Facilitators and Barriers to Implementation and Sustainability of Nutrition and Physical Activity Interventions in Early Childcare Settings: a Systematic Review.

A stronger understanding of the factors influencing implementation of interventions in community-based early childcare settings is needed. The purpose of this systematic review was to synthesize existing research on facilitators and barriers to implementation and sustainability of nutrition and physical activity interventions in early childcare settings targeting 2-5-year-old children, including considerations for equitable implementation. This review adhered to PRISMA 2020 guidelines. Peer-reviewed literature was searched in PubMed, EMBASE, CINAHL, ERIC, and PsycINFO databases up to September 2020. Primary research studies that examined facilitators and barriers (or related synonyms) to the implementation and sustainability of nutrition and physical activity interventions in early childcare settings were eligible for inclusion. The search yielded 8092 records that were screened by four analysts in Covidence software with a final review of 24 studies. Two independent reviewers conducted study selection, data extraction, and quality appraisal (Mixed Methods Appraisal Tool). A "best fit" framework was applied using the Consolidated Framework for Implementation Research (CFIR) constructs to code barriers and facilitators. The most salient constructs were (1) "Available Resources," which was composed of time, staffing, space, and staff trainings; (2) adaptability; and (3) compatibility, the latter two indicating that easily modifiable interventions facilitated a smoother "fit" and were more likely to be successful, given adequate site-level resources. Only nine (28%) reported the use of a theory, model, or framework to guide evaluation; six studies (24%) included factors related to sustainability; and nine studies (38%) conducted their interventions with low-income or minoritized groups. The findings point to the need for intervention evaluations examining nutrition and physical activity to more consistently consider (a) sustainability factors early on in design and adoption phases; (b) use of theory, model, or framework to guide evaluation; and (c) equity-related frameworks and considerations for how equitable implementation.

Relative bioavailability of ertugliflozin tablets containing the amorphous form versus tablets containing the cocrystal form.

OBJECTIVES: Ertugliflozin is a selective sodium-glucose cotransporter 2 inhibitor approved for the treatment of type 2 diabetes in adults. In its natural form, ertugliflozin exists as an amorphous solid with physicochemical properties that prevent commercial manufacture. The commercial product was developed as an immediate-release tablet, consisting of an ertugliflozin-L-pyroglutamic acid cocrystal of 1 : 1 molar stoichiometry as the active pharmaceutical ingredient. The ertugliflozin cocrystal may partially dissociate when exposed to high humidity for extended periods, leading to the formation of free amorphous ertugliflozin. Therefore, a study was conducted to estimate the relative bioavailability of ertugliflozin when administered in non-commercial formulated tablets containing the amorphous form vs. the cocrystal form. MATERIALS AND METHODS: In this phase 1, open-label, randomized, two-period, two-sequence, single-dose crossover study, 16 healthy subjects received 15 mg immediate-release ertugliflozin in its amorphous and cocrystal forms under fasted conditions, separated by a washout period of ≥ 7 days. Blood samples were collected post-dose for 72 hours to determine plasma ertugliflozin concentrations. RESULTS: Mean ertugliflozin plasma concentration-time profiles were nearly superimposable following administration of the amorphous and cocrystal forms. The 90% confidence intervals for the geometric mean ratios for AUCinf and Cmax were wholly contained within the pre-specified criteria for similarity (70 - 143%), as well as the acceptance range for bioequivalence (80 - 125%). Most adverse events were mild in intensity. CONCLUSION: Any dissociation of ertugliflozin to the amorphous form that occurs in tablets containing the cocrystal will not have any clinically meaningful impact on the oral bioavailability of ertugliflozin.

Validation of a self-report home food availability checklist against in-home food inventories conducted in low-income Black/African American and Hispanic/Latinx households with preschool-age children.

