The Fruit and Veggies for Kidney Health Study: A Prospective Randomized Trial.

Rationale & Objective: Providing fruits and vegetables (F&Vs) to health care system patients with elevated urine albumin-creatinine ratio (ACR) reduced ACR, slowed chronic kidney disease (CKD) progression and reduced cardiovascular disease (CVD) risk factors in previous studies. This study evaluated a community-based strategy in lower-income populations to identify African Americans with elevated ACR before health care system involvement and sustain them in a 6-month F&V protocol with (F&V + Cook) and without (F&V Only) cooking instructions, with the hypothesis that adjuvant cooking instructions with F&Vs would further reduce ACR. Study Design: Prospective, randomized, parallel 2-arm design. Setting & Participants: African American adults with ACR >10 mg/g creatinine randomized to 1 of 2 study arms. Interventions: Two cups/day of F&Vs with or without cooking instructions in participants followed 6 months. Outcomes: Participants sustaining the F&V protocol and between-group indicators of CVD risk, kidney injury, and dietary intake at 6 weeks and 6 months. Results: A total of 142 African American adults (mean age, 57.0 years; ACR, 27.4 mg/g; body mass index, 34.4; 24.9% CKD 1; 24.8% CKD 2; 50.4% CKD 3; 55% female) randomized to F&V Only (n=72) or F&V + Cook (n=70), and 71% were retained at 6 months. Participants received 90% of available F&V pick-ups over 6 weeks and 69% over 6 months. In the adjusted model, 6-month ACR was 31% lower for F&V + Cook than F&V Only (P = 0.02). Net 6-week F&V intake significantly increased and biometric variables improved for participants combined into a single group. Limitations: Small sample size, low-baseline ACR, and potential nonresponse bias for 24-hour dietary recall measure. Conclusions: These data support the feasibility of identifying community-dwelling African Americans with ACR indicating elevated CVD and CKD risk and sustaining a F&V protocol shown to improve kidney outcomes and CVD risk factors and provides preliminary evidence that cooking instructions adjuvant to F&Vs are needed to lower ACR. Funding: National Institute on Diabetes, Digestive, and Kidney Diseases grant "Reducing chronic kidney disease burden in an underserved population" (R21DK113440). Trial Registration: NCT03832166. Plain-Language Summary: African Americans, particularly those in low-income communities, have increased rates of chronic kidney disease (CKD) with worsening outcomes over time. Giving fruits and vegetables to individuals with CKD identified in health care systems was previously shown to reduce kidney damage, measured by urine protein albumin, and slow kidney function decline. We recruited African Americans in low-income communities with increased urine albumin levels. They received fruits and vegetables for 6 months, and we tested whether added cooking instructions further reduced urine albumin levels. Most participants continued to receive fruits and vegetables throughout the 6 months. Those given cooking instructions had lower urine albumin levels after 6 months, indicating decreased kidney damage. Providing cooking instructions with fruits and vegetables appears to lessen kidney damage more than just fruits and vegetables alone.

Community health worker navigation to improve allostatic load: The Integrated Population Health (IPOP) study.

Background: Social determinants of health (SDOH) and cumulative stress contribute to chronic disease development. The physiological response to repeated stressors typical of lower-income environments can be measured through allostatic load - a composite measure of cardiovascular, metabolic, and immune variables. Healthcare systems have employed patient navigation for social and medical needs to improve SDOH that has demonstrated limited impact on chronic disease outcomes. This study evaluates a novel community health worker navigation intervention developed using behavioral theories to improve access to social and medical services and provide social support for poverty stressed adults. Methods: The Integrated Population Health Study (IPOP) study is a randomized, parallel two arm study evaluating community health worker navigation in addition to an existing integrated population health program (IPOP CHW) as compared to Usual Care (population health program only, IPOP) on allostatic load and chronic disease risk factors. IPOP CHW participants receive a 10-month navigation intervention. Results: From 381 screened individuals, a total of 202 participants (age 58.15 ± 12.03 years, 74.75 % female, 79.21 % Black/African American, 17.33 % Hispanic) were enrolled and randomized to IPOP CHW (n = 100) or IPOP Only (n = 102). Conclusion: This study will evaluate whether CHW navigation, using a structured intervention based on health behavior theories, can effectively guide poverty stressed individuals to address social and medical needs to improve allostatic load-a composite of cumulative stress and physiological responses. Healthcare systems, nonprofit organizations, and governmental entities are interested in addressing SDOH to improve health, thus developing evidence-based interventions could have broad clinical and policy implications.

