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Food Compass is a nutrient profiling system used to assess the healthfulness of diverse foods, beverages and meals. Here we present a revised version of Food Compass (Food Compass 2.0) incorporating new data on specific ingredients and the latest diet-health evidence. Food Compass 2.0 has been validated against health outcomes in a population from the United States and demonstrates enhanced ability to characterize foods and beverages based on their healthfulness., (© 2024. The Author(s).)

Introduction: The private sector plays a critical role in influencing food choices and health outcomes of consumers. Among private sector actors, investors are a powerful yet underutilised stakeholder for driving scalable public health impact. There are systems to facilitate investors' involvement, notably environmental, social and governance (ESG) investing, which is well placed to include an assessment of business risks to social well-being. However, nutrition efforts within the ESG agenda (ESG-Nutrition) are nascent. We aimed to critically assess the strength of existing ESG-Nutrition metrics to advance the science of measuring business impacts on consumer nutrition and health., Methods: ESG-Nutrition metrics were extracted from eight ESG frameworks and categorised across four domains: product portfolio healthfulness; product distribution and equity; product marketing and labelling; and nutrition-related governance. The strength of each metric was evaluated and scored 1-3 (best), independently by two researchers, based on six attributes: materiality, objectivity, alignment, activity, resolution and verifiability. The total score (range 6-18) and intercorrelation for each attribute was calculated., Results: Across 529 metrics, most related to product marketing and labelling (n=230, 43.5%), followed by product healthfulness (n=126, 23.8%), nutrition-related governance (n=108, 20.4%) and product distribution and equity (n=65, 12.3%). Across all metrics, average total score was 10.94 (1.58), with average attribute scoring highest for verifiability (mean: 2.36 (SD: 0.57)), objectivity (2.11 (0.61)) and materiality (2.01 (0.68)) and lowest for activity (1.83 (0.74)), alignment (1.37 (0.67)) and resolution (1.26 (0.65)). Most intercorrelations were null, suggesting attributes were measuring distinct characteristics of each metric. Significant heterogeneity across domains and frameworks was also observed., Conclusions: This research identifies a range of nutrition-related metrics used in ESG frameworks with respect to food companies, but with substantial heterogeneity in relevant nutrition domains covered and strength of each metric. Efforts are required to improve the quality of metrics across frameworks, establish standardised reporting and align these with investor priorities., Competing Interests: Competing interests: MO reports research funding from Vail Innovative Global Research, as well as the Gates Foundation and the National Institutes of Health and Vail Innovative Global Research, outside of the submitted work. JR reports research funding from the Gates Foundation, the National Institutes of Health and Nestle, outside of the submitted work. ER is funded by an Australian Government Research Training Program (RTP) scholarship. GS is a recipient of a National Health and Medical Research Council (NHMRC) Emerging Leadership Fellowship (APP2008535) and is supported by a Heart Foundation Future Leader Fellowship (102035) from the National Heart Foundation of Australia. He is also a researcher within NHMRC Centres for Research Excellence entitled Reducing Salt Intake Using Food Policy Interventions (APP1117300), a Centre of Research Excellence in Food Retail Environments for Health (RE-FRESH) (APP1152968) and Healthy Food, Healthy Planet, Healthy People (APP2006620) (Australia). JBW reports research funding from the National Institutes of Health and membership in the US Preventive Services Task Force (unpaid) and National Academies of Sciences, Engineering and Medicine Committee on Evaluating the Process to Develop the Dietary Guidelines for Americans, 2020-2025 (unpaid), outside the submitted work. CE reports research funding from the US Department of Agriculture, National Institutes of Health, JPB Foundation, and Newman’s Own Foundation. She also reports her position as Vice Chair to National Academies of Science Roundtable on Obesity Solutions (unpaid) and her Advisory Board position at Care/of Scientific. None of the above relate to the manuscript. DM reports funding from the National Institutes of Health, the Gates Foundation, the Rockefeller Foundation, Vail Innovative Global Research and the Kaiser Permanente Fund at East Bay Community Foundation; personal fees from Acasti Pharma, Barilla, Danone and Motif Foodworks; scientific advisory board for Beren Therapeutics, Brightseed, Calibrate, Discern Dx, Elysium Health, Filtricine, HumanCo, January, Perfect Day, Tiny Organics and (ended) Day Two and Season Health; stock ownership in Calibrate and HumanCo and chapter royalties from UpToDate., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Corporate sustainability assessment