Cumulative risk assessment with pesticides in the framework of MRL setting.

This abstract presents a report on the proposed work programme, focus on cumulative risk assessment (CRA) for chemical risks, specifically pesticide residues in food. While not a scientific publication, this technical report aims to provide insights without including the fellow's data to avoid publication restrictions. This report focuses on addressing the question concerning the trigger value to perform a prospective CRA in case of a new maximum residue level (MRL) setting. The 1,000 margin of exposure (MOE) threshold value was tested and compared to preliminary ANSES results. Alternative thresholds were calculated and explored. The EU-FORA fellow selected two cumulative assessment groups (CAGs) related to acute craniofacial alterations and chronic thyroid effects. The fellow performed exposure assessments, integrating effects data, French monitoring data, processing factors, agricultural uses, MRLs and extrapolations into Monte Carlo risk assessment (MCRA). Retrospective cumulative exposures using MCRA were conducted for children, adults and a vulnerable group of childbearing women based on the French survey INCA3, identifying background levels at P99.9. The fellow also performed prospective assessments with MCRA, analysing results at P99.9 to evaluate the adequacy of the 1,000 MOE threshold. Alternative thresholds are discussed and proposed.

Tolerability and Acceptability of an Exogenous Ketone Monoester and Ketone Monoester/Salt Formulation in Humans.

Exogenous ketone ester and ketone ester mixed with ketone free acid formulations are rapidly entering the commercial marketspace. Short-term animal and human studies using these products suggest significant potential for primary or secondary prevention of a number of chronic disease conditions. However, a number of questions need to be addressed by the field for optimal use in humans, including variable responses among available exogenous ketones at different dosages; frequency of dosing; and their tolerability, acceptability, and efficacy in long-term clinical trials. The purpose of the current investigation was to examine the tolerability, acceptability, and circulating R-beta-hydroxybutyrate (R-ßHB) and glucose responses to a ketone monoester (KME) and ketone monoester/salt (KMES) combination at 5 g and 10 g total R-ßHB compared with placebo control (PC). Fourteen healthy young adults (age: 21 ± 2 years, weight: 69.7 ± 14.2 kg, percent fat: 28.1 ± 9.3%) completed each of the five study conditions: placebo control (PC), 5 g KME (KME5), 10 g KME (KME10), 5 g (KMES5), and 10 g KMES (KMES10) in a randomized crossover fashion. Circulating concentrations of R-ßHB were measured at baseline (time 0) following an 8-12 h overnight fast and again at 15, 30, 60, and 120 min following drink ingestion. Participants also reported acceptability and tolerability during each condition. Concentrations of R-ßHB rose to 2.4 ± 0.1 mM for KME10 after 15 min, whereas KMES10 similarly peaked (2.1 ± 0.1 mM) but at 30 min. KME5 and KMES5 achieved similar peak R-ßHB concentrations (1.2 ± 0.7 vs. 1.1 ± 0.5 mM) at 15 min. Circulating R-ßHB concentrations were similar to baseline for each condition by 120 min. Negative correlations were observed between R-ßHB and glucose at the 30 min time point for each condition except KME10 and PC. Tolerability was similar among KME and KMES, although decreases in appetite were more frequently reported for KMES. Acceptability was slightly higher for KMES due to the more frequently reported aftertaste for KME. The results of this pilot investigation illustrate that the KME and KMES products used increase circulating R-ßHB concentrations to a similar extent and time course in a dose-dependent fashion with slight differences in tolerability and acceptability. Future studies are needed to examine variable doses, frequency, and timing of exogenous ketone administration for individuals seeking to consume ketone products for health- or sport performance-related purposes.

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors.

