Racial Disparities in Evidence-Based Management of Metabolic Dysfunction-Associated Steatotic Liver Disease in Patients With Type 2 Diabetes.

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.

Type 2 Diabetes Mellitus and Helicobacter pylori Eradication in a Clinical Population.

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.

General Behavioral Engagement and Changes in Clinical and Cognitive Outcomes of Patients with Type 2 Diabetes Using the Time2Focus Mobile App for Diabetes Education: Pilot Evaluation.

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.

Triglycerides: Emerging Targets in Diabetes Care? Review of Moderate Hypertriglyceridemia in Diabetes.

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.

The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.

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/m2) 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.

Residential Racial Isolation and Spatial Patterning of Hypertension in Durham, North Carolina.

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.

Preventing Weight Gain Improves Sleep Quality Among Black Women: Results from a RCT.

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/m2); 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).

The Impact of Interventions that Integrate Accelerometers on Physical Activity and Weight Loss: A Systematic Review.

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.

Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

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.

Branch chain amino acids: biomarkers of health and disease.

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.

Association of a reduction in central obesity and phosphorus intake with changes in urinary albumin excretion: the PREMIER study.

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.

Electronic consultation: A vision for primary care management.

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.

Prescribing of evidence-based diabetes pharmacotherapy in patients with metabolic dysfunction-associated steatohepatitis.

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.

Factors Associated With Diabetes Distress Among Patients With Poorly Controlled Type 2 Diabetes.

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 (ß=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.

Association of Unmet Social Needs With Metformin Use Among Patients With Type 2 Diabetes.

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.

Sex hormone changes during weight loss and maintenance in overweight and obese postmenopausal African-American and non-African-American women.

INTRODUCTION: Changes in sex hormones with weight loss might have implications for breast cancer prevention but have not been examined extensively, particularly in African-American (AA) women. METHODS: We conducted a prospective study of 278 overweight/obese postmenopausal women (38% AA) not taking hormone therapy within the Weight Loss Maintenance Trial. All participants lost at least 4 kg after a 6-month weight-loss phase and attempted to maintain weight loss during the subsequent 12 months. We evaluated the percentage changes in estrone, estradiol, free estradiol, testosterone, free testosterone, androstenedione, dehydroepiandrosterone sulfate and sex hormone-binding globulin (SHBG) using generalized estimating equations. RESULTS: In all study phases, AA women had higher levels of estrogen and testosterone concentrations, independent of adiposity. On average, participants lost 7.7 kg during the weight-loss phase, and concentrations of estrone (-5.7%, P = 0.006), estradiol (-9.9%, P <0.001), free estradiol (-13.4%, P <0.0001), and free testosterone (-9.9%, P <0.0001) decreased, while the SHBG concentration (16.2%, P <0.001) increased. Weight change did not significantly affect total testosterone or other androgen concentrations. Compared with non-AA women, AA women experienced less change in estrogens per kilogram of weight change (that is, per 1 kg weight loss: estrone, -0.6% vs. -1.2%, P-interaction = 0.10; estradiol, -1.1% vs. -1.9%, P-interaction = 0.04; SHBG, 0.9% vs. 1.6%, P-interaction = 0.006; free estradiol, -1.4% vs. -2.1%, P-interaction = 0.01). CONCLUSION: To the best of our knowledge this is the first study to examine and compare the effects of intentional weight loss and maintenance on a panel of sex hormones in AA women and non-AA women. Although speculative, these data suggest hormonal differences may contribute to different racial patterns of breast cancer incidence and mortality and encourage further investigations to understand the long-term effects of weight loss on sex hormones in obese postmenopausal women. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00054925.

The Latino Health Project: pilot testing a culturally adapted behavioral weight loss intervention in obese and overweight Latino adults.

