Gail D'ERamo Melkus

Background: Short sleep duration is a modifiable barrier to diabetes prevention, yet no adequately powered trials have tested whether integrating a behavioral sleep intervention into a lifestyle intervention improves glycemic or weight loss outcomes in adults with prediabetes. Objective: To compare the effects of a lifestyle versus a lifestyle plus sleep intervention on glucose control and weight loss in adults with prediabetes and habitual short sleep duration. Methods: In this two-arm, parallel-group randomized controlled trial, adults with A1c-confirmed prediabetes and actigraphy-confirmed short sleep duration completed two clinic visits and 2-week at-home monitoring periods, including actigraphy-estimated sleep and continuous glucose monitoring. The 8-week intervention was delivered one-on-one via a Health Insurance Portability and Accountability Act-compliant videoconferencing platform. The primary outcome was change in the percentage of time sensor glucose was above tight range (> 140 mg/dL). Secondary outcomes included actigraphy-estimated sleep parameters, self-reported sleep quality and daytime sleepiness, and body weight. We compared pre- to post-intervention changes between groups using a modified intention-to-treat approach. Results: Among 196 participants, we found no significant between-group difference in the primary glucose outcome. Both groups achieved significant within-group increases in sleep and reductions in body weight, with no significant between-group differences for either outcome. The lifestyle plus sleep group showed significantly greater improvements in self-reported sleep quality and daytime sleepiness compared to the lifestyle group. Sleep onset advanced significantly only in lifestyle plus sleep group, though the between-group difference did not reach statistical significance. A post hoc analysis found that earlier sleep onset, regardless of group assignment, was independently associated with greater weight loss, whereas changes in sleep duration were not. Discussion: Adding a behavioral sleep intervention to a lifestyle intervention did not improve glucose control. However, advancing sleep onset time predicted greater weight loss, independent of sleep duration or group assignment, identifying circadian timing as a promising and modifiable target for diabetes prevention. Prospective trials powered to test sleep timing interventions on metabolic outcomes are warranted.

Background: Asian adults in the U.S. face increased burdens of cardiovascular risk factors and cardiovascular disease (CVD). However, trends in cardiovascular health among Asian subgroups remain understudied. Objectives: The purpose of this study was to examine 15-year trends in CVD risk factors and CVD among Chinese, Filipino, and Asian Indian adults living in the U.S. Methods: We conducted a retrospective secondary analysis using data from the 2004–2018 National Health Interview Survey. Age-standardized prevalence rates were calculated for eight variables: hypertension, type 2 diabetes, overweight/obesity, short sleep, alcohol use, smoking, insufficient physical activity (PA), and CVD (defined as having coronary heart disease, heart attack, stroke, or other cardiovascular conditions). Annual percent change and average annual percent change were employed to summarize and compare the trends of each variable over 15 years. Results: The sample consisted of 14,073 adults, with the majority aged 65 years or older and half being female. Filipino adults showed the highest prevalence for most variables, except for diabetes and insufficient PA, compared to Chinese and Asian Indian adults. From 2004 to 2018, Asian adults overall experienced increases in the prevalence of diabetes, overweight/obesity, and alcohol use, and decreases in the prevalence of smoking and insufficient PA. Specifically, Chinese adults exhibited significant upward trends in short sleep. Asian Indian adults exhibited upward trends in overweight/obesity and alcohol use, but downward trends in smoking and insufficient PA. Filipino adults demonstrated similar trends to Asian Indian adults in alcohol use and smoking. No significant trends were found for other study variables in all three groups. Discussion: U.S. Asian adults from different cultural backgrounds experience varying patterns of cardiovascular health. Public health strategies are recommended to be customized to address the specific cardiovascular risk profiles of each Asian subgroup.