Home food availability (HFA) checklists can be completed by self-report to assess the home food environment. Checklists developed for Black/African American (B/AA) and Hispanic/Latinx (H/L) households are seldom validated against objective approaches such as exhaustive in-home food inventories. This study validated a self-report HFA checklist developed for B/AA and H/L households (n = 97) against researcher-completed HFA checklists verified by exhaustive in-home food inventories. Mean estimates of sensitivity, specificity, and area of the receiver operating curve (ROC), and interrater agreement (Gwet AC1) were calculated to examine the accuracy and agreement of self-reported checklists against direct observation of individual food items. Mean differences in HFA food group scores were compared (self-report vs observed) to examine group-level relative validity. The predictive validity of this self-reported measure on observed scores and dietary intake were also examined with linear regression. The average values for ROC area (average of sensitivity and specificity) ranged from acceptable (0.76 for sweets) to excellent (0.81 for vegetables, fruits). Average interrater agreement values ranged from moderate (0.41-0.60: sweets) to substantial (0.61-0.79: vegetables, fruit, SSBs, savory foods). Self-reported mean scores, compared to observed scores, were higher for vegetables (mean diff: 1.04) and lower for sweets (mean diff: 0.38, p = 0.01), but regression analyses demonstrated that self-reported scores were good predictors of observed scores with absolute error (based on standard deviation of residuals) ranging from ±1.27 to 1.69 points. Self-reported scores also predicted multiple aspects of dietary intake but more so among H/L households. In conclusion, the HFA checklist obtained via self-report performed well based on multiple indicators of validity suggesting that this self-reported measure can be used to assess home food environments among of B/AA and H/L households.

Pre-diagnostic carbohydrate intake and treatment failure after radical prostatectomy for early-stage prostate cancer.

PURPOSE: An association between dietary carbohydrate intake and prostate cancer (PCa) prognosis is biologically plausible, but data are scarce. This prospective cohort study examined the relation between pre-diagnostic carbohydrate intake and treatment failure following radical prostatectomy for clinically early-stage PCa. METHODS: We identified 205 men awaiting radical prostatectomy and assessed their usual dietary intake of carbohydrates using the 110-item Block food frequency questionnaire. We also evaluated carbohydrate intake quality using a score based on the consumption of sugars relative to fiber, fat, and protein. Logistic regression analyzed their associations with the odds of treatment failure, defined as a detectable and rising serum prostate-specific antigen (PSA) or receiving androgen deprivation therapy (ADT) within 2 years. RESULTS: Sucrose consumption was associated with a higher odds and fiber consumption with a lower odds of ADT after accounting for age, race/ethnicity, body mass index, and tumor characteristics (odds ratio [OR] (95% confidence interval [CI]) 5.68 (1.71, 18.9) for 3rd vs. 1st sucrose tertile and 0.88 (0.81, 0.96) per gram of fiber/day, respectively). Increasing carbohydrate intake quality also associated with a lower odds of ADT (OR (95% CI) 0.78 (0.66, 0.92) per unit increase in score, range 0-12). CONCLUSIONS: Pre-diagnostic dietary carbohydrate intake composition and quality influence the risk of primary treatment failure for early-stage PCa. Future studies incorporating molecular aspects of carbohydrate metabolism could clarify possible underlying mechanisms.

The century experiment: the first twenty years of UC Davis' Mediterranean agroecological experiment.

The Century Experiment at the Russell Ranch Sustainable Agriculture Facility at the University of California, Davis provides long-term agroecological data from row crop systems in California's Central Valley starting in 1993. The Century Experiment was initially designed to study the effects of a gradient of water and nitrogen availability on soil properties and crop performance in ten different cropping systems to measure tradeoffs and synergies between agricultural productivity and sustainability. Currently systems include 11 different cropping systems-consisting of four different crops and a cover crop mixture-and one native grass system. This paper describes the long-term core data from the Century Experiment from 1993-2014, including crop yields and biomass, crop elemental contents, aerial-photo-based Normalized Difference Vegetation Index data, soil properties, weather, chemical constituents in irrigation water, winter weed populations, and operational data including fertilizer and pesticide application amounts and dates, planting dates, planting quantity and crop variety, and harvest dates. This data set represents the only known long-term set of data characterizing food production and sustainability in irrigated and rainfed Mediterranean annual cropping systems. There are no copyright restrictions associated with the use of this dataset.

