The Environmental Influences on Child Health Outcomes (ECHO)-Wide Cohort.

The Environmental Influences on Child Health Outcomes (ECHO)-Wide Cohort Study (EWC), a collaborative research design comprising 69 cohorts in 31 consortia, was funded by the National Institutes of Health (NIH) in 2016 to improve children's health in the United States. The EWC harmonizes extant data and collects new data using a standardized protocol, the ECHO-Wide Cohort Data Collection Protocol (EWCP). EWCP visits occur at least once per life stage, but the frequency and timing of the visits vary across cohorts. As of March 4, 2022, the EWC cohorts contributed data from 60,553 children and consented 29,622 children for new EWCP data and biospecimen collection. The median (interquartile range) age of EWCP-enrolled children was 7.5 years (3.7-11.1). Surveys, interviews, standardized examinations, laboratory analyses, and medical record abstraction are used to obtain information in 5 main outcome areas: pre-, peri-, and postnatal outcomes; neurodevelopment; obesity; airways; and positive health. Exposures include factors at the level of place (e.g., air pollution, neighborhood socioeconomic status), family (e.g., parental mental health), and individuals (e.g., diet, genomics).

Identifying Foods That Optimize Intake of Key Micronutrients During Pregnancy.

BACKGROUND: Most pregnant women in the United States are at risk of inadequate intake of vitamin A, vitamin D, folic acid, calcium, iron, and omega-3 fatty acids from foods alone. Very few United States dietary supplements provide sufficient doses of all 6 nutrients without inducing excess intake. OBJECTIVE: We aimed to identify energy-efficient foods that provide sufficient doses of these nutrients and could be consumed in lieu of dietary supplements to achieve the recommended intake in pregnancy. METHODS: In a previous analysis of 2,450 pregnant women, we calculated the range of additional intake needed to shift 90% of participants to intake above the estimated average requirement and keep 90% below the tolerable upper level for these 6 nutrients. Here, we identified foods and beverages from the 2019 to 2020 Food and Nutrient Database for Dietary Studies that provide target levels of these nutrients without exceeding the additional energy intake recommended for pregnancy beginning in the second trimester (340 kilocalories). RESULTS: We identified 2358 candidate foods meeting the target intake range for at least one nutrient. No candidate foods provided target amounts of all 6 nutrients. Seaweed (raw or cooked without fat) provided sufficient vitamin A, folate, calcium, iron, and omega-3s (5 of 6 nutrients) but would require an intake of >5 cups/d. Twenty-one other foods/beverages (mainly fish, vegetables, and beverages) provided target amounts of 4 of the 6 nutrients. Few foods met targets for vitamin D (n = 54) or iron (n = 93). CONCLUSIONS: Results highlight the difficulty in meeting nutritional requirements from diet alone and imply that dietary supplements are likely necessary to meet vitamin D and iron targets in pregnancy, as well as omega-3 fatty acid targets for individuals who do not consume fish products. Other foods could be added in limited amounts to help meet intake targets without exceeding caloric recommendations or nutrient safety limits.

Disparities in Risks of Inadequate and Excessive Intake of Micronutrients during Pregnancy.

BACKGROUND: Inadequate or excessive intake of micronutrients in pregnancy has potential to negatively impact maternal/offspring health outcomes. OBJECTIVE: The aim was to compare risks of inadequate or excessive micronutrient intake in diverse females with singleton pregnancies by strata of maternal age, race/ethnicity, education, and prepregnancy BMI. METHODS: Fifteen observational cohorts in the US Environmental influences on Child Health Outcomes (ECHO) Consortium assessed participant dietary intake with 24-h dietary recalls (n = 1910) or food-frequency questionnaires (n = 7891) from 1999-2019. We compared the distributions of usual intake of 19 micronutrients from food alone (15 cohorts; n = 9801) and food plus dietary supplements (10 cohorts with supplement data; n = 7082) to estimate the proportion with usual daily intakes below their age-specific daily Estimated Average Requirement (EAR), above their Adequate Intake (AI), and above their Tolerable Upper Intake Level (UL), overall and within sociodemographic and anthropometric subgroups. RESULTS: Risk of inadequate intake from food alone ranged from 0% to 87%, depending on the micronutrient and assessment methodology. When dietary supplements were included, some women were below the EAR for vitamin D (20-38%), vitamin E (17-22%), and magnesium (39-41%); some women were above the AI for vitamin K (63-75%), choline (7%), and potassium (37-53%); and some were above the UL for folic acid (32-51%), iron (39-40%), and zinc (19-20%). Highest risks for inadequate intakes were observed among participants with age 14-18 y (6 nutrients), non-White race or Hispanic ethnicity (10 nutrients), less than a high school education (9 nutrients), or obesity (9 nutrients). CONCLUSIONS: Improved diet quality is needed for most pregnant females. Even with dietary supplement use, >20% of participants were at risk of inadequate intake of ≥1 micronutrients, especially in some population subgroups. Pregnancy may be a window of opportunity to address disparities in micronutrient intake that could contribute to intergenerational health inequalities.

