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BACKGROUND/OBJECTIVES: This protocol describes a study to investigate the feasibility and preliminary efficacy of a novel Teaching Kitchen Multisite Trial (TK-MT) for adults with cardiometabolic abnormalities. The TK-MT protocol describes a hybrid lifestyle intervention combining in-person and virtual instruction in culinary skills, nutrition education, movement, and mindfulness with community support and behavior change strategies. This 18-month-long randomized controlled trial aims to evaluate the feasibility of implementing a 12-month, 24 class program, assess preliminary study efficacy, and identify barriers and facilitators to implementation. METHODS: The intervention program includes 16 weeks of intensive hands-on culinary and lifestyle education classes followed by eight monthly virtual classes. Psychometric assessments and biometric data will be collected at baseline, 4, 12, and 18 months. Semi-structured interviews and open-ended surveys will be conducted during the 12-month follow-up assessment. RESULTS: Feasibility will be assessed through recruitment, attendance, and fidelity data. Secondary outcomes will analyze changes in health behaviors, biometric data, and anthropometric measures using mixed-effects regression models. Qualitative data will undergo thematic analysis. CONCLUSIONS: As envisioned and described in detail in this manuscript, this study will inform the development and implementation of reproducible, scalable teaching kitchen interventions. The protocol described here is intended to set the stage for future investigations to evaluate evidence for the impact of teaching kitchen interventions on dietary habits, physical activity, and overall health and well-being.

OBJECTIVES: The US Preventive Services Task Force recommends screening of adults aged 35-70 with a body mass index ≥25 kg/m2 for type 2 diabetes and referral of individuals who screen positive for pre-diabetes to evidence-based prevention strategies. The diabetes burden in the USA is predicted to triple by 2060 necessitating strategic diabetes prevention efforts, particularly in areas of highest need. This study aimed to identify pre-diabetes hotspots using geospatial mapping to inform targeted diabetes prevention strategies. A hotspot is defined as a cluster of 3 or more neighbouring census tracts with elevated pre-diabetes prevalence. DESIGN: A cross-sectional study using ArcGIS software to geospatially map pre-diabetes prevalence hotspots. We used health system and census data to identify pre-diabetes hotspots using a systematic five-step geoprocessing approach that made use of incremental spatial autocorrelation and Getis-Ord Gi*. SETTING: This study was set in Kaiser Permanente Northern California (KPNC), an integrated health delivery system with over four million members. PARTICIPANTS: KPNC adults ages 35-70 who underwent a haemoglobin A1c (HbA1c) or fasting plasma glucose (FPG) screening test in 2019 were mapped to census tracts in Northern California. People were considered to have pre-diabetes with an HbA1c of 5.7%-6.4% (39-46 mmol/mol) or FPG 100-125 mg/dL. PRIMARY AND SECONDARY OUTCOME MEASURES: Individual and census-level characteristics were compared between hotspots and non-hotspots using χ2 and Wilcoxon rank sum tests, as well as risk differences (RDs) and Hodges-Lehmann (HL) estimates of location shift. Individual-level characteristics were derived from electronic health records and administrative data, while census-level characteristics were derived from the 2019 American Community Survey. RESULTS: A total of 760 044 adults met the study inclusion criteria and 40% had pre-diabetes. Individuals in pre-diabetes hotspots were less likely to be non-Hispanic white (33.6% vs 50.6%, RD: -17.04%, 95% CI -17.26% to -16.81%, p

BACKGROUND: The University of Californias Diabetes Prevention Program (UC DPP) Initiative was implemented systemwide to address diabetes and obesity risk on all 10 campuses. As little is known about implementing lifestyle change programs in university settings, we examined implementation partners (i.e., UC DPP leaders and campus leads) perceptions of factors influencing program success on UC campuses. METHODS: We conducted qualitative interviews with UC DPP leaders and campus leads to examine challenges and opportunities with university-based DPP delivery models. Interviews were recorded, professionally transcribed, and reviewed in detail by the research team. Transcripts were analyzed using rapid qualitative analysis (RQA). The study was approved by the UCLA Institutional Review Board. All implementation partners provided verbal informed consent. RESULTS: Twenty-six implementation partners (8 UC DPP leaders and 18 campus leads) completed interviews in 2021. Seven themes were identified as critical for implementation, including (1) marketing and recruitment (i.e., market and recruit broadly through established channels as well as target at-risk populations); (2) enrollment (i.e., offer the program during convenient times and let participants know what to expect); (3) use an adaptable, evidence-based program; (4) secure funding for the program, participants, lifestyle coaches, and space; (5) hire experienced and dedicated staff and lifestyle coaches; (6) ensure leadership support; and (7) utilize campus linkages and resources. Perceptions of challenges faced with respect to these themes are also described. CONCLUSIONS: This is one of the first studies to examine the challenges and opportunities of delivering an intensive lifestyle change program across 10 university sites. Understanding factors that enhance success of university-based diabetes prevention programs can facilitate UC DPP efforts and help inform delivery strategies of health and wellness programs across other university settings more broadly.

BACKGROUND: Children and adolescents with type 1 diabetes require frequent outpatient evaluation to assess glucose trends, modify insulin doses, and screen for comorbidities. Continuous glucose monitoring (CGM) provides a detailed glycemic control assessment. Telemedicine has been increasingly used since the COVID-19 pandemic. OBJECTIVE: To investigate CGM profile parameter improvement immediately following pediatric outpatient diabetes visits and determine if visit modality impacted these metrics, completion of screening laboratory tests, or diabetic emergency occurrence. METHODS: A dual-center retrospective review of medical records assessed the CGM metrics time in range and glucose management indicator for pediatric outpatient diabetes visits during 2021. Baseline values were compared with those at 2 and 4 weeks post visit. Rates of completion of screening laboratory tests and diabetic emergencies following visits were determined. RESULTS: A total of 269 outpatient visits (41.2% telemedicine) were included. Mean time in range increased by 1.63% and 1.35% at 2 and 4 weeks post visit (P=.003 and .01, respectively). Mean glucose management indicator decreased by 0.07% and 0.06% at 2 and 4 weeks post visit (P=.003 and .02, respectively). These improvements in time in range and glucose management indicator were seen across both telemedicine visits and in-person visits without a significant difference. However, patients seen in person were 2.69 times more likely to complete screening laboratory tests (P=.03). Diabetic emergencies occurred too infrequently to analyze. CONCLUSIONS: Our findings demonstrate an immediate improvement in CGM metrics following outpatient visits, regardless of modality. While statistically significant, the magnitude of these changes was small; hence, multiple visits over time would be required to achieve clinically relevant improvement. However, completion of screening laboratory tests was found to be more likely after visits occurring in person. Therefore, we suggest a hybrid approach that allows patient convenience with telemedicine but also incorporates periodic in-person assessment.