Objective: To facilitate replication and future intervention design of web-based multibehavior lifestyle interventions, we describe the rationale, development, and content of the AiM, Plan, and act on LIFestYles (AMPLIFY) Survivor Health intervention which provides healthy eating and exercise behavior change support for older cancer survivors. The intervention promotes weight loss, improvements in diet quality, and meeting exercise recommendations. Methods: The Template for Intervention Description and Replication (TIDieR) checklist was used to provide a comprehensive description of the AMPLIFY intervention, consistent with CONSORT recommendations. Results: A social cognitive theory web-based intervention founded on the core components of efficacious print and in-person interventions was conceptualized and developed through an iterative collaboration involving cancer survivors, web design experts, and a multidisciplinary investigative team. The intervention includes the AMPLIFY website, text and/or email messaging, and a private Facebook group. The website consists of: (1) Sessions (weekly interactive e-learning tutorials); (2) My Progress (logging current behavior, receiving feedback, setting goals); (3) Tools (additional information and resources); (4) Support (social support resources, frequently asked questions); and (5) Home page. Algorithms were used to generate fresh content daily and weekly, tailor information, and personalize goal recommendations. An a priori rubric was used to facilitate intervention delivery as healthy eating only (24 weeks), exercise only (24 weeks), or both behaviors concurrently over 48 weeks. Conclusions: Our TIDieR-guided AMPLIFY description provides pragmatic information helpful for researchers designing multibehavior web-based interventions and enhances potential opportunities to improve such interventions.

Perspective: Acknowledging a Hierarchy of Social Needs in Diabetes Clinical Care and Prevention.

The evidence of suboptimal social determinants of health (SDoH) on poor health outcomes has resulted in widespread calls for research to identify ways to measure and address social needs to improve health outcomes and reduce disparities. While assessing SDoH has become increasingly important in diabetes care and prevention research, little guidance has been offered on how to address suboptimal determinants in diabetes-related clinical care, prevention efforts, medical education and research. Not surprisingly, many patients experience multiple social needs - some that are more urgent (housing) than others (transportation/resources), therefore the order in which these needs are addressed needs to be considered in the context of diabetes care/outcomes. Here we discuss how conceptualizing diabetes related health through the lens of Maslow's hierarchy of needs has potential to help prioritize individual social needs that should be addressed to improve outcomes in the context of population-level determinants in the communities where people live.

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers.

BACKGROUND: Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project. METHODS: Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis. DISCUSSION: Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04000880 . Registered 27 June 2019.

The Changing Landscape of Nutrition in Cystic Fibrosis: The Emergence of Overweight and Obesity.

Cystic fibrosis has historically been characterized by malnutrition, and nutrition strategies have placed emphasis on weight gain due to its association with better pulmonary outcomes. As treatment for this disease has significantly improved, longevity has increased and overweight and obesity have emerged issues in this population. The effect of excess weight and adiposity on CF clinical outcomes is unknown but may produce similar health consequences and obesity-related diseases as those observed in the general population. This review examines the prevalence of overweight and obesity in CF, the medical and psychological impact, as well as the existing evidence for treatment in the general population and how this may be applied to people with CF. Clinicians should partner with individuals with CF and their families to provide a personalized, interdisciplinary approach that includes dietary modification, physical activity, and behavioral intervention. Additional research is needed to identify the optimal strategies for preventing and addressing overweight and obesity in CF.

Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study.

