A virtual recruitment protocol promotes enrollment of underrepresented groups in a diabetes prevention trial.

Strategies are needed to ensure greater participation of underrepresented groups in diabetes research. We examined the impact of a remote study protocol on enrollment in diabetes research, specifically the Pre-NDPP clinical trial. Recruitment was conducted among 2807 diverse patients in a safety-net healthcare system. Results indicated three-fold greater odds of enrolling in remote versus in-person protocols (AOR 2.90; P < 0.001 [95% CI 2.29-3.67]). Priority populations with significantly higher enrollment included Latinx and Black individuals, Spanish speakers, and individuals who had Medicaid or were uninsured. A remote study design may promote overall recruitment into clinical trials, while effectively supporting enrollment of underrepresented groups.

Introduction to the special issue on vaccine hesitancy and refusal.

This is an introduction to the special issue "Vaccine Hesitancy and Refusal." This special issue of Health Psychology examines various aspects of vaccine hesitancy using a health psychology lens. The timing of this issue, following a call for papers issued in the summer of 2021, in the midst of the COVID-19 pandemic, is reflected in the focus on COVID-19 vaccine hesitancy in the papers included here. This is important, as the field of vaccine hesitancy research has expanded greatly in response to the COVID-19 pandemic. As of March 2, 2023, a search of PubMed for "vaccine hesitancy" yielded 5,635 papers, dating back to 1968. A similar search for "COVID vaccine hesitancy" yielded 3,851 papers, starting in 2020. This highlights the need for new and novel theory-based interventions that can be broadly applicable to hesitancy to other routine vaccinations. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

A Year in the Life of U.S. Frontline Health Care Workers: Impact of COVID-19 on Weight Change, Physical Activity, Lifestyle Habits, and Psychological Factors.

Healthcare workers (HCWs) experienced significantly higher burdens and life demands due to the COVID-19 pandemic. This study sought to assess the longitudinal effects among HCWs throughout the pandemic. Qualtrics surveys collected self-reported data on weight changes, eating patterns, physical activity (PA), and psychological factors with data organized by timepoints prior to the pandemic (PP0­prior to March 2020), baseline (M0­January 2021), month 6 (M6­July 2021), and month 12 (M12­January 2022). Eating patterns were negatively impacted at the M0, with reported increases in snacking/grazing (69.7%), fast food/take-out consumption (57.8%), and alcohol (48.8%). However, by M6 and M12 there were no statistically significant differences in eating patterns, suggesting that eating patterns normalized over time. Mean weight increased from PP0 to M0 by 2.99 pounds (p < 0.001, n = 226) and from PP0 to M6 by 2.12 pounds (p < 0.027, n = 146), though the difference in mean weight from PP0 to M12 was not statistically significant (n = 122). PA counts decreased from 8.00 sessions per week PP0 to 6.80 by M0 (p = 0.005) before jumping to 12.00 at M6 (p < 0.001) and 10.67 at M12 (p < 0.001). Psychological factors comparing M0 to M12 found statistically significant differences for depression (p-value = 0.018) and anxiety (p-value = 0.001), meaning depression and anxiety were initially increased but improved by M12. Additionally, higher scores on depression and insomnia scales were associated with lower PA levels. These overall results imply that the COVID-19 pandemic had immediate effects on the eating patterns, weight changes, PA, and psychological factors of HCWs; however, routines and lifestyle habits appeared to have normalized one year later.

Relationship of Psychological Characteristics to Daily Life Ischemia: An Analysis From the National Heart, Lung, and Blood Institute Psychophysiological Investigations in Myocardial Ischemia.