INTRODUCTION: The University of California (UC) implemented the Diabetes Prevention Program (DPP) to address diabetes and obesity risk. This project examined the reach and effectiveness of this university-based DPP delivery approach. METHODS: This project compared 12-month weight change among three groups of UC beneficiaries with overweight/obesity: (1) those who received invitation letters and enrolled in UC DPP, (2) those mailed invitation letters but did not enroll, and (3) those who were not mailed letters and did not enroll (controls). Using 2012-2022 EHR, administrative and DPP cohort data, an interrupted time series was conducted in 2022-2023 to compare group differences in rate of weight change. RESULTS: Among 6,231 beneficiaries (132 UC DPP aware enrollees, 1,750 DPP aware non-enrollees, 4,349 controls), UC DPP enrollees were older (mean age 49), mostly women (76%), and more diverse (33% Asian, 8% Black, 20% Hispanic, 4% Multi/Other). Over 12 months of follow-up, UC DPP enrollee postenrollment rate of weight loss was -0.68 lbs./month. UC DPP enrollees had significantly greater weight change from pre- to post-enrollment than DPP aware non-enrollees (adjusted Δ-1.02 vs. Δ-0.07 lbs./month, difference= -0.95, p

OBJECTIVE: We sought to evaluate the risk of preterm labor and hypertensive disorders in adolescent pregnancies with and without diabetes. METHODS: We evaluated 1,843,139 adolescents (≤20 years old) with labor and delivery admissions in the national Kids Inpatient Database (KID) in years 2006, 2009, 2012, 2016, and 2019. International classification of disease codes was used to identify diabetes and medical factors affecting pregnancy. Weighted logistic regression was used to evaluate the association between diabetes and complications. RESULTS: Among admissions, 0.2% had type 1 diabetes (T1D), 0.2% had type 2 diabetes (T2D), and 0.7% had gestational diabetes (GDM); 10.1% of admissions were complicated by hypertensive disorders and 5.8% by preterm labor. Compared to adolescents without diabetes, those with diabetes had a higher prevalence of hypertensive disorders (T1D: 35.4%, T2D: 37.8%, GDM: 24.9%, None: 9.9%; p

BACKGROUND: The University of Californias Diabetes Prevention Program (UC DPP) Initiative was implemented across all 10 UC campuses in 2018. The COVID-19 pandemic and accompanying mandates required swift changes to program delivery, including pivoting from in-person to virtual delivery (i.e., Zoom). Our goal was to assess multilevel constituent perceptions of the use of a virtual platform to deliver UC DPP due to COVID-19 mandates. METHODS: We conducted qualitative interviews with 68 UC DPP participants, coordinators, and leaders to examine the use of virtual platform delivery on the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of UC DPP. Transcripts were analyzed using rapid qualitative analysis and emergent themes were categorized using domains corresponding to RE-AIM framework. RESULTS: Among UC DPP participants (n = 42), virtual delivery primarily impacted perceptions of UC DPP effectiveness and implementation. Some participants perceived program effectiveness to be negatively impacted, given their preference for in-person sessions, which they felt provided more engagement, peer support, and accountability. Implementation challenges included problems with virtual format (e.g., Zoom fatigue); however, several benefits were also noted (e.g., increased flexibility, maintenance of DPP connections during campus closures). UC DPP coordinators (n = 18) perceived virtual delivery as positively impacting UC DPP reach, since virtual platforms provided access for some who could not participate in-person, and negatively impacting effectiveness due to reduced engagement and lower peer support. UC leaders (n = 8) perceived that use of the virtual format had a positive impact on reach (e.g., increased availability, accessibility) and negatively impacted effectiveness (e.g., less intensive interactions on a virtual platform). Across constituent levels, the use of a virtual platform had little to no impact on perceptions of adoption and maintenance of UC DPP. CONCLUSION: Perceptions of the reach, effectiveness, and implementation of UC DPP using a virtual platform varied across constituents, although all groups noted a potential negative impact on overall program effectiveness. Unanticipated program adaptations, including virtual delivery, present potential benefits as well as perceived drawbacks, primarily across the effectiveness domain. Understanding differential constituent perceptions of the impact of virtual delivery can help maximize RE-AIM and inform future UC DPP delivery strategies.

ObjectiveWe conducted a cluster-randomized, shared decision-making (SDM) trial offering lifestyle change, metformin, or both options, to adults at risk for diabetes in a primary care network (n = 20 practices).Research design and methodsWe used propensity score matching to identify control patients and used electronic health record data to compare weight loss at 24 and 36 months of follow-up and diabetes incidence at 36 months of follow-up.ResultsIn adjusted post hoc analyses, SDM participants (n = 489) maintained modestly greater 24-month weight loss of -3.1 lb and 36-month weight loss of -2.7 lb versus controls (n = 1,430, both comparisons P < 0.001). SDM participants who chose both lifestyle change and metformin sustained weight loss at 36 months of -4.1 lb (P < 0.001 vs. controls). We found no differences in incident diabetes (15% of SDM participants, 14% of control participants; P = 0.64).ConclusionsThis is one of the first studies to demonstrate weight loss maintenance up to 36 months after diabetes prevention SDM.

BackgroundDiabetes prevention is a national goal and particularly important in the Veterans Health Administration (VHA) where 1 in 4 veterans has diabetes. There is growing evidence to support the use of Web-based diabetes prevention program (DPP) interventions, shown to be as effective and often more feasible than in-person interventions. ObjectiveOur primary objective was to qualitatively explore women veterans’ early experiences with a Web-based DPP intervention. Our secondary objective was to estimate weight loss, participation, and engagement to provide context for our qualitative findings. MethodsWe conducted and analyzed semistructured interviews and collected data on weight change, participation, and engagement. A total of 17 women veterans with prediabetes from a Midwest VA Women’s Health Clinic were eligible to participate; 15 completed interviews. ResultsParticipants perceived the DPP program as an appealing way of initiating lifestyle changes and made them feel accountable in achieving their daily goals. The online program was convenient because it could be accessed at any time, and many found that it integrated well into daily life. However, some did not like the logging aspect and some found it to be too impersonal. Participants logged in a mean 76 times, posted a mean 46 group messages, and sent a mean 20.5 private messages to the health coach over 16 weeks. Participants lost 5.24% of baseline weight, and 82% (14/17) of participants completed at least 9 of 16 core modules. ConclusionsWomen veterans’ early experiences with a Web-based DPP intervention were generally positive. Accountability and convenience were key enabling factors for participation and engagement. A Web-based DPP intervention appears to be a promising means of translating the DPP for women veterans with prediabetes.

