The longitudinal associations of physical activity, time spent outdoors in nature and symptoms of depression and anxiety during COVID-19 quarantine and social distancing in the United States.

Stressors associated with COVID-19 pandemic stay-at-home orders are associated with increased depression and anxiety and decreased physical activity. Given that physical activity and time spent outdoors in nature are associated with improved mental health, we examined the longitudinal association of these variables during the pandemic. Over 20,000 adults who participated in the U.S. Kaiser Permanente Research Bank, did not report COVID-19 symptoms, and responded to an online baseline and 3 follow-up surveys over approximately 3 months formed the cohort. Physical activity was assessed from a modified survey, time spent outdoors was assessed from one question, and anxiety and depression scores were assessed from validated instruments. Almost 60% were women, 82.8% were non-Hispanic white, and more than 93% of respondents were over the age of 50. Less in-person contact with friends and visiting crowded places was highly prevalent (>80%) initially and decreased somewhat (>70%). Participants in the lowest physical activity category (no physical activity) had the highest depression and anxiety scores compared to each successive physical activity category (p < 0.001). Spending less time outdoors was associated with higher depression and anxiety scores. This effect was greater for participants in the younger age categories compared with older age categories. The effect of less time spent outdoors on anxiety (p = 0.012) and depression (p < 0.001) scores was smaller for males than females. Results suggest that physical activity and time outdoors is associated with better mental health. People should be encouraged to continue physical activity participation during public health emergencies.

Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED) instrument: A new scale to measure food preferences following bariatric surgery.

Bariatric surgery is associated with changing food preferences, but it is not known whether these changes differ by type of operation or are associated with weight loss. The current study presents validation results for a new 27-item scale, Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED). This scale measured enjoyment, craving, and intolerance changes for nine food and beverage categories common to dietary habits in the Southern California region of the U.S. one year following bariatric surgery in the Bariatric Experience Long Term (BELONG) study. Validation of BSATED was done using exploratory factor analyses, construct validity with other conceptually related survey instruments, and criterion validity using hypothesized differences for operation type and percent total weight loss (%TWL) at 12-18 months after surgery. Participants (n = 999) were 86% female, 41% non-Hispanic White, with a mean age of 43.1 ± 11.3 years and a body mass index (BMI) of 43.4 ± 6.8 kg/m2 at the time of surgery. Participants reported less enjoyment and craving for high-fat meats (62%), grains (54%), candy and other desserts (e.g. candy bars, chocolate, ice cream) (52%), and sweet baked goods (48%) 12 months after surgery. These changes were more common among participants undergoing Roux-en-Y gastric bypass (RYGB) compared to those receiving sleeve gastrectomy (SG). Participants who reported decreased enjoyment and craving for foods and beverages that post-bariatric patients are counseled to reduce or avoid had greater %TWL at 12-18 months following surgery (p < .001 and p = .003 respectively). The foods and beverages in BSATED that post-bariatric patients are counseled to reduce or avoid could be used to understand how changes in enjoyment, craving and tolerability of these foods/beverages contribute to weight loss following surgery.

Physical inactivity is associated with a higher risk for severe COVID-19 outcomes: a study in 48 440 adult patients.

OBJECTIVES: To compare hospitalisation rates, intensive care unit (ICU) admissions and mortality for patients with COVID-19 who were consistently inactive, doing some activity or consistently meeting physical activity guidelines. METHODS: We identified 48 440 adult patients with a COVID-19 diagnosis from 1 January 2020 to 21 October 2020, with at least three exercise vital sign measurements from 19 March 2018 to 18 March 2020. We linked each patient's self-reported physical activity category (consistently inactive=0-10 min/week, some activity=11-149 min/week, consistently meeting guidelines=150+ min/week) to the risk of hospitalisation, ICU admission and death after COVID-19 diagnosis. We conducted multivariable logistic regression controlling for demographics and known risk factors to assess whether inactivity was associated with COVID-19 outcomes. RESULTS: Patients with COVID-19 who were consistently inactive had a greater risk of hospitalisation (OR 2.26; 95% CI 1.81 to 2.83), admission to the ICU (OR 1.73; 95% CI 1.18 to 2.55) and death (OR 2.49; 95% CI 1.33 to 4.67) due to COVID-19 than patients who were consistently meeting physical activity guidelines. Patients who were consistently inactive also had a greater risk of hospitalisation (OR 1.20; 95% CI 1.10 to 1.32), admission to the ICU (OR 1.10; 95% CI 0.93 to 1.29) and death (OR 1.32; 95% CI 1.09 to 1.60) due to COVID-19 than patients who were doing some physical activity. CONCLUSIONS: Consistently meeting physical activity guidelines was strongly associated with a reduced risk for severe COVID-19 outcomes among infected adults. We recommend efforts to promote physical activity be prioritised by public health agencies and incorporated into routine medical care.

