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Introduction: Patients with type 2 diabetes (T2D), particularly those from historically marginalized racial and ethnic groups, are at high risk of poor outcomes from metabolic dysfunction-associated steatotic liver disease (MASLD). Evidence-based management (EBM) of MASLD can prevent its progression to cirrhosis and poor outcomes, yet rates of EBM of MASLD are low in T2D., Methods: In this pilot study of ten participants, we examined the feasibility and acceptability of a telehealth intervention that delivered EBM of MASLD in Latino/a and Black patients with T2D in the Duke Healthcare System. The intervention included: (a) MASLD education; (b) diet/lifestyle counseling; (c) T2D medication adjustment (i.e., to promote liver health) and (d) ordering of clinically indicated tests and referrals. This 3-month intervention was delivered by an endocrinologist over three virtual study visits. Phone interviews were conducted at study conclusion. We examined rates of recruitment, retention, T2D medication adjustment, and ordering of clinically indicated tests/referrals., Results: The median age of our cohort was 54.0 (44.0, 59.0); six and four participants self-identified as Latino/a ethnicity and Black race, respectively. Retention rate in this study was 100% (n = 10/10), and all scheduled visits were completed (n = 30/30). Recruitment occurred over one month, and the rate was 25.8% (n = 8/31) by telephone call and 10% (n = 2/20) by electronic health record message. The intervention was highly acceptable based on a median Treatment Acceptability and Preferences score of 4.0 (4.0, 4.0). In exit interviews, all participants reported improved understanding of MASLD and its link to diabetes. All participants received T2D medication adjustment (n = 5/10) and/or clinically indicated testing/referral (n = 10/10) for the purpose of improving MASLD., Conclusions: We demonstrated that a telehealth intervention designed to proactively deliver EBM of MASLD was feasible and acceptable in a cohort of Latino/a and Black patients with T2D. Opportunities existed to better align each participants' care with guideline-based care of MASLD., (© 2024. The Author(s).)

Objective: To assess frequency of evidence-based management (EBM) of metabolic dysfunction-associated steatotic liver disease (MASLD) in patients with type 2 diabetes (T2D), and to examine for racial/ethnic disparities in the receipt of EBM., Methods: We conducted a cross-sectional analysis of patients with T2D and presumptive MASLD in an academic health care system between 2019 and 2021. Presumptive MASLD was defined as at least 1 alanine aminotransferase value ≥30 U/L with exclusions for alcohol overuse, viral hepatitis, liver transplantation, chemotherapy use, and liver disease other than MASLD. We calculated the proportion of patients receiving EBM, defined as a composite of liver ultrasound, transient elastography, or hepatology evaluation. We also examined the association between race/ethnicity and EBM via a logistic regression model., Results: Our sample included 6532 patients; mean age was 58.0 (SD 13.1), 41.7% were female and 3.9%, 26.6%, 58.7%, and 5.8% were of Latino/a/x ethnicity, non-Latino (NL) Black race, NL White race, and NL Asian race, respectively. Rates of EBM were low overall (11.5%), with lower odds of EBM in NL Black versus NL White patients (adjusted odds ratio 0.75; 95% confidence interval 0.59, 0.96). Odds of hepatology evaluation and placement of MASLD diagnosis codes were also lower in NL Black versus NL White patients., Conclusion: Racial disparities exist in the receipt of EBM among patients with T2D and presumptive MASLD. These findings highlight the need for research to identify drivers of disparities, and to support development of clinical interventions that equitably facilitate EBM of MASLD in patients with T2D., Competing Interests: Disclosure C.A.M. has consulted for NovoNordisk and has served on the advisory board for Boehringer Ingelheim, Inc. C.A.M. has also received grants from GlaxoSmithKline, Exact Sciences, and Madrigal to conduct research at Duke University. All other authors declare no competing interests with this work., (Copyright © 2024 AACE. Published by Elsevier Inc. All rights reserved.)

Objectives: Eradication of Helicobacter pylori reduces the risk of gastric cancer (GC). Individuals with type 2 diabetes mellitus (T2DM) are known to be at increased risk for GC. In a cohort of H. pylori -positive individuals, we assessed whether those with T2DM were at risk of persistent infection following H. pylori treatment compared with individuals without T2DM., Methods: A random subset of all individuals diagnosed as having H. pylori without intestinal metaplasia at endoscopy from 2015 to 2019 were stratified evenly by race (Black and White). After excluding those with T1DM and those without eradication testing after H. pylori treatment, logistic regression analysis was used to determine the association of T2DM with the risk of persistent H. pylori infection following treatment., Results: In 138 patients, H. pylori eradication rates did not differ between the 27% of individuals with T2DM compared to those without (81.1% vs 81.2%). After adjusting for age, race, and insurance status, we found no significant increased risk of persistent H. pylori infection for individuals with T2DM (odds ratio 1.40; 95% confidence interval 0.49-3.99)., Conclusions: H. pylori eradication rates do not differ by T2DM status, providing support for clinical trials of H. pylori eradication to reduce GC incidence among high-risk populations in the United States, such as individuals with T2DM.

Introduction: Metabolic dysfunction-associated steatohepatitis (MASH) is highly prevalent in type 2 diabetes (T2D). Pioglitazone and glucagon-like peptide-1 receptor agonists (GLP-1RA) are medications used in T2D that can resolve MASH and should be considered in all patients with T2D and MASH. We assessed prescription rates of evidence-based T2D pharmacotherapy (EBP) in MASH, and ascertained racial/ethnic disparities in prescribing., Research Design and Methods: We conducted a cross-sectional study on patients in Duke University Health System with diagnosis codes for T2D and MASH between January 2019 and January 2021. Only patients with ≥1 primary care or endocrinology encounter were included. The primary outcome was EBP, defined as ≥1 prescription for pioglitazone and/or a GLP-1RA during the study period. A multivariable logistic regression model was used to examine the primary outcome., Results: A total of 847 patients with T2D and MASH were identified; mean age was 59.7 (SD 12) years, 61.9% (n=524) were female, and 11.9% (n=101) and 4.6% (n=39) were of Black race and Latino/a/x ethnicity, respectively. EBP was prescribed in 34.8% (n=295). No significant differences were noted in the rates of EBP use across racial/ethnic groups (Latino/a/x vs White patients: adjusted OR (aOR) 1.82, 95% CI 0.78 to 4.28; Black vs White patients: aOR 0.76, 95% CI 0.44 to 1.33, p=0.20)., Conclusions: EBP prescriptions, especially pioglitazone, are low in patients with T2D and MASH, regardless of race/ethnicity. These data underscore the need for interventions to close the gap between current and evidence-based care., Competing Interests: Competing interests: CM has consulted for NovoNordisk and has served on the advisory board for Boehringer Ingelheim, Inc. CM has also received grants from GlaxoSmithKline, Exact Sciences and Madrigal to conduct research at Duke University. All other authors declare no competing interests with this work., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate the relationship between social needs and metformin use among adults with type 2 diabetes (T2D)., Research Design and Methods: In a prospective cohort study of adults with T2D (n = 722), we linked electronic health record (EHR) and Surescripts (Surescripts, LLC) prescription network data to abstract data on patient-reported social needs and to calculate metformin adherence based on expected refill frequency using a proportion of days covered methodology., Results: After adjusting for demographics and clinical complexity, two or more social needs (-0.046; 95% CI -0.089, 0.003), being uninsured (-0.052; 95% CI -0.095, -0.009) and while adjusting for other needs, being without housing (-0.069; 95% CI -0.121, -0.018) and lack of access to medicine/health care (-0.058; 95% CI -0.115, -0.000) were associated with lower use., Conclusions: We found that overall social need burden and specific needs, particularly housing and health care access, were associated with clinically significant reductions in metformin adherence among patients with T2D., (© 2023 by the American Diabetes Association.)