Use of Telehealth Early and Late in the COVID-19 Public Health Emergency: Policy Implications for Improving Health Equity.

INTRODUCTION: Early in the COVID-19 pandemic, primary care adopted telehealth rapidly to preserve access. Although policy flexibilities persist, but with in-person access restored, insight regarding long-term policy reform is needed for equitable access, especially for underserved, low income, and rural populations. METHODS: We used electronic health record data to compare primary care telehealth use in practices serving primarily commercially insured patients versus clinics serving low-income uninsured patients, in March-June 2020 ("early COVID") and March-June 2022 ("late COVID"). RESULTS: Primary care visit mode differed significantly (P < .0001) between settings in both periods. In early COVID, video visits were most used in the commercially insured practices (54.50%), followed by office visits (32.76%); in the low-income, uninsured clinics, phone visits were most used (56.67%), followed by office visits (23.55%). In late COVID, 81.05% of visits to commercially insured practices and 92.04% to uninsured clinics were in-office; continuing telehealth use was primarily video. Smaller but significant (P ≤ .0001) differences in telehealth use by race/ethnicity were also observed, with Black and/or Hispanic patients less likely than White patients to use telehealth during both periods, after adjustment for other characteristics. CONCLUSIONS: Findings demonstrate the importance of both phone and video visits in preserving primary care access early in the pandemic. Telehealth use declined in late COVID, but still accounted for ∼20% of primary care visits in the commercially insured setting and less than 10% of visits in the community care clinics. Differences in telehealth use were largely by setting, reflecting income/insurance status, indicating disparities needing to be addressed.

What's theory got to do with it: measuring effects of theory on lifestyle behaviors and weight in the Better Me Within Randomized Trial.

Background: Knowing which theoretical constructs work best to design effective interventions is essential for populations with increased disease burden. African American women (AAW) experience greater prevalence of chronic diseases and fewer benefits from weight loss interventions compared to White women. Purpose: To examine how theoretical constructs were associated with lifestyle behaviors and weight outcomes in the Better Me Within (BMW) Randomized Trial. Methods: BMW used a tailored diabetes prevention program implemented in churches among AAW with BMI ≥ 25. Regression models assessed relationships between constructs (self-efficacy, social support and motivation), and outcomes (physical activity (PA), calories, and weight). Results: Among 221 AAW (mean (SD) age 48.8 years (11.2); mean weight 215.1 pounds (50.5), several significant relationships were found including an association between change in motivation for activity and change in PA (p=.003), and change in motivation for diet and weight at follow-up (p=<.001). Discussion: The clearest relationships emerged for PA with motivation for activity and weight management social support demonstrating significance in all models. Translation to Practice: Self-efficacy, motivation and social support show promise to promote changes in PA and weight among church-going AAW. Opportunities to keep engaging AAW in research are essential for eliminating health inequities in this population.

Culinary Medicine eConsults Pair Nutrition and Medicine: A Feasibility Pilot.

The global impact of diet-sensitive disease demands innovative nutrition education for health professionals and widespread, reimbursable clinical models to apply nutrition to practice. Interprofessional collaboration across disciplines and the optimization of emerging telemedicine consultation strategies, including electronic consultation (eConsult), merge to deliver vital innovation in the delivery of nutrition-based clinical care. Aligning with an existing eConsult infrastructure in the institutional electronic health record (EHR), a physician-dietitian team developed a novel Culinary Medicine eConsult. During a pilot phase, the service was introduced to primary care clinicians, and a response algorithm for eConsults was created. During the 12-month pilot phase, the Culinary Medicine team completed 25 eConsults from 11 unique primary care clinicians with a 76% (19/25) insurance reimbursement rate. Topics varied from dietary strategies for preventing and managing common metabolic diseases to specific dietary influences on microbiome health and disease flares. Requesting clinicians reported time saved in their clinic encounters and high patient satisfaction with expert nutrition guidance. EConsults in Culinary Medicine promote the integration of interprofessional nutrition care into existing clinical structures and empower enhanced access to the vital domain of dietary health. EConsults deliver timely answers to clinical questions and create opportunities for further innovation in care delivery as communities, health systems, and payors seek solutions to the growing burden of diet-sensitive diseases.