BACKGROUND: The socioeconomic status (SES) gradient in hospital and emergency room utilization among adults with type 2 diabetes (T2DM) is partially driven by cost-related non-adherence. OBJECTIVE: To test the impact of the Diabetes Health Plan (DHP), a diabetes-specific health plan incorporating value-based insurance design principles on healthcare utilization among low-income adults with T2DM. DESIGN: To examine the impact of the DHP on healthcare utilization, we employed a difference-in-differences (DID) study design with a propensity-matched comparison group. We modeled count and dichotomous outcomes using Poisson and logit models, respectively. PARTICIPANTS: Cohort of adults (18-64) with T2DM, with an annual household income

Interventions to better coordinate care for high-need high-cost (HNHC) Medicaid patients frequently fail to demonstrate changes in hospitalizations or emergency department (ED) use. Many of these interventions are modeled after practice-level complex care management (CCM) programs. The authors hypothesized that a national CCM program may be effective for some subgroups of HNHC patients, and the overall null effect may obfuscate subgroup-level impact. They used a previously published typology defining 6 subgroups of high-cost Medicaid patients and evaluated program impact by subgroup. The analysis used an individual-level interrupted time series with a comparison group. Intervention subjects were high-cost adult Medicaid patients who enrolled in 1 of 2 national CCM programs implemented by UnitedHealthcare (UHC) (n = 39,687). The comparators were patients who met CCM program criteria but were ineligible due to current enrollment in another UHC/Optum led program (N = 26,359). The intervention was a CCM program developed by UHC/Optum to provide whole person care delivering standardized interventions to address medical, behavioral, and social needs for HNHC Medicaid patients, and the outcome was probability of hospitalization or ED use in a given month, estimated at 12 months postenrollment. A reduction in risk of ED utilization for 4 of 6 subgroups was found. A reduction in risk of hospitalization for 1 of 6 subgroups was also found. The authors conclude that standardized health plan led CCM programs demonstrate effectiveness for certain subgroups of HNHC patients in Medicaid. This effectiveness is principally in reducing ED risk and may extend to the risk of hospitalization for a small number of patients.

BackgroundGestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Metformin and lifestyle change through a Diabetes Prevention Program (DPP) are equally effective in preventing diabetes in patients with a GDM history, so women can choose a strategy based on their preferences. This study aims to test whether shared decision making (SDM) can help women with a history of GDM increase adoption of evidence-based strategies and lose weight to lower their risk of incident diabetes in real-world settings.MethodsThis pragmatic randomized controlled trial (RCT) will test the effectiveness of SDM for diabetes prevention among 310 overweight/obese women with a history of GDM and prediabetes from two large health care systems (n = 155 from UCLA Health and n = 155 from Intermountain Healthcare). The primary outcome is the proportion of participants who lose ≥5% body weight at 12 months. Secondary outcomes include uptake of DPP and/or metformin and other patient-reported outcomes such as patient activation and health-related quality of life. Rates of GDM in a subsequent pregnancy will be an exploratory outcome. A descriptive analysis of costs related to SDM implementation will also be conducted.ConclusionThis is the first RCT to examine the effectiveness of SDM on weight loss, lifestyle change and/or metformin use, and other patient-reported outcomes in participants with a GDM history at risk of developing diabetes.Trial registrationClinicalTrials.gov, NCT03766256. Registered on 6 December 2018.

ObjectiveTo test the impact of the Diabetes Health Plan (DHP), a diabetes-specific insurance plan that lowers out-of-pocket costs for diabetes-related medications and clinical visits, on adherence to oral hypoglycemic medications among low-income adults with Type 2 Diabetes (T2DM).Data sources and study settingCohort of adults (18-64) with T2DM, an annual household income Study designWe employed a linear regression Difference-In-Differences (DID) approach with a matched comparison group. To assess for differential DHP effects across adherent versus non-adherent patients, we ran a Difference-in-Difference-in-Differences (DDD) analysis by including an interaction term that included indicators for DHP exposure status and time, and low versus high baseline medication adherence.Data collectionThe analytic data set is limited to employer groups that purchased the DHP and standard benefit plans from UnitedHealthcare, had internal pharmacy contracts; complete pharmacy claims data, and sufficient medical claims and lab data to identify employees and their dependents with T2DM.Principal findingsOur DID analysis did not show improved medication adherence associated with employer DHP adoption. However, the DDD model suggested a difference between DHP-exposed and comparison beneficiaries when comparing the relative effect on individuals who were adherent versus non-adherent at baseline, as suggested by the significant three-way interaction term (10.2,p = 0.028). This effect was driven by the 8.2 percentage point increase in medication adherence for the DHP subsample that was non-adherent at baseline.ConclusionsThe DHP may benefit low-income patients with low baseline medication adherence. Value-based insurance design may be an important strategy for mitigating income disparities in T2DM outcomes.

BackgroundMany Diabetes Prevention Program (DPP) translation efforts have been less effective for underresourced populations. In the cluster-randomized Prediabetes Informed Decision and Education (PRIDE) trial, which evaluated a shared decision-making (SDM) intervention for diabetes prevention, Hispanic and non-Hispanic Black participants lost less weight than non-Hispanic White participants at 12-month follow-up.ObjectiveTo explore perspectives about weight loss from PRIDE participants of different racial and ethnic groups.ParticipantsSample of participants with prediabetes who were randomized to the PRIDE intervention arm (n=24).ApproachWe conducted semi-structured interviews within three groups stratified by DPP participation and % weight loss at 12 months: (DPP+/WL+, enrolled in DPP and lost >5% weight; DPP+/WL-, enrolled in DPP and lost

BackgroundType 2 diabetes can negatively impact long term health outcomes, healthcare costs and quality of life. However, intensive lifestyle interventions, including the Diabetes Prevention Program (DPP), can significantly lower risk of incident type 2 diabetes among overweight adults with prediabetes. Unfortunately, the majority of adults in the US who are at risk of developing diabetes do not engage in DPP-based lifestyle change programs. Increased adoption of evidence-based obesity and diabetes prevention interventions, such as the DPP, may help large employers reduce health risks and improve health outcomes among employees. In 2018, the University of California Office of thePresident (UCOP) implemented the UC DPP Initiative, a novel, multi-component program to address diabetes and obesity prevention across the UC system.MethodsThe goal of our study is to conduct a multifaceted evaluation of the UC DPP Initiative using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our evaluation will integrate unique and diverse UC data sources, including electronic health record (EHR) data, administrative claims, campus-based DPP cohort data, qualitative interviews and site visits. Our primary outcome of interest is the mean percent weight change among three groups of overweight/obese UC beneficiaries at risk for diabetes at 12-month follow-up. Secondary outcomes include mean percent weight change at 24-month follow-up, barriers and facilitators associated with implementatio, as well as  the degree of program adoption and maintenance.DiscussionOur study will help inform diabetes and obesity prevention efforts across the UC system. Findings from this evaluation will also be highly applicable to universities and large employers, as well as community organizers, healthcare organizations and insurers implementing the DPP and/or other health promotion interventions.

