Changes in coffee and caffeine intake during the pandemic in women smokers and non-smokers: a future challenge for cardiovascular prevention.

BACKGROUND: The recent pandemic has led to major lifestyle changes, especially in women, changes that will impact cardiovascular risk. The aim of the present observational study was to evaluate changes occurred during pandemic in coffee and caffeine intake in a group of adult women and compare changes in smoking versus non-smoking women. METHODS: A web questionnaire was sent through a online survey platform to a group of unselected adult women. The consumption of coffee and caffeine were investigated in 2 groups of women by comparing smokers and non-smokers. RESULTS: A total of 435 adult women (256 non-smokers and 179 smokers) answer to all questions. Smokers increase the number of cigarette/days (mean + 3.4 cig/day). Coffee intake was significantly increase in smokers compared to non-smokers (3.1+1.0 versus 1.5+0.6 cups/day p<0.01). In smokers, self-perception of increase stress was related to increased coffee intake (r = 0.84; p <0.001), increased sugar- rich foods (r=0.81; p<0.001), increased chocolate rich snacks (r=0.72; p<0.01), increased sitting time (r=0.79; p<0.01). CONCLUSIONS: These preliminary data must suggest to undertake social campaigns aimed at encouraging a return to a healthy lifestyle that certainly includes a healthy diet but also the suspension of smoking. These observational results need further evaluation with prospective studies in order to quantify the effects of pandemic-induced changes in lifestyle on cardiovascular risk in women.

The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk: a study protocol.

INTRODUCTION: India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM). This is predicted to increase to 124.9 million by 2045. In combination with controlling blood glucose levels among those with T2DM, preventing the onset of diabetes among those at high risk of developing it is essential. Although many diabetes prevention interventions have been implemented in resource-limited settings in recent years, there is limited evidence about their long-term effectiveness, cost-effectiveness, and sustainability. Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. OBJECTIVES: The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). Specific aims are 1) to measure the long-term effectiveness of K-DPP on diabetes incidence and cardiometabolic risk after nine years from participant recruitment; 2) to assess retinal microvasculature, microalbuminuria, and ECG abnormalities and their association with cardiometabolic risk factors over nine years of the intervention; 3) to evaluate the long-term cost-effectiveness and return on investment of the K-DPP; and 4) to assess the sustainability of community engagement, peer-support, and other related community activities after nine years. METHODS: The nine-year follow-up study aims to reach all 1007 study participants (500 intervention and 507 control) from 60 randomized polling areas recruited to the original trial. Data are being collected in two phases. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. All data collection is being conducted by trained Nurses. The primary outcome is the incidence of T2DM. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Analysis of the long-term cost-effectiveness of the intervention is planned. DISCUSSION: Findings from this follow-up study will contribute to improved policy and practice regarding the long-term effects of lifestyle interventions for diabetes prevention in India and other resource-limited settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry-(updated from the original trial)ACTRN12611000262909; India: CTRI/2021/10/037191.

Prevalence of Statin Use for Primary Prevention of Atherosclerotic Cardiovascular Disease by Race, Ethnicity, and 10-Year Disease Risk in the US: National Health and Nutrition Examination Surveys, 2013 to March 2020.