This article highlights the benefits of electronic-consultations and outlines steps for a primary care-centered approach to implementation. We include descriptions of traditional and electronic-consultation delivery models from the perspective of referring primary care provider. We describe five best practices for consultations regardless of modality, including clearly defined criteria that are best suited for electronic-consultation. Primary care teams must be equipped to explain the electronic-consultation process to the patient, including when and how results will be communicated. A successful electronic-consultation depends on clear questions and communication, flexibility in available data, a set-up that is easy-to-navigate and the ability to nimbly pivot if an alternative modality is needed. Electronic-consultation implementation may begin small with a single consult service and could include broader healthcare systems considerations including financial implications and service agreements. Based on increasing demand and increasing electronic-consultation familiarity and adoption, electronic-consultation will be a future necessity for primary care.

Objective: Examine factors associated with increased diabetes distress (DD) among patients with type 2 diabetes with DD assessed by Diabetes Distress Scale (DDS) total and subscale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress)., Methods: Cross-sectional analysis of data from veterans with persistently poorly controlled diabetes mellitus. Multivariable linear regression models included baseline patient characteristics (independent variables) and DDS total and subscale scores (dependent variable)., Results: The cohort's (N = 248) mean age was 58 years (SD 8.3); 21% were female, 79% were non-White, and 5% were Hispanic/Latinx. Mean hemoglobin A1c (HbA1c) was 9.8%, and 37.5% had moderate to high DD. Hispanic/Latinx ethnicity (β=0.41; 95% CI 0.01, 0.80), baseline HbA1c (0.07; 95% CI 0.01,0.13), and higher Personal Health Questionnaire-8 (PHQ-8) scores (0.07; 95% CI 0.05, 0.09) were associated with higher total DD. Hispanic/Latinx ethnicity (0.79; 95% CI 0.25, 1.34) and higher PHQ-8 (0.05; 95% CI 0.03, 0.08) were associated with higher interpersonal-related distress. Higher HbA1c (0.15; 95% CI 0.06, 0.23) and higher PHQ-8 scores (0.10; 95% CI 0.07, 0.13) were associated with higher regimen-related distress. The use of basal insulin (0.28; 95% CI 0.001, 0.56) and higher PHQ-8 (0.02; 95% CI 0.001, 0.05) were associated with higher physician-related distress. Higher PHQ-8 (0.10; 95% CI 0.07, 0.12) was associated with higher emotional burden., Conclusion: Hispanic/Latinx ethnicity, depressive symptoms, uncontrolled hyperglycemia, and insulin use were associated with higher risk for DD. Future research should explore these relationships, and interventions designed to reduce diabetes distress should consider accounting for these factors., (Published by Oxford University Press on behalf of the Endocrine Society 2023.)

Background: Health care providers are increasingly screening patients for unmet social needs (eg, food, housing, transportation, and social isolation) and referring patients to relevant community-based resources and social services. Patients' connection to referred services is often low, however, suggesting the need for additional support to facilitate engagement with resources. SMS text messaging presents an opportunity to address barriers related to contacting resources in an accessible, scalable, and low-cost manner., Objective: In this multi-methods pilot study, we aim to develop an automated SMS text message-based intervention to promote patient connection to referred social needs resources within 2 weeks of the initial referral and to evaluate its feasibility and patient acceptability. This protocol describes the intervention, conceptual underpinnings, study design, and evaluation plan to provide a detailed illustration of how SMS technology can complement current social needs screening and referral practice patterns without disrupting care., Methods: For this pilot prospective cohort study, this SMS text message-based intervention augments an existing social needs screening, referral, and navigation program at a federally qualified health center. Patients who received at least one referral for any identified unmet social need are sent 2 rounds of SMS messages over 2 weeks. The first round consists of 5-10 messages that deliver descriptions of and contact information for the referred resources. The second round consists of 2 messages that offer a brief reminder to contact the resources. Participants will evaluate the intervention via a survey and a semistructured interview, informed by an adapted technology acceptance model. Rapid qualitative and thematic analysis will be used to extract themes from the responses. Primary outcomes are implementation feasibility and patient acceptability. Secondary outcomes relate to intervention effectiveness: self-reported attempt to connect and successful connection to referred resources 2 weeks after the initial referral encounter., Results: The study received regulatory approval in May 2021, and we anticipate enrolling 15-20 participants for this initial pilot., Conclusions: This protocol presents detailed implementation methods about a novel automated SMS intervention for social care integration within primary care. By sharing the study protocol early, we intend to facilitate the development and adoption of similar tools across different clinical settings, as more health care providers seek to address the unmet social needs of patients. Study findings will provide practical insights into the design and implementation of SMS text message-based interventions to improve social and medical care coordination., International Registered Report Identifier (irrid): DERR1-10.2196/37316., (©Tyler Lian, Hadley Reid, Abigail Rader, Sarah Dewitt-Feldman, Elmira Hezarkhani, Elizabeth Gu, Malik Scott, Kate Kutzer, Sahil Sandhu, Carolyn Crowder, Kristin Ito, Howard Eisenson, Janet Prvu Bettger, Ryan J Shaw, Allison A Lewinski, David Y Ming, Hayden B Bosworth, Leah L Zullig, Bryan C Batch, Connor Drake. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.10.2022.)

Purpose of Review: Obesity and diabetes contribute to chronic kidney disease (CKD) and accelerate the loss of kidney function. Low carbohydrate diets (LCDs) are associated with weight loss and improved diabetes control. Compared to the typical Western diet, LCDs contain more protein, so individuals with CKD are not included in studies of LCDs. Therefore, there are no studies of LCDs for weight loss and their effects on kidney function., Recent Findings: Obesity, hyperglycemia, and hyperinsulinemia can be detrimental to kidney function. LCDs may improve kidney function in patients with obesity and diabetes because they are associated with weight loss, improve blood sugar control, and decrease endogenous insulin production and exogenous insulin requirements., Summary: In this study, for patients with mildly reduced and moderately to severely reduced kidney function who were prescribed an LCD, their estimated glomerular filtration rate (eGFR) was either unchanged or improved. For those with normal or elevated eGFR, their kidney function was slightly decreased. For those without diabetes, greater weight loss was associated with improved eGFR. Future studies should prospectively measure low carbohydrate dietary adherence and physical activity and directly measure changes in GFR and albuminuria for participants with CKD before and during that diet., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objectives: Examine the association of patient perceptions of care with hemoglobin A1c (HbA1c), medication adherence, and missed appointments in non-Hispanic Black (NHB) and White (NHW) patients with type 2 diabetes (T2DM)., Methods: We used linear and logistic regression models to analyze the association of the Interpersonal Processes of Care survey (IPC) with HbA1c, medication adherence, and missed appointments. We then examined how these associations differed by race., Results: There was no overall association between IPC subdomains and HbA1c in our sample (N = 221). NHB patients perceiving their provider always explained results and medications had a HbA1c on average 0.59 (-1.13, -0.04; p = 0.04) points lower than those perceiving their provider sometimes explained results and medications. No effect was observed in NHWs. Never perceiving disrespect from office staff was associated with an average 0.67 (-1.1, -0.24; p = 0.002) point improvement in medication adherence for all patients. Never perceiving discrimination from providers was associated with a 0.44 (-0.63, -0.25; p < 0.0001) decrease in the probability of missing an appointment for NHB patients., Conclusions: These results demonstrate that particular aspects of communication in the patient-provider interaction may contribute to racial disparities in T2DM., Practice Implications: Communication training for both providers and staff may reduce disparities in T2DM., Competing Interests: Declaration of Competing Interest None, (Copyright © 2021 Elsevier B.V. All rights reserved.)