tools are increasingly used to evaluate company performance on environmental, social and governance (ESG) criteria. Given the growing burden of diet-related disease and nutrition-related business risks, it is important to understand the scope of nutrition-related ESG data currently available. This study aimed to compare the nutrition-related assessment criteria and associated food company performance across three prominent assessment tools., Design: Key attributes and assessment criteria of two civil society-led and one commercially available corporate sustainability assessment tools were extracted and compared for the year 2021. Company performance scores for twenty-five major food and beverage manufacturers using these three tools were analysed by nutrition domain: 'Product Portfolio', 'Labelling', 'Marketing', 'Accessibility and Affordability', 'Governance and Reporting', 'Stakeholder Engagement' and 'Employee Health'. To enable comparison between tools, company performance scores were assigned to categories of low (score = 0-25 % score or D), moderately low (25-50 % or C), moderately high (50-75 % or B) and high (75-100 % or A)., Setting: Global., Participants: N/A., Results: The tools covered similar nutrition domains; however, there was heterogeneity in the assessment criteria used to evaluate each domain. When applied to assess the performance of twenty-five major food and beverage manufacturers, a median nutrition-related performance score of moderately low or low was observed across all tools. The highest scoring domain was 'Governance and Reporting', and the lowest scoring domains were 'Product Portfolio' and 'Accessibility and Affordability'., Conclusions: Greater standardisation of the nutrition-related criteria against which food companies are assessed is needed as part of efforts to drive improvements in food company practices.

To identify healthy, impactful, and equitable foods, we combined health scores from six diverse nutrient profiling systems (NPS) into a meta-framework (meta-NPS) and paired this with dietary guideline adherence assessment via multilevel regression and poststratification. In a case-study format, a commonly debated beverage formulation - 100% orange juice (OJ) - was chosen to showcase the utility and depth of our framework, systematically scoring high across multiple food systems (i.e. a Meta-Score percentile = 93rd and Stability percentile = 75th) and leading to an expected increase of US dietary fruit guideline adherence by ∼10%. Moreover, the increased adherence varies across the 300 sociodemographic strata, with the benefit patterns being sensitive to absolute or relative quantification of the difference of adherence affected by OJ. In sum, the adaptable, integrative framework we established deepens the science of nutrient profiling and dietary guideline adherence assessment while shedding light on the nuances of defining equitable health effects.

Given the constraints of both overseas development aid and domestic financing for nutrition, innovative financing is critical-yet nutrition lags behind other sectors in catalysing it. Here, we argue that the framing for nutrition must evolve and critical actions must be taken to generate more money for nutrition and more nutrition for money. Food systems hold some of the most powerful opportunities to improve human and planetary health while increasing productivity-and the private sector has a key role to play in this., (© 2023. Springer Nature Limited.)

The global burden of diet-attributable type 2 diabetes (T2D) is not well established. This risk assessment model estimated T2D incidence among adults attributable to direct and body weight-mediated effects of 11 dietary factors in 184 countries in 1990 and 2018. In 2018, suboptimal intake of these dietary factors was estimated to be attributable to 14.1 million (95% uncertainty interval (UI), 13.8-14.4 million) incident T2D cases, representing 70.3% (68.8-71.8%) of new cases globally. Largest T2D burdens were attributable to insufficient whole-grain intake (26.1% (25.0-27.1%)), excess refined rice and wheat intake (24.6% (22.3-27.2%)) and excess processed meat intake (20.3% (18.3-23.5%)). Across regions, highest proportional burdens were in central and eastern Europe and central Asia (85.6% (83.4-87.7%)) and Latin America and the Caribbean (81.8% (80.1-83.4%)); and lowest proportional burdens were in South Asia (55.4% (52.1-60.7%)). Proportions of diet-attributable T2D were generally larger in men than in women and were inversely correlated with age. Diet-attributable T2D was generally larger among urban versus rural residents and higher versus lower educated individuals, except in high-income countries, central and eastern Europe and central Asia, where burdens were larger in rural residents and in lower educated individuals. Compared with 1990, global diet-attributable T2D increased by 2.6 absolute percentage points (8.6 million more cases) in 2018, with variation in these trends by world region and dietary factor. These findings inform nutritional priorities and clinical and public health planning to improve dietary quality and reduce T2D globally., (© 2023. The Author(s).)