Importance: The burden of atherosclerotic cardiovascular disease (ASCVD) in the US is higher among Black and Hispanic vs White adults. Inclusion of race in guidance for statin indication may lead to decreased disparities in statin use. Objective: To evaluate prevalence of primary prevention statin use by race and ethnicity according to 10-year ASCVD risk. Design, Setting, and Participants: This serial, cross-sectional analysis performed in May 2022 used data from the National Health and Nutrition Examination Survey, a nationally representative sample of health status in the US, from 2013 to March 2020 (limited cycle due to the COVID-19 pandemic), to evaluate statin use for primary prevention of ASCVD and to estimate 10-year ASCVD risk. Participants aged 40 to 75 years without ASCVD, diabetes, low-density lipoprotein cholesterol levels 190 mg/dL or greater, and with data on medication use were included. Exposures: Self-identified race and ethnicity (Asian, Black, Hispanic, and White) and 10-year ASCVD risk category (5%-<7.5%, 7.5%-<20%, ≥20%). Main Outcomes and Measures: Prevalence of statin use, defined as identification of statin use on pill bottle review. Results: A total of 3417 participants representing 39.4 million US adults after applying sampling weights (mean [SD] age, 61.8 [8.0] years; 1289 women [weighted percentage, 37.8%] and 2128 men [weighted percentage, 62.2%]; 329 Asian [weighted percentage, 4.2%], 1032 Black [weighted percentage, 12.7%], 786 Hispanic [weighted percentage, 10.1%], and 1270 White [weighted percentage, 73.0%]) were included. Compared with White participants, statin use was lower in Black and Hispanic participants and comparable among Asian participants in the overall cohort (Asian, 25.5%; Black, 20.0%; Hispanic, 15.4%; White, 27.9%) and within ASCVD risk strata. Within each race and ethnicity group, a graded increase in statin use was observed across increasing ASCVD risk strata. Statin use was low in the highest risk stratum overall with significantly lower rates of use among Black (23.8%; prevalence ratio [PR], 0.90; 95% CI, 0.82-0.98 vs White) and Hispanic participants (23.9%; PR, 0.90; 95% CI, 0.81-0.99 vs White). Among other factors, routine health care access and health insurance were significantly associated with higher statin use in Black, Hispanic, and White adults. Prevalence of statin use did not meaningfully change over time by race and ethnicity or by ASCVD risk stratum. Conclusions and Relevance: In this study, statin use for primary prevention of ASCVD was low among all race and ethnicity groups regardless of ASCVD risk, with the lowest use occurring among Black and Hispanic adults. Improvements in access to care may promote equitable use of primary prevention statins in Black and Hispanic adults.

Systems science approaches to cardiovascular disease prevention and management in the era of COVID-19: A Humpty-Dumpty dilemma?

The coronavirus disease 2019 (COVID-19) pandemic necessitated the implementation and prioritizing of strict public health strategies to mitigate COVID-19 transmission and infection over all else. As we enter a 'recovery' phase in which the impact of the virus recedes (but does not relent), we ask, "How do we develop a game plan that considers prevention over management of public health threats of a more chronic nature, including cardiovascular disease?" We frame this choice point as a "Humpty-Dumpty" moment for public health with enduring and potentially irreversible consequences. Citing clear examples of other public health successes and failures, we outline in detail how sustaining cardiovascular population health under complex post-pandemic conditions will necessitate decision-making to be informed with a systems science approach, in which interventions, goals, outcomes and features of complex systems are carefully aligned.

Participant recruitment, baseline characteristics and at-home-measurements of cardiometabolic risk markers: insights from the Supreme Nudge parallel cluster-randomised controlled supermarket trial.