Purpose: Research suggests that providers contribute to racial disparities in health outcomes. Identifying modifiable provider perspectives that are associated with decreased racial disparities will help in the design of effective educational interventions for providers. Methods: This cross-sectional study investigated the association between primary care provider (PCP) perspectives on race and racial disparities with patient outcomes. Results: Study participants included 40 PCPs (70% White, 30% racial minority) caring for 55 patients (45% White, 55% Black) with type 2 diabetes mellitus. Associations of provider perspectives on race and racial disparities with patient variables (Interpersonal Processes of Care [IPC] Survey, which measures patient's ratings of their provider's interpersonal skills; medication adherence; glycemic control) were measured using Spearman correlation coefficients. Results suggest that Black patients of providers who reported greater skill in caring for Black patients had more positive perceptions of care in three of four IPC subdomains (Spearman correlation coefficients of -0.43, 0.44, 0.46, all with p <0.05); however, Black patients of providers who believe that racial disparities are highly prevalent had more negative perceptions of care in three of four IPC subdomains (Spearman correlation coefficients of 0.38, -0.53, -0.51, all with p <0.05). These same provider characteristics had no correlation with outcomes of medication adherence and hemoglobin A1c (HbA1c) or among White patients. Conclusion: Findings suggest that Black patients of providers who felt better equipped to take care of Black patients had a better experience. Therefore, educational interventions for providers may be most effective if they focus on skill development rather than increasing awareness about racial disparities alone., Competing Interests: No competing financial interests exist., (© Olivia M. Lin et al., 2021; Published by Mary Ann Liebert, Inc.)

Background: Type 2 diabetes affects 30 million Americans, representing a significant cause of morbidity and mortality. Self-management support is an important component of chronic illness care and is a key pillar of the chronic care model. Face-to-face teaching and patient education materials suffer from being static or incompatible with mobile lifestyles. Digital apps provide a self-management support alternative that is convenient and scalable., Objective: This pilot study tested the real-world deployment of a self-guided mobile app for diabetes education (Time2Focus app; MicroMass Communications Inc, Cary, NC), which utilizes evidence-based content and gamification to deliver an interactive learning experience., Methods: Primary care providers were approached for permission to invite their patients to participate. Eligible patients were 18 to 89 years of age, had a diagnosis of type 2 diabetes, hemoglobin A1c (HbA1c) ≥8% and <12% in the past 3 months, an active online patient portal account (tied to the electronic health record), and access to an iOS or Android smartphone. Interested patients were emailed a baseline survey, and once this was completed, were sent instructions for downloading the Time2Focus app. After completing all 12 levels, participants were sent a follow-up survey. The primary outcome was the change in HbA1c. Secondary outcomes included medication adherence, self-care activities, self-reporting of physical activities, diabetes self-efficacy, illness perceptions, diabetes distress scale, and users' engagement with and rating of the app., Results: Of 1355 potentially eligible patients screened, 201 were consented. Of these 201 patients, 101 (50.2%) did not download the app. Of the 100 participants (49.8%) who downloaded the app, 16 (16.0%) completed 0 levels, 26 (26.0%) completed 1 to 4 levels, 10 (10.0%) completed 5 to 11 levels, and 48 (48.0%) completed all 12 levels of the app and the follow-up survey. Those completing one or more levels had a mean pre/post-HbA1c change of -0.41% (compared to -0.32% among those who completed zero levels); however, the unadjusted two-tailed t test indicated no significant difference between the two groups (P=.73). Diabetes self-efficacy showed a large and significant increase during app usage for completers (mean change 1.28, P<.001, d=.83). Severity of illness perceptions showed a small but significant decrease during app usage for completers (mean change -0.51, P=.004, d=.43). Diabetes distress showed a small but significant decrease during app usage for completers (mean change -0.45, P=.006, d=.41). The net promoter score was 62.5, indicating that those who completed all levels of the app rated it highly and would recommend it to others., Conclusions: Participants who engaged in all 12 levels of the Time2Focus mobile app showed an improvement in diabetes self-efficacy and a decrease in severity of illness perceptions. The decrease in HbA1c observed in app users relative to nonusers during this limited pilot study was not statistically significant. However, uptake and application of lessons learned from self-management support may be delayed. Further research is needed to address how to increase engagement through self-management support and to investigate if follow up over a longer period demonstrates a significant change in outcomes such as HbA1c., (©Bryan C Batch, Susan E Spratt, Dan V Blalock, Chad Benditz, Andi Weiss, Rowena J Dolor, Alex H Cho. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 20.01.2021.)

Background: Obesity prevalence is higher in women veterans overall than their civilian counterparts considering 44% of women veterans are obese. Thus, there is a critical need to understand the facilitators and barriers to women veterans' participation in weight management programs. The objective of this study is to explore facilitators and barriers to weight loss for women veterans enrolled in the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere (VA MOVE!) weight management program and gather feedback on the design and delivery of the MOVE!, Program: Materials and Methods: Primary qualitative data were collected from women veterans who completed at least one MOVE! visit via semistructured telephone interviews. Two authors independently reviewed transcripts for data-derived codes. A content analysis approach was used within the software to code the transcripts. Results: The mean age of participants was 52 years. Sixty-eight percent ( N  = 17/25) were black, and 52% ( N  = 13/25) lived >64 kilometers from the location of the MOVE!, Program: Facilitators to participation included both intrinsic ( e.g. , drive to become healthy) and extrinsic ( e.g. , drive to improve laboratories) motivating factors. Women expressed difficulty with learning in a group setting and applying lessons to their everyday lives. Others reported the setup of group classes triggered their post-traumatic stress disorder and prevented them from fully participating in the program. Additional barriers included distance traveled to group sessions and lack of access to exercise space. Conclusions: Our results illuminate barriers and facilitators to engagement in the MOVE!, Program: Many of the barriers highlighted by these women veterans mirror barriers civilian women face, highlighting the possibility that our results could be applied to other programs designed to target weight loss in women., Competing Interests: B.C.B., C.B., K.M.G., and S.D. have no competing financial interests. H.B.B. reports receiving grant funding to Duke University in the past 12 months from the following entities: National Institute of Health, Pharma Foundation, Johnson & Johnson, Improved Patient Outcome, Sanofi, and Otsuka. H.B.B. also reports receiving consulting/honorarium from Sanofi, Abbott, and Novartis., (© Bryan C. Batch et al. 2020; Published by Mary Ann Liebert, Inc.)

Background: For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina., Methods: Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m 2 ) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network., Discussion: For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care., Trials Registration: NCT03003403 . Registered December 28, 2016.

Introduction: Neighborhood characteristics such as racial segregation may be associated with hypertension, but studies have not examined these relationships using spatial models appropriate for geographically patterned health outcomes. The objectives of our study were to 1) evaluate the geographic heterogeneity of hypertension; 2) describe whether and how patient-level risk factors and racial isolation relate to geographic heterogeneity in hypertension; and 3) examine cross-sectional associations of hypertension with racial isolation., Methods: We obtained electronic health records from the Duke Medicine Enterprise Data Warehouse for 2007-2011. We linked patient data with data on racial isolation determined by census block of residence. We constructed a local spatial index of racial isolation for non-Hispanic black patients; the index is scaled from 0 to 1, with 1 indicating complete isolation. We used aspatial and spatial Bayesian models to assess spatial variation in hypertension and estimate associations with racial isolation., Results: Racial isolation ranged from 0 (no isolation) to 1 (completely isolated). A 0.20-unit increase in racial isolation was associated with 1.06 (95% credible interval, 1.03-1.10) and 1.11 (95% credible interval, 1.07-1.16) increased odds of hypertension among non-Hispanic black and non-Hispanic white patients, respectively. Across Durham, census block-level odds of hypertension ranged from 0.62 to 1.88 among non-Hispanic black patients and from 0.32 to 2.41 among non-Hispanic white patients. Compared with spatial models that included patient age and sex, residual heterogeneity in spatial models that included age, sex, and block-level racial isolation was 33% lower for non-Hispanic black patients and 20% lower for non-Hispanic white patients., Conclusion: Racial isolation of non-Hispanic black patients was associated with increased odds of hypertension among both non-Hispanic black and non-Hispanic white patients. Further research is needed to identify latent spatially patterned factors contributing to hypertension.