OBJECTIVE: Cardiac ischemia during daily life is associated with an increased risk of adverse outcomes. Mental stress is known to provoke cardiac ischemia and is related to psychological variables. In this multicenter cohort study, we assessed whether psychological characteristics were associated with ischemia in daily life. METHODS: This study examined patients with clinically stable coronary artery disease (CAD) with documented cardiac ischemia during treadmill exercise (n = 196, mean [standard deviation] age = 62.64 [8.31] years; 13% women). Daily life ischemia (DLI) was assessed by 48-hour ambulatory electrocardiophic monitoring. Psychological characteristics were assessed using validated instruments to identify characteristics associated with ischemia occurring in daily life stress. RESULTS: High scores on anger and hostility were common in this sample of patients with CAD, and DLI was documented in 83 (42%) patients. However, the presence of DLI was associated with lower anger scores (odds ratio [OR] = 2.03; 95% confidence interval [CI] = 1.12-3.69), reduced anger expressiveness (OR = 2.04; 95% CI = 1.10-3.75), and increased ratio of anger control to total anger (OR = 2.33; 95% CI = 1.27-4.17). Increased risk of DLI was also associated with lower hostile attribution (OR = 2.22; 95% CI = 1.21-4.09), hostile affect (OR = 1.92; 95% CI = 1.03-3.58), and aggressive responding (OR = 2.26; 95% CI = 1.25-4.08). We observed weak inverse correlations between DLI episode frequency and anger expressiveness, total anger, and hostility scores. DLI was not associated with depression or anxiety measures. The combination of the constructs low anger expressiveness and low hostile attribution was independently associated with DLI (OR = = 2.59; 95% CI = 1.42-4.72). CONCLUSIONS: In clinically stable patients with CAD, the tendency to suppress angry and hostile feelings, particularly openly aggressive behavior, was associated with DLI. These findings warrant a study in larger cohorts, and intervention studies are needed to ascertain whether management strategies that modify these psychological characteristics improve outcomes.

Development of a weight bias reduction intervention for third-year nursing students.

To explore whether case-based learning will enhance a weight bias reduction (WBR) programme among nursing students to improve their attitudes and beliefs towards persons with obesity. A cluster-randomized controlled trial (CRT) among 13 medical-surgical clinical practicum groups consisting of six to eight third-year baccalaureate nursing students was conducted to compare a WBR training enhanced by case-based learning (WBR-I, n = 7) with a standard WBR control group (n = 6). All participants completed the Attitudes Towards Obese Persons (ATOP) and Beliefs About Obese Persons (BAOP) questionnaires before the randomized assignment and at the end of the 14-week semester. The BAOP scores of participants in the WBR-I group were significantly improved compared to controls (26.68 ± 7.85 and 22.93 ± 2.80, respectively; F = 18.23; p = .001 (<.01) indicating improved beliefs about the controllability of obesity. There were no significant changes to attitudes about individuals with obesity, as indicated by the ATOP scores. The findings of this pilot study suggest that a more intensive WBR programme that includes case-based learning scenarios that elicit critical thinking coupled with a standard WBR programme may reduce some aspects of weight bias.

The COVID-19 Study of Healthcare and Support Personnel (CHAMPS): Protocol for a Longitudinal Observational Study.

BACKGROUND: Early in the development of the COVID-19 pandemic, it was evident that health care workers, first responders, and other essential workers would face significant stress and workplace demands related to equipment shortages and rapidly growing infections in the general population. Although the effects of other sources of stress on health have been documented, the effects of these unique conditions of the COVID-19 pandemic on the long-term health and well-being of the health care workforce are not known. OBJECTIVE: The COVID-19 Study of Healthcare and Support Personnel (CHAMPS) was designed to document early and longitudinal effects of the pandemic on the mental and physical health of essential workers engaged in health care. We will investigate mediators and moderators of these effects and evaluate the influence of exposure to stress, including morbidity and mortality, over time. We will also examine the effect of protective factors and resilience on health outcomes. METHODS: The study cohort is a convenience sample recruited nationally through communities, professional organizations, networks, social media, and snowball sampling. Recruitment took place for 13 months to obtain an estimated sample of 2762 adults who provided self-reported information administered on the web through structured questionnaires about their work environment, mental and physical health, and psychosocial factors. Follow-up questionnaires will be administered after 6 months and annually thereafter to ascertain changes in health, well-being, and lifestyle. Participants who consented to be recontacted form the longitudinal cohort and the CHAMPS Registry may be contacted to ascertain their interest in ancillary studies for which they may be eligible. RESULTS: The study was approved by the Institutional Review Board and launched in May 2020, with grants from Travere Therapeutics Inc, McKesson Corporation, anonymous donors, and internal funding from the M. Louise Fitzpatrick College of Nursing at Villanova University. Recruitment ended in June 2021 after enrolling 2762 participants, 1534 of whom agreed to participate in the longitudinal study and the registry as well as to be contacted about eligibility for future studies. CONCLUSIONS: The CHAMPS Study and Registry will enable the acquisition of detailed data on the effects of extended psychosocial and workplace stress on morbidity and mortality and serve as a platform for ancillary studies related to the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04370821; https://clinicaltrials.gov/ct2/show/NCT04370821. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30757.

Patient-Centered Goal-Setting in the National Diabetes Prevention Program: A Pilot Study.