Background: Coronavirus disease 2019 (COVID-19) disrupted access to food and adequate nutrition and the types of foods consumed. However, little empiric data exists on the changes in American's food and nutrition habits 2 y into the pandemic., Objectives: To assess current and altered food choices ∼2 y into the COVID-19 pandemic in the months after historic public pandemic relief., Methods: A national sample of 1878 United States adults balanced by age, sex, race/ethnicity, and income completed a one-time, online, semi-quantitative, 44-item questionnaire in Fall 2021 asking about the demographics, COVID-19 food choice changes (including free-text), and consumer priorities. This analysis investigates COVID-19 impacts on food security, healthfulness, and access., Results: More than 35% of respondents reported improved food security and >45% reported improved food healthfulness compared with prepandemic status. Improvement was reported in more than 30% of Black/African-American and Hispanic/Latinx adults, adults with lower annual income, and female sex, despite over 75% reporting reduced choice of where to eat or buy food. The pandemic offered occasion for many to improve diet, but a similar number expressed that the pandemic destabilized healthy habits., Conclusions: Our novel findings suggest that by late 2021, most Americans had improved food security and food choice healthfulness, despite reduced access to food service and retail, although with worsening among a meaningful proportion of Americans as well as heterogeneity in these changes. Vigorous federal, state, city, and community responses to the pandemic may have played a role in improving the food security and food choice healthfulness during the COVID-19 pandemic. Health crises differently impact health behaviors, but when accompanied by vigorous civic and community response, food security, and food healthfulness can be fortified., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dariush Mozaffarian reports financial support was provided by Vail Innovative Global Research., (© 2023 The Authors.)

The Food Compass is a nutrient profiling system (NPS) to characterize the healthfulness of diverse foods, beverages and meals. In a nationally representative cohort of 47,999 U.S. adults, we validated a person's individual Food Compass Score (i.FCS), ranging from 1 (least healthful) to 100 (most healthful) based on cumulative scores of items consumed, against: (a) the Healthy Eating Index (HEI) 2015; (b) clinical risk factors and health conditions; and (c) all-cause mortality. Nationally, the mean (SD) of i.FCS was 35.5 (10.9). i.FCS correlated highly with HEI-2015 (R = 0.81). After multivariable-adjustment, each one SD (10.9 point) higher i.FCS associated with more favorable BMI (-0.60 kg/m 2 [-0.70,-0.51]), systolic blood pressure (-0.69 mmHg [-0.91,-0.48]), diastolic blood pressure (-0.49 mmHg [-0.66,-0.32]), LDL-C (-2.01 mg/dl [-2.63,-1.40]), HDL-C (1.65 mg/d [1.44,1.85]), HbA1c (-0.02% [-0.03,-0.01]), and fasting plasma glucose (-0.44 mg/dL [-0.74,-0.15]); lower prevalence of metabolic syndrome (OR = 0.85 [0.82,0.88]), CVD (0.92 [0.88,0.96]), cancer (0.95 [0.91,0.99]), and lung disease (0.92 [0.88,0.96]); and higher prevalence of optimal cardiometabolic health (1.24 [1.16,1.32]). i.FCS also associated with lower all-cause mortality (HR = 0.93 [0.89,0.96]). Findings were similar by age, sex, race/ethnicity, education, income, and BMI. These findings support validity of Food Compass as a tool to guide public health and private sector strategies to identify and encourage healthier eating., (© 2022. The Author(s).)