BayesCTDesign: An R Package for Bayesian Trial Design Using Historical Control Data.

This article introduces the R (R Core Team 2019) package BayesCTDesign for two-arm randomized Bayesian trial design using historical control data when available, and simple two-arm randomized Bayesian trial design when historical control data is not available. The package BayesCTDesign, which is available on CRAN, has two simulation functions, historic_sim() and simple_sim() for studying trial characteristics under user defined scenarios, and two methods print() and plot() for displaying summaries of the simulated trial characteristics. The package BayesCTDesign works with two-arm trials with equal sample sizes per arm. The package BayesCTDesign allows a user to study Gaussian, Poisson, Bernoulli, Weibull, Lognormal, and Piecewise Exponential (pwe) outcomes. Power for two-sided hypothesis tests at a user defined alpha is estimated via simulation using a test within each simulation replication that involves comparing a 95% credible interval for the outcome specific treatment effect measure to the null case value. If the 95% credible interval excludes the null case value, then the null hypothesis is rejected, else the null hypothesis is accepted. In the article, the idea of including historical control data in a Bayesian analysis is reviewed, the estimation process of BayesCTDesign is explained, and the user interface is described. Finally, the BayesCTDesign is illustrated via several examples.

Understanding childhood obesity in the US: the NIH environmental influences on child health outcomes (ECHO) program.

BACKGROUND: Few resources exist for prospective, longitudinal analysis of the relationships between early life environment and later obesity in large diverse samples of children in the United States (US). In 2016, the National Institutes of Health launched the Environmental influences on Child Health Outcomes (ECHO) program to investigate influences of environmental exposures on child health and development. We describe demographics and overweight and obesity prevalence in ECHO, and ECHO's potential as a resource for understanding how early life environmental factors affect obesity risk. METHODS: In this cross-sectional study of 70 extant US and Puerto Rico cohorts, 2003-2017, we examined age, race/ethnicity, and sex in children with body mass index (BMI) data, including 28,507 full-term post-birth to <2 years and 38,332 aged 2-18 years. Main outcomes included high BMI for age <2 years, and at 2-18 years overweight (BMI 85th to <95th percentile), obesity (BMI ≥ 95th percentile), and severe obesity (BMI ≥ 120% of 95th percentile). RESULTS: The study population had diverse race/ethnicity and maternal demographics. Each outcome was more common with increasing age and varied with race/ethnicity. High BMI prevalence (95% CI) was 4.7% (3.5, 6.0) <1 year, and 10.6% (7.4, 13.7) for 1 to <2 years; overweight prevalence increased from 13.9% (12.4, 15.9) at 2-3 years to 19.9% (11.7, 28.2) at 12 to <18 years. ECHO has the statistical power to detect relative risks for 'high' BMI ranging from 1.2 to 2.2 for a wide range of exposure prevalences (1-50%) within each age group. CONCLUSIONS: ECHO is a powerful resource for understanding influences of chemical, biological, social, natural, and built environments on onset and trajectories of obesity in US children. The large sample size of ECHO cohorts adopting a standardized protocol for new data collection of varied exposures along with longitudinal assessments will allow refined analyses to identify drivers of childhood obesity.

The Special Supplemental Nutrition Program for Women, Infants, and Children is Associated with Several Changes in Nutrient Intakes and Food Consumption Patterns of Participating Infants and Young Children, 2008 Compared with 2016.