Engagement With Tailored Physical Activity Content: Secondary Findings From the Families Improving Together for Weight Loss Randomized Controlled Trial.

BACKGROUND: Web-based tailored interventions offer rich opportunities for improved access to and personalization of behavioral interventions. However, despite the promise of this approach, the engagement and underrepresentation of minority groups remain major issues. OBJECTIVE: This study evaluated whether engagement (log-in status and log-in duration) with different types of tailored behavioral content from the Families Improving Together for weight loss web-based intervention was associated with changes in moderate to vigorous physical activity (MVPA) among African American families with overweight or obesity. METHODS: Parent-adolescent dyads were randomized to a web-based tailored intervention or web-based health education comparison program. The web-based intervention (N=119) was completed by parents and targeted 6 weight-related behaviors to support their adolescent children's weight loss goals (session contents included energy balance, fast food, fruits and vegetables, physical activity [PA], sedentary behavior, and sweetened beverages). MVPA was measured using accelerometers at baseline and after the intervention. RESULTS: Using a hierarchical approach, the log-in status and duration for each web-based session were used to evaluate the additive effects of engagement with different types of tailored behavioral content on MVPA after the web-based intervention. Among parents, logging in to the PA session was not associated with greater MVPA (B=-12.561, 95% CI -18.759 to -6.367), but MVPA increased with greater log-in duration for the PA (B=0.008, 95% CI 0.004-0.012) and sedentary behavior (B= 0.008, 95% CI 0.004-0.012) sessions. These results suggest that parents who logged in to the PA session had lower MVPA, but MVPA increased with greater log-in duration for the PA and sedentary behavior sessions. These associations remained even after accounting for engagement with other content sessions. However, these engagement effects did not translate to the adolescents. CONCLUSIONS: The results of this study highlight the need to disentangle the impact of engagement with different tailored content to improve the efficacy of tailored web-based interventions, especially for promoting PA in African American families. TRIAL REGISTRATION: ClinicalTrials.gov NCT01796067; https://clinicaltrials.gov/ct2/show/NCT01796067.

Factors Associated With Long COVID Symptoms in an Online Cohort Study.

Background: Few prospective studies of Long COVID risk factors have been conducted. The purpose of this study was to determine whether sociodemographic factors, lifestyle, or medical history preceding COVID-19 or characteristics of acute severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are associated with Long COVID. Methods: In March 26, 2020, the COVID-19 Citizen Science study, an online cohort study, began enrolling participants with longitudinal assessment of symptoms before, during, and after SARS-CoV-2 infection. Adult participants who reported a positive SARS-CoV-2 test result before April 4, 2022 were surveyed for Long COVID symptoms. The primary outcome was at least 1 prevalent Long COVID symptom greater than 1 month after acute infection. Exposures of interest included age, sex, race/ethnicity, education, employment, socioeconomic status/financial insecurity, self-reported medical history, vaccination status, variant wave, number of acute symptoms, pre-COVID depression, anxiety, alcohol and drug use, sleep, and exercise. Results: Of 13 305 participants who reported a SARS-CoV-2 positive test, 1480 (11.1%) responded. Respondents' mean age was 53 and 1017 (69%) were female. Four hundred seventy-six (32.2%) participants reported Long COVID symptoms at a median 360 days after infection. In multivariable models, number of acute symptoms (odds ratio [OR], 1.30 per symptom; 95% confidence interval [CI], 1.20-1.40), lower socioeconomic status/financial insecurity (OR, 1.62; 95% CI, 1.02-2.63), preinfection depression (OR, 1.08; 95% CI, 1.01-1.16), and earlier variants (OR = 0.37 for Omicron compared with ancestral strain; 95% CI, 0.15-0.90) were associated with Long COVID symptoms. Conclusions: Variant wave, severity of acute infection, lower socioeconomic status, and pre-existing depression are associated with Long COVID symptoms.