OBJECTIVE: Difficulty achieving preset goals (e.g., ≥5% weight loss, ≥150 min of weekly physical activity) in the yearlong National Diabetes Prevention Program (NDPP) can prompt dropout and diminish benefits. We piloted a more patient-centered NDPP adaptation (NDPP-Flex) that promotes a variety of attainable and individually tailored goals to reduce diabetes risks, along with flexibility to adjust goals each week as needed. RESEARCH DESIGN AND METHODS: Retention, physical activity, weight, and glycated hemoglobin (HbA1c) were evaluated among diverse participants with diabetes risks who received our pilot of NDPP-Flex beginning in January and July 2018 (n = 95), with a planned comparison with standard NDPP delivery in preceding cohorts that launched between September 2016 and October 2017 (n = 245). Both the standard NDPP and NDPP-Flex interventions were 1 year in duration and implemented in phases (i.e., nonrandomized). RESULTS: Average adjusted retention (e.g., 158.90 ± 15.20 vs. 166.71 ± 9.38 days; P = 0.674), physical activity (157.97 ± 11.91 vs. 175.64 ± 7.54 weekly min; P = 0.231), and weight loss (1.46 ± 0.38% vs. 1.90 ± 0.24%; P = 0.396) were similar between NDPP-Flex versus standard NDPP. However, NDPP-Flex participants had greater HbA1c reduction on average (0.22 ± 0.05% vs. 0.06 ± 0.03%; P = 0.018) and were more likely to have normoglycemia at follow-up (odds ratio 4.62; P = 0.013 [95% CI 1.38-15.50]) than participants in the standard NDPP. CONCLUSIONS: An adapted, more patient-centered NDPP that focuses on flexible, self-selected goals may be a promising strategy to improve glycemia even in the absence of substantial weight loss.

Health psychology in the time of COVID-19.

Health Psychology has received numerous papers over the past several months on topics related to the COVID-19 pandemic. Many of them concern depression, anxiety, stress, or other forms of distress in the general population or in health care workers. We have received far fewer papers on COVID-related health behaviors and health communications-factors that have played central roles in the spread of the pandemic and that are major topics in health psychology. Our experience is consistent with the published scientific literature on the pandemic. A Medline search that we conducted in late September yielded over 23,000 English-language articles pertaining to COVID-19. Over 1,400 of them concerned topics that are within the scope of Health Psychology. As shown in Table 1, COVID-related mental disorders comprised the largest category. Many other studies concerned other forms of stress or emotional distress. At least 248 articles addressed the profound ethnic and racial disparities in COVID-19 infection and death rates and in access to health care that are accentuating longstanding health inequities; 22 (9%) of these articles addressed behavioral or psychosocial aspects of COVID-19 health disparities. Thus, the literature on the behavioral and psychosocial aspects of the pandemic has been dominated, so far at least, by research on stress or distress. Fewer reports have been published so far on critical COVID-related health behaviors, health communication, or health disparities. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov. OBJECTIVE: This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment. METHODS: This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery. RESULTS: This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024. CONCLUSIONS: This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country. TRIAL REGISTRATION: ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15499.

Presessions to the National Diabetes Prevention Program May be a Promising Strategy to Improve Attendance and Weight Loss Outcomes.

PURPOSE: The National Diabetes Prevention Program (NDPP) is a widely disseminated lifestyle intervention. Attendance is problematic, leading to suboptimal weight loss, especially among racial/ethnic minority participants. We conducted a novel "presession" protocol to improve engagement of diverse NDPP candidates, comparing NDPP participants who attended a presession to those who did not on attendance and weight loss outcomes. DESIGN: Longitudinal cohort study. SETTING: A safety net health-care system. PARTICIPANTS: A total of 1140 patients with diabetes risks (58.9% Hispanic, 19.8% non-Hispanic black, 61.8% low income). INTERVENTION: The NDPP has been delivered in a Denver, Colorado health-care system since 2013. The program included 22 to 25 sessions over 1 year. Beginning September 2016, individuals were required to attend a presession before enrollment that focused on (1) increasing risk awareness, (2) motivational interviewing to participate in the NDPP, and (3) problem-solving around engagement barriers. MEASURES: Duration and intensity of NDPP attendance and weight loss. ANALYSIS: Outcomes of 75 presession participants who enrolled in the NDPP were compared to 1065 prior participants using analysis of covariance and multivariable logistic regression. RESULTS: Presession participants stayed in the NDPP 99.8 days longer ( P < .001) and attended 14.3% more sessions ( P < .001) on average than those without a presession. Presession participants lost 2.0% more weight ( P < .001) and were 3.5 times more likely to achieve the 5% weight loss target ( P < .001). CONCLUSION: Presessions may improve NDPP outcomes for individuals from diverse backgrounds. A full-scale trial is needed to determine whether presessions reliably improve NDPP effectiveness.

