Program ACTIVE II: 6- and 12-month outcomes of a treatment approach for major depressive disorder in adults with type 2 diabetes.

AIMS: To evaluate the long-term effects of behavioral treatments on glycemic and psychological outcomes for patients with major depressive disorder (MDD) and type 2 diabetes (T2D). METHODS: Program ACTIVE II was a multicenter randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), exercise (EXER), combination treatment (CBT + EXER) and usual care (UC) for adults with MDD and T2D. RESULTS: Primary outcomes: change in A1c and depressive symptoms at 6- (N = 87) and 12-months (N = 75) from baseline. In those with a baseline A1c ≥7.0 %, CBT + EXER showed lasting A1c benefit at 6- (-1.2 %; SE: 0.6; p = 0.032) and 12-months (-1.4 %; SE: 0.6; p = 0.025) compared to UC. All groups had clinically significant improvements in depressive symptoms. At 6 months, CBT + EXER had significant improvements in diabetes-related distress regimen burden (p = 0.005); and social support (CIRS, p = 0.043) compared to UC. CONCLUSIONS: The Program ACTIVE II CBT + EXER intervention demonstrated a sustained improvement in A1c for a subgroup of study participants with a baseline A1c ≥7.0 %. However, this finding should be considered preliminary because of small sample size. All 3 behavioral intervention groups demonstrated improvements in psychosocial outcomes one-year post-intervention. These findings point to the enduring benefits of community-based interventions to extend the availability of depression treatment for T2D patients.

Bringing an end to diabetes stigma and discrimination: an international consensus statement on evidence and recommendations.

People with diabetes often encounter stigma (ie, negative social judgments, stereotypes, prejudice), which can adversely affect emotional, mental, and physical health; self-care, access to optimal health care; and social and professional opportunities. To accelerate an end to diabetes stigma and discrimination, an international multidisciplinary expert panel (n=51 members, from 18 countries) conducted rapid reviews and participated in a three-round Delphi survey process. We achieved consensus on 25 statements of evidence and 24 statements of recommendations. The consensus is that diabetes stigma is driven primarily by blame, perceptions of burden or sickness, invisibility, and fear or disgust. On average, four in five adults with diabetes experience diabetes stigma and one in five experience discrimination (ie, unfair and prejudicial treatment) due to diabetes, such as in health care, education, and employment. Diabetes stigma and discrimination are harmful, unacceptable, unethical, and counterproductive. Collective leadership is needed to proactively challenge, and bring an end to, diabetes stigma and discrimination. Consequently, we achieved unanimous consensus on a pledge to end diabetes stigma and discrimination.

Associations between Outpatient Laboratory Test Age and Healthcare Utilization in Type 2 Diabetes Care.

Purpose: To examine the longitudinal relationship between the age or shelf-life of common type 2 diabetes laboratory tests for serum creatinine, cholesterol, and glycated hemoglobin A1c conducted in outpatient settings and subsequent inpatient hospitalizations and emergency department visits. Methods: This study analyzes panel data from two healthcare delivery systems' electronic health records (EHR) for patients aged 18 years and older managing type 2 diabetes. We used EHR data to quantify the age of three laboratory tests: serum creatinine, cholesterol, and glycated hemoglobin A1c. Encounter data were used to determine the frequency of inpatient hospitalizations and emergency department visits. Negative binomial regressions with fixed effects were performed to compute marginal effects, levels of statistical significance, and 95% confidence intervals. Results: The average age for serum creatinine laboratory tests was 1.51 months (95%CI: 1.49-1.53). We computed older average ages for hemoglobin A1c (mean:6.17 months; 95%CI: 6.11-6.23) and serum creatinine tests (mean: 8.73; 95%CI: 8.65-8.81). Older laboratory tests were associated with an increase in the total expected counts of subsequent inpatient hospitalizations (ME = 0.047; p < 0.001) and ED visits (ME = 0.034; p < 0.001). Conclusion: Findings from this study indicate that older type 2 diabetes laboratory tests are associated with increases in the total expected count of subsequent inpatient hospitalizations and emergency department visits. Future research should examine the actionability of laboratory test values to determine associations with healthcare outcomes. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01250-0.

Barriers and facilitators to mental health promotion for Mexican immigrants in the U.S. through the Ventanillas de Salud program.