Purpose of Review: Moderate hypertriglyceridemia is exceedingly common in diabetes, and there is growing evidence that it contributes to residual cardiovascular risk in statin-optimized patients. Major fibrate trials yielded inconclusive results regarding the cardiovascular benefit of lowering triglycerides, although there was a signal for improvement among patients with high triglycerides and low high-density lipoprotein (HDL)-the "diabetic dyslipidemia" phenotype. Until recently, no trials have examined a priori the impact of triglyceride lowering in patients with diabetic dyslipidemia, who are likely among the highest cardiovascular-risk patients., Recent Findings: In the recent REDUCE IT trial, omega-3 fatty acid icosapent ethyl demonstrated efficacy in lowering cardiovascular events in patients with high triglycerides, low HDL, and statin-optimized low-density lipoprotein (LDL). The ongoing PROMINENT trial is examining the impact of pemafibrate in a similar patient population. Emerging evidence suggests that lowering triglycerides may reduce residual cardiovascular risk, especially in high-risk patients with diabetic dyslipidemia.

Introduction: Obesity treatment is less successful for socioeconomically disadvantaged populations, particularly when delivered in primary care. Digital health strategies can extend the reach of clinical obesity treatments to care settings serving patients at highest risk., Methods: Track was an effectiveness RCT of a 12-month digital weight-loss intervention, embedded within a community health center system. Participants were 351 adult patients (aged 21-65 years) with obesity and hypertension, diabetes, and hyperlipidemia. Patients were randomized to usual care (n=175) or an intervention (n=176) comprising app-based self-monitoring of behavior change goals with tailored feedback, a smart scale, dietitian-delivered counseling calls, and clinician counseling informed by app-generated recommendations, delivered via electronic health record. The primary outcome was 12-month weight change. Randomization began on June 18, 2013, final assessments were completed on September 10, 2015. Data analysis was conducted in 2016 and 2017. The trial retained 92% of usual care and 96% of intervention participants at 12 months., Results: The Track intervention produced larger weight losses relative to usual care at 6 months (net effect: -4.4 kg, 95% CI= -5.5, -3.3, p<0.001) and 12 months (net effect: -3.8 kg, 95% CI= -5.0, -2.5, p<0.001). Intervention participants were more likely to lose ≥5% of their baseline weight at 6 months (43% vs 6%, p<0.001) and 12 months (40% vs 17%, p<0.001). Intervention participants completing ≥80% of expected self-monitoring episodes (-3.5 kg); counseling calls (-3.0 kg); or self-weighing days (-4.4 kg) lost significantly more weight than less engaged intervention participants (all p<0.01)., Conclusions: A digital obesity treatment, integrated with health system resources, can produce clinically meaningful weight-loss outcomes among socioeconomically disadvantaged primary care patients with elevated cardiovascular disease risk., Trial Registration: This study is registered at www.clinicaltrials.gov NCT01827800., (Copyright © 2018 American Journal of Preventive Medicine. All rights reserved.)

Background: Few evaluations of the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere (MOVE!) weight management program have assessed 6-month weight change or factors associated with weight change by gender., Materials and Methods: Analysis of administrative data from a national sample of veterans in the VA MOVE!, Results: A total of 62,882 participants were included, 14.6% were women. Compared with men, women were younger (49.6 years [standard deviation, SD, 10.8] vs. 59.3 years [SD, 9.8], p < 0.0001), less likely to be married (34.1% vs. 56.0%, p < 0.0001), and had higher rates of post-traumatic stress disorder (26.0% vs. 22.4%, p < 0.0001) and depression (49.3% vs. 32.9%, p < 0.001). The mean number of MOVE! visits attended by women was lower than men (5.6 [SD, 5.3] vs. 6.0 [SD, 5.9], p < 0.0001). Women, compared with men, reported lower rates of being able to rely on family or friends (35.7% vs. 40.8%, p < 0.0001). Observed mean percent change in weight for women was -1.5% (SD, 5.2) and for men was -1.9% (SD, 4.8, p < 0.0001). The odds of ≥5% weight loss were no different for women (body-mass index [BMI] >25 kg/m 2 ) compared with men (BMI >25 kg/m 2 ; odds ratio, 1.05 [95% confidence interval, 0.99-1.11; p = 0.13])., Conclusions: Women veterans lost less weight overall compared with men. There was no difference in the odds of achieving clinically significant weight loss by gender. The majority of women and men enrolled lost <5% weight despite being enrolled in a lifestyle intervention. Future studies should focus on identifying program- and participant-level barriers to weight loss.

Background: Women veterans are at increased risk for cardiovascular disease (CVD), but little is known about comorbidities and healthcare preferences associated with CVD risk in this population., Methods: We describe the prevalence of CVD-relevant health behaviors, mental health symptoms, and health care use characteristics and preferences among participants of the National Survey of Women Veterans (conducted 2008-2009)., Findings: Fifty-four percent of respondents were at risk for CVD (defined as a diagnosis of hypertension, diabetes, current tobacco use, or obesity without CVD). In unadjusted analysis, ORs for being at risk for CVD were greater among those interested in gender-specific clinical settings (OR, 2.0; 95% CI, 1.2-3.4) and gender-specific weight loss programs (OR, 1.8; 95% CI, 1.1-2.9). ORs were also greater for women who were physically inactive (OR, 1.9; 95% CI, 1.1-3.3), with current symptoms of depression (OR, 2.5; 95% CI, 1.1-6.1), anxiety (OR, 2.1; 95% CI, 1.2-3.6), and posttraumatic stress disorder (OR, 2.4; 95% CI, 1.2-4.8). Adjusting for age, race/ethnicity, marital status, education level, employment, and source of health care use, the ORs for CVD risk were higher for women with current posttraumatic stress disorder symptoms (2.5; 95% CI, 1.1-5.3) and gender-specific health care preferences (2.0; 95% CI, 1.1-3.4), and gender-specific weight loss programs (1.9; 95% CI, 1.1-3.2)., Conclusions: Risk for CVD was common and preferences for gender-specific care and posttraumatic stress disorder were associated with being at risk for CVD. Women's health clinics may be a good location for targeted CVD prevention interventions for women veterans both in and outside the Veterans Health Administration., (Published by Elsevier Inc.)

Background: Obesity and poor sleep are highly prevalent among Black women., Purpose: We examined whether a weight gain prevention intervention improved sleep among Black women., Methods: We conducted a randomized trial comparing a 12-month weight gain prevention intervention that included self-monitoring through mobile technologies and phone coaching to usual care in community health centers. We measured sleep using the Medical Outcomes Study Sleep Scale at baseline, 12 months, and 18 months. The scale examines quantity of sleep, sleep disturbance, sleep adequacy, daytime somnolence, snoring, shortness of breath, and global sleep problems (sleep problem indices I and II)., Results: Participants (n = 184) were on average 35.4 years and obese (BMI 30.2 kg/m 2 ); 74% made <$30,000/year. At baseline, average sleep duration was 6.4 (1.5) hours. Controlling for weight change and sleep medication, the intervention group reported greater improvements in sleep disturbance [-8.35 (-16.24, -0.45)] and sleep problems at 12 months: sleep problem index I [-8.35 (-16.24, -0.45)]; sleep problem index II [-8.35 (-16.24, -0.45)]. However, these findings did not persist at 18 months., Conclusions: Preventing weight gain may afford clinical benefit on improving sleep quality., Trial Registration Number: The trial was registered with the ClinicalTrials.gov database (NCT00938535).