Sedentary Behaviors in Today's Youth: Approaches to the Prevention and Management of Childhood Obesity: A Scientific Statement From the American Heart Association.

This scientific statement is about sedentary behavior and its relationship to obesity and other cardiometabolic outcomes in youth. A deleterious effect of sedentary behavior on cardiometabolic health is most notable for screen-based behaviors and adiposity; however, this relation is less apparent for other cardiometabolic outcomes or when sedentary time is measured with objective movement counters or position monitors. Increasing trends of screen time are concerning; the portability of screen-based devices and abundant access to unlimited programming and online content may be leading to new patterns of consumption that are exposing youth to multiple pathways harmful to cardiometabolic health. This American Heart Association scientific statement provides an updated perspective on sedentary behaviors specific to modern youth and their impact on cardiometabolic health and obesity. As we reflect on implications for practice, research, and policy, what emerges is the importance of understanding the context in which sedentary behaviors occur. There is also a need to capture the nature of sedentary behavior more accurately, both quantitatively and qualitatively, especially with respect to recreational screen-based devices. Further evidence is required to better inform public health interventions and to establish detailed quantitative guidelines on specific sedentary behaviors in youth. In the meantime, we suggest that televisions and other recreational screen-based devices be removed from bedrooms and absent during meal times. Daily device-free social interactions and outdoor play should be encouraged. In addition, parents/guardians should be supported to devise and enforce appropriate screen time regulations and to model healthy screen-based behaviors.

Sedentary Behavior and Cardiovascular Morbidity and Mortality: A Science Advisory From the American Heart Association.

Epidemiological evidence is accumulating that indicates greater time spent in sedentary behavior is associated with all-cause and cardiovascular morbidity and mortality in adults such that some countries have disseminated broad guidelines that recommend minimizing sedentary behaviors. Research examining the possible deleterious consequences of excess sedentary behavior is rapidly evolving, with the epidemiology-based literature ahead of potential biological mechanisms that might explain the observed associations. This American Heart Association science advisory reviews the current evidence on sedentary behavior in terms of assessment methods, population prevalence, determinants, associations with cardiovascular disease incidence and mortality, potential underlying mechanisms, and interventions. Recommendations for future research on this emerging cardiovascular health topic are included. Further evidence is required to better inform public health interventions and future quantitative guidelines on sedentary behavior and cardiovascular health outcomes.

Cardiometabolic Risk Factors Among 1.3 Million Adults With Overweight or Obesity, but Not Diabetes, in 10 Geographically Diverse Regions of the United States, 2012-2013.

INTRODUCTION: Various phenotypes of overweight and obesity pose various health risks. The objective of this study was to determine the prevalence of 4 commonly measured cardiometabolic risk factors (CRFs) among adults with overweight or obesity, but not diabetes, at the time of the study. METHODS: We analyzed data for 1,294,174 adults (aged ≥20 y) who were members of one of 4 integrated health systems. Each cohort member had a body mass index in 2012 or 2013 that indicated overweight or obesity. We determined the presence of 4 CRFs within 1 year of the first BMI measurement: elevated blood pressure (systolic ≥130 mm Hg or diastolic >85 mm Hg or ICD-9-CM [International Classification of Diseases, Ninth Revision, Clinical Modification] diagnosis code 401.0-405.9); elevated triglycerides (≥150 mg/dL or ICD-9-CM 272.1); low high-density lipoprotein cholesterol (<40 mg/dL for men or <50 mg/dL for women or ICD-9-CM 272.5); and prediabetes (fasting glucose 100-125 mg/dL or HbA1c 5.7%-6.4% or ICD-9-CM 790.2x). We tested the risk of having 1 or more CRFs after adjusting for obesity class and demographic characteristics with multivariable logistic regression. RESULTS: Among participants with overweight (52.5% of the sample), 18.6% had none of the 4 CRFs. Among the 47.5% of participants with obesity, 9.6% had none; among participants with morbid obesity, 5.8% had none. Age was strongly associated with CRFs in multivariable analysis. CONCLUSION: Almost 10% of participants with obesity had no CRFs. Overweight or obesity increases cardiometabolic risk, but the number and type of CRFs varied substantially by age, even among participants with morbid obesity.