Factors Associated with Long Covid Symptoms in an Online Cohort Study.

Importance: Prolonged symptoms following SARS-CoV-2 infection, or Long COVID, is common, but few prospective studies of Long COVID risk factors have been conducted. Objective: To determine whether sociodemographic factors, lifestyle, or medical history preceding COVID-19 or characteristics of acute SARS-CoV-2 infection are associated with Long COVID. Design: Cohort study with longitudinal assessment of symptoms before, during, and after SARS-CoV-2 infection, and cross-sectional assessment of Long COVID symptoms using data from the COVID-19 Citizen Science (CCS) study. Setting: CCS is an online cohort study that began enrolling March 26, 2020. We included data collected between March 26, 2020, and May 18, 2022. Participants: Adult CCS participants who reported a positive SARS-CoV-2 test result (PCR, Antigen, or Antibody) more than 30 days prior to May 4, 2022, were surveyed. Exposures: Age, sex, race/ethnicity, education, employment, socioeconomic status/financial insecurity, self-reported medical history, vaccination status, time of infection (variant wave), number of acute symptoms, pre-COVID depression, anxiety, alcohol and drug use, sleep, exercise. Main Outcome: Presence of at least 1 Long COVID symptom greater than 1 month after acute infection. Sensitivity analyses were performed considering only symptoms beyond 3 months and only severe symptoms. Results: 13,305 participants reported a SARS-CoV-2 positive test more than 30 days prior, 1480 (11.1% of eligible) responded to a survey about Long COVID symptoms, and 476 (32.2% of respondents) reported Long COVID symptoms (median 360 days after infection).Respondents' mean age was 53 and 1017 (69%) were female. Common Long COVID symptoms included fatigue, reported by 230/476 (48.3%), shortness of breath (109, 22.9%), confusion/brain fog (108, 22.7%), headache (103, 21.6%), and altered taste or smell (98, 20.6%). In multivariable models, number of acute COVID-19 symptoms (OR 1.30 per symptom, 95%CI 1.20-1.40), lower socioeconomic status/financial insecurity (OR 1.62, 95%CI 1.02-2.63), pre-infection depression (OR 1.08, 95%CI 1.01-1.16), and earlier variants (OR 0.37 for Omicron compared to ancestral strain, 95%CI 0.15-0.90) were associated with Long COVID symptoms. Conclusions and Relevance: Variant wave, severity of acute infection, lower socioeconomic status and pre-existing depression are associated with Long COVID symptoms. Key Points: Question: What are the patterns of symptoms and risk factors for Long COVID among SARS-CoV-2 infected individuals?Findings: Persistent symptoms were highly prevalent, especially fatigue, shortness of breath, headache, brain fog/confusion, and altered taste/smell, which persisted beyond 1 year among 56% of participants with symptoms; a minority of participants reported severe Long COVID symptoms. Number of acute symptoms during acute SARS-CoV-2 infection, financial insecurity, pre-existing depression, and infection with earlier variants are associated with prevalent Long COVID symptoms independent of vaccination, medical history, and other factors.Meaning: Severity of acute infection, SARS-CoV-2 variant, and financial insecurity and depression are associated with Long COVID symptoms.

The U.S. COVID-19 County Policy Database: a novel resource to support pandemic-related research.