Cardiovascular disease: Psychological, social, and behavioral influences: Introduction to the special issue.

Although deaths due to cardiovascular diseases have declined significantly since the 1970s, they remain the most common cause of morbidity and mortality in the United States. A large number of cardiovascular risk factors, such as smoking, obesity, and sedentary lifestyle, are modifiable. Psychologists and other behavioral scientists and practitioners are engaged in not only understanding the mechanistic links between behaviors and cardiovascular health but also developing effective interventions for improving health. The purpose of this special issue is to highlight some of the more innovative psychological research in cardiovascular health promotion, disease prevention, and management. Articles included in this issue focus on 2 primary areas. First, cutting-edge research on the current state of knowledge of modifiable health behaviors and their impact on cardiovascular health include articles on e-cigarette use as a putative risk factor, psychological factors involved in adherence to medications, the role of sleep in cardiovascular health, and innovative approaches to enhancing the treatment and recovery of patients with cardiovascular diseases. Second, outstanding research identifying the mechanisms by which psychological factors such as stress, depression, and anxiety impact cardiovascular disease include an overview of the current state of science examining psychological comorbidities that can accompany cardiovascular disease and influence outcomes, discussion of the neurocognitive processes that connect stress appraisal with biological functioning and diseases processes, and the role of genetics on behavioral interventions and clinical decision-making in the context of behavioral weight loss treatments. Our goal with these innovative articles is to stimulate additional advances in cardiovascular behavioral medicine. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Decline in Cardiovascular Mortality: Possible Causes and Implications.

If the control of infectious diseases was the public health success story of the first half of the 20th century, then the decline in mortality from coronary heart disease and stroke has been the success story of the century's past 4 decades. The early phase of this decline in coronary heart disease and stroke was unexpected and controversial when first reported in the mid-1970s, having followed 60 years of gradual increase as the US population aged. However, in 1978, the participants in a conference convened by the National Heart, Lung, and Blood Institute concluded that a significant recent downtick in coronary heart disease and stroke mortality rates had definitely occurred, at least in the US Since 1978, a sharp decline in mortality rates from coronary heart disease and stroke has become unmistakable throughout the industrialized world, with age-adjusted mortality rates having declined to about one third of their 1960s baseline by 2000. Models have shown that this remarkable decline has been fueled by rapid progress in both prevention and treatment, including precipitous declines in cigarette smoking, improvements in hypertension treatment and control, widespread use of statins to lower circulating cholesterol levels, and the development and timely use of thrombolysis and stents in acute coronary syndrome to limit or prevent infarction. However, despite the huge growth in knowledge and advances in prevention and treatment, there remain many questions about this decline. In fact, there is evidence that the rate of decline may have abated and may even be showing early signs of reversal in some population groups. The National Heart, Lung, and Blood Institute, through a request for information, is soliciting input that could inform a follow-up conference on or near the 40th anniversary of the original landmark conference to further explore these trends in cardiovascular mortality in the context of what has come before and what may lie ahead.

A Strategic Framework for Utilizing Late-Stage (T4) Translation Research to Address Health Inequities.

Achieving health equity requires that every person has the opportunity to attain their full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances. Inequity experienced by populations of lower socioeconomic status is reflected in differences in health status and mortality rates, as well as in the distribution of disease, disability and illness across these population groups. This article gives an overview of the health inequities literature associated with heart, lung, blood and sleep (HLBS) disorders. We present an ecological framework that provides a theoretical foundation to study late-stage T4 translation research that studies implementation strategies for proven effective interventions to address health inequities.

Transdisciplinary cardiovascular and cancer health disparities training: experiences of the centers for population health and health disparities.

The Centers for Population Health and Health Disparities program promotes multilevel and multifactorial health equity research and the building of research teams that are transdisciplinary. We summarized 5 areas of scientific training for empowering the next generation of health disparities investigators with research methods and skills that are needed to solve disparities and inequalities in cancer and cardiovascular disease. These areas include social epidemiology, multilevel modeling, health care systems or health care delivery, community-based participatory research, and implementation science. We reviewed the acquisition of the skill sets described in the training components; these skill sets will position trainees to become leaders capable of effecting significant change because they provide tools that can be used to address the complexities of issues that promote health disparities.