Opportunities for public health to increase physical activity among youths.

Despite the well-known benefits of youths engaging in 60 or more minutes of daily physical activity, physical inactivity remains a significant public health concern. The 2008 Physical Activity Guidelines for Americans (PAG) provides recommendations on the amount of physical activity needed for overall health; the PAG Midcourse Report (2013) describes effective strategies to help youths meet these recommendations. Public health professionals can be dynamic change agents where youths live, learn, and play by changing environments and policies to empower youths to develop regular physical activity habits to maintain throughout life. We have summarized key findings from the PAG Midcourse Report and outlined actions that public health professionals can take to ensure that all youths regularly engage in health-enhancing physical activity.

Associations between physical activity and cardiometabolic risk factors assessed in a Southern California health care system, 2010-2012.

INTRODUCTION: Risk factors associated with many chronic diseases can be improved through regular physical activity. This study investigated whether cross-sectional associations between physical activity, assessed by the Exercise Vital Sign (EVS), and cardiometabolic risk factors can be detected in clinical settings. METHODS: We used electronic records from Kaiser Permanente Southern California members (N = 622,897) to examine the association of EVS category with blood pressure, fasting glucose, random glucose, and glycosylated hemoglobin. Adults aged 18 years or older with at least 3 EVS measures between April 2010 and December 2012, without comorbid conditions, and not taking antihypertension or glucose-lowering medications were included. We compared consistently inactive (EVS = 0 min/wk for every measure) with consistently active (EVS ≥150 min/wk) and irregularly active (EVS 1-149 min/wk or not meeting the consistently active or inactive criteria) patients. Separate linear regression analyses were conducted controlling for age, sex, race/ethnicity, body mass index, and smoking status. RESULTS: Consistently active women had lower systolic (-4.60 mm Hg; 95% confidence interval [CI], -4.70 to -4.44) and diastolic (-3.28 mm Hg; 95% CI, -3.40 to -3.17) blood pressure than inactive women. Active men had lower diastolic blood pressure than inactive men. Consistently active patients (women, -5.27 mg/dL [95% CI, -5.56 to -4.97]; men, -1.45 mg/dL [95% CI, -1.75 to -1.16] and irregularly active patients (women, -4.57 mg/dL [95% CI, -4.80 to -4.34]; men, -0.42 mg/dL [95% CI, -0.66 to -0.19]) had lower fasting glucose than consistently inactive patients. Consistently active and irregularly active men and women also had favorable random glucose and HbA1c compared with consistently inactive patients. CONCLUSION: Routine clinical physical activity assessment may give health care providers additional information about their patients' cardiometabolic risk factors.

The Effect of City-Level Sugar-Sweetened Beverage Taxes on Longitudinal HbA1c and Incident Diabetes in Adults With Prediabetes.

OBJECTIVE: Prediabetes, which is a condition characterized by higher-than-normal blood glucose levels that are under the threshold for diabetes, impacts over one-third of U.S. adults. Excise taxes on sugar-sweetened beverages (SSBs) are a proposed policy intervention to lower population consumption of SSBs and generate revenue to support health-related programs, thus potentially delaying or preventing the development of diabetes in individuals with prediabetes. We leveraged data from Kaiser Permanente in California to examine the impact of SSB taxes in California on individual-level mean HbA1c levels and rates of incident diabetes. RESEARCH DESIGN AND METHODS: We compared two outcomes, mean HbA1c levels and rates of incident diabetes, among a matched cohort of adults with prediabetes who lived and did not live in SSB excise tax cities, using outcomes collected in the 6 years prior and 4 years following SSB tax implementation. We used multivariable linear mixed effects models to analyze longitudinal mean HbA1c and discrete-time survival models for incident diabetes. RESULTS: We included 68,658 adults in the analysis. In adjusted models, longitudinal mean HbA1c was 0.007% (95% CI 0.002, 0.011) higher in the tax cities compared with control individuals; while the estimated difference was statistically significant, it was not clinically significant (HbA1c <0.5%). There was no significant difference in the risk of incident diabetes between individuals living in tax and control cities. CONCLUSIONS: We found no clinically significant association between SSB taxes and either longitudinal mean HbA1c or incident diabetes among adults with prediabetes in the 4 years following SSB tax implementation.