BACKGROUND: In 2009 the USDA's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) updated the food packages provided to participants. OBJECTIVES: This study investigates associations between WIC participation and nutrients and food groups consumed using data from the Feeding Infants and Toddlers Study's 2008 and 2016 nationwide, cross-sectional surveys of children <4 y, weighted to be representative of the US population. METHODS: The study data included 2892 children aged 6-47.9 mo in 2008 and 2635 in 2016. Differences were analyzed by WIC participation, survey year, and child age (infants 6-11.9 mo old, toddlers 12-23.9 mo old, preschoolers 24-47.9 mo old). Usual nutrient intake distributions were estimated using National Cancer Institute methodology. Daily food group consumption differences were tested via multivariate regression. All analyses controlled for income. RESULTS: In 2016 18.6% of infants had iron intakes below the estimated average requirement (EAR), compared to 7.6% in 2008; 87% of WIC infants met the EAR, compared with 69% of non-WIC infants. In 2016 37% of WIC preschoolers met saturated fat guidelines, compared with 25% in 2008; in both years, fewer than one-third of non-WIC preschoolers met the guidelines. More WIC infants than non-WIC infants consumed infant cereals in 2016 (58% compared with 45%, respectively). More WIC infants ate vegetables daily in 2016 than in 2008 (74% compared with 59%, respectively).  In 2016, as compared with 2008, more WIC infants consumed baby-food vegetables (55% compared with 29%, respectively) and fruits (56% compared with 41%, respectively). In 2016 47% of WIC preschoolers drank low-fat milk, compared with 19% of non-WIC preschoolers. CONCLUSIONS: Infant iron intakes are concerning, although more WIC infants meet the EAR. WIC infants' vegetable intakes have improved; baby-food vegetables have become important contributors to their intakes. In 2016 WIC children were more likely than non-WIC children to shift to lower-fat milks at 2 y of age, likely contributing to lower saturated fat intakes.

Trends in Mean Nutrient Intakes of US Infants, Toddlers, and Young Children from 3 Feeding Infants and Toddlers Studies (FITS).

BACKGROUND: Many updates to young child feeding recommendations have been published over the past decade, but concurrent intake trends have not been assessed. OBJECTIVE: The aim of this study was to evaluate adequacy and trends in energy and nutrient intakes of US infants and children aged 0-47.9 mo through use of Feeding Infants and Toddlers Study (FITS) data from 2002, 2008, and 2016. METHODS: FITS are cross-sectional surveys of parents/caregivers of infants and young children (FITS 2002, n = 2962; FITS 2008, n = 3276; FITS 2016, n = 3235). Dietary intakes were assessed by telephone with trained interviewers using the Nutrition Data System for Research. Mean ± SE nutrient intakes were calculated. Diet adequacy was assessed with the nutrient adequacy ratio (NAR) for 17 nutrients and the corresponding mean adequacy ratio. RESULTS: Energy and macronutrient intakes were generally stable across surveys, but significant decreases for saturated fat and total sugars and an increase in fiber were observed among 6-11.9-mo-olds and 12-23.9-mo-olds (P-trend < 0.0001). Mean sodium intakes exceeded Adequate Intakes (AI) for all ages, whereas fiber intakes were universally below the AI. Nutrients with the lowest NAR values were vitamin D (range 0.41-0.67/1.00) and vitamin E (range 0.60-0.79/1.00 for 2008 and 2016). For iron, infants aged 6-11.9 mo had the lowest NAR values at 0.77-0.88/1.00, compared to 0.85-0.89/1.00 for 12-47.9-mo-olds. Potassium was low from 12 to 47.9 mo (NAR range 0.55-0.63/1.00 across survey years). The nutrients with the greatest decline in mean intakes were iron and vitamins D and E among 6-11.9-mo-olds, and vitamin D and potassium among 12-23.9-mo-olds in 2016 compared to 2002. CONCLUSIONS: The diets of US infants and young children were generally adequate for most micronutrients and stable over time, but sodium intakes were too high, and nutrient gaps still existed, especially for vitamins D, E, and fiber across ages and for iron among infants.

Room for Improvement Remains in Food Consumption Patterns of Young Children Aged 2-4 Years.

Background: Healthy food consumption patterns in early childhood support optimal growth and development and promote lifelong health. Objective: The objective of the Feeding Infants and Toddlers Study (FITS) 2016 is to provide updated information on food consumption patterns of children aged 0 to <4 y. This article focuses on several key aspects of the food consumption patterns of 2- and 3-y-olds and how those patterns differ between racial/ethnic groups. Methods: The FITS 2016 is a cross-sectional study in caregivers of children aged 0 to <4 y living in the United States. Dietary data were collected in a national random sample of children (n = 3235, of whom 600 were aged 24-47.9 mo) by using a 24-h dietary recall telephone survey with the primary caregiver of the child. Data from the recall were used to calculate the percentage of children consuming specific food groups on the day of the recall and energy from these foods (kilocalories per consumer). Differences in food patterns between racial/ethnic groups were analyzed by using ANOVA and t tests. Results: On the day of the 24-h dietary recall, 27% of 2- and 3-y-olds did not consume a distinct portion of vegetables. Fried potatoes were the most commonly consumed vegetable. Approximately 75% consumed a distinct portion of fruit and 45% consumed 100% fruit juice. Eighty-one percent of children consumed cow milk. Almost all (95%) consumed a grain product, and 59% consumed a whole grain-rich product. The majority of children (88%) consumed meat or another protein food. Nearly all (90%) consumed a dessert, sugar-sweetened beverage (SSB), or sweet; and 45% consumed an SSB. Thirty-six percent of children consumed a savory snack. There were some differences in food consumption patterns between racial/ethnic groups. Conclusion: Findings from the FITS 2016 indicate that individual-, community-, and policy-level strategies are needed to improve the diets of young children in the United States.