BACKGROUND: It is increasingly recognized that policies have played a role in both alleviating and exacerbating the health and economic consequences of the COVID-19 pandemic. There has been limited systematic evaluation of variation in U.S. local COVID-19-related policies. This study introduces the U.S. COVID-19 County Policy (UCCP) Database, whose objective is to systematically gather, characterize, and assess variation in U.S. county-level COVID-19-related policies. METHODS: In January-March 2021, we collected an initial wave of cross-sectional data from government and media websites for 171 counties in 7 states on 22 county-level COVID-19-related policies within 3 policy domains that are likely to affect health: (1) containment/closure, (2) economic support, and (3) public health. We characterized the presence and comprehensiveness of policies using univariate analyses. We also examined the correlation of policies with one another using bivariate Spearman's correlations. Finally, we examined geographical variation in policies across and within states. RESULTS: There was substantial variation in the presence and comprehensiveness of county policies during January-March 2021. For containment and closure policies, the percent of counties with no restrictions ranged from 0% (for public events) to more than half for public transportation (67.8%), hair salons (52.6%), and religious gatherings (52.0%). For economic policies, 76.6% of counties had housing support, while 64.9% had utility relief. For public health policies, most were comprehensive, with 70.8% of counties having coordinated public information campaigns, and 66.7% requiring masks outside the home at all times. Correlations between containment and closure policies tended to be positive and moderate (i.e., coefficients 0.4-0.59). There was variation within and across states in the number and comprehensiveness of policies. CONCLUSIONS: This study introduces the UCCP Database, presenting granular data on local governments' responses to the COVID-19 pandemic. We documented substantial variation within and across states on a wide range of policies at a single point in time. By making these data publicly available, this study supports future research that can leverage this database to examine how policies contributed to and continue to influence pandemic-related health and socioeconomic outcomes and disparities. The UCCP database is available online and will include additional time points for 2020-2021 and additional counties nationwide.

Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension.

RATIONALE AND OBJECTIVE: APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease. STUDY DESIGN: Multicenter, pragmatic, randomized controlled clinical trial. SETTING AND PARTICIPANTS: 6650 individuals with African ancestry and hypertension from 13 health systems. INTERVENTION: APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use. OUTCOMES: Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months. RESULTS: To date, the trial has enrolled 3423 participants. CONCLUSIONS: The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record. TRIAL REGISTRATION: ClinicalTrials.govNCT04191824.

Integrating Population Health Strategies into Primary Care: Impact on Outcomes and Hospital Use for Low-Income Adults.

Objective: Our objectives were two-fold: 1) To evaluate the benefits of population health strategies focused on social determinants of health and integrated into the primary care medical home (PCMH) and 2) to determine how these strategies impact diabetes and cardiovascular disease outcomes among a low-income, primarily minority community. We also investigated associations between these outcomes and emergency department (ED) and inpatient (IP) use and costs. Design: Retrospective cohort. Setting: Community-based PCMH: Baylor Scott & White Health and Wellness Center (BSW HWC). Patients/Participants: All patients who attended at least two primary care visits at BSW HWC within a 12-month time span from 2011-2015. Methods: Outcomes for patients participating in PCMH only (PCMH) as compared to PCMH plus population health services (PCMH+PoPH) were compared using electronic health record data. Main Outcomes: Diastolic and systolic blood pressure, hemoglobin A1c, ED visits and costs, and IP hospitalizations and costs were examined. Results: From 2011-2015, 445 patients (age=46±12 years, 63% African American, 61% female, 69.5% uninsured) were included. Adjusted regression analyses indicated PCMH+PoPH had greater improvement in diabetes outcomes (prediabetes HbA1c= -.65[SE=.32], P=.04; diabetes HbA1c= -.74 [SE=.37], P<.05) and 37% lower ED costs than the PCMH group (P=.01). Worsening chronic disease risk factors was associated with 39% higher expected ED visits (P<.01), whereas improved chronic disease risk was associated with 32% fewer ED visits (P=.04). Conclusions: Integrating population health services into the PCMH can improve chronic disease outcomes, and impact hospital utilization and cost in un- or under-insured populations.

Effect of Comprehensive Multi-Provider Primary Care Visits in Type 2 Diabetes Management in a Primarily Uninsured, Ethnic Minority Population: The Comprehensive Care Initiative (CCI) Program.

The Comprehensive Care Initiative (CCI) utilized a quasi-experimental design to evaluate the effects of same room, multi-provider primary care visits on the management of type 2 diabetes (T2D). Patients with T2D were invited to enroll in CCI if they had T2D with glycated hemoglobin (HbA1c) >8.0% or T2D with BMI >30. CCI intervention included delivery of comprehensive same room multi-provider visits with a primary care physician, community health worker, pharmacist, dietitian, medical assistant, and licensed social worker at the same appointment. CCI patients were compared with a propensity score matched control group receiving usual care (n = 56, 50 ± 11 years old, 77% female, 41% African American, 95% uninsured). After 6 months, the adjusted average reduction in HbA1c in the CCI group was 0.97% (SE = 0.45) in comparison to 0.05% (SE = 0.20) in the control group (P = .04). This pilot study showed promising results in lowering HbA1c in an uninsured, ethnic minority population of T2D patients through delivery of comprehensive multi-provider primary care visits.