What "price" means when buying food: insights from a multisite qualitative study with Black Americans.

OBJECTIVES: We explored the role of price in the food purchasing patterns of Black adults and youths. METHODS: We analyzed qualitative data from interviews and focus groups with socioeconomically diverse, primarily female, Black adults or parents (n = 75) and youths (n = 42) in 4 US cities. Interview protocols were locality specific, but all were designed to elicit broad discussion of food marketing variables. We performed a conventional qualitative content analysis by coding and analyzing data from each site to identify common salient themes. RESULTS: Price emerged as a primary influence on food purchases across all sites. Other value considerations (e.g., convenience, food quality, healthfulness of product, and family preferences) were discussed, providing a more complex picture of how participants considered the price of a product. CONCLUSIONS: Food pricing strategies that encourage consumption of healthful foods may have high relevance for Black persons across income or education levels. Accounting for how price intersects with other value considerations may improve the effectiveness of these strategies.

Associations of Physical Inactivity and COVID-19 Outcomes Among Subgroups.

INTRODUCTION: Physical activity before COVID-19 infection is associated with less severe outcomes. The study determined whether a dose‒response association was observed and whether the associations were consistent across demographic subgroups and chronic conditions. METHODS: A retrospective cohort study of Kaiser Permanente Southern California adult patients who had a positive COVID-19 diagnosis between January 1, 2020 and May 31, 2021 was created. The exposure was the median of at least 3 physical activity self-reports before diagnosis. Patients were categorized as follows: always inactive, all assessments at 10 minutes/week or less; mostly inactive, median of 0-60 minutes per week; some activity, median of 60-150 minutes per week; consistently active, median>150 minutes per week; and always active, all assessments>150 minutes per week. Outcomes were hospitalization, deterioration event, or death 90 days after a COVID-19 diagnosis. Data were analyzed in 2022. RESULTS: Of 194,191 adults with COVID-19 infection, 6.3% were hospitalized, 3.1% experienced a deterioration event, and 2.8% died within 90 days. Dose‒response effects were strong; for example, patients in the some activity category had higher odds of hospitalization (OR=1.43; 95% CI=1.26, 1.63), deterioration (OR=1.83; 95% CI=1.49, 2.25), and death (OR=1.92; 95% CI=1.48, 2.49) than those in the always active category. Results were generally consistent across sex, race and ethnicity, age, and BMI categories and for patients with cardiovascular disease or hypertension. CONCLUSIONS: There were protective associations of physical activity for adverse COVID-19 outcomes across demographic and clinical characteristics. Public health leaders should add physical activity to pandemic control strategies.

Perceptions of the food marketing environment among African American teen girls and adults.

Obesity disproportionately affects African American adolescents, particularly girls. While ethnically targeted marketing of unhealthful food products contributes to this disparity, it is not known how African Americans perceive the food marketing environment in their communities. Qualitative methods, specifically photovoice and group discussions, were used to understand perceptions of African American adults and teen girls regarding targeted food marketing to adolescent girls. An advisory committee of four students, two faculty, and two parents was formed, who recruited peers to photograph their environments and participate in group discussions to answer "what influences teen girls to eat what they do." Seven adults and nine teens (all female) participated in the study. Discussions were transcribed, coded, and analyzed with ATLAS.ti to identify common and disparate themes among participants. Results indicated that adults and teens perceived the type of food products, availability of foods, and price to influence the girls' choices. The girls spoke about products that were highly convenient and tasty as being particularly attractive. The adults reported that advertisements and insufficient nutrition education were also influencers. The teens discussed that the places in which food products were available influenced their choices. Results suggest that the marketing of highly available, convenient food at low prices sell products to teen girls. Future work is needed to better understand the consumer's perspective on the food and beverage marketing strategies used.

Influence of change in aerobic fitness and weight on prevalence of metabolic syndrome.