Food Consumption Patterns of Infants and Toddlers: Findings from the Feeding Infants and Toddlers Study (FITS) 2016.

Background: The prevalence of obesity and type 2 diabetes continues to increase. These conditions disproportionately affect minorities and are associated with poor nutrition early in life. Current food-consumption patterns can inform pending dietary guidelines for infants and toddlers. Objective: The aim of this study was to describe infant feeding, complementary feeding, and food and beverage consumption patterns of 0- to 23.9-mo-olds in the general population. Methods: The Feeding Infants and Toddlers Study 2016 is a cross-sectional survey of caregivers of children aged <4 y. Dietary data were collected from a national random sample by using a 24-h dietary recall (n = 3235). The percentage of children consuming foods from >400 food groups was calculated. Differences in the percentage consuming between Hispanic, non-Hispanic white, and non-Hispanic black children aged 0-23.9 mo were evaluated with the use of ORs and 95% CIs. Results: Eighty-three percent of 0- to 23.9-mo-olds (n = 2635) were ever breastfed, 34% of 0- to 3.9-mo-olds (n = 305) and 15% of 4- to 5.9-mo-olds (n = 295) were exclusively breastfed, and 24% of 12- to 14.9-mo-olds (n = 412) consumed breast milk on the day of the recall. Complementary foods were more likely to be introduced before 4 mo in formula-fed infants (27%) than in infants who did not consume formula (5%). Half of 4- to 5.9-mo-olds consumed iron-fortified infant cereal, but few consumed iron-rich meats. Among toddlers (12-23.9 mo; n = 1133), >20% consumed no servings of fruit or vegetables on the day of the recall, approximately half consumed 100% fruit juice, and one-quarter to one-third consumed a sugar-sweetened beverage (SSB). Conclusions: Breastfeeding initiation and duration have improved, but exclusivity remains low. Low consumption of iron-rich foods, fruit, and vegetables and lack of variety in vegetable consumption are problems. Efforts to reduce the consumption of SSBs and 100% fruit juice are warranted in early childhood.

Usual Nutrient Intakes from the Diets of US Children by WIC Participation and Income: Findings from the Feeding Infants and Toddlers Study (FITS) 2016.

Background: A recent report of the National Academies of Sciences, Engineering, and Medicine (NASEM) outlined priority nutrients for infants and children participating in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Objective: The objective of this study was to assess usual nutrient intakes from foods and beverages (not supplements) among US children aged <4 y by WIC participation status. Methods: A national random sample of children aged <4 y (n = 3,235) from the Feeding Infants and Toddlers Study (FITS) 2016 was categorized by WIC participation status (participants, lower-income nonparticipants, or higher-income nonparticipants) and age (younger infants aged 0-5.9 mo, older infants aged 6-11.9 mo, toddlers aged 12-23.9 mo, or preschoolers aged 24-47.9 mo). All participants contributed one 24-h dietary recall, with a second recall from a representative subsample (n = 799). Usual intakes and compliance with federal dietary recommendations were estimated by using the National Cancer Institute method. Differences between WIC participants and either lower-income nonparticipants or higher-income nonparticipants were tested using t tests. Results: The diets of infants (aged <12 mo) were nutritionally adequate in general. Older infants participating in WIC had higher compliance with iron and vitamin D guidelines than either group of nonparticipants and greater compliance with calcium, zinc, and potassium guidelines than higher-income nonparticipants. WIC toddlers had a higher risk of inadequate calcium and excessive sodium intakes than higher-income nonparticipants. Eight percent of WIC toddlers exceeded added sugar guidelines compared with either nonparticipant group (∼2%). WIC toddlers and preschoolers had a lower risk of inadequate vitamin D intake than lower-income nonparticipants, but inadequacy was >75% across all subgroups. WIC preschoolers had higher compliance with saturated fat guidelines but lower compliance with sodium and added sugar guidelines than higher-income nonparticipants. Conclusions: WIC participants had better intakes of iron (ages 6-23.9 mo), zinc and potassium (ages 6-11.9 mo), saturated fat (ages 24-47.9 mo), and vitamin D (all ages). Regardless of WIC participation status, most infants and children met the calcium and zinc guidelines, but large proportions had intakes not meeting the recommendations for iron (ages 6-11.9 mo), vitamin D, potassium, fiber, saturated fat, and sodium.