IntroductionWhile the Diabetes Prevention Program Study demonstrated that intensive lifestyle change and metformin both reduce type 2 diabetes incidence, there are little data on patient preferences in real-world, clinical settings.MethodsThe Prediabetes Informed Decisions and Education (PRIDE) study was a cluster-randomized trial of shared decision making (SDM) for diabetes prevention. In PRIDE, pharmacists engaged patients with prediabetes in SDM using a decision aid with information about both evidence-based options. We recorded which diabetes prevention option(s) participants chose after the SDM visit. We also evaluated logistic regression models examining predictors of choosing intensive lifestyle change ± metformin, compared to metformin or usual care, and predictors of choosing metformin ± intensive lifestyle change, compared to intensive lifestyle change or usual care.ResultsAmong PRIDE participants (n = 515), 55% chose intensive lifestyle change, 8.5% chose metformin, 15% chose both options, and 21.6% declined both options. Women (odds ratio [OR] = 1.60, P = 0.023) had higher odds than men of choosing intensive lifestyle change. Patients >60 years old (OR = 0.50, P = 0.028) had lower odds than patients

Military service presents unique challenges and opportunities for health care and public health. In the USA, there are over 2 million military servicemembers, 20 million veterans, and millions more military and veteran family members. Military servicemembers and eligible family members, many veterans, and retirees receive health care through the two largest learning health care systems in the USA, managed and delivered through the Departments of Defense (DoD), Veterans Affairs (VA), and contracted health care organizations. Through a network of collaborative relationships, DoD, VA, and partnering health care and research organizations (university, corporate, community, and government) accelerate research translation into best practices and policy across the USA and beyond. This article outlines military and veteran health research translation as summarized from a collaborative workshop led by experts across health care research, practice, and administration in DoD, VA, the National Institutes of Health, and affiliated universities. Key themes and recommendations for research translation are outlined in areas of: (a) stakeholder engagement and collaboration; (b) implementation science methods; and (c) funding along the translation continuum. Overall, the ability to rapidly translate research into clinical practice and policy for positive health outcomes requires collaborative relationships among many stakeholders. This includes servicemembers, veterans, and their families along with researchers, health care clinicians, and administrators, as well as policymakers and the broader population.

IntroductionTo examine the association of a novel disease-specific health plan, known as the Diabetes Health Plan (DHP), with emergency room (ER) and hospital utilization among patients with diabetes and pre-diabetes.Research design and methodsQuasi-experimental design, with employer group as the unit of analysis, comparing changes in any ER and inpatient hospital utilization over a 3-year period. Inverse probability weighting was used to control for differences between employers purchasing DHP versus standard plans. Estimated differences in utilization are calculated as average treatment effects on the treated. We used employees and dependents from employer groups contracting with a large, national private insurer between 2009 and 2012. Eligibility and claims data from continuously covered employees and dependents with diabetes and pre-diabetes (n=74 058) were aggregated to the employer level. The analysis included 9 DHP employers (n=7004) and 183 control employers (n=67 054).ResultsDHP purchase was associated with 2.4 and 1.8 percentage points absolute reduction in mean rates of any ER utilization, representing 13% and 10% relative reductions at 1 and 2 years post-DHP (p=0.012 and p=0.046, respectively). There was no significant association between DHP purchase and hospital utilization.ConclusionEmployers purchasing diabetes-specific health benefit designs may experience lower rates of resource-intensive services such as ER utilization.

Background: The Diabetes Prevention Program (DPP) showed that lifestyle change or metformin is equally efficacious in preventing diabetes in women who have had gestational diabetes mellitus (GDM). Few studies have investigated the relationship between education and willingness to engage in either intervention and between education and preferred decision-making style. Methods: Within a large health system, we surveyed insured women 18-64 years old with a history of GDM, identified through the electronic health record. We estimated preference for decision-making style and interest in DPP lifestyle change and/or metformin by educational level, using multivariate logistic regression models controlling for age, race, and ethnicity. Results: Our sample (n = 264) was 36% Latino, 29% Asian, 28% non-Latino white, and 5% African American, with a mean age of 37 years. In terms of education, 31% had a postgraduate degree, 41% were college graduates, and 29% did not graduate from college. In multivariate analyses, willingness to engage in either intervention did not vary by education. Women who did not graduate from college were more likely to leave medical decisions to their provider (p = 0.004) compared to women with a college or postgraduate degree. However, regardless of education, over 80% of women preferred to make medical decisions themselves or jointly with their provider. Conclusions: Most women prefer to play an active role in their own medical decisions and have an interest in both evidence-based diabetes prevention strategies. This suggests that shared decision-making is appropriate for many women with a history of GDM and different levels of educational attainment.

BackgroundPatient activation is associated with better outcomes in chronic conditions.ObjectiveWe evaluated the psychometric properties of the 12-item Altarum Consumer Engagement™ Measure (ACE-12) in patients with prediabetes.ParticipantsACE-12 was administered to patients in the Prediabetes Informed Decisions and Education Study.Main measuresWe conducted an exploratory factor analysis followed by confirmatory factor analytic models. We evaluated item response categories using item characteristic curves. Construct validity was assessed by examining correlations of the ACE-12 scales with education, depressive symptoms, self-rated health, hemoglobin A1c, body mass index, and weight loss.Key resultsParticipants (n = 515) had a median age of 58; 56% were female; 17% Hispanic; 54% were non-White. The scree plot and Tucker and Lewis reliability coefficient (0.95) suggested three factors similar to the original scales. One item loaded on the navigation rather than the informed choice scale. Ordinal alpha coefficients for the original scales were commitment (0.75); informed choice (0.71); and navigation (0.54). ICCs indicated that one or more of the response categories for 5 of the 12 items were never most likely to be selected. Patients with lower education were less activated on the commitment (r = - 0.124, p = 0.004), choice (r = - 0.085, p = 0.009), and overall score (r = - 0.042, p = 0.011). Patients with depressive symptoms had lower commitment (r = - 0.313, p ≤ 0.001) and overall scores (r = - 0.172, p = 0.012). Patients with poorer health scored lower on the Commitment (r = - 0.308, p ≤ 0.001), Navigation (r = - 0.137, p ≤ 0.001), and overall score (r = - 0.279, p ≤ 0.001).ConclusionThe analyses provide some support for the psychometric properties of the ACE-12 in prediabetic patients. Future research evaluating this tool among patients with other chronic conditions are needed to determine whether Q1 (I spend a lot of time learning about health) should remain in the informed choice or be included in the navigation scale. Additional items may be needed to yield acceptable reliability for the navigation scale.