INTRODUCTION: The metabolic syndrome is the clustering of several cardiometabolic risk factors that can lead to the development of coronary heart disease and type 2 diabetes. We evaluated whether a change in aerobic fitness resulting from a lifestyle intervention could significantly change the odds of metabolic syndrome prevalence. METHODS: Participants (n = 810) were recruited into PREMIER, a multicenter, randomized, controlled clinical trial with outcome assessments at 6 and 18 months. The primary eligibility criterion was a diagnosis of prehypertension or stage 1 hypertension. PREMIER randomized participants to 2 lifestyle interventions, both of which included increased physical activity, or an advice-only control group. Participants completed a submaximal treadmill exercise test; we used reduction in heart rate as the measure of improved aerobic fitness. We used logistic regression to determine intervention effects on metabolic syndrome prevalence. Our models controlled for dietary pattern change. RESULTS: The lifestyle interventions had no significant effect on metabolic syndrome prevalence at 6 months or 18 months. When combining intervention and control groups, at 6 and 18 months, a 1-beat-per-minute reduction in heart rate was associated with a 4% reduction in prevalence of metabolic syndrome (P < .001). When we tested for weight change as a mediator, the association was no longer significant. CONCLUSION: Increased aerobic fitness may reduce prevalence of metabolic syndrome. This association appears to be mediated through concomitant weight change.

The Bariatric Experience Long Term (BELONG): Factors Related to Having Bariatric Surgery in a Large Integrated Healthcare System.

PURPOSE: Bariatric surgery is the most effective treatment for severe obesity, but currently, only 1-2% of all eligible patients undergo surgery each year. This study examined which factors were associated with a patient receiving bariatric surgery after referral in a real-world healthcare setting. MATERIALS AND METHODS: The current study used the baseline survey and electronic medical record (EMR) data from the Bariatric Experience Long Term (BELONG) study (n = 1975). Predictors of who did (n = 1680) and who did not (n = 295) have surgery were analyzed using multivariate logistic regression. RESULTS: Participants (n = 1975; 42.4% response rate) were primarily women (84%) and either non-Hispanic Black or Hispanic (60%). In the fully adjusted multivariate model, the strongest predictors of having surgery were being a woman (OR = 3.17; 95% CI = 2.15, 4.68; p < .001) and losing at least 5% of their body weight in the year before surgery (OR = 3.16; 95% CI = 2.28, 4.38; p < .001). The strongest predictors of not having surgery were a ≥ BMI 50 kg/m2 (OR = .39; 95% CI = .27, .56; p < .001) and having a higher physical comorbidity burden (OR = .84; 95% CI = .75, .94; p = .004). CONCLUSIONS: Practices such as 5-10% total weight loss before surgery and selection of patients with safer operative risk profiles (younger with lower comorbidity burden) may inadvertently contribute to under-utilization of bariatric surgery among some demographic subpopulations who could most benefit from this intervention.

Effects of the PREMIER interventions on health-related quality of life.

BACKGROUND: Health-related quality of life (HRQOL) is an important aspect of well-being that may improve with health behavior interventions. However, health behavior change is difficult with pressure to maintain status quo. PURPOSE: This report examines the effects of two lifestyle interventions and an advice-only condition on HRQOL. Effects of meeting behavioral goals and weight loss also were examined. METHODS: Participants were 295 men and 467 women (34% African American) with pre-hypertension or stage 1 hypertension from the PREMIER trial. HRQOL was assessed by the Short Form-36. Participants were assigned randomly to (1) advice only (ADVICE), (2) established guidelines for blood pressure control (EST), or (3) established guidelines plus the Dietary Approaches to Stop Hypertension (DASH) dietary pattern (EST + DASH). RESULTS: Assignment to EST resulted in improvement in three HRQOL subscales at 6 months and one at 18 months relative to ADVICE. EST + DASH improved in two subscales at 6 and 18 months compared with ADVICE. Across conditions, total fat, saturated fat, fruit, and vegetable intake change, along with ≥ 4-kg weight loss, resulted in HRQOL improvements at 6 and 18 months. No improvement was found for change in physical activity, and only a few HRQOL subscales were associated with change in sodium and low-fat dairy intake. CONCLUSIONS: Intensive lifestyle interventions can result in improvements in HRQOL. Change in dietary intake and weight loss is also important.

Dietary behaviors and poor sleep quality among young adult women: watch that sugary caffeine!

