater than 400 mg/dL or below 50 mg/dL in adults with poorly controlled T2D. Methods Patients (N=119) receiving care at a diabetes center of excellence participated in a two-arm, 12-month randomized crossover study. The intervention included a cellular-connected glucose meter and phone-based diabetes coaching provided by Livongo Health. The coach answered questions, assisted in goal setting, and provided support in response to abnormal glucose levels. One group received the intervention for 6 months before returning to usual care (IV/UC). The other group received usual care before enrolling in the intervention (UC/IV) for 6 months. Change in hemoglobin A1c (HbA1c) was the primary outcome, and change in treatment satisfaction was the secondary outcome. Results Improvements in mean HbA1c were seen in both groups during the first 6 months (IV/UC −1.1%, SD 1.5 vs UC/IV −0.8%, SD 1.5; P Conclusions Patients enrolled in the diabetes remote monitoring program intervention experienced improvements in HbA1c and treatment satisfaction similar to usual care at a specialty diabetes center. Future studies on diabetes remote monitoring programs should incorporate scheduled coaching components and involve family members and caregivers. Trial Registration ClinicalTrials.gov NCT03124043; https://clinicaltrials.gov/ct2/show/NCT03124043

Background Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management. Objective The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach–delivered intervention on hemoglobin A1c (HbA1c, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes. Methods A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA1c ≥8%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year. Results Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022. Conclusions This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals. International Registered Report Identifier (IRRID) DERR1-10.2196/17170

Background Sex influences health and related behaviors due to biological and psychosocial/socioeconomic factors. Assessing sex-specific responses to integrated treatment for comorbid obesity and depression could inform intervention targeting. Purpose To test (a) whether sex moderates the effects of integrated collaborative care on weight and depression outcomes through 24 months and (b) whether treatment response at 6 months predicts 12 and 24 month outcomes by sex. Methods Secondary data analyses on weight and depression severity (SCL-20) measured over 24 months among 409 adults with obesity and depression in the Research Aimed at Improving Both Mood and Weight trial. Results Men achieved significantly greater weight reductions in intervention versus usual care than women, whereas women achieved significantly greater percentage reductions in SCL-20 than men at both 12 and 24 months. In logistic models, at 80% specificity for correctly identifying participants not achieving clinically significant long-term outcomes, women who lost Conclusions Sex modified the integrated treatment effects for obesity and depression. Sex-specific responses at 6 months predicted clinically significant weight loss and depression outcomes through 24 months. Based on early responses, interventions may need to be tailored to address sex-specific barriers and facilitators to achieving healthy weight and depression outcomes at later time points. Clinical Trial Registration NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).

African Americans report higher rates of chronic stress compared to non-Hispanic Whites. Consequently, chronic stress contributes to disproportionately higher rates of poor health outcomes among African Americans. Mindfulness meditation is a well-established and studied strategy to reduce stress and potentially improve health outcomes. However, the practice of mindfulness meditation is largely underutilized in African American communities despite its potential health benefits. In this commentary, we will discuss the relevance of mindfulness interventions, limited research available, reasons for low representation, and cultural adaptations for mindfulness meditation in African American communities. We also provide additional strategies to guide future mindfulness research that target African Americans.