Background: Persons living with HIV have an increased risk of cardiovascular and metabolic diseases compared with HIV-seronegative individuals. Objective: This study aims to assess the feasibility and acceptability of a virtual environment (VE) for cardiovascular disease and metabolic disease prevention education among men living with HIV through a pilot waitlist-control randomized trial. Methods: In phase 1, we conducted interviews and VE beta testing with 25 individuals. In phase 2, reported here, we conducted a waitlist-controlled trial using permuted block randomization. Participants were allocated to either the VE intervention (n=40) or the waitlist control arm (n=38). The primary outcomes were feasibility (defined by recruitment and retention metrics) and acceptability (defined by levels of engagement) of the VE. We also examined preliminary effect sizes across several cardiovascular health–related indicators. Results: Participants had a mean age of 41.8 (SD 10.4) years and had been living with HIV for a mean of 15.9 (SD 9.7) years. Of the 56 total participants, 35 (63%) were Black and 15 (27%) were Hispanic. A total of 14 out of 31 (45%) of participants with baseline data in the intervention arm engaged with the VE, with an average session duration of 110 minutes. The most highly engaged content modules were nutrition (146 engagements), oral health (138 engagements), fitness tips and videos (82 engagements), and relaxation techniques (75 engagements). Retention was 48 out of 78 (61%) at the final assessment, which, to our knowledge, is higher than the typical retention rates reported in remote digital health and behavioral intervention research. Preliminary efficacy analyses of changes at 3 and 6 months revealed medium effect sizes favoring the intervention for key nutritional outcomes (vegetable consumption: d=0.59-0.66; whole grain intake: d=0.41-0.46) and vigorous physical activity (d=0.38-0.57). Small-to-medium effect sizes were observed for fast food reduction (d=0.37 at 6 months), total physical activity (d=0.37 at 6 months), depressive symptoms (d=0.22 at 3 months), and HIV illness perceptions, including Timeline Acute/Chronic subscale score (d=0.44 at 3 months), Illness Coherence (d=0.33 at 3 months), and Emotional Representations (d=0.23-0.33). Conclusions: The LEARN (LEveraging A viRtual eNvironment to enhance prevention of HIV-related comorbidities) study demonstrated the feasibility and acceptability of a VE designed for cardiovascular and metabolic disease prevention education among persons living with HIV. High engagement with specific educational content and favorable retention rates highlight the promise of this innovative approach. Preliminary effect sizes suggested positive trends in cardiovascular health indicators and mental well-being, indicating the potential for additional benefits associated with the intervention. These findings support progression to a fully powered randomized controlled trial. Subsequent funding has been awarded based on this work to expand the research in LEARN2. We will integrate lessons learned from this study and focus on HIV-related conditions with shared risk factors to enhance the intervention’s impact. By addressing HIV-related conditions with interrelated risk factors, we aim to provide a more comprehensive intervention to improve the overall health and well-being of individuals living with HIV. Trial Registration: ClinicalTrials.gov NCT05242952; https://clinicaltrials.gov/ct2/show/NCT05242952 International Registered Report Identifier (IRRID): RR2-10.2196/38348