Background: Compared with men, women have poorer lipid control. Although potential causes of this disparity have been explored, it is unknown whether patient-centered factors such as satisfaction and confidence contribute. We evaluated (1) whether satisfaction with lipid control and confidence in ability to improve it vary by gender and (2) whether sociodemographic characteristics modify the association., Materials and Methods: We evaluated baseline survey responses from the Cardiovascular Intervention Improvement Telemedicine Study, including self-rated satisfaction with cholesterol levels and confidence in controlling cholesterol. Participants had poorly controlled hypertension and/or hypercholesterolemia., Results: A total of 428 veterans (15% women) participated. Compared with men, women had higher low-density lipoprotein values at 141.2 versus 121.7 mg/dL, respectively (p < 0.05), higher health literacy, and were less likely to have someone to help track their medications (all p < 0.05). In an adjusted model, women were less satisfied with their cholesterol levels than men with estimated mean scores of 4.3 versus 5.6 on a 1-10 Likert scale (p < 0.05). There was no significant difference in confidence by gender. Participants with support for tracking medications reported higher confidence levels than those without, estimated mean 7.8 versus 7.2 (p < 0.05)., Conclusions: Women veterans at high risk for cardiovascular disease were less satisfied with their lipid control than men; however, confidence in ability to improve lipid levels was similar. Veterans without someone to help to track medications were less confident, and women were less likely to have this type of social support. Lack of social support for medication tracking may be a factor in lingering gender-based disparities in hyperlipidemia.

Objective: We assessed the sensitivity and specificity of 8 electronic health record (EHR)-based phenotypes for diabetes mellitus against gold-standard American Diabetes Association (ADA) diagnostic criteria via chart review by clinical experts., Materials and Methods: We identified EHR-based diabetes phenotype definitions that were developed for various purposes by a variety of users, including academic medical centers, Medicare, the New York City Health Department, and pharmacy benefit managers. We applied these definitions to a sample of 173 503 patients with records in the Duke Health System Enterprise Data Warehouse and at least 1 visit over a 5-year period (2007-2011). Of these patients, 22 679 (13%) met the criteria of 1 or more of the selected diabetes phenotype definitions. A statistically balanced sample of these patients was selected for chart review by clinical experts to determine the presence or absence of type 2 diabetes in the sample., Results: The sensitivity (62-94%) and specificity (95-99%) of EHR-based type 2 diabetes phenotypes (compared with the gold standard ADA criteria via chart review) varied depending on the component criteria and timing of observations and measurements., Discussion and Conclusions: Researchers using EHR-based phenotype definitions should clearly specify the characteristics that comprise the definition, variations of ADA criteria, and how different phenotype definitions and components impact the patient populations retrieved and the intended application. Careful attention to phenotype definitions is critical if the promise of leveraging EHR data to improve individual and population health is to be fulfilled., (© The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com)

Background: Low-normal potassium is a risk factor for diabetes and may account for some of the racial disparity in diabetes risk. Aldosterone affects serum potassium and is associated with insulin resistance., Objectives: We sought to confirm the association between potassium and incident diabetes in an African-American cohort, and to determine the effect of aldosterone on this association., Design: We studied participants from the Jackson Heart Study, an African-American adult cohort, who were without diabetes at baseline. With the use of logistic regression, we characterized the associations of serum, dietary, and urinary potassium with incident diabetes. In addition, we evaluated aldosterone as a potential effect modifier of these associations., Results: Of 2157 participants, 398 developed diabetes over 8 y. In a minimally adjusted model, serum potassium was a significant predictor of incident diabetes (OR: 0.83; 95% CI: 0.74, 0.92 per SD increment in serum potassium). In multivariable models, we found a significant interaction between serum potassium and aldosterone (P = 0.046). In stratified multivariable models, in those with normal aldosterone (<9 ng/dL, n = 1163), participants in the highest 2 potassium quartiles had significantly lower odds of incident diabetes than did those in the lowest potassium quartile [OR (95% CI): 0.61 (0.39, 0.97) and 0.54 (0.33, 0.90), respectively]. Among those with high-normal aldosterone (≥9 ng/dL, n = 202), we found no significant association between serum potassium and incident diabetes. In these stratified models, serum aldosterone was not a significant predictor of incident diabetes. We found no statistically significant associations between dietary or urinary potassium and incident diabetes., Conclusions: In this African-American cohort, we found that aldosterone may modify the association between serum potassium and incident diabetes. In participants with normal aldosterone, high-normal serum potassium was associated with a lower risk of diabetes than was low-normal serum potassium. Additional studies are warranted to determine whether serum potassium is a modifiable risk factor that could be a target for diabetes prevention. This trial was registered at clinicaltrials.gov as NCT00415415., (© 2017 American Society for Nutrition.)

Background: Regular physical activity is important for improving and maintaining health, but sedentary behavior is difficult to change. Providing objective, real-time feedback on physical activity with wearable motion-sensing technologies (activity monitors) may be a promising, scalable strategy to increase physical activity or decrease weight., Purpose: We synthesized the literature on the use of wearable activity monitors for improving physical activity and weight-related outcomes and evaluated moderating factors that may have an impact on effectiveness., Methods: We searched five databases from January 2000 to January 2015 for peer-reviewed, English-language randomized controlled trials among adults. Random-effects models were used to produce standardized mean differences (SMDs) for physical activity outcomes and mean differences (MDs) for weight outcomes. Heterogeneity was measured with I 2 ., Results: Fourteen trials (2972 total participants) met eligibility criteria; accelerometers were used in all trials. Twelve trials examined accelerometer interventions for increasing physical activity. A small significant effect was found for increasing physical activity (SMD 0.26; 95 % CI 0.04 to 0.49; I 2  = 64.7 %). Intervention duration was the only moderator found to significantly explain high heterogeneity for physical activity. Eleven trials examined the effects of accelerometer interventions on weight. Pooled estimates showed a small significant effect for weight loss (MD -1.65 kg; 95 % CI -3.03 to -0.28; I 2   = 81 %), and no moderators were significant., Conclusions: Accelerometers demonstrated small positive effects on physical activity and weight loss. The small sample sizes with moderate to high heterogeneity in the current studies limit the conclusions that may be drawn. Future studies should focus on how best to integrate accelerometers with other strategies to increase physical activity and weight loss., Competing Interests: STATEMENT This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Center located at the Durham VA Medical Center, Durham, NC, funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative. The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of the Department of Veterans Affairs or the United States government. Therefore, no statement in this article should be construed as an official position of the Department of Veterans Affairs. No investigators have any affiliations or financial involvement (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in the report.

Background: Although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP) for adults with normal kidney function, evidence is lacking regarding its safety and efficacy in chronic kidney disease (CKD). We aimed to test the effects of the DASH diet on serum electrolytes and BP in adults with moderate CKD., Methods: In a prospective before-after feeding study, 11 adults with an estimated glomerular filtration rate of 30-59 mL/min/1.73 m(2) and medication-treated hypertension were provided a reduced-sodium, run-in diet for 1 week followed by a reduced-sodium, DASH diet for 2 weeks. Changes in serum electrolytes and BP were compared pre-post DASH., Results: Eleven participants underwent feeding; 1 completed 1 week and 10 completed 2 weeks of DASH. Compared with baseline, DASH modestly increased serum potassium at 1 week (mean ± standard deviation, +0.28 ± 0.4 mg/dL; P = 0.043) but had no significant effect on potassium at 2 weeks (+0.15 ± 0.28 mg/dL; P = 0.13). Serum bicarbonate was reduced (-2.5 ± 3.0 mg/dL; P = 0.03) at 2 weeks. Neither incident hyperkalemia nor new onset metabolic acidosis was observed. Clinic BP and mean 24-h ambulatory BP was unchanged. DASH significantly reduced mean nighttime BP (-5.3 ± 5.8 mmHg; P = 0.018), and enhanced percent declines in both nocturnal systolic BP (-2.1% to -5.1%; P = 0.004) and diastolic BP (-3.7% to -10.0%; P = 0.008)., Conclusions: These pilot data suggest that a reduced-sodium DASH dietary pattern does not cause acute metabolic events in adults with moderate CKD and may improve nocturnal BP. Definitive studies are needed to determine long-term effects of DASH in CKD.