Background: Integrated treatments for depression (and associated anxiety) and obesity are lacking; mechanisms are poorly investigated. This mechanistic pilot trial tested the degree to which engaging pre-specified neural targets at 2 months produces desired outcomes at 6 months. Methods: Adults with a body mass index (BMI) of ≥30 (≥27, if Asian) and Patient Health Questionnaire-9 (PHQ-9) score of ≥10 were recruited from academic internal medicine clinics between March 1, 2019 and March 19, 2020, and followed for 6 months until August 31, 2020. Participants were randomized to receive usual care (n=35) or an integrated collaborative care intervention (n=71), providing 6 problem-solving therapy (PST) sessions for depression by 2 months, 3 additional PST sessions and 11 home videos on lifestyle changes for weight loss by 6 months. Outcomes were changes in BMI, Depression Symptom Checklist 20-item (SCL-20) scores, and Generalized Anxiety Disorder Scale (GAD-7) scores at 6 months. Neural targets were changes in affective, cognitive control, and default mode circuits by functional neuroimaging at 2 months. Outcomes: Among 106 participants (mean [SD] age 47.0 [11.9] years, 76% women, 55% Blacks, 20% Latino, BMI 37.1 [6.0], SCL-20 1.2 [0.7], GAD-7 6.9 [4.8]), 86.8% completed the trial. The intervention led to significant reductions in SCL-20 (-0.3 [95% CI: -0.6, -0.1]) and GAD-7 (-2.9 [-4.7, -1.1]), but not BMI, at 6 months compared with usual care. Changes in the activation or functional connectivity of neural targets in the negative affect (anterior insula, subgenual and pregenual ACC, amygdala) and cognitive control circuits (dlPFC, dACC) at 2 months significantly correlated with changes in GAD-7, but not SCL-20 or BMI, at 6 months, and the correlations differed by the intervention vs. usual care. Effect sizes were medium to large (0.41ꟷ1.18 SDs). Changes in the neural targets of the cognitive control circuit, but not the negative affect circuit, at 2 months differed by treatment group. Effect sizes were medium (0.58ꟷ0.79 SDs). Interpretation: Short-term changes in the cognitive control circuit mediated changes in anxiety symptoms, suggesting possible neural mechanisms to target for enhanced treatment effect. Clinical Trial Registration Details: ClinicalTrials.gov Identifier: NCT03841682. Funding Information: National Heart, Lung, and Blood Institute grant number UH2HL132368 and UH3HL132368. Declaration of Interests: Dr. Jun Ma is a paid scientific consultant for Health Mentor, Inc. (San Jose, CA). Dr. Leanne M. Williams is on the Scientific Advisory Board for One Mind Psyberguide and the External Advisory Board for the Laureate Institute for Brain Research. Dr. Olusola A. Ajilore is the co-founder of Keywise AI and serves on the advisory boards of Blueprint Health and Embodied Labs. The other authors report no conflicts of interest. Dr. Thomas Kannampallil is a paid consultant for Pfizer, Inc, outside of this work Ethics Approval Statement: The Institutional Review Boards for the University of Illinois at Chicago and Stanford University approved the study. All participants provided written consent.

BACKGROUND Patients with poorly controlled type 2 diabetes (T2D) experience increased morbidity, increased mortality, and higher cost of care. Self-monitoring of blood glucose (SMBG) is a critical component of diabetes self-management with established diabetes outcome benefits. Technological advancements in blood glucose meters, including cellular-connected devices that automatically upload SMBG data to secure cloud-based databases, allow for improved sharing and monitoring of SMBG data. Real-time monitoring of SMBG data presents opportunities to provide timely support to patients that is responsive to abnormal SMBG recordings. Such diabetes remote monitoring programs can provide patients with poorly controlled T2D additional support needed to improve critical outcomes. OBJECTIVE To evaluate 6 months of a diabetes remote monitoring program facilitated by cellular-connected glucose meter, access to a diabetes coach, and support responsive to abnormal blood glucose recordings greater than 400 mg/dL or below 50 mg/dL in adults with poorly controlled T2D. METHODS Patients (N=119) receiving care at a diabetes center of excellence participated in a two-arm, 12-month randomized crossover study. The intervention included a cellular-connected glucose meter and phone-based diabetes coaching provided by Livongo Health. The coach answered questions, assisted in goal setting, and provided support in response to abnormal glucose levels. One group received the intervention for 6 months before returning to usual care (IV/UC). The other group received usual care before enrolling in the intervention (UC/IV) for 6 months. Change in hemoglobin A1c (HbA1c) was the primary outcome, and change in treatment satisfaction was the secondary outcome. RESULTS Improvements in mean HbA1c were seen in both groups during the first 6 months (IV/UC −1.1%, SD 1.5 vs UC/IV −0.8%, SD 1.5; P1c in IV/UC (mean HbA1c change +0.2, SD 1.7, P=.41); however, those in UC/IV showed further improvement (mean HbA1c change −0.4%, SD 1.0, P=.008). A mixed-effects model showed no significant treatment effect (IV vs UC) over 12 months (P=.06). However, participants with higher baseline HbA1c and those in the first time period experienced greater improvements in HbA1c. Both groups reported similar improvements in treatment satisfaction throughout the study. CONCLUSIONS Patients enrolled in the diabetes remote monitoring program intervention experienced improvements in HbA1c and treatment satisfaction similar to usual care at a specialty diabetes center. Future studies on diabetes remote monitoring programs should incorporate scheduled coaching components and involve family members and caregivers. CLINICALTRIAL ClinicalTrials.gov NCT03124043; https://clinicaltrials.gov/ct2/show/NCT03124043