ObjectiveDiabetes that develops in human immunodeficiency virus-infected individuals is typically classified as type 2 diabetes mellitus. Although less commonly reported, it has been shown that autoimmune diabetes can also develop in this population.MethodsWe present a case of a patient found to have autoimmune diabetes following initiation of anti-retroviral therapy.ResultsA 68-year-old, African American man with human immunodeficiency virus had a nadir CD4 count of 2 cells/μL, which improved with anti-retroviral therapy. He was subsequently diagnosed with type 2 diabetes mellitus but developed worsening glycemic control. Further investigation demonstrated an elevated glutamic acid decarboxylase antibody level >250 IU/mL and a declining C peptide level from 1.82 ng/mL to 0.56 ng/mL. He was ultimately diagnosed with autoimmune diabetes that was treated with insulin glargine and insulin aspart with improvement in his glycemic control.ConclusionAutoimmune diabetes in this case was attributed to immune reconstitution after anti-retroviral therapy led to recovery from a significantly low CD4 count. While this phenomenon has been described in previous case reports, our case was unique in that autoimmune diabetes affected an older African American man, a different demographic than previously reported. Although the true mechanism of this association remains unknown, the recognition of autoimmune diabetes is crucial as it greatly impacts diabetes management.

Prediabetes affects one-third of U.S. adults. Lifestyle change interventions, such as the Diabetes Prevention Program (DPP), can significantly lower type 2 diabetes risk, but little is known about how the DPP could be best adapted for women. This mixed-methods study assessed the impact of gender-tailoring and modality choice on DPP engagement among women Veterans with prediabetes. Participants were offered women-only groups and either in-person/peer-led or online modalities. Implementation outcomes were assessed using attendance logs, recruitment calls, and semi-structured interviews about patient preferences. Between June 2016 and March 2017, 119 women Veterans enrolled in the DPP (n = 51 in-person, n = 68 online). We conducted 22 interviews between August and September 2016 (n = 10 early-implementation) and March and July 2017 (n = 12 follow-up). Most interviewees preferred women-only groups, citing increased comfort, camaraderie, and mutual understanding of gender-specific barriers to lifestyle change. More women preferred online DPP, and those using this modality participated at higher rates. Most endorsed the importance of modality choice and were satisfied with their selection; however, selection was frequently based on participants' personal circumstances and access barriers and not on a "preferred choice" of two equally accessible options. Patient engagement and program reach can be expanded by tailoring the DPP for population-specific needs.

BACKGROUND: Medical, behavioral, and social determinants of health are each associated with high levels of emergency department (ED) visits and hospitalizations. OBJECTIVE: The objective of this study was to evaluate a care coordination program designed to provide combined whole-person care, integrating medical, behavioral, and social support for high-cost, high-need Medicaid beneficiaries by targeting access barriers and social determinants. RESEARCH DESIGN: Individual-level interrupted time series with a comparator group, using person-month as the unit of analysis. SUBJECTS: A total of 42,214 UnitedHealthcare Medicaid beneficiaries (194,834 person-months) age 21 years or above with diabetes, with Temporary Assistance to Needy Families, Medicaid expansion, Supplemental Security Income without Medicare, or dual Medicaid/Medicare. MEASURES: Our outcome measures were any hospitalizations and any ED visits in a given month. Covariates of interest included an indicator for intervention versus comparator group and indicator and spline variables measuring changes in an outcomes time trend after program enrollment. RESULTS: Overall, 6 of the 8 examined comparisons were not statistically significant. Among Supplemental Security Income beneficiaries, we observed a larger projected decrease in ED visit risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -6.6%; 95% confidence interval: -11.2%, -2.1%). Among expansion beneficiaries, we observed a greater decrease in hospitalization risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -5.8%; 95% confidence interval: -11.4%, -0.2%). CONCLUSION: A care coordination program designed to reduce utilization among high-cost, high-need Medicaid beneficiaries was associated with fewer ED visits and hospitalizations for patients with diabetes in selected Medicaid programs but not others.

BACKGROUND/OBJECTIVES: Medicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices. RESEARCH DESIGN: Interrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible]. SUBJECTS/MEASURES: Eligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation. RESULTS: Analyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories. CONCLUSIONS: Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.

Background/objectivesMedicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices.Research designInterrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible].Subjects/measuresEligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation.ResultsAnalyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories.ConclusionsMedicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.

BackgroundMedical, behavioral, and social determinants of health are each associated with high levels of emergency department (ED) visits and hospitalizations.ObjectiveThe objective of this study was to evaluate a care coordination program designed to provide combined "whole-person care," integrating medical, behavioral, and social support for high-cost, high-need Medicaid beneficiaries by targeting access barriers and social determinants.Research designIndividual-level interrupted time series with a comparator group, using person-month as the unit of analysis.SubjectsA total of 42,214 UnitedHealthcare Medicaid beneficiaries (194,834 person-months) age 21 years or above with diabetes, with Temporary Assistance to Needy Families, Medicaid expansion, Supplemental Security Income without Medicare, or dual Medicaid/Medicare.MeasuresOur outcome measures were any hospitalizations and any ED visits in a given month. Covariates of interest included an indicator for intervention versus comparator group and indicator and spline variables measuring changes in an outcome's time trend after program enrollment.ResultsOverall, 6 of the 8 examined comparisons were not statistically significant. Among Supplemental Security Income beneficiaries, we observed a larger projected decrease in ED visit risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -6.6%; 95% confidence interval: -11.2%, -2.1%). Among expansion beneficiaries, we observed a greater decrease in hospitalization risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -5.8%; 95% confidence interval: -11.4%, -0.2%).ConclusionA care coordination program designed to reduce utilization among high-cost, high-need Medicaid beneficiaries was associated with fewer ED visits and hospitalizations for patients with diabetes in selected Medicaid programs but not others.

BackgroundPre-diabetes affects one-third of adults in the USA and a subset will progress to type 2 diabetes. Our objective was to determine whether a disease-specific health plan, known as the Diabetes Health Plan (DHP), designed to improve care for persons with pre-diabetes and diabetes also led to lower rates of incident diabetes among adults with pre-diabetes.MethodsWe examined eligibility and claims data from a large payer who offered the DHP to a national sample of employers. We included adult employees and dependents who were continuously covered by the DHP over a 4-year study window. The primary outcome was incident diabetes. We conducted propensity score matching at the employer level to find comparable control employer groups offering standard plans. Using an adjusted logistic regression model at the individual level, we tested the association between DHP employer group status and incident diabetes diagnosis during the 3 years of postbaseline follow-up.FindingsOur analysis included data from 11 965 continuously enrolled adults with pre-diabetes (n=1538 from nine employers offering DHP; n=10 427 from 105 control employers offering standard plans). DHP employees and covered dependents with pre-diabetes had an 8% lower absolute predicted probability of incident diabetes compared with individuals from employer groups offering standard benefit plans (29% predicted probability of incident diabetes for DHP vs 37% for controls, p