BACKGROUND: Recruiting participants for lifestyle programmes is known to be challenging. Insights into recruitment strategies, enrolment rates and costs are valuable but rarely reported. We provide insight into the costs and results of used recruitment strategies, baseline characteristics and feasibility of at-home cardiometabolic measurements as part of the Supreme Nudge trial investigating healthy lifestyle behaviours. This trial was conducted during the COVID-19 pandemic, requiring a largely remote data collection approach. Potential sociodemographic differences were explored between participants recruited through various strategies and for at-home measurement completion rates. METHODS: Participants were recruited from socially disadvantaged areas around participating study supermarkets (n = 12 supermarkets) across the Netherlands, aged 30-80 years, and regular shoppers of the participating supermarkets. Recruitment strategies, costs and yields were logged, together with completion rates of at-home measurements of cardiometabolic markers. Descriptive statistics are reported on recruitment yield per used method and baseline characteristics. We used linear and logistic multilevel models to assess the potential sociodemographic differences. RESULTS: Of 783 recruited, 602 were eligible to participate, and 421 completed informed consent. Most included participants were recruited via letters/flyers at home (75%), but this strategy was very costly per included participant (89 Euros). Of paid strategies, supermarket flyers were the cheapest (12 Euros) and the least time-invasive (< 1 h). Participants who completed baseline measurements (n = 391) were on average 57.6 (SD 11.0) years, 72% were female and 41% had high educational attainment, and they often completed the at-home measurements successfully (lipid profile 88%, HbA1c 94%, waist circumference 99%). Multilevel models suggested that males tended to be recruited more often via word-of-mouth (ORfemales 0.51 (95%CI 0.22; 1.21)). Those who failed the first attempt at completing the at-home blood measurement were older (ß 3.89 years (95% CI 1.28; 6.49), whilst the non-completers of the HbA1c (ß - 8.92 years (95% CI - 13.62; - 4.28)) and LDL (ß - 3.19 years (95% CI - 6.53; 0.09)) were younger. CONCLUSIONS: Supermarket flyers were the most cost-effective paid strategy, whereas mailings to home addresses recruited the most participants but were very costly. At-home cardiometabolic measurements were feasible and may be useful in geographically widespread groups or when face to face contact is not possible. TRIAL REGISTRATION: Dutch Trial Register ID NL7064, 30 May 2018, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7302.

Pneumonia-Induced Inflammation, Resolution and Cardiovascular Disease: Causes, Consequences and Clinical Opportunities.

Pneumonia is inflammation in the lungs, which is usually caused by an infection. The symptoms of pneumonia can vary from mild to life-threatening, where severe illness is often observed in vulnerable populations like children, older adults, and those with preexisting health conditions. Vaccines have greatly reduced the burden of some of the most common causes of pneumonia, and the use of antimicrobials has greatly improved the survival to this infection. However, pneumonia survivors do not return to their preinfection health trajectories but instead experience an accelerated health decline with an increased risk of cardiovascular disease. The mechanisms of this association are not well understood, but a persistent dysregulated inflammatory response post-pneumonia appears to play a central role. It is proposed that the inflammatory response during pneumonia is left unregulated and exacerbates atherosclerotic vascular disease, which ultimately leads to adverse cardiac events such as myocardial infarction. For this reason, there is a need to better understand the inflammatory cross talk between the lungs and the heart during and after pneumonia to develop therapeutics that focus on preventing pneumonia-associated cardiovascular events. This review will provide an overview of the known mechanisms of inflammation triggered during pneumonia and their relevance to the increased cardiovascular risk that follows this infection. We will also discuss opportunities for new clinical approaches leveraging strategies to promote inflammatory resolution pathways as a novel therapeutic target to reduce the risk of cardiac events post-pneumonia.

The effect of SGLT2 inhibitors, GLP1 agonists, and their sequential combination on cardiometabolic parameters: A randomized, prospective, intervention study.

BACKGROUND: Pulse wave velocity (PWV) and augmentation index (AIx) are indices used to assess arterial stiffness. We aim to compare the effect of empagliflozin, liraglutide and their sequential combination on arterial stiffness indices in patients with type 2 diabetes (T2D). METHODS: This was a randomized single blind study evaluating the effect of empagliflozin vs liraglutide in adult patients with T2D. Patients were randomized to liraglutide titrated gradually to 1.8 mg or empagliflozin 25 mg in 1:1 ratio. Three months later empagliflozin was added to the liraglutide group, and liraglutide was added to the empagliflozin group. Patients were assessed with non-invasive tests for arterial stiffness (i.e., carotid-femoral PWV and AIx of aortic pressure) at baseline, 3-month and 9-month visits (final visit was extended for 3 months from the initial design due to Covid 19 pandemic). The primary outcome was the between-group difference of PWV change (ΔPWV) and ΔAIx at 3 months. Secondary outcomes included the between-group difference of ΔPWV and ΔAIx at 9 months, as well as the ΔPWV and ΔAIx between baseline and 9-month visit when total study population was assessed. RESULTS: A total of 62 patients with T2D (30 started liraglutide; 32 empagliflozin, mean age 63 years, 25 % with established cardiovascular disease) participated in the study. We failed to show any significant between-group differences of ΔPWV and ΔΑΙx at 3 and 9 months, as well as between-group difference of ΔPWV and ΔAIx for the total study population between baseline and 9-month visit. In contrast, systemic vascular resistance and lipoprotein(a) levels improved, showing better results with liraglutide than empagliflozin. Favorable effects were also observed on body weight, body mass index, body and visceral fat, blood pressure, HbA1c, and uric acid levels. CONCLUSION: No evidence of a favorable change in arterial stiffness indices was seen with empagliflozin or liraglutide or their combination in this study. Well-designed powerful studies are needed to address any potential effects on arterial stiffness in selected populations.