Introduction Without treatment, prediabetic women with a history of gestational diabetes mellitus (GDM) are at greater risk for developing type 2 diabetes compared with women without a history of GDM. Both intensive lifestyle intervention and metformin can reduce risk. To predict risk and treatment response, we developed a risk prediction model specifically for women with prior GDM. Methods The Diabetes Prevention Program was a randomized controlled trial to evaluate the effectiveness of intensive lifestyle intervention, metformin (850mg twice daily), and placebo in preventing diabetes. Data from the Diabetes Prevention Program (DPP) was used to conduct a secondary analysis to evaluate 11 baseline clinical variables of 317 women with prediabetes and a self-reported history of GDM to develop a 3-year diabetes risk prediction model using Cox proportional hazards regression. Reduced models were explored and compared with the main model. Results Within three years, 82 (25.9%) women developed diabetes. In our parsimonious model using 4 of 11 clinical variables, higher fasting glucose and hemoglobin A1C were each associated with greater risk for diabetes (each hazard ratio approximately 1.4), and there was an interaction between treatment arm and BMI suggesting that metformin was more effective relative to no treatment for BMI ≥ 35kg/m2 than BMI < 30kg/m2. The model had fair discrimination (bias corrected C index = 0.68) and was not significantly different from our main model using 11 clinical variables. The estimated incidence of diabetes without treatment was 37.4%, compared to 20.0% with intensive lifestyle intervention or metformin treatment for women with a prior GDM. Conclusions A clinical prediction model was developed for individualized decision making for prediabetes treatment in women with prior GDM.

Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.

Background Heart failure (HF) is a complex and serious condition associated with substantial morbidity, mortality, and health care costs. We conducted a systematic review and meta-analysis to evaluate the effects of mobile health (mHealth) interventions compared with usual care in patients with HF. Methods We searched MEDLINE, CENTRAL, CINAHL, and EMBASE databases to identify eligible randomized controlled trials (RCTs) of mHealth interventions. Primary outcomes included: all-cause mortality, cardiovascular mortality, HF-related hospitalizations, and all-cause hospitalizations. Meta-analyses using a random effects model were performed for all outcomes. Risk of bias and quality of evidence were evaluated using the Cochrane Tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results Sixteen RCTs involving 4389 patients were included. Compared with usual care, mHealth interventions reduced the risk of all-cause mortality (risk ratio [RR], 0.80; 95% confidence interval [CI], 0.65-0.97; absolute risk reduction [ARR], 2.1%; high-quality evidence), cardiovascular mortality (RR, 0.70; 95% CI, 0.53-0.91; ARR, 2.9%; high-quality evidence), and HF hospitalizations (RR, 0.77; 95% CI, 0.67-0.88; ARR, 5%; high-quality evidence), but had no effect on all-cause hospitalizations. Results were driven by mHealth interventions with remote monitoring and clinical feedback, which were associated with larger reductions than stand-alone mHealth interventions. However, subgroup differences were not statistically significant. Conclusions mHealth interventions with remote monitoring and clinical feedback reduce mortality and HF-related hospitalizations, but might not reduce all-cause hospitalizations in patients with HF. Additional studies are needed to determine the efficacy of stand-alone mHealth interventions as well as active features of mHealth that contribute to efficacy.