BACKGROUND: Internet-based lifestyle programs are increasingly being used to deliver health behavior change interventions to survivors of cancer. However, little is known about website use in this population or its association with healthy lifestyle changes. OBJECTIVE: The aim of this study is to describe lifestyle intervention website use (log-ins, time on website, and page views) among survivors of cancer and patterns of use by participant characteristics. In addition, associations were explored between website use and changes in healthy lifestyle knowledge and practice. METHODS: A total of 35 survivors of cancer were recruited between August 2017 and 2018 to participate in a 2-week, single-arm pilot test of the SurvivorSHINE lifestyle intervention website. Knowledge and practices related to healthy diet and physical activity behaviors were measured at baseline and follow-up. Website use (eg, time spent on the website, frequency of log-ins, and page views) were collected from the SurvivorSHINE administrative site during the intervention period. Patterns of use were examined by participants' gender and race. Correlations between website use and changes in healthy lifestyle knowledge, physical activity, diet, and weight were explored. Mann-Whitney U tests were used to compare demographic factors on website use. RESULTS: Participants logged into the SurvivorSHINE intervention website an average of 3.2 (SD 2) times over the 2-week period and spent a total average of 94 (SD 56) minutes viewing the website during the intervention. Examining website activity, 1905 page views were logged. The User Profile (344 page views) and Home sections (301 page views) were the most frequently visited components. No associations were observed between the frequency of log-ins or the total time on the website, improvements in knowledge related to healthy lifestyles, or changes in body weight or dietary intake. However, the total time on the website was positively correlated with improvements in accelerometer-measured physical activity (r=0.74; P=.02) and self-reported physical activity (r=0.35; P=.04). CONCLUSIONS: Survivors of cancer demonstrated clear interest in a diet and exercise intervention website, as evidenced by their frequency of log-ins, page views on numerous features, and total viewing time. Moreover, increased website use was correlated with improvements in physical activity.

A Web-based Lifestyle Intervention for Cancer Survivors: Feasibility and Acceptability of SurvivorSHINE.

Assess the feasibility, acceptability, and preliminary efficacy of a healthy lifestyle website, SurvivorSHINE ( www.survivorshine.org ), for cancer survivors using a mixed-methods approach. Formative research included a comprehensive literature review and four focus groups on website preferences with diagnosis-diverse cancer survivors (N = 17). Their feedback informed a web adaptation of a telephone counseling and mailed-print lifestyle intervention previously found effective for cancer survivors. The resulting web-based intervention was examined in a 3-week, single-arm trial among 41 cancer survivors. Assessments of physical activity, diet, body weight, and knowledge related to exercise and diet guidelines for cancer survivors occurred at baseline and 3 weeks later, along with exit interviews. Themes from focus groups indicated cancer survivors' desire for easy-to-use, interactive web-based platforms to access credible diet and exercise information. The study sample was recruited within 12 months, and study retention was high (85.4%). Participants showed significant pre- to post-test improvements in diet and exercise knowledge (t = 5.31, p < .0001) and physical activity (t = 2.40, p = .02). Improvements in body weight and some dietary components (red meat, alcohol) were observed, but did not reach statistical significance. Results support the feasibility and acceptability of SurvivorSHINE. The significant increases in healthy lifestyle knowledge and physical activity found in the current study are promising, but a larger, randomized-controlled trial is needed to determine efficacy.

Identification and pathogenicity of Alternaria species associated with leaf blotch disease and premature defoliation in French apple orchards.

Leaf blotch caused by Alternaria spp. is a common disease in apple-producing regions. The disease is usually associated with one phylogenetic species and one species complex, Alternaria alternata and the Alternaria arborescens species complex (A. arborescens SC), respectively. Both taxa may include the Alternaria apple pathotype, a quarantine or regulated pathogen in several countries. The apple pathotype is characterized by the production of a host-selective toxin (HST) which is involved in pathogenicity towards the apple. A cluster of genes located on conditionally dispensable chromosomes (CDCs) is involved in the production of this HST (namely AMT in the case of the apple pathotype). Since 2016, leaf blotch and premature tree defoliation attributed to Alternaria spp. have been observed in apple-producing regions of central and south-eastern France. Our study aimed to identify the Alternaria species involved in apple tree defoliation and assess the presence of the apple pathotype in French orchards. From 2016 to 2018, 166 isolates were collected and identified by multi-locus sequence typing (MLST). This analysis revealed that all these French isolates belonged to either the A. arborescens SC or A. alternata. Specific PCR detection targeting three genes located on the CDC did not indicate the presence of the apple pathotype in France. Pathogenicity was assessed under laboratory conditions on detached leaves of Golden Delicious and Gala apple cultivars for a representative subset of 28 Alternaria isolates. All the tested isolates were pathogenic on detached leaves of cultivars Golden Delicious and Gala, but no differences were observed between the pathogenicity levels of A. arborescens SC and A. alternata. However, the results of our pathogenicity test suggest that cultivar Golden Delicious is more susceptible than Gala to Alternaria leaf blotch. Implications in the detection of the Alternaria apple pathotype and the taxonomic assignment of Alternaria isolates involved in Alternaria leaf blotch are discussed.

Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team.

Background During the COVID-19 pandemic, in-person research assessments needed to be adapted to ensure safety of participants and staff. Participants' willingness to participate in research activities, how to prepare assessors to ensure data integrity, and the feasibility of modified protocols, were unknown. Within the AMPLIFI randomized clinical trial (RCT) for cancer survivors, we elicited participants' preferences and willingness to participate in Clinic, Home, or Virtual assessments, prepared assessors for, and implemented virtual assessments. Methods 1) We conducted phone surveys of potential AMPLIFI participants; 2) Based on survey results, we modified assessments from in-person to virtual visits (VV) by videoconference. Assessors were trained and certified, i.e., assessors recorded 3 assessments that were reviewed and scored by 2 investigators. The modified protocol was proposed to 62 participants: we report numbers of those who agreed to attend VV. Results 1) Survey results: Among 74 survey respondents, 44.6% preferred, 75.7% were willing to attend Clinic Visits; 32.4% preferred, 83.8% were willing to do VV; 23% preferred, 77% were willing to do Home Visits. Survivors 70+ were less likely than 50-69 years old to be willing to do VV: no other differences were noted by gender, race, rural status or education. 2) Assessment uptake: 66.1% agreed to attend VV, and of them 75.6% completed them. Conclusion Diverse research participants adapted to protocols that prioritize their safety, although older participants may be reluctant to do virtual assessments. Virtual assessments are feasible and research teams can rigorously prepare to collect quality data through them.

Ketogenic Diet for Cancer: Critical Assessment and Research Recommendations.

Despite remarkable improvements in screening, diagnosis, and targeted therapies, cancer remains the second leading cause of death in the United States. It is increasingly clear that diet and lifestyle practices play a substantial role in cancer development and progression. As such, various dietary compositions have been proposed for reducing cancer risk and as potential adjuvant therapies. In this article, we critically assess the preclinical and human trials on the effects of the ketogenic diet (KD, i.e., high-fat, moderate-to-low protein, and very-low carbohydrate content) for cancer-related outcomes. The mechanisms underlying the hypothesized effects of KD, most notably the Warburg Effect, suggest that restricting carbohydrate content may impede cancer development and progression via several pathways (e.g., tumor metabolism, gene expression). Overall, although preclinical studies suggest that KD has antitumor effects, prolongs survival, and prevents cancer development, human clinical trials are equivocal. Because of the lack of high-quality clinical trials, the effects of KD on cancer and as an adjunctive therapy are essentially unknown. We propose a set of research recommendations for clinical studies examining the effects of KD on cancer development and progression.

Features That Middle-aged and Older Cancer Survivors Want in Web-Based Healthy Lifestyle Interventions: Qualitative Descriptive Study.