The global burden of osteoporotic fractures is associated with significant morbidity, mortality, and healthcare costs. We examined the ClinicalTrials.gov database to determine whether recently registered clinical trials addressed prevention and treatment in those at high risk for fracture. A dataset of 96,346 trials registered in ClinicalTrials.gov was downloaded on September 27, 2010. At the time of the dataset download, 40,970 interventional trials had been registered since October 1, 2007. The osteoporosis subset comprised 239 interventional trials (0.6%). Those trials evaluating orthopedic procedures were excluded. The primary purpose was treatment in 67.0%, prevention in 20.1%, supportive care in 5.8%, diagnostic in 2.2%, basic science in 3.1%, health services research in 0.9%, and screening in 0.9%. The majority of studies (61.1%) included drug-related interventions. Most trials (56.9%) enrolled only women, 38.9% of trials were open to both men and women, and 4.2% enrolled only men. Roughly one fifth (19.7%) of trials excluded research participants older than 65 years, and 33.5% of trials excluded those older than 75 years. The funding sources were industry in 51.0%, the National Institutes of Health in 6.3%, and other in 42.7%. We found that most osteoporosis-related trials registered from October 2007 through September 2010 examined the efficacy and safety of drug treatment, and fewer trials examined prevention and non-drug interventions. Trials of interventions that are not required to be registered in ClinicalTrials.gov may be underrepresented. Few trials are specifically studying osteoporosis in men and older adults. Recently registered osteoporosis trials may not sufficiently address fracture prevention.

Introduction: Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings., Methods: Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months., Results: Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression., Conclusions: Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: In the Weight Loss Maintenance (WLM) Trial, a personal contact (PC) intervention sustained greater weight loss relative to a self-directed (SD) group over 30 months. This study investigated the effects of continued intervention over an additional 30 months and overall weight change across the entire WLM Trial., Methods: WLM had 3 phases. Phase 1 was a 6-month weight loss program. In Phase 2, those who lost ≥4 kg were randomized to a 30-month maintenance trial. In Phase 3, PC participants (n = 196, three sites) were re-randomized to no further intervention (PC-Control) or continued intervention (PC-Active) for 30 more months; 218 SD participants were also followed., Results: During Phase 3, weight increased 1.0 kg in PC-Active and 0.5 kg in PC-Control (mean difference 0.6 kg; 95% CI:-1.4 to 2.7; P = 0.54). Mean weight change over the entire study was -3.2 kg in those originally assigned to PC (PC-Combined) and -1.6 kg in SD (mean difference -1.6 kg; 95% CI:-3.0 to -0.1; P = 0.04)., Conclusions: After 30 months of the PC maintenance intervention, continuation for another 30 months provided no additional benefit. However, across the entire study, weight loss was slightly greater in those originally assigned to PC., (© 2016 The Obesity Society.)

Background: The Affordable Care Act encourages healthcare systems to integrate behavioral and medical healthcare, as well as to employ electronic health records (EHRs) for health information exchange and quality improvement. Pragmatic research paradigms that employ EHRs in research are needed to produce clinical evidence in real-world medical settings for informing learning healthcare systems. Adults with comorbid diabetes and substance use disorders (SUDs) tend to use costly inpatient treatments; however, there is a lack of empirical data on implementing behavioral healthcare to reduce health risk in adults with high-risk diabetes. Given the complexity of high-risk patients' medical problems and the cost of conducting randomized trials, a feasibility project is warranted to guide practical study designs., Methods: We describe the study design, which explores the feasibility of implementing substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adults with high-risk type 2 diabetes mellitus (T2DM) within a home-based primary care setting. Our study includes the development of an integrated EHR datamart to identify eligible patients and collect diabetes healthcare data, and the use of a geographic health information system to understand the social context in patients' communities. Analysis will examine recruitment, proportion of patients receiving brief intervention and/or referrals, substance use, SUD treatment use, diabetes outcomes, and retention., Discussion: By capitalizing on an existing T2DM project that uses home-based primary care, our study results will provide timely clinical information to inform the designs and implementation of future SBIRT studies among adults with multiple medical conditions., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Background/aims: The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults., Methods: Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely., Results: The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated., Conclusion: The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves., (© The Author(s) 2015.)

Background: Comorbid diabetes and substance use diagnoses (SUD) represent a hazardous combination, both in terms of healthcare cost and morbidity. To date, there is limited information about the association of SUD and related mental disorders with type 2 diabetes mellitus (T2DM)., Methods: We examined the associations between T2DM and multiple psychiatric diagnosis categories, with a focus on SUD and related psychiatric comorbidities among adults with T2DM. We analyzed electronic health record (EHR) data on 170,853 unique adults aged ≥18 years from the EHR warehouse of a large academic healthcare system. Logistic regression analyses were conducted to estimate the strength of an association for comorbidities., Results: Overall, 9% of adults (n=16,243) had T2DM. Blacks, Hispanics, Asians, and Native Americans had greater odds of having T2DM than whites. All 10 psychiatric diagnosis categories were more prevalent among adults with T2DM than among those without T2DM. Prevalent diagnoses among adults with T2MD were mood (21.22%), SUD (17.02%: tobacco 13.25%, alcohol 4.00%, drugs 4.22%), and anxiety diagnoses (13.98%). Among adults with T2DM, SUD was positively associated with mood, anxiety, personality, somatic, and schizophrenia diagnoses., Conclusions: We examined a large diverse sample of individuals and found clinical evidence of SUD and psychiatric comorbidities among adults with T2DM. These results highlight the need to identify feasible collaborative care models for adults with T2DM and SUD related psychiatric comorbidities, particularly in primary care settings, that will improve behavioral health and reduce health risk., (Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Objective: To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults., Methods: Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control., Results: The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months., Conclusions: Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design., (© 2015 The Obesity Society.)

Objective: The Durham Diabetes Coalition (DDC) was established in response to escalating rates of disability and death related to type 2 diabetes mellitus, particularly among racial/ethnic minorities and persons of low socioeconomic status in Durham County, North Carolina. We describe a community-based demonstration project, informed by a geographic health information system (GHIS), that aims to improve health and healthcare delivery for Durham County residents with diabetes., Materials and Methods: A prospective, population-based study is assessing a community intervention that leverages a GHIS to inform community-based diabetes care programs. The GHIS integrates clinical, social, and environmental data to identify, stratify by risk, and assist selection of interventions at the individual, neighborhood, and population levels., Results: The DDC is using a multifaceted approach facilitated by GHIS to identify the specific risk profiles of patients and neighborhoods across Durham County. A total of 22,982 patients with diabetes in Durham County were identified using a computable phenotype. These patients tended to be older, female, African American, and not covered by private health insurance, compared with the 166,041 persons without diabetes. Predictive models inform decision-making to facilitate care and track outcomes. Interventions include: 1) neighborhood interventions to improve the context of care; 2) intensive team-based care for persons in the top decile of risk for death or hospitalization within the coming year; 3) low-intensity telephone coaching to improve adherence to evidence-based treatments; 4) county-wide communication strategies; and 5) systematic quality improvement in clinical care., Conclusions: To improve health outcomes and reduce costs associated with type 2 diabetes, the DDC is matching resources with the specific needs of individuals and communities based on their risk characteristics.

Background: The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population., Purpose: To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition., Methods: A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014., Conclusions: If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364., (Published by Elsevier Inc.)