The relationship between home- and individual-level diet quality among African American and Hispanic/Latino households with young children.

BACKGROUND: The quality of most Americans' diets is far from optimal. Given that many Americans consume a significant portion of calories in the home, intervening in this setting could be beneficial. However, the relationship between the home food environment and diet quality is not well understood. This study examined the relationship between diet quality at the individual level with home-level diet quality using an index that measures compliance with federal dietary guidance. METHODS: This was a cross sectional study that enrolled 97 African American and Hispanic/Latino low-income parent-child dyads. Diet quality at the individual level was assessed through two 24-h dietary recalls collected for parents and children, respectively. Diet quality at the home level was assessed with two home food inventories conducted in participants' homes. Diet quality scores at the home and individual levels were computed by applying the Healthy Eating Index-2010 (HEI-2010) to these data. Linear models adjusted for potential confounding factors were used to examine the relationship between diet quality at the home and individual levels. RESULTS: Total HEI-2010 scores from parents and children's diets were positively associated with HEI-2010 scores based on home food inventories (parent diet: ß: 0.36, 95% CI: 012-0.60; child diet: 0.38 95% CI: 013-0.62). Positive associations were also observed between individual level and home level subcomponent HEI-2010 scores for total fruit (parent: 0.55 95% CI: 0.16-0.94; child: 0.49 95% CI: 0.03-0.94), whole fruit (parent only: 0.41 95% CI: 0.07-0.74), greens and beans (parent only: 0.39 95% CI: 0.05-0.74), and whole grain (children only: 0.33 95% CI: 0.04-0.63). CONCLUSION: This study demonstrated that individual level diet quality was positively associated with home-level diet quality. Findings from this study can help us to address modifiable targets of intervention in the home to improve diet quality.

Health Behavior and Weight Changes Among Ethnic and Racial Minority Preschoolers and Their Parents: Associations Across 1 Year.

OBJECTIVE: To determine whether parent health behavior changes and feeding practices were associated with child changes in body mass index z-score and related health behaviors over the course of 1 year. METHODS: Anthropometric data from 590 child-parent dyads of ethnic/racial minority groups were collected at baseline, 14 weeks (postintervention), and 1-year follow-up. Additionally, parent screen time and feeding practices and child dietary consumption, diet quality, physical activity, and screen time were collected. RESULTS: Random effects growth models revealed that changes in child screen time moved in tandem with parent screen time from baseline to 14-week postintervention and from postintervention to 1-year follow-up. Greater parental monitoring predicted greater reduction in child calorie consumption at 1 year. CONCLUSIONS: Future studies should include innovative ways to explicitly involve parents in prevention efforts.

The effects of separate and combined dietary weight loss and exercise on fasting ghrelin concentrations in overweight and obese women: a randomized controlled trial.

OBJECTIVE: Compensatory metabolic changes that accompany weight loss, for example, increased ghrelin, contribute to weight regain and difficulty in long-term weight loss maintenance; however, the separate effects of long-term caloric restriction and exercise on total circulating ghrelin in humans are unknown. DESIGN: A 12-month randomized controlled trial comparing: i) dietary weight loss with a 10% weight loss goal ('diet'; n = 118); ii) moderate-to-vigorous intensity aerobic exercise for 45 min/day, 5 days/week ('exercise'; n = 117); iii) dietary weight loss and exercise ('diet + exercise'; n = 117); or iv) no-lifestyle-change control (n = 87). PARTICIPANTS: 439 overweight or obese postmenopausal women (50-75 y). MEASUREMENTS: Fasting total serum ghrelin was measured by radioimmunoassay at baseline and 12 months. Fasting serum leptin, adiponectin and insulin were also measured. RESULTS: Fasting total ghrelin significantly increased in the diet + exercise arm (+7·4%, P = 0·008) but not in either the diet (+6·5%, P = 0·07) or exercise (+1·0%, P = 0·53) arms compared with control. Greater weight loss was associated with increased ghrelin concentrations, regardless of intervention. Neither baseline ghrelin nor body composition modified the intervention effects on changes in total ghrelin. The 12-month change in total ghrelin was inversely associated with changes in leptin, insulin and insulin resistance, and positively associated with change in adiponectin. CONCLUSIONS: Greater weight loss, achieved through a reduced calorie diet or exercise, is associated with increased total ghrelin concentrations in overweight or obese postmenopausal women.