BACKGROUND: With the increasing number of older cancer survivors, it is imperative to optimize the reach of interventions that promote healthy lifestyles. Web-based delivery holds promise for increasing the reach of such interventions with the rapid increase in internet use among older adults. However, few studies have explored the views of middle-aged and older cancer survivors on this approach and potential variations in these views by gender or rural and urban residence. OBJECTIVE: The aim of this study was to explore the views of middle-aged and older cancer survivors regarding the features of web-based healthy lifestyle programs to inform the development of a web-based diet and exercise intervention. METHODS: Using a qualitative descriptive approach, we conducted 10 focus groups with 57 cancer survivors recruited from hospital cancer registries in 1 southeastern US state. Data were analyzed using inductive thematic and content analyses with NVivo (version 12.5, QSR International). RESULTS: A total of 29 male and 28 female urban and rural dwelling Black and White survivors, with a mean age of 65 (SD 8.27) years, shared their views about a web-based healthy lifestyle program for cancer survivors. Five themes emerged related to program content, design, delivery, participation, technology training, and receiving feedback. Cancer survivors felt that web-based healthy lifestyle programs for cancer survivors must deliver credible, high-quality, and individually tailored information, as recommended by health care professionals or content experts. Urban survivors were more concerned about information reliability, whereas women were more likely to trust physicians' recommendations. Male and rural survivors wanted information to be tailored to the cancer type and age group. Privacy, usability, interaction frequency, and session length were important factors for engaging cancer survivors with a web-based program. Female and rural participants liked the interactive nature and visual appeal of the e-learning sessions. Learning from experts, an attractive design, flexible schedule, and opportunity to interact with other cancer survivors in Facebook closed groups emerged as factors promoting program participation. Low computer literacy, lack of experience with web program features, and concerns about Facebook group privacy were important concerns influencing cancer survivors' potential participation. Participants noted the importance of technology training, preferring individualized help to standardized computer classes. More rural cancer survivors acknowledged the need to learn how to use computers. The receipt of regular feedback about progress was noted as encouragement toward goal achievement, whereas women were particularly interested in receiving immediate feedback to stay motivated. CONCLUSIONS: Important considerations for designing web-based healthy lifestyle interventions for middle-aged and older cancer survivors include program quality, participants' privacy, ease of use, attractive design, and the prominent role of health care providers and content experts. Cancer survivors' preferences based on gender and residence should be considered to promote program participation.

A Pilot Study of Associations Between Visceral Fat, IL-6, and Urinary F2-Isoprostanes in Older Adults Exposed to a Diet Intervention.

BACKGROUND: Short-term markers of successful visceral adipose tissue (VAT) loss are needed. Urinary F2-isoprostanes might serve as a marker for intensified lipid metabolism, whereas circulating IL-6 might stimulate fat oxidation and enhance mobilization of VAT. OBJECTIVES: This pilot study was designed to explore the hypotheses that 1) reduction in VAT is associated with increase in IL-6, and 2) that increases in urinary F2-isoprostanes are associated with increases in IL-6 and reduction in VAT. METHODS: Eighteen participants (aged 60-75 y, BMI 30-40 kg/m2) were randomly assigned to either a very-low-carbohydrate diet (VLCD; <10:25:>65% energy from carbohydrate:protein:fat) or a low-fat diet (LFD; 55:25:20%) for 8 wk. Changes in fat distribution were assessed by MRI. Four urinary F2-isoprostane isomers were quantified in 24-h urine collection using LC-MS/MS analyses. Changes in 4 F2-isoprostane isomers were summarized using factor analysis (Δ-F2-isoprostane factor). Statistical significance was set at P < 0.1. RESULTS: Within the VLCD group, change in VAT was inversely associated with change in IL-6 (r = -0.778, P = 0.069) and Δ-F2-isoprostane factor (r = -0.690, P = 0.086), demonstrating that participants who maintained higher concentrations of F2-isoprostane factor across the intervention showed greater decreases in VAT. A positive relation between Δ-F2-isoprostane factor and change in IL-6 was observed (r = 0.642, P = 0.062). In the LFD group, no significant associations between changes in VAT, F2-isoprostane factor, or IL-6 were observed. CONCLUSIONS: Results from this exploratory study in older adults with obesity suggest that, in the context of a VLCD, IL-6 could be involved in VAT mobilization, and urinary F2-isoprostanes could reflect intensified oxidation of mobilized fatty acids.Trial registration: This study is registered at clinicaltrials.gov as NCT02760641.

An Exploratory Analysis of the Association Between Catechol-O-Methyltransferase and Response to a Randomized Open-Label Placebo Treatment for Cancer-Related Fatigue.