BackgroundChronic kidney disease (CKD) is a global public health problem, exhibiting sharp increases in incidence, prevalence, and attributable morbidity and mortality. There is a critical need to better understand the demographics, clinical characteristics, and key risk factors for CKD; and to develop platforms for testing novel interventions to improve modifiable risk factors, particularly for the CKD patients with a rapid decline in kidney function.MethodsWe describe a novel collaboration between two large healthcare systems (Providence St. Joseph Health and University of California, Los Angeles Health) supported by leadership from both institutions, which was created to develop harmonized cohorts of patients with CKD or those at increased risk for CKD (hypertension/HTN, diabetes/DM, pre-diabetes) from electronic health record data.ResultsThe combined repository of candidate records included more than 3.3 million patients with at least a single qualifying measure for CKD and/or at-risk for CKD. The CURE-CKD registry includes over 2.6 million patients with and/or at-risk for CKD identified by stricter guide-line based criteria using a combination of administrative encounter codes, physical examinations, laboratory values and medication use. Notably, data based on race/ethnicity and geography in part, will enable robust analyses to study traditionally disadvantaged or marginalized patients not typically included in clinical trials.DiscussionCURE-CKD project is a unique multidisciplinary collaboration between nephrologists, endocrinologists, primary care physicians with health services research skills, health economists, and those with expertise in statistics, bio-informatics and machine learning. The CURE-CKD registry uses curated observations from real-world settings across two large healthcare systems and has great potential to provide important contributions for healthcare and for improving clinical outcomes in patients with and at-risk for CKD.

The Diabetes Prevention Program (DPP) is a 12-month behavior change program designed to increase physical activity and improve dietary patterns among patients at risk for Type 2 diabetes, in order to facilitate modest weight loss and improve cardio-metabolic profiles. It is unknown whether baseline patient activation is related to increased DPP uptake, and whether DPP attendance leads to subsequent improvement in patient activation. We analyzed data from 352 adult participants in the Prediabetes Informed Decisions and Education (PRIDE) trial of shared decision-making (SDM) in diabetes prevention, collected from November 2015 through September 2017. PRIDE participants completed baseline and 4-month follow-up surveys, including the Altarum Consumer Engagement (ACE) Measure™ of patient activation. We tracked DPP attendance over 8 months using data from partnering DPP providers. In multivariate models, we measured whether self-reported baseline activation was associated with DPP "uptake" (1+ session attended) or DPP "attendance" (9+ sessions). We also examined whether DPP attendance was associated with change in activation at 4-months follow-up. We did not find an association between baseline activation and DPP uptake or attendance. However, we did find that DPP attendance was associated with an increase in the overall ACE score (6.68 points, 95% CI 1.97-11.39, p = 0.005) and increased activation in 2 of the 3 ACE subscales (Commitment and Informed Choice). Our finding of increased patient activation with DPP attendance suggests a mechanism for the improved health outcomes seen in DPP real-world translational studies. This work has important implications for diabetes prevention and other behavior change programs.

The Diabetes Prevention Program (DPP) is a 12-month behavior change program designed to increase physical activity and improve dietary patterns among patients at risk for Type 2 diabetes, in order to facilitate modest weight loss and improve cardio-metabolic profiles. It is unknown whether baseline patient activation is related to increased DPP uptake, and whether DPP attendance leads to subsequent improvement in patient activation. We analyzed data from 352 adult participants in the Prediabetes Informed Decisions and Education (PRIDE) trial of shared decision-making (SDM) in diabetes prevention, collected from November 2015 through September 2017. PRIDE participants completed baseline and 4-month follow-up surveys, including the Altarum Consumer Engagement (ACE) Measure™ of patient activation. We tracked DPP attendance over 8 months using data from partnering DPP providers. In multivariate models, we measured whether self-reported baseline activation was associated with DPP "uptake" (1+ session attended) or DPP "attendance" (9+ sessions). We also examined whether DPP attendance was associated with change in activation at 4-months follow-up. We did not find an association between baseline activation and DPP uptake or attendance. However, we did find that DPP attendance was associated with an increase in the overall ACE score (6.68 points, 95% CI 1.97-11.39, p = 0.005) and increased activation in 2 of the 3 ACE subscales (Commitment and Informed Choice). Our finding of increased patient activation with DPP attendance suggests a mechanism for the improved health outcomes seen in DPP real-world translational studies. This work has important implications for diabetes prevention and other behavior change programs.

ImportanceIntensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.ObjectiveTo test the effectiveness of a prediabetes SDM intervention.DesignCluster randomized controlled trial.SettingTwenty primary care clinics within a large regional health system.ParticipantsOverweight/obese adults with prediabetes (BMI ≥ 24 kg/m2 and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.InterventionIntervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care.Main outcomes and measuresPrimary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months.ResultsUptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p

IN BRIEF This review highlights examples of the translation of the Diabetes Prevention Program (DPP) to underserved populations. Here, underserved populations are defined as groups whose members are at greater risk for health conditions such as diabetes but often face barriers accessing treatment. Strategies to develop and evaluate future DPP translations are discussed.

Sodium‐glucose cotransporter‐2 inhibitors (SGLT2i) and glucagon‐Like peptide‐1 receptor agonists (GLP‐1 RA) are recommended in people with type 2 diabetes (T2D) for glycaemic control and for people with high cardiovascular risk. However, current guidelines do not specifically address the role of initial early combination therapy with SGLT2i and GLP‐1 RA or dual gastric inhibitory polypeptide (GIP)/GLP‐1 RA, but rather sequential initiation with either in T2D. This review synthesizes the available evidence on the use of SGLT2i and GLP‐1‐based therapies for T2D and provides a rationale for their combination. The combination of SGLT2i with GLP‐1‐based therapies addresses complementary pathophysiological mechanisms and enhances efficacy in achieving target haemoglobin A1C (HbA1c) levels. SGLT2i and GLP‐1 RA also have been shown to prevent complications of T2D. While both classes reduce adverse cardiorenal events, SGLT2i has a predominant effect on prevention of kidney dysfunction and heart failure, whereas GLP‐1 RA has a more marked effect on the risk of atherosclerotic cardiovascular disease. Both drug classes have favourable safety profiles. Finally, weight loss with combination therapy may have disease‐modifying effects that may reverse T2D progression. We propose that the combination of SGLT2i with GLP‐1 RA or dual GIP/GLP‐1 RA should be considered for most patients with T2D who do not have contraindications. [ABSTRACT FROM AUTHOR]