Confirmatory factor analysis and measurement invariance of the Child Feeding Questionnaire in low-income Hispanic and African-American mothers with preschool-age children.

Validation work of the Child Feeding Questionnaire (CFQ) in low-income minority samples suggests a need for further conceptual refinement of this instrument. Using confirmatory factor analysis, this study evaluated 5- and 6-factor models on a large sample of African-American and Hispanic mothers with preschool-age children (n = 962). The 5-factor model included: 'perceived responsibility', 'concern about child's weight', 'restriction', 'pressure to eat', and 'monitoring' and the 6-factor model also tested 'food as a reward'. Multi-group analysis assessed measurement invariance by race/ethnicity. In the 5-factor model, two low-loading items from 'restriction' and one low-variance item from 'perceived responsibility' were dropped to achieve fit. Only removal of the low-variance item was needed to achieve fit in the 6-factor model. Invariance analyses demonstrated differences in factor loadings. This finding suggests African-American and Hispanic mothers may vary in their interpretation of some CFQ items and use of cognitive interviews could enhance item interpretation. Our results also demonstrated that 'food as a reward' is a plausible construct among a low-income minority sample and adds to the evidence that this factor resonates conceptually with parents of preschoolers; however, further testing is needed to determine the validity of this factor with older age groups.

Evaluating the initial impact of the revised Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) food packages on dietary intake and home food availability in African-American and Hispanic families.

OBJECTIVE: The present study assessed the impact of the 2009 food packages mandated by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) on dietary intake and home food availability in low-income African-American and Hispanic parent/child dyads. DESIGN: A natural experiment was conducted to assess if the revised WIC food package altered dietary intake, home food availability, weight and various lifestyle measures immediately (6 months) following policy implementation. SETTING: Twelve WIC clinics in Chicago, IL, USA. SUBJECTS: Two hundred and seventy-three Hispanic and African-American children aged 2-3 years, enrolled in WIC, and their mothers. RESULTS: Six months after the WIC food package revisions were implemented, we observed modest changes in dietary intake. Fruit consumption increased among Hispanic mothers (mean = 0·33 servings/d, P = 0·04) and low-fat dairy intake increased among Hispanic mothers (0·21 servings/d, P = 0·02), Hispanic children (0·34 servings/d, P < 0·001) and African-American children (0·24 servings/d, P = 0·02). Home food availability of low-fat dairy and whole grains also increased. Dietary changes, however, varied by racial/ethnic group. Changes in home food availability were not significantly correlated with changes in diet. CONCLUSIONS: The WIC food package revisions are one of the first efforts to modify the nutrition guidelines that govern foods provided in a federal food and nutrition assistance programme. It will be important to examine the longer-term impact of these changes on dietary intake and weight status.

Socioecologic Factors and Racial Differences in Breast Cancer Multigene Prognostic Scores in US Women.