Introduction: Mental health promotion and screenings are recommended as part of standard preventive care. Mexican immigrants in the U.S. are at high risk for mental health illness especially after the COVID-19 pandemic, however access to mental health prevention for this population has been limited, which results in important implementation and equity gaps. The Ventanilla de Salud (VDS) program provides preventive services through Mexican consulates in the U.S. Objective: The objective of this study was to assess capability, opportunity, and motivation for promotores to implement mental health programming through the VDS, leveraging early experiences of ongoing mental health prevention efforts. Methods: This was a qualitative study using the Capability, Opportunity, and Motivation for Behavior Change model (COM-B). We conducted 9 focus groups with 40 VDS promotores and 6 semi-structured interviews with program stakeholders. Data were analyzed using inductive and deductive coding. Results: We found high levels of interest from the leadership, partners, and promotores to provide mental health services through the VDS. Early implementation of a mental health strategy that included training sessions for promotores and mental health promotion, screenings and referrals for VDS users was ongoing. We identified facilitators and barriers that could affect capability, opportunity, and motivation to provide mental health services. Facilitators included promotores' extensive knowledge about the importance of mental health, promotores service mindset and commitment to provide services to VDS users, and general support from the VDS network and partners. Barriers included promotores' turnover, need for additional economic compensation, burnout, competing priorities, and lack of mental health professionals to provide clinical services or supervision. Additional investments are recommended to support promotores' well-being. Conclusion: The main lesson learned from this study was that investing in VDS promotores' training, resources, and well-being is key to their capability, opportunity and motivation to provide mental health services for Mexican immigrants in the US. Results from this study can be applied to improve the ongoing VDS mental health strategy and increase its impact on the mental health of Mexican immigrants.

The Diabetes Tune-Up Group: A Multidisciplinary Approach to Improve Diabetes Distress and A1C Among Adults With Type 1 and Type 2 Diabetes.

PURPOSE: The purpose of this study was to assess the feasibility of delivering the Diabetes Tune-Up Group (DTU), a cognitive-behavioral-therapy-based (CBT) multidisciplinary intervention for adults with diabetes distress and elevated A1C using a group in-person delivery format. METHODS: The DTU intervention consisted of 6 weekly group sessions (90 minutes in duration per session). The groups were cofacilitated by a diabetes care and education specialist (DCES) and a master's-level clinical psychology trainee. The intervention integrated CBT with patient-centered diabetes education. Using a pre/post study design, participants completed assessments at baseline, post-intervention, and 3 months following the intervention. RESULTS: The sample consisted of 29 adults with type 1 diabetes (N = 8) or type 2 diabetes (N = 21) who were predominantly female (79%), White (59%), and educated (56% with a college degree or greater). Participants attended 131 total sessions out of 174 possible sessions, for an overall attendance rate of 75.3%. At 3-month follow-up, significant improvements were observed in A1C values (mean decrease = 0.39%). Diabetes distress improved significantly from baseline (mean = 3.44, SD = 0.68) to post-intervention (mean = 2.94, SD = 0.68), and 3-month follow-up (mean = 2.55, SD = 0.75). Significant improvements were also observed in diabetes self-efficacy from baseline to post-intervention and at 3-month follow-up. CONCLUSIONS: This group-based, multidisciplinary intervention resulted in improvements in A1C, diabetes distress, and patient self-efficacy in caring for diabetes. Future studies to validate this intervention approach across settings and delivery platforms are needed.

Diabetes and Depression: Strategies to Address a Common Comorbidity Within the Primary Care Context.

Diabetes and depression represent a prevalent, bidirectional, and impactful comorbidity that affects patient and family quality of life, glycemic self-management, long-term diabetes complications, usage of medical services, medical costs, and early mortality. Primary care providers (PCPs) are frequently the first medical providers to observe changes in mood and diabetes management, as well as the primary point of contact for making referrals to specialty providers (e.g. endocrinology, psychiatry). PCPs play a critical role in screening, evaluating, and treating these conditions. Critical to fostering and maintaining a position of trust and patient engagement in medication recommendations is the use of person-centered, nonjudgmental language used by the provider within the clinical encounter. Key strategies for the management of these conditions include the following: routine screening for depressive symptoms, securing access to behavioral health professionals, either within or beyond the primary care setting, collaboration with diabetes care and education specialists to support problem-solving of diabetes self-management, and monitoring the use and effectiveness of antidepressant medications.

Improving Care for People Living With Dementia and Diabetes: Applying the Human-Centered Design Process to Continuous Glucose Monitoring.