Background: Economic evaluations of nutrition-sensitive agriculture (NSA) interventions are scarce, limiting assessment of their potential affordability and scalability., Objectives: We conducted cost-consequence analyses of 3 participatory video-based interventions of fortnightly women's group meetings using the following platforms: 1) NSA videos; 2) NSA and nutrition-specific videos; or 3) NSA videos with a nutrition-specific participatory learning and action (PLA) cycle., Methods: Interventions were tested in a 32-mo, 4-arm cluster-randomized controlled trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) in the Keonjhar district, Odisha, India. Impacts were evaluated in children aged 0-23 mo and their mothers. We estimated program costs using data collected prospectively from expenditure records of implementing and technical partners and societal costs using expenditure assessment data collected from households with a child aged 0-23 mo and key informant interviews. Costs were adjusted for inflation, discounted, and converted to 2019 US$., Results: Total program costs of each intervention ranged from US$272,121 to US$386,907. Program costs per pregnant woman or mother of a child aged 0-23 mo were US$62 for NSA videos, US$84 for NSA and nutrition-specific videos, and US$78 for NSA videos with PLA (societal costs: US$125, US$143, and US$122, respectively). Substantial shares of total costs were attributable to development and delivery of the videos and PLA (52-69%) and quality assurance (25-41%). Relative to control, minimum dietary diversity was higher in the children who underwent the interventions incorporating nutrition-specific videos and PLA (adjusted RRs: 1.19 and 1.27; 95% CIs: 1.03-1.37 and 1.11, 1.46, respectively). Relative to control, minimum dietary diversity in mothers was higher in those who underwent NSA video (1.21 [1.01, 1.45]) and NSA with PLA (1.30 [1.10, 1.53]) interventions., Conclusion: NSA videos with PLA can increase both maternal and child dietary diversity and have the lowest cost per unit increase in diet diversity. Building on investments made in developing UPAVAN, cost-efficiency at scale could be increased with less intensive monitoring, reduced startup costs, and integration within existing government programs. This trial was registered at clinicaltrials.gov as ISRCTN65922679., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Background: Few studies have assessed U.S. cardiometabolic health trends-optimal levels of multiple risk factors and absence of clinical cardiovascular disease (CVD)-or its impact on health disparities., Objectives: The purpose of this study was to investigate U.S. trends in optimal cardiometabolic health from 1999 to 2018., Methods: We assessed proportions of adults with optimal cardiometabolic health, based on adiposity, blood glucose, blood lipids, blood pressure, and clinical CVD; and optimal, intermediate, and poor levels of each component among 55,081 U.S. adults in the National Health and Nutrition Examination Survey., Results: In 2017-2018, only 6.8% (95% CI: 5.4%-8.1%) of U.S. adults had optimal cardiometabolic health, declining from 1999-2000 (P trend = 0.02). Among components of cardiometabolic health, the largest declines were for adiposity (optimal levels: 33.8%-24.0%; poor levels: 47.7%-61.9%) and glucose (optimal levels: 59.4%-36.9%; poor levels: 8.6%-13.7%) (P trend <0.001 for each). Optimal levels of blood lipids increased from 29.9%-37.0%, whereas poor decreased from 28.3%-14.7% (P trend <0.001). Trends over time for blood pressure and CVD were smaller. Disparities by age, sex, education, and race/ethnicity were evident in all years, and generally worsened over time. By 2017-2018, prevalence of optimal cardiometabolic health was lower among Americans with lower (5.0% [95% CI: 2.8%-7.2%]) vs higher education (10.3% [95% CI: 7.6%-13.0%]); and among Mexican American (3.2% [95% CI: 1.4%-4.9%]) vs non-Hispanic White (8.4% [95% CI: 6.3%-10.4%]) adults., Conclusions: Between 1999 and 2000 and 2017 and 2018, U.S. cardiometabolic health has been poor and worsening, with only 6.8% of adults having optimal cardiometabolic health, and disparities by age, sex, education, and race/ethnicity. These novel findings inform the need for nationwide clinical and public health interventions to improve cardiometabolic health and health equity., Competing Interests: Funding Support and Author Disclosures This research was supported by the National Institutes of Health and the National Heart, Lung, and Blood Institute, Bethesda, Maryland (grant 2R01HL115189-06A1 to Dr Mozaffarian). The funding agency did not contribute to the design or conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. All authors have received research funding from the National Institutes of Health. Dr Mozaffarian has received additional research funding from the Gates Foundation, the Rockefeller Foundation, and Vail Institute for Global Research; is on the scientific advisory board for Beren Therapeutics, Calibrate, DayTwo (ended 6/20), Elysium Health, Filtricine, Foodome, HumanCo, January Inc., Perfect Day, Season, and Tiny Organics; all outside the submitted work. Dr Wong has membership in the U.S. Preventive Services Task Force, outside the submitted work. Ms Lauren has received personal fees from Abt Associates and the Centers for Disease Control and Prevention, both outside the submitted work., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Nutrient profiling systems (NPS) aim to discriminate the healthfulness of