Previous studies have identified catechol-O-methyltransferase (COMT), as a key enzyme influencing sympathetic function. Although the COMT SNP rs4680 and rs4818, are well-studied, little is known about their influence on cancer-related fatigue (CrF) and placebo response. In this study, we examined whether genetic variation in COMT, at the functional SNP rs4680 and linked rs4818, influenced open-label placebo (OLP) responses found in cancer survivors reporting moderate to severe CrF. We randomized cancer survivors (N = 74) reporting moderate-to-severe CrF to receive OLP or to treatment-as-usual (TAU) and assessed if rs4680 and rs4818 were associated with changes in fatigue severity and fatigue-distressed quality of life. At the end of the initial 21 days, the treatments were crossed over and both groups were re-assessed. Participants with the rs4680 high-activity G-allele (G/G or G/A) or rs4818 C/G genotypes reported significant decreases in fatigue severity and improvements in fatigue-distressed quality of life. The COMT rs4818 findings replicated findings in a similar study of OLP in cancer fatigue. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02522988.

The daily Self-Weighing for Obesity Management in Primary Care Study: Rationale, design and methodology.

Background Daily self-weighing (DSW) may be an effective harm-reduction intervention to disrupt continued weight gain. Self-Weighing for Obesity Management in Primary Care (SWOP) is a 24-month randomized controlled trial in 400 adults with obesity (BMI: kg/m2 ≥ 30) receiving primary care through a clinical network affiliated with an academic medical center. Objective To test DSW as a potentially scalable way to deter age-related weight gain among primary care patients with obesity. Methods Randomized-controlled trial with two conditions: DSW (instruction to weigh daily and provision of a web-enabled digital scale with graphical weight feedback) or Standard Care (receive a monetary gift card equivalent to value of the scale). Both groups receive standardized weight management educational material. SWOP will test the causal effect of assignment to DSW (Aim 1) and adherence to DSW (Aim 2) on weight (primary outcome) and adoption of weight management practices (secondary outcomes), as well as evaluate the cost-effectiveness of DSW compared to standard care (Aim 3). Findings may inform clinical guidelines for weight management by providing evidence that DSW attenuates continued age-related weight gain among adults with obesity. This trial is registered with ClinicalTrials.gov (NCT04044794).

Science dialogue mapping of knowledge and knowledge gaps related to the effects of dairy intake on human cardiovascular health and disease.

Dairy has been described as everything from a superfood to a poison; yet, arguments, assumptions, and data justifying these labels are not always clear. We used an issue-based information system, "dialogue mapping™," to summarize scientific points of a live panel discussion on the putative effects of dairy on cardiovascular diseases (CVD) from a day-long session among experts in nutrition and CVD. Dialogue mapping captures relations among ideas to explicitly, logically, and visually connect issues/questions, ideas, pro/con arguments, and agreements, even if discussed at different times. Experts discussed two propositions: for CVD risk, consumption of full-fat dairy products 1) should be minimized, in part because of their saturated fat content, or 2) need not be minimized, despite their saturated fat content. The panel discussed the dairy-CVD relation through blood lipids, diabetes, obesity, energy balance, blood pressure, dairy bioactives, biobehavioral components, and other putative causal pathways. Associations and effects reported in the literature have varied by fat content of dairy elements considered, study design, intake methods, and biomarker versus disease outcomes. Two conceptual topics emerged from the discussion: 1) individual variability: whether recommendations should be targeted only to those at high CVD risk; 2) quality of evidence: whether data on dairy-CVD relations are strong enough for reliable conclusions-positive, negative, or null. Future procedural improvements for science dialog mapping include using singular rather than competing propositions for discussion.

Geospatial analysis of Mediterranean diet adherence in the United States.