Publication of trials funded by the National Heart, Lung, and Blood Institute.

BACKGROUND: Rapid publication of clinical trials is essential in order for the findings to yield maximal benefits for public health and scientific progress. Factors affecting the speed of publication of the main results of government-funded trials have not been well characterized. METHODS: We analyzed 244 extramural randomized clinical trials of cardiovascular interventions that were supported by the National Heart, Lung, and Blood Institute (NHLBI). We selected trials for which data collection had been completed between January 1, 2000, and December 31, 2011. Our primary outcome measure was the time between completion of the trial and publication of the main results in a peer-reviewed journal. RESULTS: As of March 31, 2012, the main results of 156 trials (64%) had been published (Kaplan-Meier median time to publication, 25 months, with 57% published within 30 months). Trials that focused on clinical events were published more rapidly than those that focused on surrogate measures (median, 9 months vs. 31 months; P<0.001). The only independent predictors of more rapid publication were a focus on clinical events rather than surrogate end points (adjusted publication rate ratio, 2.11; 95% confidence interval, 1.26 to 3.53; P=0.004) and higher costs of conducting the trial, up to a threshold of approximately $5 million (P<0.001). The 37 trials that focused on clinical events and cost at least $5 million accounted for 67% of the funds spent on clinical trials but received 82% of the citations. After adjustment of the analysis for a focus on clinical events and for cost, trial results that were classified as positive were published more quickly than those classified as negative. CONCLUSIONS: Results of less than two thirds of NHLBI-funded randomized clinical trials of cardiovascular interventions were published within 30 months after completion of the trial. Trials that focused on clinical events were published more quickly than those that focused on surrogate end points. (Funded by the National Heart, Lung, and Blood Institute.).

Midcourse correction to a clinical trial when the event rate is underestimated: the Look AHEAD (Action for Health in Diabetes) Study.

The Look AHEAD (Action for Health in Diabetes) Study is a long-term clinical trial that aims to determine the cardiovascular disease (CVD) benefits of an intensive lifestyle intervention (ILI) in obese adults with type 2 diabetes. The study was designed to have 90% statistical power to detect an 18% reduction in the CVD event rate in the ILI Group compared to the Diabetes Support and Education (DSE) Group over 10.5 years of follow-up. The original power calculations were based on an expected CVD rate of 3.125% per year in the DSE group; however, a much lower-than-expected rate in the first 2 years of follow-up prompted the Data and Safety Monitoring Board (DSMB) to recommend that the Steering Committee undertake a formal blinded evaluation of these design considerations. The Steering Committee created an Endpoint Working Group (EPWG) that consisted of individuals masked to study data to examine relevant issues. The EPWG considered two primary options: (1) expanding the definition of the primary endpoint and (2) extending follow-up of participants. Ultimately, the EPWG recommended that the Look AHEAD Steering Committee approve both strategies. The DSMB accepted these modifications, rather than recommending that the trial continue with inadequate statistical power. Trialists sometimes need to modify endpoints after launch. This decision should be well justified and should be made by individuals who are fully masked to interim results that could introduce bias. This article describes this process in the Look AHEAD study and places it in the context of recent articles on endpoint modification and recent trials that reported endpoint modification.

AHA science advisory. Depression and coronary heart disease. Recommendations for screening, referral, and treatment. A science advisory from the American Heart Association Prevention Committee to the Council on Cardiovascular Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Interdisciplinary Council on Quality of Care Outcomes Research. Endorsed by the American Psychiatric Association.

Depression is commonly present in patients with coronary heart disease (CHD) and is independently associated with increased cardiovascular morbidity and mortality. Screening tests for depressive symptoms should be applied to identify patients who may require further assessment and treatment. This multispecialty consensus document reviews the evidence linking depression with CHD and provides recommendations for healthcare providers for the assessment, referral, and treatment of depression.

Depression and coronary heart disease: recommendations for screening, referral, and treatment: a science advisory from the American Heart Association Prevention Committee of the Council on Cardiovascular Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Interdisciplinary Council on Quality of Care and Outcomes Research: endorsed by the American Psychiatric Association.

Depression is commonly present in patients with coronary heart disease (CHD) and is independently associated with increased cardiovascular morbidity and mortality. Screening tests for depressive symptoms should be applied to identify patients who may require further assessment and treatment. This multispecialty consensus document reviews the evidence linking depression with CHD and provides recommendations for healthcare providers for the assessment, referral, and treatment of depression.