The Results of the Families Improving Together (FIT) for Weight Loss Randomized Trial in Overweight African American Adolescents.

BACKGROUND: Few intervention studies have integrated cultural tailoring, parenting, behavioral, and motivational strategies to address African American adolescent weight loss. PURPOSE: The Families Improving Together (FIT) for Weight Loss trial was a randomized group cohort study testing the efficacy of a cultural tailoring, positive parenting, and motivational intervention for weight loss in overweight African American adolescents (N = 241 adolescent/caregiver dyads). METHODS: The trial tested an 8-week face-to-face group motivational plus family weight loss program (M + FWL) compared with a comprehensive health education control program. Participants were then rerandomized to an 8-week tailored or control online program to test the added effects of the online intervention on reducing body mass index and improving physical activity (moderate-to-vigorous physical activity [MVPA], light physical activity [LPA]), and diet. RESULTS: There were no significant intervention effects for body mass index or diet. There was a significant effect of the group M + FWL intervention on parent LPA at 16 weeks (B = 33.017, SE = 13.115, p = .012). Parents in the group M + FWL intervention showed an increase in LPA, whereas parents in the comprehensive health education group showed a decrease in LPA. Secondary analyses using complier average causal effects showed a significant intervention effect at 16 weeks for parents on MVPA and a similar trend for adolescents. CONCLUSIONS: While the intervention showed some impact on physical activity, additional strategies are needed to impact weight loss among overweight African American adolescents.

Embedded Health Systems Science as a driver of care improvement within an integrated delivery organization.

BACKGROUND: Embedded Health Systems Science (HSS) has the potential to reduce gaps between research and delivery of evidence-based medicine. Models are needed to guide the development of embedded HSS in health care delivery organizations particularly with the rise of value-based care. METHODS: The development of HSS infrastructure at a large nonprofit health care delivery organization is described, along with an embedded HSS diabetes study to illustrate the integration of program specific data, electronic health records, and health care system data infrastructure. To compare diabetes outcomes across four evidenced-based programs, a control group was developed from EHR data using propensity score matching. Mixed effect adjusted models were used to estimate reductions in hemoglobin A1c (HbA1c) and body weight. RESULTS: Adjusted analyses using an EHR derived comparison group demonstrated significantly different findings than unadjusted pre to post analyses. The embedded HSS study indicates that appropriate statistical methods, staff with required expertise, and integration with health system data infrastructure are needed to develop timely and rigorous HSS outcomes that effectively improve patient care. CONCLUSIONS: Embedded HSS has the potential to inform value-based care models and contribute to evidence-based medicine approaches that improve patient care. Although developing system wide integrated data structures and staff with the appropriate skills requires substantial effort, the outcome is more reliable evaluations that lead to higher quality and higher value care. IMPLICATIONS: Health care delivery organizations can improve patient care by dedicating resources to embed HSS into its routine operations.

Working with communities: Meeting the health needs of those living in vulnerable communities when Primary Health Care and Universal Health Care are not available.

