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.

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.

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.

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.

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.

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.

Retrospective cohort study of changes in estimated glomerular filtration rate for patients prescribed a low carb diet.

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.

Association of Provider Perspectives on Race and Racial Health Care Disparities with Patient Perceptions of Care and Health Outcomes.

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.

Racial differences in patient perception of interactions with providers are associated with health outcomes in type II diabetes.

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.

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.

Women Veterans Experience with the VA MOVE! Weight Management Program.

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.

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.

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.

Effectiveness of an App and Provider Counseling for Obesity Treatment in Primary Care.

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.

The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial.

BACKGROUND: Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies. OBJECTIVE: This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement. METHODS: The CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%). RESULTS: Data from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=-.213; personal coaching: r=-.319), number of apps use per day (cell phone: r=-.264; personal coaching: r=-.308), and percentage of days self-weighed (cell phone: r=-.297; personal coaching: r=-.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement. CONCLUSIONS: Engagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X).

Outcome by Gender in the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere Weight Management Program.

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/m2) compared with men (BMI >25 kg/m2; 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.