Purpose of Review: There is burgeoning evidence that branch chain amino acids (BCAAs) are biomarkers of metabolic, cardiovascular, renal and cerebrovascular disease. The purpose of this review is to summarize the current evidence in this area., Recent Findings: Recent evidence demonstrates that BCAAs are associated with insulin resistance, type 2 diabetes, risk of cardiovascular disease, stage I and II chronic kidney disease and ischemic stroke. Further, circulating levels of BCAAs have the potential to predict populations at risk for cardiometabolic disease, type 2 diabetes and mortality from ischemic heart disease. Importantly, the relationship of BCAAs to insulin resistance is affected by the intake of fat in the diet as well as age., Summary: Current evidence supports the potential use of BCAAs as biomarkers of disease. However, questions regarding the mechanisms underlying the relationship of BCAAs to disease process and severity need to be answered prior to the use of BCAAs as a biomarker in clinical practice.

Objective: To determine the effect of age on weight loss and weight loss maintenance in participants in the Weight Loss Maintenance trial (WLM)., Design and Methods: Secondary analysis of a randomized controlled trial of overweight/obese adults with CVD risk factors was conducted. Participants were 1685 adults with baseline BMI 25-45 kg m(2) with hypertension and/or dyslipidemia. Those who lost at least 4kg in an initial 6-month behavioral weight loss intervention (N = 1,032) were randomly assigned to a 30-month maintenance phase of self-directed control (SD), monthly personal counseling (PC), or unlimited access to an internet-based intervention (IT). Age groups were defined post-hoc and weight change was compared among age groups., Results: Participants ≥60 years old initially lost more weight than younger individuals, and sustained greater weight loss in IT and PC but not in SD (P value for trend 0.024, 0.002, and 0.36, respectively)., Conclusions: In WLM, adults age ≥60 years had greater initial weight loss and greater sustained weight loss over 3 years, compared to younger adults. Older adults had greater weight loss maintenance with either personal counseling or internet-based intervention. Future research should determine optimal implementation strategies and effects of weight loss on health outcomes in older adults., (Copyright © 2013 The Obesity Society.)

Objective: This study compares the yield and characteristics of diabetes cohorts identified using heterogeneous phenotype definitions., Materials and Methods: Inclusion criteria from seven diabetes phenotype definitions were translated into query algorithms and applied to a population (n=173 503) of adult patients from Duke University Health System. The numbers of patients meeting criteria for each definition and component (diagnosis, diabetes-associated medications, and laboratory results) were compared., Results: Three phenotype definitions based heavily on ICD-9-CM codes identified 9-11% of the patient population. A broad definition for the Durham Diabetes Coalition included additional criteria and identified 13%. The electronic medical records and genomics, NYC A1c Registry, and diabetes-associated medications definitions, which have restricted or no ICD-9-CM criteria, identified the smallest proportions of patients (7%). The demographic characteristics for all seven phenotype definitions were similar (56-57% women, mean age range 56-57 years).The NYC A1c Registry definition had higher average patient encounters (54) than the other definitions (range 44-48) and the reference population (20) over the 5-year observation period. The concordance between populations returned by different phenotype definitions ranged from 50 to 86%. Overall, more patients met ICD-9-CM and laboratory criteria than medication criteria, but the number of patients that met abnormal laboratory criteria exclusively was greater than the numbers meeting diagnostic or medication data exclusively., Discussion: Differences across phenotype definitions can potentially affect their application in healthcare organizations and the subsequent interpretation of data., Conclusions: Further research focused on defining the clinical characteristics of standard diabetes cohorts is important to identify appropriate phenotype definitions for health, policy, and research.

In overweight/obese individuals, cardiometabolic risk factors differ by race and sex categories. Small-molecule metabolites and metabolic hormone levels might also differ across these categories and contribute to risk factor heterogeneity. To explore this possibility, we performed a cross-sectional analysis of fasting plasma levels of 69 small-molecule metabolites and 13 metabolic hormones in 500 overweight/obese adults who participated in the Weight Loss Maintenance trial. Principal-components analysis (PCA) was used for reduction of metabolite data. Race and sex-stratified comparisons of metabolite factors and metabolic hormones were performed. African Americans represented 37.4% of the study participants, and females 63.0%. Of thirteen metabolite factors identified, three differed by race and sex: levels of factor 3 (branched-chain amino acids and related metabolites, p<0.0001), factor 6 (long-chain acylcarnitines, p<0.01), and factor 2 (medium-chain dicarboxylated acylcarnitines, p<0.0001) were higher in males vs. females; factor 6 levels were higher in Caucasians vs. African Americans (p<0.0001). Significant differences were also observed in hormones regulating body weight homeostasis. Among overweight/obese adults, there are significant race and sex differences in small-molecule metabolites and metabolic hormones; these differences may contribute to risk factor heterogeneity across race and sex subgroups and should be considered in future investigations with circulating metabolites and metabolic hormones.

Purpose: Poor adherence to prescribed medicines is associated with increased rates of poor outcomes, including hospitalization, serious adverse events, and death, and is also associated with increased healthcare costs. However, current approaches to evaluation of medication adherence using real-world electronic health records (EHRs) or claims data may miss critical opportunities for data capture and fall short in modeling and representing the full complexity of the healthcare environment. We sought to explore a framework for understanding and improving data capture for medication adherence in a population-based intervention in four U.S. counties., Approach: We posited that application of a data model and a process matrix when designing data collection for medication adherence would improve identification of variables and data accessibility, and could support future research on medication-taking behaviors. We then constructed a use case in which data related to medication adherence would be leveraged to support improved healthcare quality, clinical outcomes, and efficiency of healthcare delivery in a population-based intervention for persons with diabetes. Because EHRs in use at participating sites were deemed incapable of supplying the needed data, we applied a taxonomic approach to identify and define variables of interest. We then applied a process matrix methodology, in which we identified key research goals and chose optimal data domains and their respective data elements, to instantiate the resulting data model., Conclusions: Combining a taxonomic approach with a process matrix methodology may afford significant benefits when designing data collection for clinical and population-based research in the arena of medication adherence. Such an approach can effectively depict complex real-world concepts and domains by "mapping" the relationships between disparate contributors to medication adherence and describing their relative contributions to the shared goals of improved healthcare quality, outcomes, and cost.