Understanding factors affecting implementation success and sustainability of a comprehensive prevention program for cardiovascular disease in primary health care: a qualitative process evaluation study combining RE-AIM and CFIR.

AIM: Our aim was to evaluate the implementation process of a comprehensive cardiovascular disease prevention program in general practice, to enhance understanding of influencing factors to implementation success and sustainability, and to learn how to overcome barriers. BACKGROUND: Cardiovascular disease and its risk factors are the world's leading cause of mortality, yet can be prevented by addressing unhealthy lifestyle behavior. Nevertheless, the transition toward a prevention-oriented primary health care remains limited. A better understanding of factors facilitating or hindering implementation success and sustainability of prevention programs, and how barriers may be addressed, is needed. This work is part of Horizon 2020 project 'SPICES', which aims to implement validated preventive interventions in vulnerable populations. METHODS: We conducted a qualitative process evaluation with participatory action research approach of implementation in five general practices. Data were collected through 38 semi-structured individual and small group interviews with seven physicians, 11 nurses, one manager and one nursing assistant, conducted before, during, and after the implementation period. We applied adaptive framework analysis guided by RE-AIM Qualitative Evaluation for Systematic Translation (RE-AIM QuEST) and Consolidated Framework for Implementation Research (CFIR). FINDINGS: Multiple facilitators and barriers affected reach of vulnerable target populations: adoption by primary health care providers, implementation and fidelity and intention to maintain the program into routine practice. In addition, our study revealed concrete actions, linked to implementation strategies, that can be undertaken to address identified barriers. Prioritization of prevention in general practice vision, ownership, and shared responsibility of all team members, compatibility with existing work processes and systems, expanding nurse's roles and upskilling competence profiles, supportive financial and regulatory frameworks, and a strong community - health care link are crucial to increase implementation success and long-term maintenance of prevention programs. COVID-19 was a major barrier to the implementation. RE-AIM QuEST, CFIR, and participatory strategies are useful to guide implementation of prevention programs in primary health care.

The impact of the COVID-19 pandemic on cardiovascular health behaviors and risk factors: A new troubling normal that may be here to stay.

In March 2020, the Coronavirus disease 2019 (COVID-19) outbreak was officially declared a global pandemic, leading to closure of public facilities, enforced social distancing and stay-at-home mandates to limit exposures and reduce transmission rates. While the severity of this "lockdown" period varied by country, the disruptions of the pandemic on multiple facets of life (e.g., daily activities, education, the workplace) as well as the social, economic, and healthcare systems impacts were unprecedented. These disruptions and impacts are having a profound negative effect on multiple facets of behavioral health and psychosocial wellbeing that are inextricably linked to cardiometabolic health and associated with adverse outcomes of COVID-19. For example, adoption of various cardiometabolic risk behavior behaviors observed during the pandemic contributed to irretractable trends in weight gain and poor mental health, raising concerns on the possible long-term consequences of the pandemic on cardiometabolic disease risk, and vulnerabilities to future viral pandemics. The purpose of this review is to summarize the direct and indirect effects of the pandemic on cardiometabolic health risk behaviors, particularly related to poor diet quality, physical inactivity and sedentary behaviors, smoking, sleep patterns and mental health. Additional insights into how the pandemic has amplified cardiovascular risk behaviors, particularly in our most vulnerable populations, and the potential implications for the future if these modifiable risk behaviors do not become better controlled, are described.