BACKGROUND Persons living with HIV have an increased risk of cardiovascular and metabolic diseases compared with HIV-seronegative individuals. OBJECTIVE This study aims to assess the feasibility and acceptability of a virtual environment (VE) for cardiovascular disease and metabolic disease prevention education among men living with HIV through a pilot waitlist-control randomized trial. METHODS In phase 1, we conducted interviews and VE beta testing with 25 individuals. In phase 2, reported here, we conducted a waitlist-controlled trial using permuted block randomization. Participants were allocated to either the VE intervention (n=40) or the waitlist control arm (n=38). The primary outcomes were feasibility (defined by recruitment and retention metrics) and acceptability (defined by levels of engagement) of the VE. We also examined preliminary effect sizes across several cardiovascular health–related indicators. RESULTS Participants had a mean age of 41.8 (SD 10.4) years and had been living with HIV for a mean of 15.9 (SD 9.7) years. Of the 56 total participants, 35 (63%) were Black and 15 (27%) were Hispanic. A total of 14 out of 31 (45%) of participants with baseline data in the intervention arm engaged with the VE, with an average session duration of 110 minutes. The most highly engaged content modules were nutrition (146 engagements), oral health (138 engagements), fitness tips and videos (82 engagements), and relaxation techniques (75 engagements). Retention was 48 out of 78 (61%) at the final assessment, which, to our knowledge, is higher than the typical retention rates reported in remote digital health and behavioral intervention research. Preliminary efficacy analyses of changes at 3 and 6 months revealed medium effect sizes favoring the intervention for key nutritional outcomes (vegetable consumption: d=0.59-0.66; whole grain intake: d=0.41-0.46) and vigorous physical activity (d=0.38-0.57). Small-to-medium effect sizes were observed for fast food reduction (d=0.37 at 6 months), total physical activity (d=0.37 at 6 months), depressive symptoms (d=0.22 at 3 months), and HIV illness perceptions, including Timeline Acute/Chronic subscale score (d=0.44 at 3 months), Illness Coherence (d=0.33 at 3 months), and Emotional Representations (d=0.23-0.33). CONCLUSIONS The LEARN (LEveraging A viRtual eNvironment to enhance prevention of HIV-related comorbidities) study demonstrated the feasibility and acceptability of a VE designed for cardiovascular and metabolic disease prevention education among persons living with HIV. High engagement with specific educational content and favorable retention rates highlight the promise of this innovative approach. Preliminary effect sizes suggested positive trends in cardiovascular health indicators and mental well-being, indicating the potential for additional benefits associated with the intervention. These findings support progression to a fully powered randomized controlled trial. Subsequent funding has been awarded based on this work to expand the research in LEARN2. We will integrate lessons learned from this study and focus on HIV-related conditions with shared risk factors to enhance the intervention’s impact. By addressing HIV-related conditions with interrelated risk factors, we aim to provide a more comprehensive intervention to improve the overall health and well-being of individuals living with HIV. CLINICALTRIAL ClinicalTrials.gov NCT05242952; https://clinicaltrials.gov/ct2/show/NCT05242952 INTERNATIONAL REGISTERED REPORT RR2-10.2196/38348

Background: Chinese Americans with type 2 diabetes (T2D) face significant challenges in dietary management, which is crucial for glycemic control. Wearable sensors, such as the electronic button (eButton) and continuous glucose monitor (CGM), offer a promising solution. Objective: We aimed to explore the experience of using the eButton and CGM for dietary management among Chinese Americans with T2D. Methods: Chinese Americans with T2D (N=11) participated in a one-group prospective cohort study, recruited via convenience sampling from the electronic medical records of NYU Langone Health. Participants wore an eButton on their chest to record their 10-day meals and a CGM for the 2 weeks and kept a diary to track food intake, medication, and physical activity. Individual interviews were conducted after 2 weeks to discuss their experience, barriers, and facilitators of use. Interview transcripts were thematically analyzed using ATLAS.ti (Scientific Software Development GmbH) software. Results: Facilitators of using an eButton included the device’s ease of use, ability to make participants more mindful, and influence on increased sense of control. Greater awareness of food intake enabled participants to eat smaller portions. Reported barriers included privacy concerns, difficulty positioning the camera for pictures, and the lack of a meal photo record to track glucose trends. For the CGM, facilitators included its comfort and ease of use, its ability to increase mindfulness of meal choices, and its motivating changes in eating behaviors. The most common barriers included the sensor falling off, getting trapped in clothes, and causing skin sensitivity. Conclusions: Our findings suggest that it is feasible for Chinese Americans with T2D to use eButton and CGM for dietary management. When paired, these tools offer a promising method to help patients visualize the relationship between food intake and glycemic response. For clinical implementation, structured support from health care providers—such as dietitians or diabetes educators—is essential to help patients interpret the data meaningfully. Clinicians should also consider cultural factors, privacy concerns, and individual preferences when introducing wearable technologies, ensuring a personalized and patient-centered approach to diabetes care. Future studies should apply these devices to a larger sample over a longer duration to better inform effective diabetes management strategies.