foods for front-of-package labelling, warning labels, taxation, company ratings and more. Existing NPS often assess relatively few nutrients and ingredients, use inconsistent criteria across food categories and have not incorporated the newest science. Here, we developed and validated an NPS, the Food Compass, to incorporate a broader range of food characteristics, attributes and uniform scoring principles. We scored 54 attributes across 9 health-relevant domains: nutrient ratios, vitamins, minerals, food ingredients, additives, processing, specific lipids, fibre and protein, and phytochemicals. The domain scores were summed into a final Food Compass Score (FCS) ranging from 1 (least healthy) to 100 (most healthy) for all foods and beverages. Content validity was confirmed by assessing nutrients, food ingredients and other characteristics of public health concern; face validity was confirmed by assessing the FCS for 8,032 foods and beverages reported in NHANES/FNDDS 2015-16; and convergent and discriminant validity was confirmed from comparisons with the NOVA food processing classification, the Health Star Rating and the Nutri-Score. The FCS differentiated food categories and food items well, with mean ± s.d. ranging from 17.1 ± 17.2 for savoury snacks and sweet desserts to 81.6 ± 16.0 for legumes, nuts and seeds. In many food categories, the FCS provided important discrimination of specific foods and beverages as compared with NOVA, the Health Star Rating or the Nutri-Score. On the basis of demonstrated content, convergent and discriminant validity, the Food Compass provides an NPS scoring a broader range of attributes and domains than previous systems with uniform and transparent principles. This publicly available tool will help guide consumer choice, research, food policy, industry reformulations and mission-focused investment decisions., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: Almost a quarter of the world's undernourished people live in India. We tested the effects of three nutrition-sensitive agriculture (NSA) interventions on maternal and child nutrition in India., Methods: We did a parallel, four-arm, observer-blind, cluster-randomised trial in Keonjhar district, Odisha, India. A cluster was one or more villages with a combined minimum population of 800 residents. The clusters were allocated 1:1:1:1 to a control group or an intervention group of fortnightly women's groups meetings and household visits over 32 months using: NSA videos (AGRI group); NSA and nutrition-specific videos (AGRI-NUT group); or NSA videos and a nutrition-specific participatory learning and action (PLA) cycle meetings and videos (AGRI-NUT+PLA group). Primary outcomes were the proportion of children aged 6-23 months consuming at least four of seven food groups the previous day and mean maternal body-mass index (BMI). Secondary outcomes were proportion of mothers consuming at least five of ten food groups and child wasting (proportion of children with weight-for-height Z score SD <-2). Outcomes were assessed in children and mothers through cross-sectional surveys at baseline and at endline, 36 months later. Analyses were by intention to treat. Participants and intervention facilitators were not blinded to allocation; the research team were. This trial is registered at ISRCTN, ISRCTN65922679., Findings: 148 of 162 clusters assessed for eligibility were enrolled and randomly allocated to trial groups (37 clusters per group). Baseline surveys took place from Nov 24, 2016, to Jan 24, 2017; clusters were randomised from December, 2016, to January, 2017; and interventions were implemented from March 20, 2017, to Oct 31, 2019, and endline surveys done from Nov 19, 2019, to Jan 12, 2020, in an average of 32 households per cluster. All clusters were included in the analyses. There was an increase in the proportion of children consuming at least four of seven food groups in the AGRI-NUT (adjusted relative risk [RR] 1·19, 95% CI 1·03 to 1·37, p=0·02) and AGRI-NUT+PLA (1·27, 1·11 to 1·46, p=0·001) groups, but not AGRI (1·06, 0·91 to 1·23, p=0·44), compared with the control group. We found no effects on mean maternal BMI (adjusted mean differences vs control, AGRI -0·05, -0·34 to 0·24; AGRI-NUT 0·04, -0·26 to 0·33; AGRI-NUT+PLA -0·03, -0·3 to 0·23). An increase in the proportion of mothers consuming at least five of ten food groups was seen in the AGRI (adjusted RR 1·21, 1·01 to 1·45) and AGRI-NUT+PLA (1·30, 1·10 to 1·53) groups compared with the control group, but not in AGRI-NUT (1·16, 0·98 to 1·38). We found no effects on child wasting (adjusted RR vs control, AGRI 0·95, 0·73 to 1·24; AGRI-NUT 0·96, 0·72 to 1·29; AGRI-NUT+PLA 0·96, 0·73 to 1·26)., Interpretation: Women's groups using combinations of NSA videos, nutrition-specific videos, and PLA cycle meetings improved maternal and child diet quality in rural Odisha, India. These components have been implemented separately in several low-income settings; effects could be increased by scaling up together., Funding: Bill & Melinda Gates Foundation, UK AID from the UK Government, and US Agency for International Development., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