People with Alzheimer's disease or related dementias and diabetes mellitus (ADRD-DM) are at high risk for hypoglycemic events. Their cognitive impairment and psychosocial situation often hinder detection of hypoglycemia. Extending use and benefits of continuous glucose monitoring (CGM) to people with ADRD-DM could improve hypoglycemia detection, inform care, and reduce adverse events. However, cognitive impairment associated with ADRD presents unique challenges for CGM use. This commentary proposes applying the human-centered design process to CGM, investigating design solutions or interventions needed to integrate CGM into the health care of patients with ADRD-DM. With this process, we can identify and inform CGM designs for people with ADRD-DM, broadening CGM access, increasing detection and treatment of the silent threat posed by hypoglycemia.

A Window Into Mental Health: Developing and Pilot-Testing a Mental Health Promotion Intervention for Mexican Immigrants Through the Ventanilla de Salud Program.

Background: Mexican immigrants in the United States face mental health challenges, disparities, and limited access to healthcare; however, mental health promotion efforts specifically targeting this population have been insufficient. The objective of this study was to develop and test a mental health promotion intervention based on protective mental health factors and coping strategies for Mexican immigrants recruited through a free, consulate-based program in Atlanta. Material and Methods: Working with the Ventanilla de Salud program, we conducted a longitudinal study in three phases: formative research and design, pre-intervention assessment and post-implementation evaluation. The intervention was designed based on the health promotion model and interviews with stakeholders. Qualitative information was collected by semi-structured interviews with participants before and after the intervention. Quantitative outcomes were knowledge about protective factors and coping mechanisms, and psychosocial distress. Differences were assessed using the Wilcoxon non-parametrical test. Intent-to-treat analysis was conducted with all participants who signed the informed consent (carrying last observation forward), and a complete case analysis was conducted with those who attended at least 70% of the sessions and completed the post- implementation evaluation. Results: Twenty-five participants were enrolled in the intervention. Mean age was 38 years, and the majority were women. Only nine participants attended at least 70% of the sessions and completed the final evaluation. Men, those who did not complete high school, and workers in service or construction jobs were more likely to drop out. Knowledge about protective factors [pre- vs. post-intervention median (inter-quartile range) = 111 (100, 120) vs. 115 (100, 124)] and coping mechanisms [96 (85, 104) vs. 99 (90, 110)], as well as psychosocial distress [3 (2, 3) vs. 2 (2, 3)] improved after the intervention in both intent-to treat and complete case analyses (p < 0.05). Qualitative results also support improvements in targeted protective factors. Discussion: The intervention was successful in improving psychological distress among Mexican immigrants. These results support the implementation of evidence-based mental health promotion interventions among Mexican immigrants via free and familiar programs. A limitation was the high attrition; future studies should explore approaches to improve retention in this population.

Diabetes distress, emotional regulation, HbA1c in people with diabetes and A controlled pilot study of an emotion-focused behavioral therapy intervention in adults with type 2 diabetes.

AIM: One potential barrier for people with diabetes to reach glycemic goals is diabetes distress. Accumulating evidence suggests diabetes distress may be linked to individuals' emotion regulation capacities. Thus, we conducted two studies to elucidate a model for how emotion regulation impacts diabetes distress and A1c levels and determine preliminary effect size estimates for an intervention targeting poor emotion regulation on glycemic control. METHODS: Study I used structural equation modeling to assess the cross-sectional relationships between these variables in a sample of 216 individuals with Type 1 and Type 2 diabetes. Study II built on findings from Study I that highlighted the role of emotion regulation capacities in diabetes distress and A1c by conducting a pilot study of an emotion-focused behavioral intervention compared to treatment as usual in a sample of individuals with Type 2 diabetes. RESULTS: Study I examined two potential explanatory models with one of the models (Model II) showing a more comprehensive view of the data revealing a total effect of poor emotional regulation of 42% of all effects on A1c levels. Study II tested an emotion-focused behavioral intervention in patients with Type 2 diabetes compared to treatment as usual and found medium sized reductions in A1c levels and smaller reductions in diabetes distress that correlated with changes in emotion regulation. CONCLUSIONS: These studies suggest that, in people with diabetes, elevated A1c levels and diabetes distress are linked with poor emotion regulation. While the effect sizes from Study 2 are preliminary, an emotion-focused behavioral intervention may reduce both A1c and diabetes distress levels, through improvements in emotion regulation. Overall, these data suggest that targeting difficulties in emotion regulation may hold promise for maximizing improvement in diabetes distress and A1c in individuals with diabetes.