Total Usual Nutrient Intakes of US Children (Under 48 Months): Findings from the Feeding Infants and Toddlers Study (FITS) 2016.

Background: The US Dietary Guidelines will expand in 2020 to include infants and toddlers. Understanding current dietary intakes is critical to inform policy. Objective: The purpose of this analysis was to examine the usual total nutrient intakes from diet and supplements among US children. Methods: The Feeding Infants and Toddlers Study 2016 is a national cross-sectional study of children aged <48 mo (n = 3235): younger infants (birth to 5.9 mo), older infants (6-11.9 mo), toddlers (12-23.9 mo), younger preschoolers (24-36.9 mo), and older preschoolers (36-47.9 mo) based on the use of a 24-h dietary recall. A second 24-h recall was collected from a representative subsample (n = 799). Energy, total nutrient intake distributions, and compliance with Dietary Reference Intakes were estimated with the use of the National Cancer Institute method. Results: Dietary supplement use was 15-23% among infants and toddlers and 35-45% among preschoolers. Dietary intakes of infants were adequate, with mean intakes exceeding Adequate Intake for all nutrients except vitamins D and E. Iron intakes fell below the Estimated Average Requirement for older infants (18%). We found that 31-33% of children aged 12-47.9 mo had low percentage of energy from total fat, and >60% of children aged 24-47.9 mo exceeded the saturated fat guidelines. The likelihood of nutrient inadequacy for many nutrients was higher for toddlers: 3.2% and 2.5% greater than the Adequate Intake for fiber and potassium and 76% and 52% less than the Estimated Average Requirement for vitamins D and E, respectively. These patterns continued through older ages. Intakes exceeded the Tolerable Upper Intake Level of sodium, retinol, and zinc across most age groups. Conclusions: Dietary intakes of US infants are largely nutritionally adequate; concern exists over iron intakes in those aged 6-11.9 mo. For toddlers and preschoolers, high intake of sodium and low intakes of potassium, fiber, and vitamin D and, for preschoolers, excess saturated fat are of concern. Excess retinol, zinc, and folic acid was noted across most ages, especially among supplement users.

WIC and non-WIC Infants and Children Differ in Usage of Some WIC-Provided Foods.

Background: USDA's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provides expert-chosen supplemental foods to improve the diets and health of low-income infants and children <5 y of age, but dietary behaviors of WIC participants are not well characterized. Objective: The purpose of this analysis was to examine differences in food consumption patterns between WIC participants and nonparticipants. Methods: FITS 2016 is a nationwide cross-sectional study of children <4 y (n = 3235). Data were weighted to provide US population-representative results. Children were categorized as WIC participants or nonparticipants, with the latter divided into lower- and higher-income nonparticipants. Group differences were assessed via the Wald test (demographics) and Rao-Scott modified chi-square test (breastfeeding prevalence). Differences in percentage consuming WIC-provided and selected other foods between WIC participants and nonparticipants were evaluated with the use of ORs and 95% CIs. Results: WIC infants were less likely to breastfeed than were higher-income nonparticipants at 0-5.9 mo (45% compared with 74%) and less likely than both nonparticipant groups at 6-11.9 mo (30% compared with 49-60%). WIC 6- to 11.9-mo-olds were more likely to consume infant cereals and vegetables than were lower-income nonparticipants. WIC 12 to 23.9-mo-olds were more likely to drink whole milk (which WIC provides at this age) than were nonparticipants (72% compared with 59-64%), whereas WIC participants 24-47.9 mo were more likely to drink low- and nonfat milks (which WIC provides at this age) than were nonparticipants (45% compared with 13-22%). WIC participants 6-47.9 mo were more likely to drink juice than were nonparticipants. Conclusions: Continued improvements in early dietary patterns are warranted for WIC and non-WIC children. Breastfeeding among WIC participants is a continuing challenge. Findings suggest that baby-food cereals, vegetables, and fruits (all provided by WIC) contribute importantly to WIC infants' diets, whereas WIC children are more likely to use lower-fat milks after 2 y of age than are non-WIC participants.