Objectives: To describe the impacts of four Veterans Health Administration (VA) Quality Enhancement Research Initiative (QUERI) projects implementing an evidence‐based lifestyle intervention known as the Diabetes Prevention Program (DPP). Data Sources and Study Setting: 2012–2024 VA administrative and survey data. Study Design: This is a summary of findings and impacts from four effectiveness‐implementation projects focused on in‐person and/or online DPP across VA sites. Data Collection/Extraction Methods: Patient demographics, participation data, and key findings and impacts were summarized across reports from the VA Diabetes‐Mellitus Quality Enhancement Research Initiative (QUERI‐DM) Diabetes Prevention Program (VA DPP) Trial, QUERI‐DM Online DPP Trial, the Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER) QUERI DPP Project, and EMPOWER 2.0 QUERI Program. Principal Findings: Between 2012 and 2024, four VA QUERI studies enrolled 963 Veterans in DPP across 16 VA sites. All participants had overweight/obesity with one additional risk factor for type 2 diabetes (i.e., prediabetes, elevated risk score, or history of gestational diabetes) and 56% (N = 536) were women. In addition to enhancing the reach of and engagement in diabetes prevention services among Veterans, these projects resulted in three key impacts as follows: (1) informing the national redesign of VA MOVE! including recommendations to increase the number of MOVE! sessions and revise guidelines across 150+ VA sites, (2) enhancing the national evidence base to support online DPP delivery options with citations in national care guidelines outside VA, and (3) demonstrating the importance of gender‐tailoring of preventive care services by and for women Veterans to enhance engagement in preventive services. Conclusions: Over the past decade, the evolution of VA QUERI DPP projects increased the reach of and engagement in diabetes prevention services among Veterans, including women Veterans who have been harder to engage in lifestyle change programs in VA, and resulted in three key impacts informing type 2 diabetes and obesity prevention efforts within and outside of VA. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine the associations of energy intake and glycemic load (GL) in different time periods during the day with cardiovascular disease (CVD) mortality risk in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS: This cohort study included 2,911 adults with diabetes from who were part of the U.S. National Health and Nutrition Examination Survey 2003–2014 (baseline), and CVD mortality data obtained by linkage to the National Death Index through 2019. Energy intake and GL in early morning (6:00–7:59 a.m.), late morning (8:00–10:59 a.m.), afternoon (11:00 a.m.–5:59 p.m.), evening (6:00–11:59 p.m.), and night (0:00–5:59 a.m.) were derived from two 24-h dietary recalls at baseline. Cox models were used to estimate hazard ratios (HRs) for CVD mortality, adjusted for total energy intake, diet quality, sociodemographic and lifestyle characteristics, and medical conditions. RESULTS: At baseline, the study population (51.8% female, 62.3% non-Hispanic White) had a mean age of 57.4 (SE, 0.4) years. Over a median follow-up of 9.3 (interquartile range = 6.8, 12.1) years, 190 CVD deaths were documented. Energy intake and GL in late morning were inversely associated with CVD mortality risk (per 100-kcal energy intake increment, HR 0.90 [95% CI 0.83–0.98]; per 10-unit GL increment, HR 0.86 [95% CI 0.77–0.95]). In contrast, energy intake and GL at night were positively associated with CVD mortality risk (per 100-kcal energy intake increment, HR 1.22 [95% CI 1.07–1.40]; per 10-unit GL increment, HR 1.44 [95% CI 1.17–1.77]). CONCLUSIONS: For adults with type 2 diabetes, late morning may be a protective eating time against CVD mortality, whereas night may be a detrimental eating time. [ABSTRACT FROM AUTHOR]

ObjectiveTo investigate whether older veterans enrolled in two diabetes prevention programs (DPPs) in the Veterans Health Administration will have similar weight loss as younger veterans.Research design and methodsPost hoc analysis of data from two prospective, pragmatic, nonrandomized studies of behavioral weight management interventions that were delivered in-person (Department of Veterans Affairs [VA]-DPP) or online (Online-DPP), comparing participation and weight loss between participants aged ≥65 years (N = 120) vs. 0.05).ConclusionsDPPs delivered in person or online can be similarly effective in older and younger veterans. Online programs may be an important means to improve the reach of DPPs for older adults.

BackgroundEthnography has been proposed as a valuable method for understanding how implementation occurs within dynamic healthcare contexts, yet this method can be time-intensive and challenging to operationalize in pragmatic implementation. The current study describes an ethnographically-informed method of guided discussions developed for use by a multi-project national implementation program.MethodsThe EMPOWER QUERI is conducting three projects to implement innovative care models in VA women's health for high-priority health concerns - prediabetes, cardiovascular risk, and mental health - utilizing the Replicating Effective Programs (REP) implementation strategy enhanced with stakeholder engagement and complexity science. Drawing on tenets of ethnographic research, we developed a lightly-structured method of guided "periodic reflections" to aid in documenting implementation phenomena over time. Reflections are completed as 30-60 min telephone discussions with implementation team members at monthly or bi-monthly intervals, led by a member of the implementation core. Discussion notes are coded to reflect key domains of interest and emergent themes, and can be analyzed singly or in triangulation with other qualitative and quantitative assessments to inform evaluation and implementation activities.ResultsThirty structured reflections were completed across the three projects during a 15-month period spanning pre-implementation, implementation, and sustainment activities. Reflections provide detailed, near-real-time information on projects' dynamic implementation context, including characteristics of implementation settings and changes in the local or national environment, adaptations to the intervention and implementation plan, and implementation team sensemaking and learning. Reflections also provide an opportunity for implementation teams to engage in recurring reflection and problem-solving.ConclusionsTo implement new, complex interventions into dynamic organizations, we must better understand the implementation process as it unfolds in real time. Ethnography is well suited to this task, but few approaches exist to aid in integrating ethnographic insights into implementation research. Periodic reflections show potential as a straightforward and low-burden method for documenting events across the life cycle of an implementation effort. They offer an effective means for capturing information on context, unfolding process and sensemaking, unexpected events, and diverse viewpoints, illustrating their value for use as part of an ethnographically-minded implementation approach.Trial registrationThe two implementation research studies described in this article have been registered as required: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (NCT02991534); and Implementation of Tailored Collaborative Care for Women Veterans (NCT02950961).

IntroductionOnline Diabetes Prevention Programs (DPPs) can be scaled up and delivered broadly. However, little is known about real-world effectiveness and how outcomes compare with in-person DPP. This study examined online DPP weight loss and participation outcomes and secondarily compared outcomes among participating individuals with parallel in-person interventions.Study designA large non-randomized trial supplemented by a comparative analysis of participating individuals from a concurrent trial of two parallel in-person programs: in-person DPP and the Veterans Administration's standard of care weight loss program (MOVE!).Setting/participantsObese/overweight Veterans with prediabetes enrolled in online DPP (n = 268) between 2013 and 2014. Similar eligibility criteria were used to enroll in-person participants between 2012 and 2014 (n = 273 in-person DPP, n = 114 MOVE!) within a separate trial.InterventionOnline DPP included a virtual group format, live e-coach, weekly modules delivered asynchronously, and wireless home scales. In-person programs included eight to 22 group-based, face-to-face sessions.Main outcomes measuresWeight change at 6 and 12 months using wirelessly uploaded home scale data or electronic medical record weights from clinical in-person visits. Outcomes were analyzed between 2015 and 2017.ResultsFrom 1,182 invitations, 268 (23%) participants enrolled in online DPP. Among these, 158 (56%) completed eight or more modules; mean weight change was -4.7kg at 6 months and -4.0kg at 12 months. In a supplemental analysis of participants completing one or more sessions/modules, online DPP participants were most likely to complete eight or more sessions/modules (87% online DPP vs 59% in-person DPP vs 55% MOVE!, p