BACKGROUND Risk of coronavirus disease 2019 (COVID-19) hospitalization is robustly linked to cardiometabolic health. We estimated the absolute and proportional COVID-19 hospitalizations in US adults attributable to 4 major US cardiometabolic conditions, separately and jointly, and by race/ethnicity, age, and sex. METHODS AND RESULTS We used the best available estimates of independent associations of cardiometabolic conditions with a risk of COVID-19 hospitalization; nationally representative data on cardiometabolic conditions from the National Health and Nutrition Examination Survey 2015 to 2018; and US COVID-19 hospitalizations stratified by age, sex, and race/ethnicity from the Centers for Disease Control and Prevention's Coronavirus Disease 2019-Associated Hospitalization Surveillance Network database and from the COVID Tracking Project to estimate the numbers and proportions of COVID-19 hospitalizations attributable to diabetes mellitus, obesity, hypertension, and heart failure. Inputs were combined in a comparative risk assessment framework, with probabilistic sensitivity analyses and 1000 Monte Carlo simulations to jointly incorporate stratum-specific uncertainties in data inputs. As of November 18, 2020, an estimated 906 849 COVID-19 hospitalizations occurred in US adults. Of these, an estimated 20.5% (95% uncertainty interval [UIs], 18.9-22.1) of COVID-19 hospitalizations were attributable to diabetes mellitus, 30.2% (UI, 28.2-32.3) to total obesity (body mass index ≥30 kg/m 2 ), 26.2% (UI, 24.3-28.3) to hypertension, and 11.7% (UI, 9.5-14.1) to heart failure. Considered jointly, 63.5% (UI, 61.6-65.4) or 575 419 (UI, 559 072-593 412) of COVID-19 hospitalizations were attributable to these 4 conditions. Large differences were seen in proportions of cardiometabolic risk-attributable COVID-19 hospitalizations by age and race/ethnicity, with smaller differences by sex. CONCLUSIONS A substantial proportion of US COVID-19 hospitalizations appear attributable to major cardiometabolic conditions. These results can help inform public health prevention strategies to reduce COVID-19 healthcare burdens.

Many public health interventions aim to promote healthful behaviours, with varying degrees of success. With a lack of existing empirical evidence on the optimal number or combination of behaviours to promote to achieve a given health outcome, a key challenge in intervention design lies in deciding what behaviours to prioritise, and how best to promote them. We describe how key behaviours were selected and promoted within a multisectoral nutrition-sensitive agriculture intervention that aimed to address maternal and child undernutrition in rural India. First, we formulated a Theory of Change, which outlined our hypothesised impact pathways. To do this, we used the following inputs: existing conceptual frameworks, published empirical evidence, a feasibility study, formative research and the intervention team's local knowledge. Then, we selected specific behaviours to address within each impact pathway, based on our formative research, behaviour change models, local knowledge and community feedback. As the intervention progressed, we mapped each of the behaviours against our impact pathways and the transtheoretical model of behaviour change, to monitor the balance of behaviours across pathways and along stages of behaviour change. By collectively agreeing on definitions of complex concepts and hypothesised impact pathways, implementing partners were able to communicate clearly between each other and with intervention participants. Our intervention was iteratively informed by continuous review, by monitoring implementation against targets and by integrating community feedback. Impact and process evaluations will reveal whether these approaches are effective for improving maternal and child nutrition, and what the effects are on each hypothesised impact pathway., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Study design: Case Report. Purpose: Stroke is the most common cause of long-term disability. Dysesthesia, an unpleasant sensory disturbance, is common following thalamic stroke and evidence-based interventions for this impairment are limited. The purpose of this case report was to describe a decrease in dysesthesia following manual therapy intervention in a patient with history of right lacunar thalamic stroke. Case description: A 66-year-old female presented with tingling and dysesthesia in left hemisensory distribution including left trunk and upper/lower extremities, limiting function. Decreased left shoulder active range of motion, positive sensory symptoms but no sensory loss in light touch was found. She denied pain and moderate shoulder muscular weakness was demonstrated. Laterality testing revealed right/left limb discrimination deficits and neglect-like symptoms were reported. Passive accessory joint motion assessment of glenohumeral and thoracic spine revealed hypomobility and provoked dysesthesia. Interventions included passive oscillatory joint mobilization of glenohumeral joint, thoracic spine, ribs and shoulder strengthening. Results: After six sessions, shoulder function, active range of motion, strength improved and dysesthesia decreased. Global Rating of Change Scale was +5 and QuickDASH score decreased from 45% to 22% disability. Laterality testing was unchanged. Conclusion: Manual therapy may be a beneficial intervention in management of thalamic stroke-related dysesthesia. Implications for Rehabilitation While pain is common following thalamic stroke, patients may present with chronic paresthesia or dysesthesia, often in a hemisensory distribution. Passive movement may promote inhibition of hyperexcitable cortical pathways, which may diminish aberrant sensations. Passive oscillatory manual therapy may be an effective way to treat sensory disturbances such as paresthesias or dysesthesia.