OBJECTIVE: To pilot test a culturally adapted behavioral weight loss intervention in obese and overweight Latino adults. DESIGN: Pilot study. SETTING: Latino community organization in Durham, North Carolina. PARTICIPANTS: Overweight and obese, self-identified Latinos > or =18 years old. INTERVENTION: Intervention consisted of 20 weekly group sessions (90-120 minutes each) incorporating motivational interviewing techniques. The intervention goal was weight loss by adopting the Dietary Approach to Stop Hypertension (DASH) dietary pattern, increasing physical activity, and reducing caloric intake. The cultural adaptation included foods and physical activities commonly used in the Latino culture, using a Spanish-speaking interventionist, and conducting the intervention at a local Latino community organization. MAIN OUTCOME MEASURES: Weight, body mass index (BMI), blood pressure, dietary pattern, and physical activity were measured at baseline and at 20 weeks. RESULTS: A total of 56 participants are included in the final analysis. The average weight loss was 5.1 lbs (95% CI -8.7 to -1.5; P = .006); and there was a reduction in BMI of 1.3 kg/m2 (95% CI -2.2 to -0.5; P =.002) at 20 weeks. Systolic blood pressure decreased by 2.6 mm Hg (95% CI -4.7 to -0.6; P = .013). CONCLUSION: A culturally adapted behavioral intervention for the treatment of overweight and obesity is potentially effective in a diverse group of Latino adults.

A culturally targeted self-management program for African Americans with type 2 diabetes mellitus.

Inadequate knowledge of the influence of lifestyle on clinical outcomes contributes to the difficulties many African Americans experience with type 2 diabetes mellitus (T2DM). This pilot study examined a 12-week church-based culturally targeted diabetes self-management education (DSME) intervention for middle-aged and older African Americans with T2DM. Quantitative data were collected at baseline and at 12 weeks and included questionnaires and anthropometric measures. There were significant increases in medication adherence (p = .006), healthy eating (p = .009), and foot care adherence (p = .003). The intervention had a clinically significant effect on systolic blood pressure, blood lipids, physical activity, and waist circumference. Church-based culturally targeted DSME interventions may result in improved outcomes for African-American adults with T2DM. The authors discuss the value of community-based interventions that target behavioural changes in populations of chronically ill patients, particularly those who historically have been disenfranchised and/or underserved.

A Tailored SMS Text Message-Based Intervention to Facilitate Patient Access to Referred Community-Based Social Needs Resources: Protocol for a Pilot Feasibility and Acceptability Study.

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.

Reducing consumption of sugar-sweetened beverages is associated with reduced blood pressure: a prospective study among United States adults.

BACKGROUND: Increased consumption of sugar-sweetened beverages (SSBs) has been associated with an elevated risk of obesity, metabolic syndrome, and type II diabetes mellitus. However, the effects of SSB consumption on blood pressure (BP) are uncertain. The objective of this study was to determine the relationship between changes in SSB consumption and changes in BP among adults. METHODS AND RESULTS: This was a prospective analysis of 810 adults who participated in the PREMIER Study (an 18-month behavioral intervention trial). BP and dietary intake (by two 24-hour recalls) were measured at baseline and at 6 and 18 months. Mixed-effects models were applied to estimate the changes in BP in responding to changes in SSB consumption. At baseline, mean SSB intake was 0.9+/-1.0 servings per day (10.5+/-11.9 fl oz/d), and mean systolic BP/diastolic BP was 134.9+/-9.6/84.8+/-4.2 mm Hg. After potential confounders were controlled for, a reduction in SSB of 1 serving per day was associated with a 1.8-mm Hg (95% confidence interval, 1.2 to 2.4) reduction in systolic BP and 1.1-mm Hg (95% confidence interval, 0.7 to 1.4) reduction in diastolic BP over 18 months. After additional adjustment for weight change over the same period, a reduction in SSB intake was still significantly associated with reductions in systolic and diastolic BPs (P<0.05). Reduced intake of sugars was also significantly associated with reduced BP. No association was found for diet beverage consumption or caffeine intake and BP. These findings suggest that sugars may be the nutrients that contribute to the observed association between SSB and BP. CONCLUSIONS: Reduced consumption of SSB and sugars was significantly associated with reduced BP. Reducing SSB and sugar consumption may be an important dietary strategy to lower BP. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00000616.