Importance: Disproportionately aggressive tumor biology among non-Hispanic Black women with early-stage, estrogen receptor (ER)-positive breast cancer contributes to racial disparities in breast cancer mortality. It is unclear whether socioecologic factors underlie racial differences in breast tumor biology. Objective: To examine individual-level (insurance status) and contextual (area-level socioeconomic position and rural or urban residence) factors as possible mediators of racial and ethnic differences in the prevalence of ER-positive breast tumors with aggressive biology, as indicated by a high-risk gene expression profile. Design, Setting, and Participants: This retrospective cohort study included women 18 years or older diagnosed with stage I to II, ER-positive breast cancer between January 1, 2007, and December 31, 2015. All data analyses were conducted between December 2022 and April 2023. Main Outcomes and Measures: The primary outcome was the likelihood of a high-risk recurrence score (RS) (≥26) on the Oncotype DX 21-gene breast tumor prognostic genomic biomarker. Results: Among 69 139 women (mean [SD] age, 57.7 [10.5] years; 6310 Hispanic [9.1%], 274 non-Hispanic American Indian and Alaskan Native [0.4%], 6017 non-Hispanic Asian and Pacific Islander [8.7%], 5380 non-Hispanic Black [7.8%], and 51 158 non-Hispanic White [74.0%]) included in our analysis, non-Hispanic Black (odds ratio [OR], 1.33; 95% CI, 1.23-1.43) and non-Hispanic American Indian and Alaska Native women (OR, 1.38; 95% CI, 1.01-1.86) had greater likelihood of a high-risk RS compared with non-Hispanic White women. There were no significant differences among other racial and ethnic groups. Compared with non-Hispanic White patients, there were greater odds of a high-risk RS for non-Hispanic Black women residing in urban areas (OR, 1.35; 95% CI, 1.24-1.46), but not among rural residents (OR, 1.05; 95% CI, 0.77-1.41). Mediation analysis demonstrated that lack of insurance, county-level disadvantage, and urban vs rural residence partially explained the greater odds of a high-risk RS among non-Hispanic Black women (proportion mediated, 17%; P < .001). Conclusions and Relevance: The findings of this cohort study suggest that the consequences of structural racism extend beyond inequities in health care to drive disparities in breast cancer outcome. Additional research is needed with more comprehensive social and environmental measures to better understand the influence of social determinants on aggressive ER-positive tumor biology among racial and ethnic minoritized women from disadvantaged and historically marginalized communities.

Weight and metabolic effects of dietary weight loss and exercise interventions in postmenopausal antidepressant medication users and non-users: a randomized controlled trial.

OBJECTIVE: Antidepressants may attenuate the effects of diet and exercise programs. We compared adherence and changes in body measures and biomarkers of glucose metabolism and inflammation between antidepressant users and non-users in a 12-month randomized controlled trial. METHODS: Overweight or obese, postmenopausal women were assigned to: diet (10% weight loss goal, N=118); moderate-to-vigorous aerobic exercise (225 min/week, N=117); diet+exercise (N=117); and control (N=87) in Seattle, WA 2005-2009. Women using antidepressants at baseline were classified as users (N=109). ANCOVA and generalized estimating equation approaches, respectively, were used to compare adherence (exercise amount, diet session attendance, and changes in percent calorie intake from fat, cardiopulmonary fitness, and pedometer steps) and changes in body measures (weight, waist and percent body fat) and serum biomarkers (glucose, insulin, homeostasis assessment-insulin resistance, and high-sensitivity C-reactive protein) between users and non-users. An interaction term (intervention×antidepressant use) tested effect modification. RESULTS: There were no differences in adherence except that diet session attendance was lower among users in the diet+exercise group (P<0.05 vs. non-users). Changes in body measures and serum biomarkers did not differ by antidepressant use (Pinteraction>0.05). CONCLUSION: Dietary weight loss and exercise improved body measures and biomarkers of glucose metabolism and inflammation independent of antidepressant use.

Race/Ethnicity Modifies the Relationship Between Diet Quality at the Home- and Individual-Levels and Weight Status Among African American and Hispanic/Latinx Households With Preschool-Age Children.

Background: Higher obesity prevalence and poorer diet quality disproportionately impacting groups based on income and race/ethnicity may be partially attributed to the home food environment. This study examined home- and individual-level diet quality with weight status among racially/ethnically diverse households. Methods: This cross-sectional study included African American (AA) and Hispanic/Latinx (H/L) households with preschool-age children (n = 97). Home-level diet quality was based on comprehensive home food inventories and individual-level diet quality was based on 24-hour dietary recalls; scores were estimated with the Healthy Eating Index. Child and adult appropriate weight categories based on BMI were estimated with measured heights and weights. Multiple linear regression models (independent variable: weight status, outcome: diet quality scores) with an interaction term for weight status and race/ethnicity and adjusting for potential confounding factors were used to estimate adjusted mean diet quality scores. Postestimation pairwise comparisons of these scores were used to look for within and between group differences by weight status and race/ethnicity. Results: Home-level diet quality scores were significantly higher among H/L households compared to AA counterparts regardless of weight status. AA parents with BMI <30 and AA children with BMI <85th percentile had poorer individual-level diet quality scores compared to AA parents and children of lower weight status and all H/L parents and children. Conclusions: These findings offer evidence that race/ethnicity modifies the relationship between diet quality and weight among AA and H/L households. Future research needs to examine the distinctive ways race/ethnicity shapes the relationship between weight and diet quality in these households.