The Feeding Infants and Toddlers Study (FITS) 2016: Study Design and Methods.

Background: Diet and feeding patterns during the infant, toddler, and preschool years affect nutrient adequacy or excess during critical developmental periods. Understanding food consumption, feeding practices, and nutrient adequacy or excess during these periods is essential to establishing appropriate recommendations aimed at instilling healthy eating behaviors in children. Objective: The objective of the 2016 Feeding Infants and Toddlers Study (FITS 2016) was to update our knowledge on the diets and feeding patterns of young children and to provide new data in related areas such as feeding behaviors, sleep, physical activity, and screen use. This article describes the study design, data collection methods, 24-h dietary recall (24-h recall) protocol, and sample characteristics of FITS 2016. Methods: FITS 2016 is a cross-sectional study of caregivers of children aged <4 y living in the 50 states and Washington, DC. Data collection occurred between June 2015 and May 2016. A recruitment interview (respondent and child characteristics, feeding practices, physical activity, screen use, and sleep habits) was completed by telephone or online. This was followed by a feeding practices questionnaire and the 24-h recall conducted by telephone. A second 24-h recall was collected for a random subsample of 25% of the total sampled population. Results: Among the 4830 recruited households with an age-eligible child, 3248 (67%) completed the 24-h recall. The respondents were more likely to be white, less likely to be Hispanic, and more highly educated than the US population of adults in households with a child <4 y of age. The sample was subsequently calibrated and weighted, and the distribution of respondents was compared with known population distributions. Conclusions: FITS 2016 provides data based on sound methods that can inform researchers, policymakers, and practitioners about the food and nutrient intakes of young children. New findings may also be compared with previous FITS studies.

An Environmental influences on Child Health Outcomes viewpoint of data analysis centers for collaborative study designs.

PURPOSE OF REVIEW: A highly complex collaborative study design that pools and extends existing studies, such as the Environmental influences on Child Health Outcomes (ECHO) Program, requires a Data Analysis Center (DAC) with resources and expertise to create a secure environment for housing and analyzing the shared data, harmonize and structure the shared data for different purposes, and apply appropriate and innovative designs and analytic methods. The DAC, in partnership with cohort investigators, must ensure that results from ECHO-wide cohort analyses are appropriately interpreted and reproducible. RECENT FINDINGS: Understanding the cohorts contributing to ECHO is critical for developing a collaborative environment and the methods to best analyze the data without bias. We further describe the development of the ECHO-wide cohort Metadata Catalog, the architecture of the ECHO-wide cohort data platform, and analytical approaches to facilitate early productivity. SUMMARY: The ECHO DAC has established a secure environment for the transfer and storage of ECHO cohort data and information, and initiated processes to promote productive collaborations. Understanding the ECHO DAC responsibilities and assets will help to overcome communication and trust challenges encountered in the initiation of this complex ECHO-wide cohort collaborative research study.

The Physical Activity and Redesigned Community Spaces (PARCS) Study: Protocol of a natural experiment to investigate the impact of citywide park redesign and renovation.

BACKGROUND: The built environment plays a critical role in promoting physical activity and health. The association between parks, as a key attribute of the built environment, and physical activity, however, remains inconclusive. This project leverages a natural experiment opportunity to assess the impact of the Community Parks Initiative (CPI), a citywide park redesign and renovation effort in New York City, on physical activity, park usage, psychosocial and mental health, and community wellbeing. METHODS: The project will use a longitudinal design with matched controls. Thirty intervention park neighborhoods are socio-demographically matched to 20 control park neighborhoods. The study will investigate whether improvements in physical activity, park usage, psychosocial and mental health, and community wellbeing are observed from baseline to 3 years post-renovation among residents in intervention vs. control neighborhoods. DISCUSSION: This study represents a rare opportunity to provide robust evidence to further our understanding of the complex relationship between parks and health. Findings will inform future investments in health-oriented urban design policies and offer evidence for addressing health disparities through built environment strategies.

Differences in Chronic Disease Behavioral Indicators by Sexual Orientation and Sex.