Emotional Correlates of the COVID-19 Pandemic in Individuals With and Without Diabetes.

OBJECTIVE: To compare the mental health experiences associated with coronavirus disease 2019 (COVID-19) in adults with and without diabetes. RESEARCH DESIGN AND METHODS: Between 29 May 2020 and 30 June 2020, 2,176 U.S. adults completed an online survey including demographics, COVID-19 experiences, depression (eight-item Patient Health Questionnaire) and anxiety (seven-item Generalized Anxiety Disorder) symptoms, perceived stress (10-item Perceived Stress Scale), resilience (Brief Resilience Scale), and diabetes-related distress (in participants with diabetes) (17-item Diabetes Distress Scale). RESULTS: Mean age was 49.6 years (SD 16.9); participants were primarily women (80.0%) and White (88.3%), with an annual household income of ≥$60,000 (57.6%). One hundred reported a diagnosis of type 1 diabetes (4.6%), 304 type 2 diabetes (13.9%), and 145 prediabetes (6.6%). Nearly one-third (29.7%) indicated decreases in income attributable to the pandemic. Participants with type 1 diabetes had higher levels of diabetes distress than participants with type 2 diabetes (P < 0.05), with moderate severity in both groups. Participants with type 2 diabetes had significantly more comorbidities and COVID-19 risk factors than all other groups (all P < 0.01). After controlling for covariates, participants with type 2 diabetes reported significantly more depressive symptoms than those without diabetes (P < 0.05) and lower levels of resilience (P < 0.05). Subgroup analyses by sex and age indicated that women and younger adults, particularly those age 18-34 years, reported significantly more depression and anxiety symptoms, stress, and diabetes-related distress and lower levels of resilience than men and adults age ≥51 years. CONCLUSIONS: In this naturalistic observational study, participants with type 2 diabetes reported more depression, lower resilience, and significantly more COVID-19 risk factors and medical comorbidities than participants without diabetes. Overall, our participants demonstrated worse depression and anxiety symptoms during compared with before the pandemic.

Influence of patient immigrant status on physician trainee diabetes treatment decisions: a virtual patient experimental study.

To determine the effect of patient immigrant status on physician trainees' diabetes treatment decisions. Participants were 140 physician trainees ('providers'). Providers viewed videos and vignettes of virtual patients differing in immigrant status (born in Mexico or U.S.; other characteristics held constant). Analyses were completed at the group and individual levels. Providers were less likely to refer foreign-born (vs. U.S.-born) patients to endocrinology. Individual-level results showed an almost even split between treatment ratings for foreign-born vs. U.S.-born patients for three decisions (take no action, add oral hypoglycemic agent, add/switch to insulin), explaining why group-level differences for these ratings did not emerge (i.e., they were cancelled out). Physician trainees are less likely to refer foreign-born patients to endocrinology. Half of individual-level decisions were influenced by patient immigrant status, but group-level analyses mask these differences. Systematic treatment differences based on non-relevant factors could lead to adverse outcomes for immigrants.

Mandated Benefits for Diabetes Education and the Availability of Accredited Programs and Certified Diabetes Educators.

States have the latitude to mandate coverage of diabetes self-management education (DSME) services for privately insured and Medicaid patients. The impact of these mandates on the supply of DSME resources is unknown. This study compared changes in the supply of DSME programs and program sites accredited by the American Association for Diabetes Educators (AADE) and certified diabetes educators (CDE) between states that did and did not mandate benefits for DSME. Using a unique combination of legal and programmatic data sources, the authors employed fixed effects regression models with clustered robust standard errors to compare changes in the supply of AADE-accredited DSME programs, program sites, and CDEs in states that mandated benefits with states that did not. Given the variation in state mandates, models also estimated the impact of "flexible" reimbursement provisions on the supply of resources among adopting states. The supply of DSME resources has increased over time, but results indicate that mandated benefits were not a significant driver of these changes in the supply. The impact of flexible reimbursement provisions varied. Interestingly, provisions of the Affordable Care Act were associated with an increased supply of resources. Results suggest that extending benefits to previously insured patients does not increase the supply of DSME resources, but a rapid increase in patients entering the health system does encourage growth.

Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II.