Magnesium stearate surface coverage on tablets and drug crystals: Insights from SEM-EDS elemental mapping.

Scanning electron microscopy-based energy dispersive X-ray spectroscopy (SEM-EDS) is proposed as a versatile tool for quantifying surface area coverage (SAC) by magnesium stearate (MgSt) on pharmaceutical tablets and particles. Our approach involved fast elemental mapping and subsequent SAC quantitation by image analysis. The study was conducted using a multi-component system, but the particle-level mapping was limited to active pharmaceutical ingredient (API) crystals. For both tablets and API particles, the calculated SAC against MgSt loading afforded a positive linear correlation over the range of MgSt levels examined in this work. On the tablet surface, MgSt was found to be preferentially concentrated at or in the close vicinity of grain boundaries, supporting the idea of compression-driven migration and relocation of MgSt within the tablet. On the particle surface, only discrete aggregates of MgSt were observed, as opposed to the widely accepted phenomenon of the formation of a thin lubricant film around host particles. The selection of proper SEM-EDS operating conditions and the challenges confronted in particle surface mapping are discussed in detail.

Understanding the role of magnesium stearate in lowering punch sticking propensity of drugs during compression.

The sticking of active pharmaceutical ingredient (API) to the surfaces of compaction tooling, frequently referred to as punch sticking, causes costly downtime or product failures in commercial tablet manufacturing. Magnesium stearate (MgSt) is a common tablet lubricant known to ameliorate the sticking problem, even though there exist exceptions. The mechanism by which MgSt lowers punch sticking propensity (PSP) by covering API surface is sensible but not yet experimentally proven. This work was aimed at elucidating the link between PSP and surface area coverage (SAC) of tablets by MgSt, in relation to some key formulation properties and process parameters, namely MgSt concentration, API loading, API particle size, and mixing conditions. The study was conducted using two model APIs with known high PSPs, tafamidis (TAF) and ertugliflozin-pyroglutamic acid (ERT). Results showed that PSP decreases exponentially with increasing SAC by MgSt. The composition of material stuck to punch face was also explored to better understand the onset of punch sticking and the impact of possible MgSt-effected punch conditioning event.

Perceived factors that influence adoption, implementation and sustainability of an evidence-based intervention promoting healthful eating and physical activity in childcare centers in an urban area in the United States serving children from low-income, racially/ethnically diverse families.

Introduction: Early childcare centers offer optimal settings to provide healthy built environments where preschool age children spend a majority of their week. Many evidence-based interventions (EBIs) promoting healthful eating and physical activity for early childcare settings exist, but there is a limited understanding of how best to support adoption, implementation and sustainability in community settings. This study examined how early childcare teachers and administrators from Chicago-area childcare centers serving children from low-income, racially/ethnically diverse communities viewed an EBI called Hip to Health (H3), and the factors they perceived as relevant for EBI adoption, implementation, and sustainability. Methods: A multiple methods study including key informant interviews and a brief survey was conducted. Key informant interviews with teachers and administrators from childcare centers located in Chicago, IL were completed between December 2020 and May 2021. An interview guide and coding guide based on the Consolidated Framework for Implementation Research (CFIR) was developed. Interview transcripts were team coded in MAXQDA Qualitative Data Analysis software. Thematic analysis was used to identify findings specific to adoption, implementation, and sustainability. Participants were also asked to respond to survey measures about the acceptability, feasibility, and appropriateness of H3. Results: Overall, teachers (n = 20) and administrators (n = 16) agreed that H3 was acceptable, appropriate, and feasible. Low start-up costs, ease-of-use, adaptability, trialability, compatibility, and leadership engagement were important to EBI adoption. Timely and flexible training was critical to implementation. Participants noted sustainability was tied to low ongoing costs, access to ongoing support, and positive observable benefits for children and positive feedback from parents. Conclusions: These findings suggest that EBIs suitable for adoption, implementation, and sustainment in childcare centers serving racially/ethnically diverse, low-income families should be adaptable, easy to use, and low-cost (initial and ongoing). There is also some evidence from these findings of the heterogeneity that exists among childcare centers serving low-income families in that smaller, less resourced centers are often less aware of EBIs, and the preparation needed to implement EBIs. Future research should examine how to better support EBI dissemination and implementation to these settings.