CONTEXT: Lesbian, gay, and bisexual (LGB) populations experience significant health inequities in preventive behaviors and chronic disease compared with non-LGB populations. OBJECTIVES: To examine differences in physical activity and diet by sexual orientation and sex subgroups and to assess the influences of home and neighborhood environments on these relationships. DESIGN: A population-based survey conducted in 2013-2014. SETTING: A stratified, simple, random sample of households in 20 sites in the United States. PARTICIPANTS: A total of 21 322 adult LGB and straight-identified men and women. OUTCOME MEASURES: Any leisure-time physical activity in the past month; physical activity 150 min/wk or more; daily frequency of consumption of vegetables, fruit, water, and sugar-sweetened beverages; and the number of meals prepared away from home in the past 7 days. RESULTS: Physical activity and diet varied by sexual orientation and sex; differences persisted after adjusting for sociodemographic factors and household and community environments. Bisexual men reported a higher odds of engaging in frequent physical activity than straight men (odds ratio [OR] = 3.10; 95% confidence interval [CI], 1.57-6.14), as did bisexual women compared with straight women (OR = 1.84; 95% CI, 1.20-2.80). LGB subgroups reported residing in more favorable walking and cycling environments. In contrast, gay men and lesbian and bisexual women reported a less favorable community eating environment (availability, affordability, and quality of fruit and vegetables) and a lower frequency of having fruit or vegetables in the home. Lesbian women reported lower daily vegetable consumption (1.79 vs 2.00 mean times per day; difference = -0.21; 95% CI, -0.03 to -0.38), and gay men reported consumption of more meals prepared away from home (3.17 vs 2.63; difference = 0.53; 95% CI, 0.11-0.95) than straight women and men, respectively. Gay men and lesbian and bisexual women reported a higher odds of sugar-sweetened beverage consumption than straight men and women. CONCLUSIONS: Findings highlight opportunities for targeted approaches to promote physical activity and mitigate differences in diet to reduce health inequities.

Recommendations for choosing an analysis method that controls Type I error for unbalanced cluster sample designs with Gaussian outcomes.

We used theoretical and simulation-based approaches to study Type I error rates for one-stage and two-stage analytic methods for cluster-randomized designs. The one-stage approach uses the observed data as outcomes and accounts for within-cluster correlation using a general linear mixed model. The two-stage model uses the cluster specific means as the outcomes in a general linear univariate model. We demonstrate analytically that both one-stage and two-stage models achieve exact Type I error rates when cluster sizes are equal. With unbalanced data, an exact size α test does not exist, and Type I error inflation may occur. Via simulation, we compare the Type I error rates for four one-stage and six two-stage hypothesis testing approaches for unbalanced data. With unbalanced data, the two-stage model, weighted by the inverse of the estimated theoretical variance of the cluster means, and with variance constrained to be positive, provided the best Type I error control for studies having at least six clusters per arm. The one-stage model with Kenward-Roger degrees of freedom and unconstrained variance performed well for studies having at least 14 clusters per arm. The popular analytic method of using a one-stage model with denominator degrees of freedom appropriate for balanced data performed poorly for small sample sizes and low intracluster correlation. Because small sample sizes and low intracluster correlation are common features of cluster-randomized trials, the Kenward-Roger method is the preferred one-stage approach.

Rituximab and three dexamethasone cycles provide responses similar to splenectomy in women and those with immune thrombocytopenia of less than two years duration.

Adults with newly diagnosed or persistent immunothrombocytopenia frequently relapse upon tapering steroids; adults and children with chronic disease have an even lower likelihood of lasting response. In adults with newly-diagnosed immunothrombocytopenia, two studies showed that dexamethasone 40 mg/day × four days and 4 rituximab infusions were superior to dexamethasone alone. Studies have also shown three cycles of dexamethasone are better than one and patients with persistent/chronic immunothrombocytopenia respond less well to either dexamethasone or rituximab. Therefore, 375 mg/m(2) × 4 rituximab was combined with three 4-day cycles of 28 mg/m(2) (max. 40 mg) dexamethasone at 2-week intervals and explored in 67 ITP patients. Best long-term response was assessed as complete (platelet count ≥ 100 × 10(9)/L) or partial (50-99 × 10(9)/L). Only 5 patients had not been previously treated. Fifty achieved complete (n=43, 64%) or partial (n=7, 10%) responses. Thirty-five of 50 responders maintained treatment-free platelet counts over 50 × 10(9)/L at a median 17 months (range 4-67) projecting 44% event-free survival. Duration of immunothrombocytopenia less than 24 months, achieving complete responses, and being female were associated with better long-term response (P<0.01). Adverse events were generally mild-moderate, but 3 patients developed serum sickness and 2 colitis; there were no sequelae. Dexamethasone could be difficult to tolerate. Fourteen patients became hypogammaglobulinemic and half had increased frequency of minor infections; 9 of 12 evaluable patients recovered their IgG levels. Rituximab combined with three cycles of dexamethasone provides apparently better results to reported findings with rituximab alone, dexamethasone alone, or the combination with one cycle of dexamethasone. The results suggest medical cure may be achievable in immunothrombocytopenia, especially in women and in patients within two years of diagnosis. (clinicaltrials.gov identifier:02050581).