Recent evidence suggests that diabetic retinopathy (DR) is associated with abnormal melatonin regulation, possibly related to dysfunction of the melanopsin-expressing intrinsically photosensitive retinal ganglion cells. This study explored melatonin regulation in type 2 diabetes (T2D) patients with DR and its relation to sleep and circadian functioning.Thirty-five participants (10 non-diabetic controls, 10 T2D without DR, and 15 T2D with DR) were recruited. Overnight urine 6-sulfatoxymelatonin (aMT6s) and objective sleep and wrist activity (7-day actigraphy) were obtained.After adjusting for covariates, having T2D with DR was significantly associated with lower urinary aMT6s (β = - 1.369, p = 0.004) compared with controls, while having T2D without DR was not (p = 0.418). T2D patients with DR reported poorer sleep quality (p = 0.014) and had greater variability of sleep duration (p = 0.017) than others, while no differences were found in sleep duration, efficiency, and rest-activity rhythm. After adjusting for covariates, lower nocturnal aMT6s was significantly associated with greater sleep variability.T2D patients with DR exhibited low overnight production of aMT6s which likely contributed to sleep irregularities possibly due to weak circadian signaling. Whether or not melatonin supplementation could improve health in T2D patients with DR remains to be explored.

Introduction: Obesity and depression often co-occur, especially in women. Efficacious treatments exist for both conditions, but treatment outcomes vary. Assessing sex-specific responses to integrated therapy of these conditions could inform opportunities for tailoring. Hypothesis: Sex will significantly moderate the effects of an integrated collaborative care intervention on weight loss and depression outcomes through 24 months. Short-term treatment response at 6 months will reliably predict 12- and 24-month outcomes by sex. Methods: We conducted secondary analyses using data from the RAINBOW trial, which demonstrated efficacy of an integrated collaborative care intervention at reducing weight (BMI) and depression severity (SCL-20) at 12 months relative to usual care in adults with obesity and depression. Linear mixed models were used to assess treatment effects by sex, an a priori hypothesized biological moderator, on BMI and SCL-20 at 6, 12, and 24 months. Areas under the receiver operating characteristic curves (AUCs) based on logistic regressions were used to assess sex-specific thresholds of weight loss (%) and SCL-20 reduction at 6 months that reliably predicted clinically significant weight loss (i.e., ≥5% of baseline weight) and depression response (i.e., ≥50% decrease in SCL-20 scores) at 12 and 24 months. Results: Sex significantly moderated the treatment effects on BMI and SCL-20. Compared with women, men achieved significantly greater reductions in BMI at 6, 12, and 24 months in the intervention relative to usual care. Compared with men, women achieved significantly greater reductions in SCL-20 at 12 months only in the intervention relative to usual care. AUCs in the logistic models were similar for both sexes: >0.82 at 12 months and >0.65 at 24 months predicting clinically significant weight loss; >0.70 at 12 months and >0.67 at 24 months predicting clinically significant depression response. With 80% specificity to ensure good probability of correctly identifying participants not achieving longer-term outcomes of clinical significance, women who lost 2.5-3.0% weight and men who lost 3.4-4.1% weight at 6 months were likely to achieve ≥5% weight loss at 12 and 24 months. Similarly, women who reduced SCL-20 by 0.70 and men who reduced by 0.60-0.65 were likely to achieve ≥50% decrease in SCL-20 at 12 and 24 months. Conclusions: The treatment effects of this integrated intervention for obesity and depression differed significantly by sex, with men showing greater weight loss and women showing greater depression reduction. Sex-specific short-term responses at 6 months were identified for predicting clinically significant weight loss and depression outcomes at 12 and 24 months. Results suggest that sex may be an important tailoring variable when designing collaborative care interventions.