Background: Undernutrition causes around 3.1 million child deaths annually, around 45% of all child deaths. India has one of the highest proportions of maternal and child undernutrition globally. To accelerate reductions in undernutrition, nutrition-specific interventions need to be coupled with nutrition-sensitive programmes that tackle the underlying causes of undernutrition. This paper describes the planned economic evaluation of the UPAVAN trial, a four-arm, cluster randomised controlled trial that tests the nutritional and agricultural impacts of an innovative agriculture extension platform of women's groups viewing videos on nutrition-sensitive agriculture practices, coupled with a nutrition-specific behaviour-change intervention of videos on nutrition, and a participatory learning and action approach., Methods: The economic evaluation of the UPAVAN interventions will be conducted from a societal perspective, taking into account all costs incurred by the implementing agency (programme costs), community and health care providers, and participants and their households, and all measurable outcomes associated with the interventions. All direct and indirect costs, including time costs and donated goods, will be estimated. The economic evaluation will take the form of a cost-consequence analysis, comparing incremental costs and incremental changes in the outcomes of the interventions, compared with the status quo. Robustness of the results will be assessed through a series of sensitivity analyses. In addition, an analysis of the equity impact of the interventions will be conducted., Discussion: Evidence on the cost and cost-effectiveness of nutrition-sensitive agriculture interventions is scarce. This limits understanding of the costs of rolling out or scaling up programs. The findings of this economic evaluation will provide useful information for different multisectoral stakeholders involved in the planning and implementation of nutrition-sensitive agriculture programmes., Trial Registration: ISRCTN65922679 . Registered on 21 December 2016.

Background: Maternal and child undernutrition have adverse consequences for pregnancy outcomes and child morbidity and mortality, and they are associated with low educational attainment, economic productivity as an adult, and human wellbeing. 'Nutrition-sensitive' agriculture programs could tackle the underlying causes of undernutrition., Methods/design: This study is a four-arm cluster randomised controlled trial in Odisha, India. Interventions are as follows: (1) an agricultural extension platform of women's groups viewing and discussing videos on nutrition-sensitive agriculture (NSA) practices, and follow-up visits to women at home to encourage the adoption of new practices shown in the videos; (2) women's groups viewing and discussing videos on NSA and nutrition-specific practices, with follow-up visits; and (3) women's groups viewing and discussing videos on NSA and nutrition-specific practices combined with a cycle of Participatory Learning and Action meetings, with follow-up visits. All arms, including the control, receive basic nutrition training from government community frontline workers. Primary outcomes, assessed at baseline and 32 months after the start of the interventions, are (1) percentage of children aged 6-23 months consuming ≥ 4 out of 7 food groups per day and (2) mean body mass index (BMI) (kg/m 2 ) of non-pregnant, non-postpartum (gave birth > 42 days ago) mothers or female primary caregivers of children aged 0-23 months. Secondary outcomes are percentage of mothers consuming ≥ 5 out of 10 food groups per day and percentage of children's weight-for-height z-score < -2 standard deviations (SD). The unit of randomisation is a cluster, defined as one or more villages with a combined minimum population of 800 residents. There are 37 clusters per arm, and outcomes will be assessed in an average of 32 eligible households per cluster. For randomisation, clusters are stratified by distance to nearest town (< 10 km or ≥ 10 km), and low (< 30%), medium (30-70%), or high (> 70%) proportion of Scheduled Tribe or Scheduled Caste (disadvantaged) households. A process evaluation will assess the quality of implementation and mechanisms behind the intervention effects. A cost-consequence analysis will compare incremental costs and outcomes of the interventions., Discussion: This trial will contribute evidence on the impacts of NSA extension through participatory, low-cost, video-based approaches on maternal and child nutrition and on whether integration with nutrition-specific goals and enhanced participatory approaches can increase these impacts., Trial Registration: ISRCTN , ISRCTN65922679 . Registered on 21 December 2016.