OBJECTIVE: We estimated the cost-effectiveness of the Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II community-based exercise (EXER), cognitive behavioral therapy (CBT), and EXER+CBT interventions in adults with type 2 diabetes and depression relative to usual care (UC) and each other. RESEARCH DESIGN AND METHODS: Data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year simulation time horizon from the health care sector and societal perspectives, discounting costs and benefits at 3% annually. Primary outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS: From the health care sector perspective, the EXER intervention strategy saved $313 (USD) per patient and produced 0.38 more QALY (cost saving), the CBT intervention strategy cost $596 more and gained 0.29 more QALY ($2,058/QALY), and the EXER+CBT intervention strategy cost $403 more and gained 0.69 more QALY ($585/QALY) compared with UC. Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared with EXER, the EXER+CBT intervention strategy cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared with UC, the EXER intervention strategy saved $126 (cost saving), the CBT intervention strategy cost $2,838/QALY, and the EXER+CBT intervention strategy cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. In comparison with EXER, the EXER+CBT intervention strategy cost $3,021/QALY. Results were robust in sensitivity analyses. CONCLUSIONS: All three Program ACTIVE II interventions represented a good value for money compared with UC. The EXER+CBT intervention was highly cost-effective or cost saving compared with the CBT or EXER interventions.

50 Years of Behavioral Science in Diabetes: A 2020 Vision of the Future.

This article is adapted from a speech Dr. de Groot delivered in June 2020 as President, Health Care & Education, of the American Diabetes Association at the Association's 80th Scientific Sessions, which was held online as a result of coronavirus disease 2019. Dr. de Groot is an Associate Professor of Medicine in the Division of Endocrinology, Diabetes and Metabolism at Indiana University (IU) School of Medicine. She serves as the Acting Director of the IU Diabetes Translational Research Center. Dr. de Groot is the 2020 recipient of the Rachmiel Levine Medal for Leadership from the American Diabetes Association.In the year 2020, we marked the 50th anniversary of the field of behavioral science in diabetes in the modern era. Over this relatively short period of time, this field has charted the psychosocial landscape of prediabetes and diabetes by establishing the prevalence and impact of emotional and behavioral aspects of diabetes. Interventions to address these conditions have been developed that span the T2 to T4 translational research spectrum ranging from the intrapsychic to population-based interventions. Policies ranging from standards of care to Medicare benefits have been implemented. A review of research in the area of diabetes and depression is provided as an example of innovations in this field. Behavior is the foundation of all interventions we make in diabetes and prediabetes. As a mature science, it is critical to stemming the tide of diabetes and its outcomes. To make additional strides, we must rebalance our focus and augment funding for behavioral interventions for individuals, communities, and health care systems in conjunction with other forms of treatment.

50 Years of Behavioral Science in Diabetes: A 2020 Vision of the Future.

Editor's Note: This article is adapted from a speech Dr. de Groot delivered in June 2020 as President, Health Care & Education, of the American Diabetes Association. She delivered her address at the Association's 80th Scientific Sessions, which was held online as a result of the coronavirus disease 2019.

Emotional Regulation and Diabetes Distress in Adults With Type 1 and Type 2 Diabetes.

OBJECTIVE: To explore the correlates of diabetes-related distress (DD) with psychometrically valid assessments of emotional regulation in individuals with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS: Adults with diabetes (n = 298) were assessed for psychological issues possibly associated with diabetes and were further evaluated with measures of negative emotional experience (ER-Exp) and skill at regulating such experiences (ER-Skill) and measures of DD, perceived psychosocial stress, diabetes literacy, and diabetes self-care. RESULTS: ER-Exp was directly related to DD, while ER-Skill was inversely related to DD. Together, these ER variables displayed a medium-size relationship (ß = 0.45) with DD. Inclusion of variables related to diabetes self-care and perceived psychosocial stress was associated with only an 18% reduction (i.e., ß = 0.45 to ß = 0.38) in the strength of this relationship, while the magnitude of relationships between DD and perceived psychosocial stress (ß = 0.15) and diabetes self-care (ß = -0.09) was relatively small. CONCLUSIONS: These data suggest that DD is meaningfully linked with negative emotionality, and skill at regulating such emotions, in adults with diabetes. This relationship appears to be stronger than that between DD and perceived psychological stress or diabetes self-care. If so, DD (and possibly A1C) may be improved in those with diabetes and difficulties with negative emotionality.

Undiagnosed diabetes among immigrant and racial/ethnic minority adults in the United States: National Health and Nutrition Examination Survey 2011-2018.