Background: Women with a history of gestational diabetes mellitus (GDM) have an elevated risk for cardiometabolic diseases. Chinese American immigrants are disproportionately affected by GDM, yet their cardiometabolic risk factors are understudied. Little is known about physical activity (PA) of this understudied high-risk minority group. Objective: The purpose of this study was to describe self-reported PA and the facilitators of and barriers to PA in Chinese American immigrants with a history of GDM. Methods: We conducted an exploratory multimethod study between 2020 and 2021 among 106 Chinese American immigrant women. PA was self-reported using the International Physical Activity Questionnaire—Long form. Four domains of PA (work, transportation, housework, and leisure time) and daily sitting time were recorded. Open-ended questions were asked about the facilitators of and barriers to PA. Results: Participants' mean age was 34.3 ± 3.7 years, and body mass index was 21.7 ± 2.6 kg/m². Approximately 25% had low PA. Over half (N = 56, 53%) reported no leisure-time moderate-to-vigorous PA. Walking and housework were the most common types of PA. Barriers to PA included being busy with life, physical health issues (eg, sleep and postpartum health issues), low motivation or not enjoying PA, COVID-related barriers, and an unfavorable environment for PA. Conclusions: Strategies are needed to increase leisure-time moderate-to-vigorous PA in this population. Modifiable factors include providing convenient PA programs (eg, technology or home-based) and addressing postpartum health issues (eg, sleep). Increasing providers' awareness of barriers to PA and cardiometabolic disease risk in this hard-to-reach, high-risk group may improve assessment and referral for high-risk women. Future research is needed to further explore opportunities for PA that Chinese American immigrant women would be open to at this stage in their life.

Background: In clinical settings, counseling patients on physical activity starts by assessing patients’ current physical activity levels. Self-report measures of PA are generally easy to administer; however, they may be too long to be convenient and are known to correlate poorly with objective measures of physical activity. Objective: To assess the concurrent validity of a self-report three-question physical activity vital sign with objective Fitbit step counts and the distance walked during a 6-min walk test. Methods: This pilot study tested a best practice advisory embedded in the Epic electronic health record, which was designed to prompt providers in a preventive cardiology clinic to counsel patients reporting low levels of physical activity. Patients were invited to participate in the remote patient monitoring phase to assess the change in their physical activity by wearing a Fitbit for 12 weeks and completing a 6-min walk test at baseline and 12 weeks. This analysis used the cross-sectional data collected in this phase. Pearson correlations were conducted between self-reported physical activity, Fitbit step counts, and the distance walked during the 6-min walk—a measure associated with current physical activity levels. Kappa coefficients were calculated to assess agreement between self-reported physical activity and step counts. Results: Participants who enrolled in the Fitbit monitoring were approximately 50% female, with the majority identified as White non-Hispanic adults. Their most common cardiovascular risk factor was hypertension. The self-reported physical activity vital signs were significantly associated with step counts at baseline and 12 weeks but were not associated with the distance during the 6-min walk test. However, the distance walked was significantly associated with step counts at baseline and 12 weeks. The Kappa results demonstrate a poor level of agreement between two categories (meeting or not meeting current physical activity guidelines) of self-report physical activity vitals and the objective Fitbit step counts. Discussion: There were moderate correlations between the self-reported physical activity vital signs and the Fitbit step counts, but there was lack of agreement when they were categorized. Further validation of this physical activity vital sign is warranted.

Background: Depression affects 33% of women with type 2 diabetes (T2D) and leads to increased risks of premature mortality. Fluctuation and variation of depressive presentations can hinder clinical identification. Purpose: We aimed to identify and examine subgroups characterized by distinct depressive symptom trajectories among women with T2D. Methods: This retrospective analysis leveraged the Women’s Interagency HIV Study data to identify depressive symptom trajectories based on the Center for Epidemiological Studies Depression scores (2014-2019) among women with and without HIV. Descriptive statistics characterized sample demographics (eg, age, race, income), clinical indices (eg, hemoglobin A1C [HbA1c], BMI, HIV status), and psychosocial experiences (eg, discrimination, social support, anxiety, pain). We used growth mixture modeling to identify groups defined by distinct depressive symptom trajectories and parametric and non-parametric tests to examine demographic, clinical, and psychosocial differences across subgroups. Results: Among the 630 women included, the mean age was 50.4 (SD = 8.3) years, 72.4% identified as Black and non-Hispanic, and 68.2% were living with HIV. Five subgroups were identified and distinguished by severity and symptom type. Participants with lower incomes (P = .01), lower employment (P < .0001), lower social support (P = .0001), and experiences of discrimination (P < .0001) showed greater membership in threshold, moderate, and severe depressive subgroups. Subgroup membership was not associated with metabolic indices (BMI, HbA1c) or HIV status. Anxiety, pain, and loneliness (all P = .0001) were worse in subgroups with higher depressive symptoms. Conclusions: Among women with T2D, depressive symptom trajectories differ across clinical and social contexts. This study advances precision by delineating subgroups within a broad clinical category.