OBJECTIVE: The current study aims to describe the Mediterranean diet (MD) adherence across the US regions, and explore the predictive factors of MD adherence among US adults. DESIGN: Cross-sectional secondary data analysis. MD adherence score (0-9) was calculated using the Block 98 FFQ. Hot spot analysis was conducted to describe the geospatial distribution of MD adherence across the US regions. Logistic regression explored predictors of MD adherence. SETTING: Nationwide community-dwelling residency in the USA. PARTICIPANTS: Adults aged ≥45 years (n 20 897) who participated in the REasons for Geographic and Racial Differences in Stroke study and completed baseline assessment during January 2003 and October 2007. RESULTS: The mean of MD adherence score was 4·36 (sd 1·70), and 46·5 % of the sample had high MD adherence (score 5-9). Higher MD adherence clusters were primarily located in the western and northeastern coastal areas of the USA, whereas lower MD adherence clusters were majorly observed in south and east-north-central regions. Being older, black, not a current smoker, having a college degree or above, an annual household income ≥ $US 75K, exercising ≥4 times/week and watching TV/video <4 h/d were each associated with higher odds of high MD adherence. CONCLUSIONS: There were significant geospatial and population disparities in MD adherence across the US regions. Future studies are needed to explore the causes of MD adherence disparities and develop effective interventions for MD promotion in the USA.

Effects of weight loss during a very low carbohydrate diet on specific adipose tissue depots and insulin sensitivity in older adults with obesity: a randomized clinical trial.

BACKGROUND: Insulin resistance and accumulation of visceral adipose tissue (VAT) and intermuscular adipose tissue (IMAT) place aging adults with obesity at high risk of cardio-metabolic disease. A very low carbohydrate diet (VLCD) may be a means of promoting fat loss from the visceral cavity and skeletal muscle, without compromising lean mass, and improve insulin sensitivity in aging adults with obesity. OBJECTIVE: To determine if a VLCD promotes a greater loss of fat (total, visceral and intermuscular), preserves lean mass, and improves insulin sensitivity compared to a standard CHO-based/low-fat diet (LFD) in older adults with obesity. DESIGN: Thirty-four men and women aged 60-75 years with obesity (body mass index [BMI] 30-40 kg/m2) were randomized to a diet prescription of either a VLCD (< 10:25:> 65% energy from CHO:protein:fat) or LFD diet (55:25:20) for 8 weeks. Body composition by dual-energy X-ray absorptiometry (DXA), fat distribution by magnetic resonance imaging (MRI), insulin sensitivity by euglycemic hyperinsulinemic clamp, and lipids by a fasting blood draw were assessed at baseline and after the intervention. RESULTS: Participants lost an average of 9.7 and 2.0% in total fat following the VLCD and LFD, respectively (p < 0.01). The VLCD group experienced ~ 3-fold greater loss in VAT compared to the LFD group (- 22.8% vs - 1.0%, p < 0.001) and a greater decrease in thigh-IMAT (- 24.4% vs - 1.0%, p < 0.01). The VLCD group also had significantly greater thigh skeletal muscle (SM) at 8 weeks following adjustment for change in total fat mass. Finally, the VLCD had greater increases in insulin sensitivity and HDL-C and decreases in fasting insulin and triglycerides compared to the LFD group. CONCLUSIONS: Weight loss resulting from consumption of a diet lower in CHO and higher in fat may be beneficial for older adults with obesity by depleting adipose tissue depots most strongly implicated in poor metabolic and functional outcomes and by improving insulin sensitivity and the lipid profile. TRIAL REGISTRATION: NCT02760641. Registered 03 May 2016 - Retrospectively registered.

Does Adherence to Mediterranean Diet Mediate the Association Between Food Environment and Obesity Among Non-Hispanic Black and White Older US Adults? A Path Analysis.