ContextPrediabetes is prevalent and significantly increases lifetime risk of progression to type 2 diabetes. This review summarizes the evidence surrounding metformin use for type 2 diabetes prevention.Evidence acquisitionArticles published between 1998 and 2017 examining metformin use for the primary indication of diabetes prevention available on MEDLINE.Evidence synthesisForty articles met inclusion criteria and were summarized into four general categories: (1) RCTs of metformin use for diabetes prevention (n=7 and n=2 follow-up analyses); (2) observational analyses examining metformin use in heterogeneous subgroups of patients with prediabetes (n=9 from the Diabetes Prevention Program, n=1 from the biguanides and the prevention of the risk of obesity [BIGPRO] trial); (3) observational analyses examining cost effectiveness of metformin use for diabetes prevention (n=11 from the Diabetes Prevention Program, n=1 from the Indian Diabetes Prevention Program); and (4) real-world assessments of metformin eligibility or use for diabetes prevention (n=9). Metformin was associated with reduced relative risk of incident diabetes, with the strongest evidence for use in those at highest risk (i.e., aged

ObjectivesMental illness may impact outcomes from structured behavioral weight loss interventions. This secondary analysis investigated the influence of mental health on weight loss among Veterans with prediabetes enrolled in either an in-person diabetes prevention program (DPP) or the usual care weight management program (MOVE!) designed to help patients achieve weight loss through changes in physical activity and diet.MethodsPrediabetes was defined by Hemoglobin A1c between 5.7 and 6.4% or Fasting Plasma Glucose 100-125 mg/dL and no use of antiglycemic medications during the past six months. Veterans Health Administrative data were used to assign Veterans into one of three mental health diagnoses: severe mental illness (SMI), affective disorder (AD) without SMI, or No SMI/No AD. The influence of mental health on weight changes at 6 and 12 months was modeled using linear mixed-effects regression.ResultsOn average, Veterans with prediabetes (n = 386) were 59 years old (SD = 10.0 years), with a BMI of 34.8 kg/m2 (SD = 5.3 kg/m2) and A1c of 6.0% (SD = 0.2%). The sample consisted of 12% (n = 47), 39% (n = 150), and 49% (n = 189) diagnosed with SMI, AD and No SMI/No AD, respectively. Across interventions, Veterans with SMI lost less weight than those with AD or No SMI/No AD. From baseline to 6 months, weight loss was significantly less for Veterans with SMI (1.53 kg) compared to Veterans with AD (3.85 kg) or No SMI/No AD (3.73 kg). This weight loss trend by mental health diagnosis continued from baseline to 12 months but was no longer statistically significant at 12 months.ConclusionWeight loss was not clinically or statistically different among Veterans with prediabetes diagnosed with AD or No SMI/No AD. However, Veterans diagnosed with SMI exhibited less weight loss over 6 months than Veterans with AD or No SMI/No AD and though not statistically significant, the trend continued to 12 months, suggesting that SMI may influence weight loss outcomes.

IntroductionGreater specification of implementation strategies is a challenge for implementation science, but there is little guidance for delineating the use of multiple strategies involved in complex interventions. The Cardiovascular (CV) Toolkit project entails implementation of a toolkit designed to reduce CV risk by increasing women's engagement in appropriate services. The CV Toolkit project follows an enhanced version of Replicating Effective Programs (REP), an evidence-based implementation strategy, to implement the CV Toolkit across four phases: pre-conditions, pre-implementation, implementation, and maintenance and evolution. Our current objective is to describe a method for mapping implementation strategies used in real time as part of the CV Toolkit project. This method supports description of the timing and content of bundled strategies and provides a structured process for developing a plan for implementation evaluation.MethodsWe conducted a process of strategy mapping to apply Proctor and colleagues' rubric for specification of implementation strategies, constructing a matrix in which we identified each implementation strategy, its conceptual group, and the corresponding REP phase(s) in which it occurs. For each strategy, we also specified the actors involved, actions undertaken, action targets, dose of the implementation strategy, and anticipated outcome addressed. We iteratively refined the matrix with the implementation team, including use of simulation to provide initial validation.ResultsMapping revealed patterns in the timing of implementation strategies within REP phases. Most implementation strategies involving the development of stakeholder interrelationships and training and educating stakeholders were introduced during the pre-conditions or pre-implementation phases. Strategies introduced in the maintenance and evolution phase emphasized communication, re-examination, and audit and feedback. In addition to its value for producing valid and reliable process evaluation data, mapping implementation strategies has informed development of a pragmatic blueprint for implementation and longitudinal analyses and evaluation activities.DiscussionWe update recent recommendations on specification of implementation strategies by considering the implications for multi-strategy frameworks and propose an approach for mapping the use of implementation strategies within complex, multi-level interventions, in support of rigorous evaluation. Developing pragmatic tools to aid in operationalizing the conduct of implementation and evaluation activities is essential to enacting sound implementation research.

BackgroundThe Diabetes Prevention Program (DPP) is an effective lifestyle intervention to reduce incidence of type 2 diabetes. However, there are gaps in knowledge about how to implement DPP. The aim of this study was to evaluate implementation of DPP via assessment of a clinical demonstration in the Veterans Health Administration (VHA).MethodsA 12-month pragmatic clinical trial compared weight outcomes between the Veterans Affairs Diabetes Prevention Program (VA-DPP) and the usual care MOVE!® weight management program (MOVE!). Eligible participants had a body mass index (BMI) ≥30 kg/m2 (or BMI ≥ 25 kg/m2 with one obesity-related condition), prediabetes (glycosylated hemoglobin (HbA1c) 5.7-6.5% or fasting plasma glucose (FPG) 100-125 mg/dL), lived within 60 min of their VA site, and had not participated in a weight management program within the last year. Established evaluation and implementation frameworks were used to guide the implementation evaluation. Implementation barriers and facilitators, delivery fidelity, participant satisfaction, and implementation costs were assessed. Using micro-costing methods, costs for assessment of eligibility and scheduling and maintaining adherence per participant, as well as cost of delivery per session, were also assessed.ResultsSeveral barriers and facilitators to Reach, Adoption, Implementation, Effectiveness and Maintenance were identified; barriers related to Reach were the largest challenge encountered by site teams. Fidelity was higher for VA-DPP delivery compared to MOVE! for five of seven domains assessed. Participant satisfaction was high in both programs, but higher in VA-DPP for most items. Based on micro-costing methods, cost of assessment for eligibility was $68/individual assessed, cost of scheduling and maintaining adherence was $328/participant, and cost of delivery was $101/session.ConclusionsMulti-faceted strategies are needed to reach targeted participants and successfully implement DPP. Costs for assessing patients for eligibility need to be carefully considered while still maximizing reach to the targeted population.