Objective: The aim of the study was to compare the metabolic and morphological effects of enfuvirtide plus an optimized background (OB) regimen vs. OB alone (control group) in treatment-experienced patients in the T-20 vs. Optimized Regimen Only (TORO) studies., Methods: Body composition and metabolic changes were investigated in patients over 48 weeks, based on fasting chemistries, body weight, and other anthropometric measurements. Dual-energy X-ray absorptiometry (DEXA) and computed tomography (CT) scans were performed in a patient subgroup (n=155) at baseline and at weeks 24 and 48., Results: At week 48, mean changes from baseline were similar between treatment groups for glucose, insulin, C-peptide, total cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglyceride levels. The enfuvirtide group experienced a significant increase in body weight [mean change from baseline +0.99 kg; 95% confidence interval (CI) +0.54, +1.44] and, in those who had body scans, there was a significant increase in truncal fat (by DEXA: median change +419.4 g; 95% CI+71.3, +767.5) and total fat [visceral adipose tissue (VAT)+subcutaneous adipose tissue (SAT) by single-slice abdominal CT scan: median change +25.5 cm(2) ; 95% CI+8.9, +42.0] over 48 weeks; significant increases in these parameters were not seen in the control group. There was no significant change in truncal:peripheral fat ratio in either the enfuvirtide or the control group., Conclusion: The addition of enfuvirtide to an OB regimen does not appear to have unfavourable effects on fat distribution or metabolic parameters., (© 2010 British HIV Association.)

Background: Antiretroviral tolerability is a critical factor contributing to treatment outcome. The T-20 Versus Optimized Background Regimen Only (TORO) studies assessed the safety and efficacy of enfuvirtide in treatment-experienced HIV-1-infected patients., Methods: A total of 997 patients were randomized at a 2:1 ratio to an optimized background antiretroviral regimen plus enfuvirtide (n = 663) or an optimized background regimen alone (control group; n = 334). Control patients could switch to enfuvirtide on virologic failure., Results: In total, 26.5% of patients randomized to enfuvirtide and 36.6% to the control group discontinued study treatment before week 48; the percentage of patients withdrawn for safety reasons (including adverse events [AEs], deaths, and laboratory abnormalities) was 14.0% in the enfuvirtide group and 11.6% in the control group. Injection site reactions (ISRs) occurred in 98% of enfuvirtide patients and led to treatment discontinuation in 4.4%. Treatment-related (defined as possibly, probably, or remotely) AE rates per 100 patient-years were lower with enfuvirtide (96.2) than in the control group (149.9); diarrhea, nausea, and fatigue, the most frequently reported AEs, were significantly less frequent with enfuvirtide than in the control group. Pneumonia was significantly more frequent in patients treated with enfuvirtide (6.7 vs. 0.6 events per 100 patient-years), although the incidence was within expected ranges for this population. Lymphadenopathy was also higher in enfuvirtide-treated patients (7.1 vs. 1.2 events per 100 patient-years) for control patients., Conclusion: The addition of enfuvirtide to an optimized background regimen does not exacerbate AEs commonly associated with antiretrovirals. ISRs limited treatment in <5% of patients.

Background: The T-20 Versus Optimized Background Regimen Only (TORO) 1 and TORO 2 clinical trials are open-label, controlled, parallel-group, phase 3 studies comparing enfuvirtide plus an optimized background (OB) of antiretrovirals (n = 661) with OB alone (n = 334) in treatment-experienced HIV-1-infected patients., Methods: The primary objective at week 48 was to investigate durability of efficacy, as measured by the percentage of patients maintaining their week 24 response or improving. Efficacy analyses used the intent-to-treat population., Results: A total of 73.7% of patients randomized to the enfuvirtide group remained on treatment through week 48 versus 21.3% originally randomized to the control group. At week 48, a higher proportion of week 24 responders maintained their response or were new responders in the enfuvirtide group than in the control group in each responder category: HIV-1 RNA level > or =1.0 log(10) change from baseline, <400 copies/mL and <50 copies/mL (37.4%, 30.4%, and 18.3% in the enfuvirtide group vs. 17.1%, 12.0%, and 7.8% in the control group, respectively; P < 0.0001 for all comparisons). CD4 cell count increases from baseline were twice as great in the enfuvirtide group as in the control group., Conclusion: These data demonstrate durable efficacy of enfuvirtide plus OB over 48 weeks.