PURPOSE: Undiagnosed diabetes disproportionately affects medically underserved groups. It is unknown whether being an immigrant confers additional risk for undiagnosed diabetes. The purpose of this study was to examine independent associations of immigrant status and race/ethnicity with the prevalence of diagnosed and undiagnosed diabetes in a U.S.-based population sample. METHODS: Respondents were 21,306 adults from the 2011-2018 National Health and Nutrition Examination Survey. Immigrant status was coded as foreign-born or U.S.-born. Six racial/ethnic categories were white, Black, Mexican American, other Hispanic, Asian, and other/multiracial. Self-report and laboratory data yielded a three-level diabetes status outcome: no diabetes (88%), diagnosed diabetes (10%), and undiagnosed diabetes (2%). RESULTS: Adjusted multinomial logistic regression models evaluating immigrant status and race/ethnicity as simultaneous predictors revealed that foreign-born (vs. U.S.-born) adults had a similar prevalence of diagnosed diabetes (OR = 0.98, 95% CI: 0.79-1.22, P = .84) but a higher prevalence of undiagnosed diabetes (OR = 1.54, 95% CI: 1.21-1.97, P = .004). Models showed that all racial/ethnic minority groups except the other/multiracial group (vs. whites) had a higher prevalence of diagnosed and undiagnosed diabetes (Ps < .04). CONCLUSIONS: Immigrants and racial/ethnic minority adults have increased odds of undiagnosed diabetes, even after accounting for health insurance. These groups are likely at increased risk for diabetes complications because of prolonged periods of undetected diabetes.

Joint international consensus statement for ending stigma of obesity.

People with obesity commonly face a pervasive, resilient form of social stigma. They are often subject to discrimination in the workplace as well as in educational and healthcare settings. Research indicates that weight stigma can cause physical and psychological harm, and that affected individuals are less likely to receive adequate care. For these reasons, weight stigma damages health, undermines human and social rights, and is unacceptable in modern societies. To inform healthcare professionals, policymakers, and the public about this issue, a multidisciplinary group of international experts, including representatives of scientific organizations, reviewed available evidence on the causes and harms of weight stigma and, using a modified Delphi process, developed a joint consensus statement with recommendations to eliminate weight bias. Academic institutions, professional organizations, media, public-health authorities, and governments should encourage education about weight stigma to facilitate a new public narrative about obesity, coherent with modern scientific knowledge.

New research directions on disparities in obesity and type 2 diabetes.

Obesity and type 2 diabetes disproportionately impact U.S. racial and ethnic minority communities and low-income populations. Improvements in implementing efficacious interventions to reduce the incidence of type 2 diabetes are underway (i.e., the National Diabetes Prevention Program), but challenges in effectively scaling-up successful interventions and reaching at-risk populations remain. In October 2017, the National Institutes of Health convened a workshop to understand how to (1) address socioeconomic and other environmental conditions that perpetuate disparities in the burden of obesity and type 2 diabetes; (2) design effective prevention and treatment strategies that are accessible, feasible, culturally relevant, and acceptable to diverse population groups; and (3) achieve sustainable health improvement approaches in communities with the greatest burden of these diseases. Common features of guiding frameworks to understand and address disparities and promote health equity were described. Promising research directions were identified in numerous areas, including study design, methodology, and core metrics; program implementation and scalability; the integration of medical care and social services; strategies to enhance patient empowerment; and understanding and addressing the impact of psychosocial stress on disease onset and progression in addition to factors that support resiliency and health.

Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes.

BACKGROUND: Participant recruitment for clinical trials is a significant challenge for the scientific research community. Federal funding agencies have made continuation of funding of clinical trials contingent on meeting recruitment targets. It is incumbent on investigators to carefully set study recruitment timelines and resource needs to meet those goals as required under current funding mechanisms. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states. METHODS: Quantitative and qualitative data on recruitment were gathered from study staff throughout the study recruitment period and were used to calculate costs and effort. The study utilized two main approaches to recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff. RESULTS: Contact was attempted with 18,925 people to obtain the enrolled sample of 140. The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant. Qualitative evaluations identified multiple barriers to recruitment. CONCLUSIONS: Recruitment for Program ACTIVE II exemplifies the magnitude of resources needed to reach recruitment targets in the current era. Continuous evaluation, flexibility, and adaptation are required on the part of investigators, community partners, and funding agencies to successfully reach high-risk populations in rural and urban areas. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03371940 . Registered on 13 December 2017.