PURPOSE: Associations of dietary patterns with sleep quality have not been sufficiently studied, particularly among young adults. Studying factors associated with sleep quality among young adults are especially important given the significant life changes they are experiencing, which can influence not only sleep quality but also dietary behaviors. METHODS: We examined the cross-sectional association of sleep quality among 462 women at age 23 years. We used the Pittsburg Sleep Quality Index (PSQI) to define sleep quality. Intake over the previous 7 days of fruits and vegetables, soda, sports drinks, other sweetened drinks, and coffee drinks was assessed by a self-report questionnaire. Linear regression analysis examined the association between PSQI scores and dietary intake. RESULTS: About 47% of participants were White, 25% Black, 10% Hispanic, and 18% Other. Almost ½ (45%) reported poor sleep quality. Compared with participants reporting consuming no energy drinks, participants who reported consuming any energy drinks had PSQI scores that were 0.84 points higher (7.08 ± 0.51 vs 6.24 ± 0.39; p=0.04) (indicating poorer sleep quality). Participants who reported drinking one or more high-calorie coffee drinks had PSQI scores that were 1.00 points higher compared with those reporting drinking no high-calorie coffee drinks (7.14 ± 0.51 vs 6.14 ± 0.42; p=0.02). Fruit or vegetable intake was not associated with PSQI score. CONCLUSIONS: Poor sleep quality is prevalent among young women. Young women with poor sleep quality should consider their sugary caffeine use to determine if it may be associated with their sleep.

Characteristics of adults with overweight and obesity who have not attempted weight loss in the prior 12 months.

OBJECTIVE: To determine weight-related characteristics of adults with overweight or obesity who had not attempted weight loss in the prior 12 months. METHODS: Adults from the obesity cohort of the PORTAL clinical data research network were randomly selected to complete a survey in 2015. It included topics of experiences with health care providers, weight history, and health-promoting behaviors. RESULTS: A total of 2811 adults completed the survey, of whom 24% reported not attempting weight loss in the previous 12 months. Controlling for sociodemographic characteristics and body mass index, respondents who reported that their health care provider never talked about weight were more likely to not attempt weight loss in the previous 12 months compared with respondents who reported providers frequently brought up weight (OR: 0.45; 95% CI: 0.24, 0.66). Respondents who perceived themselves as normal weight or underweight were 4.22 times more likely (95% CI: 3.53, 5.05) to not attempt weight loss compared with respondents who perceived themselves as overweight. Respondents who reported that they never tried to lose at least 10 lbs, ate 0-2 servings of fruits and vegetables daily, or engaged in 0-29 min of physical activity weekly were less likely to attempt weight loss. CONCLUSIONS: Receiving advice on weight loss from health care providers to improve awareness of overweight and obesity status may be important factors for a person's weight management. Provider discussions about weight may be a strategy to motivate weight loss attempts.

Evidence-Based Policy Making for Public Health Interventions in Cardiovascular Diseases: Formally Assessing the Feasibility of Clinical Trials.

Implementation of prevention policies has often been impeded or delayed due to the lack of randomized controlled trials (RCTs) with hard clinical outcomes (eg, incident disease, mortality). Despite the prominent role of RCTs in health care, it may not always be feasible to conduct RCTs of public health interventions with hard outcomes due to logistical and ethical considerations. RCTs may also lack external validity and have limited generalizability. Currently, there is insufficient guidance for policymakers charged with establishing evidence-based policy to determine whether an RCT with hard outcomes is needed before policy recommendations. In this context, the purpose of this article is to assess, in a case study, the feasibility of conducting an RCT of the oft-cited issue of sodium reduction on cardiovascular outcomes and then propose a framework for decision-making, which includes an assessment of the feasibility of conducting an RCT with hard clinical outcomes when such trials are unavailable. We designed and assessed the feasibility of potential individual- and cluster-randomized trials of sodium reduction on cardiovascular outcomes. Based on our assumptions, a trial using any of the designs considered would require tens of thousands of participants and cost hundreds of millions of dollars, which is prohibitively expensive. Our estimates may be conservative given several key challenges, such as the unknown costs of sustaining a long-term difference in sodium intake, the effect of differential cotreatment with antihypertensive medications, and long lag time to clinical outcomes. Thus, it would be extraordinarily difficult to conduct such a trial, and despite the high costs, would still be at substantial risk for a spuriously null result. A robust framework, such as the one we developed, should be used to guide policymakers when establishing evidence-based public health interventions in the absence of trials with hard clinical outcomes.