Background: Excess adiposity and dietary factors may be important determinants of urinary albumin excretion (UAE)., Study Design: Observational analysis of PREMIER, a randomized trial designed to lower blood pressure using behavioral interventions (counseling on weight loss, healthy diet, and exercise)., Setting & Participants: 481 participants with normal kidney function who provided adequate 24-hour urine collections at baseline and 6 months., Predictors: Change in waist circumference; 24-hour urine sodium, potassium, and phosphorus excretion; and protein intake estimated from urea nitrogen., Outcomes & Measurements: The primary outcome was change in log-transformed 24-hour UAE over 6 months., Results: After 6 months, the proportion of individuals with UAE ≥10 mg/d decreased from 18.7% to 12.7% (P < 0.001). Changes in mean waist circumference (-4.2 ± 6.6 [SD] cm), 24-hour excretion of sodium (-28.2 ± 71.7 mmol/d), potassium (+8.4 ± 27.8 mmol/d), phosphorus (-27.7 ± 314.1 mg/d), and protein intake (-1.7 ± 19.4 g/d) were observed. After adjustment for relevant covariates, the following variables were associated significantly with reduction in ln(UAE) in separate models: decrease in waist circumference (P = 0.001), decrease in 24-hour urine phosphorus excretion (P < 0.001), and decrease in protein intake (P = 0.01). In a multivariable model including these 3 predictors, decreases in waist circumference (P = 0.002) and 24-hour urine phosphorus excretion (P = 0.03), but not change in protein intake (P = 0.5), remained associated significantly with reduction in ln(UAE). These associations remained significant even after adjustment for changes in blood pressure and insulin resistance. Baseline UAE and metabolic syndrome modified the relationship of waist circumference with ln(UAE); specifically, individuals with higher UAE and baseline metabolic syndrome experienced greater reductions in ln(UAE) from decreases in waist circumference., Limitations: Observational study with potential for confounding., Conclusions: In adults with normal kidney function, decreases in waist circumference and 24-hour urine phosphorus excretion are associated with reductions in UAE. These findings support the rationale for clinical trials to determine whether reducing dietary phosphorus intake or waist circumference could prevent chronic kidney disease or slow its progression., (Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Efficient dietary interventions for patients with hypertension in clinical settings are needed., Objective: To assess the separate and combined influence of a physician intervention (MD-I) and a patient intervention (PT-I) on dietary intakes of patients with hypertension., Design: A nested 2×2 design, randomized controlled trial conducted over 18 months., Participants: A total of 32 physicians and 574 outpatients with hypertension., Intervention: MD-I included training modules addressing the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure hypertension management guidelines and lifestyle modification. PT-I included lifestyle coaching to adopt the Dietary Approaches to Stop Hypertension (DASH) eating pattern, reduce sodium intake, manage weight, increase exercise, and moderate alcohol intake., Main Outcome Measures: Dietary intakes were measured by the Block Food Frequency Questionnaire. Concordance with the DASH dietary pattern was estimated by a DASH score., Statistical Analyses: The main effects of MD-I and PT-I, and their interaction, were evaluated using analysis of covariance., Results: After 6 months of intervention, MD-I participants significantly increased intakes of potassium, fruits, juices, and carbohydrate; decreased intake of fat; and improved overall dietary quality as measured by the Healthy Eating Index. PT-I intervention resulted in increased intakes of carbohydrate, protein, fiber, calcium, potassium, fruits and fruit juices, vegetables, dairy and Healthy Eating Index score, and decreased intakes in fat, saturated fat, cholesterol, sodium, sweets, and added fats/oils/sweets. In addition, PT-I improved overall DASH concordance score. The change in DASH score was significantly associated with the changes in blood pressure and weight at 6 months. At 18 months, most changes reversed back toward baseline levels, including the DASH score., Conclusions: Both MD-I and PT-I improved eating patterns at 6 months with some sustained effects at 18 months. Even though all dietary changes observed were consistent with the DASH nutrient targets or food group guidelines, only the PT-I intervention was effective in improving the overall DASH concordance score. This finding affirms the role of medical nutrition therapy in long-term intensive interventions for hypertension risk reduction and weight management and underlines the need for development of maintenance strategies. Furthermore, this study emphasizes the importance of collaborations among physicians, registered dietitians and other dietetics practitioners, and lay health advisors while assisting patients to make healthy behavior changes., (Copyright © 2013 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Objective: To identify novel biomarkers through metabolomic profiles that distinguish metabolically well (MW) from metabolically unwell (MUW) individuals, independent of body mass index (BMI)., Materials/methods: This study was conducted as part of the Measurement to Understand the Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) project. Individuals from 3 cohorts were classified as lean (BMI<25kg/m²), overweight (BMI≥25kg/m², BMI<30kg/m²) or obese (BMI≥30kg/m²). Cardiometabolic abnormalities were defined as: (1) impaired fasting glucose (≥100mg/dL and ≤126mg/dL); (2) hypertension; (3) triglycerides ≥150mg/dL; (4) HDL-C <40mg/dL in men, <50mg/dL in women; and (5) insulin resistance (calculated Homeostatic Model Assessment (HOMA-IR) index of >5.13). MW individuals were defined as having <2 cardiometabolic abnormalities and MUW individuals had≥two cardiometabolic abnormalities. Targeted profiling of 55 metabolites used mass-spectroscopy-based methods. Principal components analysis (PCA) was used to reduce the large number of correlated metabolites into clusters of fewer uncorrelated factors., Results: Of 1872 individuals, 410 were lean, 610 were overweight, and 852 were obese. Of lean individuals, 67% were categorized as MUW, whereas 80% of overweight and 87% of obese individuals were MUW. PCA-derived factors with levels that differed the most between MW and MUW groups were factors 4 (branched chain amino acids [BCAA]) [p<.0001], 8 (various metabolites) [p<.0001], 9 (C4/Ci4, C3, C5 acylcarnitines) [p<.0001] and 10 (amino acids) [p<.0002]. Further, Factor 4, distinguishes MW from MUW individuals independent of BMI., Conclusion: BCAA and related metabolites are promising biomarkers that may aid in understanding cardiometabolic health independent of BMI category., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Obesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Aims/hypothesis: Clinical trials assessing interventions for treating and preventing diabetes mellitus and its complications are needed to inform evidence-based practice. To examine whether current studies adequately address these needs, we conducted a descriptive analysis of diabetes-related trials registered with ClinicalTrials.gov from 2007 to 2010., Methods: From a dataset including 96,346 studies registered in ClinicalTrials.gov downloaded on 27 September, 2010, a subset of 2,484 interventional trials was created by selecting trials with disease condition terms relevant to diabetes., Results: Of the diabetes-related trials, 74.8% had a primarily therapeutic purpose while 10% were preventive. Listed interventions included drugs (63.1%) and behavioural (11.7%). Most trials were designed to enrol ≤ 500 (91.1%) or ≤ 100 (58.6%) participants, with mean/median times to completion of 1.8/1.4 years. Small percentages of trials targeted persons aged ≤ 18 years (3.7%) or ≥ 65 years (0.6%), while 30.8% excluded patients >65 years and the majority excluded those >75 years. Funding sources included industry (50.9%), NIH (7.5%) or other, with most being single-centre trials of other sponsorship (37.7%) or industry-funded multicentre studies (27.4%). A small number of trials (1.4%) listed primary outcomes including mortality or clinically significant cardiovascular complications. The distribution of trials by global region and US state does not correlate with prevalence of diabetes., Conclusions/interpretation: The majority of diabetes-related trials include small numbers of participants, exclude those at the extremes of age, are of short duration, involve drug therapy rather than preventive or non-drug interventions and do not focus upon significant cardiovascular outcomes. Recently registered diabetes trials may not sufficiently address important diabetes care issues or involve affected populations.

Objective: We have previously shown that racial composition of behavioral intervention groups does not affect achieved weight loss. However, it is unclear if the race of the interventionist affects intervention outcomes. The objective of this analysis is to estimate the impact of race concordance between participant and interventionist on weight change in the initial weight loss phase (phase I) of the Weight Loss Maintenance trial (WLM)., Design and Methods: A total of 1,685 overweight or obese adults (BMI 25-45 kg/m(2) ) who were taking medication for hypertension and/or dyslipidemia participated in phase I of the WLM trial. All participants received a 6-month intensive behavioral intervention in groups of 15-20 facilitated by a trained interventionist. The main outcome is change in weight at 6 months., Results: Participants were on average 55 years of age, 67% female and 44% African American (AA). Three of seventeen interventionists were AA, 14 were non-AA. Seventy-three percent of participants shared race concordance with the interventionist. There was a small but statistically significant difference in weight change of participants who were the same race as the interventionist (-5.84 kg, s.e. 0.17) as compared with those who were not race concordant (-5.04 kg, s.e. 0.33), a difference of 0.8 kg, (P = 0.04). The impact of concordance on weight change differed by race (i.e., interaction of race and concordance was significant, P = 0.02)., Conclusions: In a post hoc analysis of a group-based behavioral intervention, race concordance for non-AA participants was associated with slightly greater weight loss. Race concordance was not associated with weight loss for AA participants., (Copyright © 2012 The Obesity Society.)

Data within a continuing use context (also known as secondary use) can require translation into the variables necessary for project analysis. We have developed and applied a framework in which: Project objectives inform the curation of data elements. Data elements are rendered into system-readable metadata. Metadata are applied to the source data and used to produce data sets. This process distinguishes between data sets and source data. Data sets contain project-specific variables that are structured for analytic activities. This can differ from source data, which may be stored in a structure dictated by the original source system for data collection, or in a data structure contrary to what is desired for analysis. Data elements mediate this translation, and the process of curation refines their definitions and associated attributes. This framework improves analysis workflow through the application of best practices, consistent processes, and centralized decision-making.