RATIONALE, AIMS, AND OBJECTIVES: The health care delivery model in the United States does not work; it perpetuates unequal access to care, favours treatment over prevention, and contributes to persistent health disparities and lack of insurance. The vast majority of those who suffer from preventable diseases and health disparities, and who are at greatest risk of not having insurance, are low-income minorities (Native Americans, Hispanics, and African-Americans) who live in high risk and vulnerable communities. The historical lack of support in the United States for Universal Health Care (UHC) and Primary Health Care (PHC)-with their emphasis on health care for all, population health, and social determinants of health-requires community health scientists to develop innovative local solutions for addressing unmet community health needs. METHODS: We developed a model community health science approach for improving health in fragile communities, by combining community-oriented primary care (COPC), community-based participatory research (CBPR), asset-based community development, and service learning principles. During the past two decades, our team has collaborated with community residents, local leaders, and many different types of organizations, to address the health needs of vulnerable patients. The approach defines health as a social outcome, resulting from a combination of clinical science, collective responsibility, and informed social action. RESULTS: From 2000 to 2020, we established a federally funded research programme for testing interventions to improve health outcomes in vulnerable communities, by working in partnership with community organizations and other stakeholders. The partnership goals were reducing chronic disease risk and multimorbidity, by stimulating lifestyle changes, increasing healthy behaviours and health knowledge, improving care seeking and patient self-management, and addressing the social determinants of health and population health. Our programmes have also provided structured community health science training in high-risk communities for hundreds of doctors in training. CONCLUSION: Our community health science approach demonstrates that the factors contributing to health can only be addressed by working directly with and in affected communities to co-develop health care solutions across the broad range of causal factors. As the United States begins to consider expanding health care options consistent with PHC and UHC principles, our community health science experience provides useful lessons in how to engage communities to address the deficits of the current system. Perhaps the greatest assets US health care systems have for better addressing population health and the social determinants of health are the important health-related initiatives already underway in most local communities. Building partnerships based on local resources and ongoing social determinants of health initiatives is the key for medicine to meaningfully engage communities for improving health outcomes and reducing health disparities. This has been the greatest lesson we have learned the past two decades, has provided the foundation for our community health science approach, and accounts for whatever success we have achieved.

Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women.

PURPOSE: Previous DPP translations in African American women have been suboptimal. This trial evaluated a community-based participatory research developed faith-based diabetes prevention program (DPP) to improve weight loss in African American women. DESIGN: This cluster randomized trial allocated churches to faith-based (FDPP) or standard (SDPP) DPP interventions. Setting. African American churches. Subjects. Eleven churches with 221 African American women (aged 48.8 ± 11.2 years, BMI = 36.7 ± 8.4) received the FDPP (n = 6) or SDPP (n = 5) intervention. INTERVENTION: FDPP incorporated 5 faith-based components, including pastor involvement, into the standard DPP curriculum. The SDPP used the standard DPP curriculum. Lay health leaders facilitated interventions at church sites. MEASURES: Weight and biometrics were collected by blinded staff at baseline, 4- and 10-months. ANALYSIS: A multilevel hierarchical regression model compared the FDPP and SDPP groups on outcomes. RESULTS: FDPP and SDPP churches significantly lost weight at 10-months (overall -2.6%, p < .01). Women in FDPP churches who attended at least 15 sessions lost an additional 6.1 pounds at 4-months compared to SDPP corresponding to a 5.8% reduction at 10-months (p < .05). Both groups had significant improvements in health behaviors and biometrics. CONCLUSIONS: Faith-based and standard DPP interventions led by lay health leaders successfully improved weight, health behaviors, and chronic disease risk. However, the faith-based DPP when fully implemented met the CDC's recommendation for weight loss for diabetes prevention in African American women.

Methods to identify and prioritize research projects and perform embedded research in learning healthcare systems.

BACKGROUND: The Embedded Healthcare Research Conference aimed to promote and enhance research-operations partnerships in diverse health care settings. Within this conference, the Priorities and Methods Workgroup set out to define a vision of embedded research that leverages diverse methods to address clearly articulated research questions of importance to health systems. METHODS: The Workgroup session involved a combination of small and large group discussions around three broadly focused topics: the integration of embedded research within the existing quality improvement (QI) ecosystem; the identification, prioritization and formulation of embedded research questions; the creation of an embedded research "tool kit." RESULTS: Workgroup participants envisioned a future for embedded research that is characterized by authentic engagement between researchers and health system leaders; seamless integration between research, QI and clinical operations; clear and explicit articulation of research questions; an appropriate balance between rigor and relevance in applied methodology; alignment between study design, available resources and the importance of the knowledge to be gained; efficient processes; and bi-directional communication. Important barriers to achieving this vision include limited access to executive leaders, silos that discourage integration of research and QI, generally low tolerance for disruption in high-risk clinical settings, limited access to data, and limited availability of researchers with requisite skills and training. CONCLUSIONS: Embedded research holds potential to enhance the relevance, value and use of research, while also creating generalizable knowledge. Key recommendations include building authentic relationships, discouraging silos, encouraging innovation and experimentation, and expanding opportunities for funding research in delivery systems.