PURPOSE: This study aims to test the hypothesis that in addition to a direct effect of food environment on obesity, food environment is indirectly associated with obesity through consuming Mediterranean diet (MD). DESIGN: Cross-sectional secondary data analysis. SETTING: Nationwide community-dwelling residency. SAMPLE: A total of 20 897 non-Hispanic black and white adults aged ≥45 years who participated in the REasons for Geographic and Racial Differences in Stroke study and completed baseline assessment during January 2003 and October 2007. MEASURES: The Modified Retail Food Environment Index (mRFEI; 0-100) was used as food environment indicator. The MD score (0-9) was calculated to indicate the dietary pattern adherence. Body mass index (BMI; kg/m2) was used to estimate obesity. ANALYSIS: Path analysis was used to quantify the pathways between food environment, MD adherence, and obesity. Proper data transformation was made using Box-Cox power transformation to meet certain analysis assumptions. RESULTS: The participants were from 49 states of the United States, with the majority (64.42%) residing in the South. Most of the participants were retired, female, white, married, having less than college graduate education, having annual household income ≤75 000, and having health insurance. The means of mRFEI was 10.92 (standard deviation [SD] = 10.19), MD score was 4.36 (SD = 1.70), and the BMI was 28.96 kg/m2 (SD = 5.90). Access to healthy food outlets (ß = .04, P < .0001) and MD adherence (ß = .08, P < .0001) had significant and inverse relationships with BMI, respectively. Mediterranean diet adherence mediated the relationship between food environment and obesity among a subpopulation who had an annual household income of <$75 000 (ß = -.02, P = .0391). CONCLUSION: Population-tailored interventions/policies to modify food environment and promote MD consumption are needed in order to combat the obesity crisis in the United States.

Development and validation of the Capacity to Treat Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire.

Background: Patients with co-occurring chronic pain and opioid use disorder (OUD) have unique needs that may present challenges for clinicians and health care systems. Primary care providers' (PCPs) capacity to deliver high quality, research-informed care for this population is unknown. The objective of this study was to develop and test a questionnaire of factors influencing PCP capacity to treat co-occurring chronic pain and OUD. Methods: Capacity to Treat Co-Occurring Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire items were developed over a 2-year process including literature review, semi-structured interviews, and expert panel review. In 2018, a national sample of 509 PCPs was recruited through email to complete a questionnaire including the initial 44-item draft CAP-POD questionnaire. CAP-POD items were analyzed for dimensionality, inter-item reliability, and construct validity. Results: Principal component analysis resulted in a 22-item questionnaire. Twelve more items were removed for parsimony, resulting in a final 10-item questionnaire with the following 4 scales: (1) Motivation to Treat patients with chronic pain and OUD (α = .87), (2) Trust in Evidence (α = .87), (3) Assessing Risk (α = .82), and (4) Patient Access to therapies (α = .79). These scales were associated with evidence-based practice attitudes, knowledge of pain management, and self-reported behavioral adherence to best practice recommendations. Conclusion: We developed a brief, 10-item questionnaire that assesses factors influencing the capacity of PCPs to implement best practice recommendations for the treatment of co-occurring chronic pain and OUD. The questionnaire demonstrated good reliability and initial evidence of validity, and may prove useful in future research as well as clinical settings. Plain language abstract: Patients with co-occurring chronic pain and opioid use disorder (OUD) have unique needs that may present challenges for clinicians and health care systems. Primary care providers' (PCPs) ability to deliver high quality, research-informed care for this population is unknown. There are no validated instruments to assess factors influencing PCP capacity to implement best practices for treating these patients. The objective of this study was to develop and test a questionnaire of factors influencing PCP capacity to treat co-occurring chronic pain and OUD. We recruited 509 PCPs to participate in an online questionnaire that included 44 potential items that assess PCP capacity. Analyses resulted in a 10-item questionnaire that assesses factors influencing capacity to implement best practice recommendations for the treatment of co-occurring chronic pain and OUD. PCPs reported moderately high confidence in the strength and quality of evidence for best practices, and in their ability to identify patients at risk. However, PCPs reported low motivation to treat co-occurring chronic pain and OUD, and perceived patients' access to relevant services as suboptimal, highlighting two areas that should be targeted with tailored implementation strategies. The 10-item Capacity to Treat Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire can be used for two purposes: (1) to assess factors influencing PCP capacity before implementation and identify areas that may require improvement for implementation and (2) to evaluate implementation interventions aimed at increasing PCP capacity to treat this population.