Background: Sexual minority men with HIV are at an increased risk of cardiovascular disease (CVD) and have been underrepresented in behavioral research and clinical trials. Objective: This study aims to explore perceptions of HIV-related comorbidities and assess the interest in and usability of a virtual environment for CVD prevention education in Black and Latinx sexual minority men with HIV. Methods: This is a 3-phase pilot behavioral randomized controlled trial. We report on formative phases 1 and 2 that informed virtual environment content and features using qualitative interviews, usability testing, and beta testing with a total of 25 individuals. In phase 1, a total of 15 participants completed interviews exploring HIV-related illnesses of concern that would be used to tailor the virtual environment. In phase 2, usability testing and beta testing were conducted with 10 participants to assess interest, features, and content. Results: In phase 1, we found that CVD risk factors included high blood pressure, myocardial infarction, stroke, and diabetes. Cancer (prostate, colon, and others) was a common concern, as were mental health conditions. In phase 2, all participants completed the 12-item usability checklist with favorable feedback within 30 to 60 minutes. Beta-testing interviews suggested (1) mixed perceptions of health and HIV, (2) high risk for comorbid conditions, (3) virtual environment features were promising, and (4) the need for diverse avatar representations. Conclusions: We identified several comorbid conditions of concern, and findings carry significant implications for mitigating barriers to preventive health screenings, given the shared risk factors between HIV and related comorbidities. Highly rated aspects of the virtual environment were anonymity; meeting others with HIV who identify as gay or bisexual; validating lesbian, gay, bisexual, transgender, queer, and others (LGBTQ+) images and content; and accessibility to CVD prevention education. Critical end-user feedback from beta testing suggested more options for avatar customization in skin, hair, and body representation. Our next phase will test the virtual environment as a new approach to advancing cardiovascular health equity in ethnic and racial sexual minority men with HIV. Trial Registration: ClinicalTrials.gov NCT04061915; https://clinicaltrials.gov/study/NCT05242952 International Registered Report Identifier (IRRID): RR2-10.2196/38348

Background: Chinese American immigrants have been underrepresented in health research partly due to challenges in recruitment. Objectives: This study aims to describe recruitment and retention strategies and report adherence in a 7-day observational physical activity study of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic. Methods: Foreign-born Chinese women aged 18–45 years, with a gestational diabetes index pregnancy of 0.5–5 years, who were not pregnant and had no current diabetes diagnosis were recruited. They wore an accelerometer for 7 consecutive days and completed an online survey. Multiple recruitment strategies were used: (a) culturally and linguistically tailored flyers, (b) social media platforms (e.g., WeChat [a popular Chinese platform] and Facebook), (c) near-peer recruitment and snowball sampling, and (d) a study website. Retention strategies included flexible scheduling and accommodation, rapid communications, and incentives. Adherence strategies included a paper diary and/or automated daily text reminders with a daily log for device wearing, daily email reminders for the online survey, close monitoring, and timely problem-solving. Results: Participants were recruited from 17 states; 108 were enrolled from August 2020 to August 2021. There were 2,479 visits to the study webpage, 194 screening entries, and 149 inquiries about the study. Their mean age was 34.3 years, and the mean length of U.S. stay was 9.2 years. Despite community outreach, participants were mainly recruited from social media (e.g., WeChat). The majority were recruited via near-peer recruitment and snowball sampling. The retention rate was 96.3%; about 99% had valid actigraphy data, and 81.7% wore the device for 7 days. The majority of devices were successfully returned, and the majority completed the online survey on time. Discussion: We demonstrated the feasibility of recruiting and retaining a geographically diverse sample of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic. Recruiting Chinese immigrants via social media (e.g., WeChat) is a viable approach. Nonetheless, more inclusive recruitment strategies are needed to ensure broad representation from diverse socioeconomic groups of immigrants.