Reducing metabolic syndrome through a community-based lifestyle intervention in African American women.

BACKGROUND AND AIMS: Metabolic syndrome (MetS) increases the risk of cardiovascular disease and type 2 diabetes. Despite a higher prevalence of MetS in African American (AA) women, little is known about the effectiveness of lifestyle interventions in improving metabolic markers in this high-risk group. This study investigated the effectiveness of a community-based lifestyle intervention delivered by lay health coaches in reducing MetS among AA women. METHODS AND RESULTS: A cluster-randomized diabetes prevention program (DPP) was implemented in 11 churches utilizing a community-based participatory research (CBPR) approach to develop and deliver the interventions. A total of 221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study. The prevalence of MetS was 42.08% before receiving the DPP intervention and 31.22% after the intervention that represented a 10.86% absolute reduction and a 25.81% relative reduction from baseline. The adjusted odds ratio (OR) of being free from MetS at post-intervention in contrast to baseline was 2.14 (p = 0.02). Factors that increased the odds of being free from MetS were younger age, reduction in intake of total calories, total fat, saturated and trans-fat, and dietary sodium. CONCLUSION: A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese. Findings from this study can be used to translate evidence into public health programs at the community level for the prevention of type 2 diabetes and cardiovascular disease. CLINICAL TRIAL REGISTRATION NUMBER: NCT04082702 (www.clinicaltrials.gov).

A population health dietary intervention for African American adults with chronic kidney disease: The Fruit and Veggies for Kidney Health randomized study.

BACKGROUND: Chronic kidney disease (CKD) is commonly asymptomatic until its late stages, reduces life quality and length, is costly to manage, and is disproportionately prevalent in low-income, African American (AA) communities. Traditional health system strategies that engage only patients with symptomatic CKD limit opportunities to prevent progression to end stage kidney disease (ESKD) with the need for expensive kidney replacement therapy and to reduce risk for their major mortality cause, cardiovascular disease (CVD). Published studies show that giving fruits and vegetables (F&V) to AA with early-stage CKD along with preparation instructions slowed CKD progression. This effective, evidenced-based, and potentially scalable dietary intervention might be a component of a community-based strategy to prevent CKD progression. DESIGN: This study supported by NIH grant (R21DK113440) will test the feasibility of an innovative screening strategy conducted at community-based institutions in low-income AA communities and the ability to intervene in individuals identified to have CKD and increased CVD risk with F&V, with or without preparation instructions. OBJECTIVES: The study will prospectively compare changes in urine indices predictive of CKD progression and CVD in participants receiving, compared to those not receiving, preparation instructions along with F&V, six months after the intervention. DISCUSSION: Addressing the challenge of increasing progression of early to more advanced stages of CKD with its increased CVD risk requires development of effective strategies to screen, identify, and intervene with individuals found to have CKD with effective, comparatively inexpensive, community-based, and scalable strategies to prevent CKD progression, particularly in low-income, AA communities.

Families Improving Together (FIT) for weight loss: a resource for translation of a positive climate-based intervention into community settings.

Climate-based weight loss interventions, or those that foster a nurturing family environment, address important ecological influences typically ignored by the traditional biomedical treatments. Promoting a climate characterized by positive communication, autonomy support, and parental warmth supports adolescents in making healthy behavioral changes. In addition, encouraging these skills within the family may have additional benefits of improved family functioning and other mental and physical health outcomes. Although several programs have identified essential elements and established the evidence base for the efficacy of these interventions, few have offered resources for the translation of these constructs from theoretical concepts to tangible practice. This paper provides strategies and resources utilized in the Families Improving Together (FIT) for weight loss randomized controlled trial to create a warm, supportive climate characterized by positive communication within the parent-child relationship. Detailed descriptions of how Project FIT emphasized these constructs through facilitator training, intervention curriculum, and process evaluation are provided as a resource for clinical and community interventions. Researchers are encouraged to provide resources to promote translation of evidence-based interventions for programs aiming to utilize a positive climate-based family approach for lifestyle modification.