Linked experimental and modelling approaches for tablet property predictions.

Recent years have seen the advent of Quality-by-Design (QbD) as a philosophy to ensure the quality, safety, and efficiency of pharmaceutical production. The key pharmaceutical processing methodology of Direct Compression to produce tablets is also the focus of some research. The traditional Design-of-Experiments and purely experimental approach to achieve such quality and process development goals can have significant time and resource requirements. The present work evaluates potential for using combined modelling and experimental approach, which may reduce this burden by predicting the properties of multicomponent tablets from pure component compression and compaction model parameters. Additionally, it evaluates the use of extrapolation from binary tablet data to determine theoretical pure component model parameters for materials that cannot be compacted in the pure form. It was found that extrapolation using binary tablet data - where one known component can be compacted in pure form and the other is a challenging material which cannot be - is possible. Various mixing rules have been evaluated to assess which are suitable for multicomponent tablet property prediction, and in the present work linear averaging using pre-compression volume fractions has been found to be the most suitable for compression model parameters, while for compaction it has been found that averaging using a power law equation form produced the best agreement with experimental data. Different approaches for estimating component volume fractions have also been evaluated, and using estimations based on theoretical relative rates of compression of the pure components has been found to perform slightly better than using constant volume fractions (that assume a fully compressed mixture). The approach presented in this work (extrapolation of, where necessary, binary tablet data combined with mixing rules using volume fractions) provides a framework and path for predictions for multicomponent tablets without the need for any additional fitting based on the multicomponent formulation composition. It allows the knowledge space of the tablet to be rapidly evaluated, and key regions of interest to be identified for follow-up, targeted experiments that that could lead to an establishment of a design and control space and forgo a laborious initial Design-of-Experiments.

Dietary weight loss and exercise interventions effects on quality of life in overweight/obese postmenopausal women: a randomized controlled trial.

BACKGROUND: Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventing unhealthy weight gain and chronic diseases than intervening on a single behavior, few studies have compared individual and combined effects of diet and/or exercise interventions on health-related quality of life (HRQOL). In addition, the mechanisms of how these lifestyle interventions affect HRQOL are unknown. The primary aim of this study was to examine the individual and combined effects of dietary weight loss and/or exercise interventions on HRQOL and psychosocial factors (depression, anxiety, stress, social support). The secondary aim was to investigate predictors of changes in HRQOL. METHODS: This study was a randomized controlled trial. Overweight/obese postmenopausal women were randomly assigned to 12 months of dietary weight loss (n = 118), moderate-to-vigorous aerobic exercise (225 minutes/week, n = 117), combined diet and exercise (n = 117), or control (n = 87). Demographic, health and anthropometric information, aerobic fitness, HRQOL (SF-36), stress (Perceived Stress Scale), depression [Brief Symptom Inventory (BSI)-18], anxiety (BSI-18) and social support (Medical Outcome Study Social Support Survey) were assessed at baseline and 12 months. The 12-month changes in HRQOL and psychosocial factors were compared using analysis of covariance, adjusting for baseline scores. Multiple regression was used to assess predictors of changes in HRQOL. RESULTS: Twelve-month changes in HRQOL and psychosocial factors differed by intervention group. The combined diet + exercise group improved 4 aspects of HRQOL (physical functioning, role-physical, vitality, and mental health), and stress (p ≤ 0.01 vs. controls). The diet group increased vitality score (p < 0.01 vs. control), while HRQOL did not change differently in the exercise group compared with controls. However, regardless of intervention group, weight loss predicted increased physical functioning, role-physical, vitality, and mental health, while increased aerobic fitness predicted improved physical functioning. Positive changes in depression, stress, and social support were independently associated with increased HRQOL, after adjusting for changes in weight and aerobic fitness. CONCLUSIONS: A combined diet and exercise intervention has positive effects on HRQOL and psychological health, which may be greater than that from exercise or diet alone. Improvements in weight, aerobic fitness and psychosocial factors may mediate intervention effects on HRQOL.