Effect of Plant-Based Diets on Gut Microbiota: A Systematic Review of Interventional Studies.

Plant-based diets have grown increasingly popular across the globe, mainly for their health and environmental benefits. Several studies have identified a link between plant-based diets and the decreased risk of developing cardiovascular diseases, obesity, and other health issues. We systematically reviewed human interventions to identify the relationship between various plant-based food items and the gut microbiome, alongside the biochemical and anthropometric measurements as secondary findings. The study selection process was completed using the COVIDENCE platform. Overall, 203 studies were identified, of which 101 were chosen for title and abstract screening by two independent authors. Following this process, 78 studies were excluded, and the full texts and the reference lists of the remaining 23 records were reviewed using the review eligibility criteria. A manual search yielded five additional articles. In the end, 12 studies were included in the systematic review. We found evidence for short- to moderate-term beneficial effects of plant-based diets versus conventional diets (duration ≤ 13 months) on gut microbiome composition and biochemical and anthropometric measurements in healthy participants as well as obese, cardiovascular, and rheumatoid arthritis patients. However, contradictory results were observed for Enterobacteriaceae, at the family level, and for Faecalibacterium and Coprococcus, at the genus level, of gut microbiome composition. The relationship between plant-based diets and the gut microbiome, alongside their underlying metabolic and inflammatory effects, remains largely unexplored. Hence more interventional studies are needed to address these questions.

The anti-inflammatory effects of a Mediterranean diet: a review.

PURPOSE OF REVIEW: Chronic noncommunicable diseases remain the leading cause of morbidity and mortality worldwide and the majority are preventable with a healthy diet and lifestyle, but controversy remains as to the best approach. Greater adherence to a traditional Mediterranean diet has consistently been associated with lower morbidity and mortality from cardiovascular disease, diabetes and many cancers, and lower all-cause mortality. Despite the well known benefits on chronic disease risk there remains some scepticism as to the effects of this dietary pattern across populations outside the Mediterranean and the mechanisms of action of this traditional plant-based dietary pattern.This narrative review aims to summarize the latest evidence on the health protective effects of a traditional Mediterranean diet on chronic noncommunicable diseases, specifically focussing on the anti-inflammatory effects of this highly published dietary pattern. RECENT FINDINGS: Recent high-quality evidence now supports a Mediterranean diet in secondary prevention of cardiovascular disease with impacts on atherosclerosis progression, likely through reduction of systemic inflammation and irrespective of changes in cholesterol or weight. The Mediterranean diet has a low Dietary Inflammatory Index illustrating its anti-inflammatory potential. This dietary pattern beneficially modulates the gut microbiota and immune system, including emerging evidence for efficacy against severe acute respiratory syndrome coronavirus 2 (coronavirus disease 2019). Emerging evidence shows clinicians are not routinely recommending a Mediterranean diet despite well known evidence due to barriers such as lack of training, patient materials and concerns about potential patient adherence. SUMMARY: The physiological mechanisms of action of this healthy diet pattern are becoming better understood to be multisystem and involving the gut. Larger controlled trials investigating mechanistic effects in broader non-Mediterranean populations are warranted. Although reflected in therapeutic guidelines for chronic disease management worldwide there are individual, clinical practice and health system barriers to its implementation that need a multisectoral approach to address.

Implementing and Evaluating Community Health Worker-Led Cardiovascular Disease Risk Screening Intervention in Sub-Saharan Africa Communities: A Participatory Implementation Research Protocol.