Associations between lipoprotein(a) levels and cardiovascular outcomes in black and white subjects: the Atherosclerosis Risk in Communities (ARIC) Study.

BACKGROUND: On the basis of studies with limited statistical power, lipoprotein(a) [Lp(a)] is not considered a risk factor for cardiovascular disease (CVD) in blacks. We evaluated associations between Lp(a) and incident CVD events in blacks and whites in the Atherosclerosis Risk in Communities (ARIC) study. METHODS AND RESULTS: Plasma Lp(a) was measured in blacks (n=3467) and whites (n=9851). Hazards ratios (HRs) for incident CVD events (coronary heart disease and ischemic strokes) were calculated. Lp(a) levels were higher with wider interindividual variation in blacks (median [interquartile range], 12.8 [7.1-21.7] mg/dL) than whites (4.3 [1.7-9.5] mg/dL; P<0.0001). At 20 years of follow-up, 676 CVD events occurred in blacks, and 1821 events occurred in whites. Adjusted HRs (95% confidence interval) per race-specific 1-SD-greater log-transformed Lp(a) were 1.13 (1.04-1.23) for incident CVD, 1.11 (1.00-1.22) for incident coronary heart disease, and 1.21 (1.06-1.39) for ischemic strokes in blacks. For whites, the respective HRs (95% confidence intervals) were 1.09 (1.04-1.15), 1.10 (1.05-1.16), and 1.07 (0.97-1.19). Quintile analyses showed that risk for incident CVD was graded but statistically significant only for the highest compared with the lowest quintile (HR [95% confidence interval], 1.35 [1.06-1.74] for blacks and 1.27 [1.10-1.47] for whites). Similar results were obtained with the use of Lp(a) cutoffs of ≤10 mg/dL, >10 to ≤20 mg/dL, >20 to ≤30 mg/dL, and >30 mg/dL. CONCLUSIONS: Lp(a) levels were positively associated with CVD events. Associations were at least as strong, with a larger range of Lp(a) concentrations, in blacks compared with whites.

Selecting a dietary supplement with appropriate dosing for 6 key nutrients in pregnancy.

BACKGROUND: Most pregnant women in the United States (US) are at risk of inadequate intake of key nutrients during pregnancy from foods alone. Current dietary supplement practices reduce risk of inadequacy for only some nutrients and induce excessive intake of other nutrients. OBJECTIVES: Our study aimed to estimate the doses of supplementation needed to help most pregnant women achieve the recommended intake without exceeding upper limits for key prenatal nutrients and to identify US dietary supplements providing these doses. METHODS: We conducted 24-h dietary recalls in 2450 pregnant participants aged 14-50 y from 2007 to 2019. We estimated the usual intake of vitamins A and D, folate, calcium, iron, and ω-3 FAs from foods alone. We calculated the target doses of supplementation needed to shift 90% of participants to consume above the estimated average requirement and keep 90% below the tolerable upper limit. We identified products in the Dietary Supplement Label Database providing these target doses of supplementation. RESULTS: The target dose for supplementation was ≥198 mcg retinol activity equivalents of total vitamin A (with ≤2063 mcg preformed retinol); 7-91 mcg vitamin D; 169-720 mcg dietary folate equivalents of folic acid; 383-943 mg calcium; 13-22 mg iron; and ≥59 mg ω-3 FAs. Out of 20,547 dietary supplements (including 421 prenatal products), 69 products (33 prenatal) contained all 6 nutrients; 7 products (2 prenatal) contained target doses for 5 nutrients. Only 1 product (not a prenatal) contained target doses for all 6 nutrients, but it currently costs ∼USD200/mo and requires 7 tablets per daily serving. CONCLUSIONS: Almost no US dietary supplements provide key nutrients in the doses needed for pregnant women. Affordable and convenient products that fill the gap between food-based intake and estimated requirements of pregnancy without inducing excess intake are needed to support pregnant women and their offspring. Am J Clin Nutr 20XX;xx:xx-xx.