Microbial community composition and carbon cycling within soil microenvironments of conventional, low-input, and organic cropping systems.

This study coupled stable isotope probing with phospholipid fatty acid analysis ((13)C-PLFA) to describe the role of microbial community composition in the short-term processing (i.e., C incorporation into microbial biomass and/or deposition or respiration of C) of root- versus residue-C and, ultimately, in long-term C sequestration in conventional (annual synthetic fertilizer applications), low-input (synthetic fertilizer and cover crop applied in alternating years), and organic (annual composted manure and cover crop additions) maize-tomato (Zea mays - Lycopersicum esculentum) cropping systems. During the maize growing season, we traced (13)C-labeled hairy vetch (Vicia dasycarpa) roots and residues into PLFAs extracted from soil microaggregates (53-250 µm) and silt-and-clay (<53 µm) particles. Total PLFA biomass was greatest in the organic (41.4 nmol g(-1) soil) and similar between the conventional and low-input systems (31.0 and 30.1 nmol g(-1) soil, respectively), with Gram-positive bacterial PLFA dominating the microbial communities in all systems. Although total PLFA-C derived from roots was over four times greater than from residues, relative distributions (mol%) of root- and residue-derived C into the microbial communities were not different among the three cropping systems. Additionally, neither the PLFA profiles nor the amount of root- and residue-C incorporation into the PLFAs of the microaggregates were consistently different when compared with the silt-and-clay particles. More fungal PLFA-C was measured, however, in microaggregates compared with silt-and-clay. The lack of differences between the mol% within the microbial communities of the cropping systems and between the PLFA-C in the microaggregates and the silt-and-clay may have been due to (i) insufficient differences in quality between roots and residues and/or (ii) the high N availability in these N-fertilized cropping systems that augmented the abilities of the microbial communities to process a wide range of substrate qualities. The main implications of this study are that (i) the greater short-term microbial processing of root- than residue-C can be a mechanistic explanation for the higher relative retention of root- over residue-C, but microbial community composition did not influence long-term C sequestration trends in the three cropping systems and (ii) in spite of the similarity between the microbial community profiles of the microaggregates and the silt-and-clay, more C was processed in the microaggregates by fungi, suggesting that the microaggregate is a relatively unique microenvironment for fungal activity.

Society of Behavioral Medicine (SBM) does not support "Public Charge Rule" changes affecting immigrants' food security.

Federal nutrition assistance programs, especially the Supplemental Nutrition Assistance Program (SNAP), are an important safety net for households in the USA. Although few immigrant households are eligible for SNAP, those who need the program are less likely to participate than nonimmigrant households. Documented barriers to participation include language challenges and anti-immigrant rhetoric. However, previous research indicates that when immigrant households do participate in SNAP, their young children experience less food insecurity and the household as a whole makes fewer tradeoffs between food and other necessities. The Public Charge Rule limits ability to obtain a green card based on participation in public assistance programs. A recent change to this rule added programs to include some noncash programs, including SNAP. Although the vast majority of immigrants who are subject to the Public Charge Rule are not eligible for SNAP, misunderstanding of the rule and fear threaten to reduce SNAP enrollment and consequently increase food insecurity in immigrant families. Spillover effects may occur for families not targeted by changes in the Public Charge Rule as well as decreasing access to other safety net programs that are not impacted by the proposed changes, such as The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and school meals programs. In order to support the food security of immigrant families in the USA, we recommend that the Department of Homeland Security and the Department of State remove all non-cash safety net programs from the Public Charge Rule.