The increasing burden of non-communicable diseases (NCDs), particularly cardiovascular diseases (CVD) in low- and middle-income countries (LMICs) poses a considerable threat to public health. Community-driven CVD risk screening, referral and follow-up of those at high CVDs risk is essential to supporting early identification, treatment and secondary prevention of cardiovascular events such as stroke and myocardial infarction. This protocol describes a multi-country study that aims to implement and evaluate a community health worker (CHW)-led CVD risk screening programme to enhance referral linkages within the local primary care systems in sub-Saharan Africa (SSA), using a participatory implementation science approach. The study builds upon a prior community-driven multicentre study conducted by the Collaboration for Evidence-based Health Care and Public Health in Africa (CEBHA+). This is a participatory implementation research. The study will leverage on the CVD risk citizen science pilot studies conducted in the four selected CEBHA+ project countries (viz. Ethiopia, Rwanda, Malawi, and South Africa). Through planned engagements with communities and health system stakeholders, CHWs and lay health worker volunteers will be recruited and trained to screen and identify persons that are at high risk of CVD, provide referral services, and follow-up at designated community health clinics. In each country, we will use a multi-stage random sampling to select and then screen 1000 study participants aged 35-70 years from two communities (one rural and one urban). Screening will be done using a simple validated non-laboratory-based CVD risk assessment mobile application. The RE-AIM model will be used in evaluating the project implementation outcomes, including reach, fidelity, adoption and perceived effectiveness. Developing the capacities of CHWs and lay health worker volunteers in SSA to support population-based, non-invasive population-based CVD risk prevention has the potential to impact on early identification, treatment and secondary prevention of CVDs in often under-resourced communities. Using a participatory research approach to implementing mobile phone-based CHW-led CVD risk screening, referral and follow-up in SSA will provide the evidence needed to determine the effectiveness of CVD risk screening and the potential for scaling up in the wider region.

Cardiorespiratory fitness as a vital sign of CVD risk in the COVID-19 era.

The severe health consequences of the corona virus disease 2019 (COVID-19) pandemic have been exacerbated by the prevalence of cardiovascular disease (CVD) risk factors, such as physical inactivity, obesity, hypertension, and diabetes. Further, policy decisions during the pandemic augmented unhealthy lifestyle behaviors and health inequalities, likely increasing the global disease burden. Cardiorespiratory fitness (CRF) is a well-established biomarker associated with CVD risk. Emerging data demonstrate that high CRF offers some protection against severe outcomes from COVID-19 infection, highlighting the importance of CRF for population health and the potential for limiting the severity of future pandemics. CRF is best assessed by cardiopulmonary exercise testing (CPET), which will be an important tool for understanding the prolonged pathophysiology of COVID-19, the emergence of long-COVID, and the lasting effects of COVID-19 on CVD risk. Utilization of CRF and CPET within clinical settings should become commonplace because of lessons learned from the COVID-19 pandemic.

Rationale and design of the Effects of intensive Systolic blood Pressure lowering treatment in reducing RIsk of vascular evenTs (ESPRIT): A multicenter open-label randomized controlled trial.

BACKGROUND: Lowering blood pressure (BP) effectively reduces the risk of cardiovascular (CV) events in high CV risk individuals. The optimal target of BP lowering among high CV risk individuals remains unclear. METHODS: The Effects of intensive Systolic blood Pressure lowering treatment in reducing RIsk of vascular evenTs (ESPRIT) trial is a multi-center, open-label, randomized controlled trial to compare the efficacy and safety of intensive BP lowering strategy (Systolic BP target <120 mm Hg) and standard BP lowering strategy (Systolic BP target <140 mm Hg). Participants aged at least 50 years old with baseline systolic BP within 130 to 180 mm Hg at high CV risk, defined by established CV diseases or 2 major CV risk factors, were enrolled. The primary outcome is a composite CV outcome of myocardial infarction, coronary or non-coronary revascularization, hospitalization or emergency department visit from new-onset heart failure or acute decompensated heart failure, stroke, or death from CV diseases. Secondary outcomes include components of the primary composite outcome, all-cause death, a composite of the primary outcome or all-cause death, kidney outcomes, as well as cognitive outcomes. RESULTS: Despite of the interruption of COVID-19 outbreak, the ESPRIT trial successfully enrolled and randomized 11,255 participants from 116 hospitals or primary health care institutions. The mean age of the participants was 64.6 (standard deviation [SD], 7.1) years, 4,650 (41.3%) were women. Among them 28.9%, 26.9% and 38.7% had coronary heart disease, prior stroke and diabetes mellitus, respectively. COVID-19 outbreak affected the BP lowering titration process of the trial, and delayed the reach of BP target. CONCLUSIONS: The ESPRIT trial will address the important question on the optimal BP lowering target for individuals with high CV risk, and generate high quality evidence for treating millions of patients from East Asian countries.

Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African American Adults: A Randomized Clinical Trial.

Importance: More African American individuals die from cardiovascular disease (CVD) than any other chronic disease condition. Despite this disparity, African American individuals are underrepresented in nutrition and CVD interventions. Objective: To compare the effects of an entirely plant-based (vegan) or low-fat omnivorous (omni) diet on change in body weight and lipids during a 2-year intervention. Design, Setting, and Participants: The Nutritious Eating With Soul (NEW Soul) study was a 2-year, randomized clinical trial conducted in 2 cohorts (2018-2020 and 2019-2021) that took place in a university teaching kitchen in Columbia, South Carolina (before March 2020), and via online videoconference sessions (after March 2020). Participants included African American adults aged 18 to 65 years with overweight or obesity (body mass index of 25.0-49.9) and without type 2 diabetes, uncontrolled thyroid disease, recent weight loss, or pregnancy. Data assessors and statisticians were blinded to study condition. Data analysis was performed from March to June 2022. Interventions: The intervention included weekly nutrition classes for 6 months biweekly classes for 6 months, and monthly classes for 12 months. Dietary interventions either emphasized no animal product intake (vegan) or a low-fat omnivorous diet (omni). Both dietary patterns emphasized soul food cuisine (traditional African American southern foodways). Main Outcomes and Measures: Primary outcomes included change in body weight and lipid measures at 12 months. Results: There were 568 participants who completed an online screening questionnaire; 409 were excluded and 159 were randomized (77 to the vegan group and 82 to the omni group). Of the 159 participants (mean [SD] age, 48.4 [10.6] years; 126 female [79%]) who began the study, the main outcome of body weight was obtained for 121 participants (76%) at 12 months. There were no differences in outcomes between groups, including 12-month changes in weight (mean, -2.39 kg [95% CI, -3.48 to -1.30 kg] for the vegan group vs -2.03 kg [95% CI, -3.07 to -1.00 kg] for the omni group; P = .64), total cholesterol (-1.05 mg/dL [95% CI, -9.60 to 7.50 mg/dL] for the vegan group vs 1.66 mg/dL [95% CI, -7.20 to 10.50 mg/dL] for the omni group; P = .67), or low-density lipoprotein cholesterol (mean, -2.56 mg/dL [95% CI, -9.52 to 4.40 mg/dL] for the vegan group vs -0.79 mg/dL [95% CI, -7.98 to 6.40 mg/dL] for the omni group; P = .73). Weight loss at 12 months among cohort 1, whose weight was assessed in 2019 before the COVID-19 pandemic, was significantly greater than that for cohort 2, whose weight was assessed summer 2020 during COVID-19 (-3.45 kg [95% CI, -4.67 to -2.22 kg] vs -1.24 kg [95% CI, -2.24 to -0.25 kg]; P = .01). Conclusions and Relevance: In this randomized clinical trial examining weight loss and CVD risk factor reduction among African American adults, there were no differences between the groups, and the magnitude of changes overall was small. Trial Registration: ClinicalTrials.gov Identifier: NCT03354377.