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  • The Impact of WASH on Handwashing Practices Among School Children in Nigeria.

    This research project will be conducted as a school cluster-randomized study with 50 randomly selected low-cost private primary schools in the Lagos region. The expected number of schools included is 25 intervention and 25 control schools (schools that have not received the intervention but that are similar enough to the intervention schools to facilitate comparison). Quantitative data will be collected on the implementation and impact of the intervention, and qualitative data will be collected to explore teacher perceptions of best WASH practices. The intervention WASHED-UP (Water, Sanitation and Hygiene Education Against Diarrhoea, Undernutrition and Pneumonia) will be implemented as a 2-week health awareness campaign that will train children and teachers to deliver the program on hygiene promotion in schools. Intervention components include the presentation of interactive stories, games and songs, nutrition education, participatory food demonstration classes using food models, the use of animated characters representing occasions for handwashing with soap, practical and visual demonstrations to communicate the presence of germs and handwashing with soap removes them in comparison to only water, the use of daily diaries by students to record their handwashing behaviour and making a public commitment to handwashing with soap as a club. Digital surveys and implementation checklists will be used to collect the impact (survey) and implementation data, respectively and audio recordings of focus groups will be used to collect data related to stakeholder perceptions of the WASHED-UP program. For school absence, data are planned to be obtained from paper-based school records, including registers and sick-bay records. Approximately 3500 children will be recruited for data collection which will involve administering questions on socio-demographics, illness, reasons for school absence, disease history, sanitation behaviour at home and school and attendance at WASH clubs. At the end of the study all control schools will receive the intervention subsequently. Data will be collected in three phases: - Phase 1: February to March 2024 and will consist of a baseline survey. - Phase 2: May to June 2024 and will consist of an implementation phase in the form of the intervention in the randomly selected 25 primary schools in Lagos. - Phase 3: September to November 2024 and will consist of three months of follow-up post-implementation and comparison to control schools. Data will be collated using the Kobo Toolbox survey tool and analyzed with Statistical Package for Social Sciences (SPSS).

    Phase

    N/A

    Span

    46 weeks

    Sponsor

    The Neo Child Initiative for Africa

    Recruiting

    Healthy Volunteers

  • Shelf-Stable MDCF-2 for Children With Undernutrition

    Study site: The study will be conducted among residents of an under slum community in Baoniabad of Mirpur, one of the 21 administrative units of the nation's capital, Dhaka. Mirpur is selected as the study site because it is inhabited by poor and lower middle-class families, residential and sanitary conditions are typical of any congested urban settlement. Additionally, the investigators have established several field sites in the area and they have ongoing research activities in the community. Enrollment: A trained Field Research Assistant (FRA) will explain the study in detail, answer any questions from the parent(s), and invite the parent(s) to enrol the child in the study. If the parent(s) are interested to volunteer in the study, the designated staff will proceed to screening and consenting. Screening will consist of a review of the inclusion and exclusion criteria listed above. If the subject is eligible to participate, the process will proceed to consenting consisting of a thorough review of the written consent form in a manner appropriate for the child's parents' literacy level. Prior to signing the consent form, the parents of the participants will have an opportunity to ask any questions about the study. If the FRA determines that participants have demonstrated adequate comprehension of the study, the consent form will be signed by the FRA and the child's parent(s). If the parent(s) are not sufficiently literate to read and/or sign the consent form, consenting and a thumbprint signature will be obtained in the presence of a witness who is not associated with the study. The child's parent(s) will be provided with a copy of the signed consent form. Children will undergo thorough clinical assessment and laboratory tests (if needed) to exclude any organic diseases or any other causes of secondary malnutrition. Detailed inclusion/exclusion criteria are provided separately below. At the beginning of the study, information will be collected on the demographic characteristics of the participants (family income, standard/type of housing, family structure, parental education, etc.). FRAs will collect anthropometry data by recording the child's weight using a digital scale with 2 g precision (Seca, model 728, Germany), length (using infantometer, Seca, model 416, Germany), and mid-upper arm circumference (MUAC) to the nearest millimeter (using a non-stretch tape). Collection of anthropometric data will subsequently occur at weekly intervals throughout the study. Study Design: The study will be 8 weeks in duration and comprise 5 arms, with a minimum of 23 children per arm required to complete the study. Children will be randomly assigned to one of the five arms using a computer generated randomization scheme. Efforts will be made to balance arms with respect to gender. Mothers/primary caregivers will be be advised to maintain their child's current dietary and breastfeeding practices throughout the study. Following a 2-week 'run-in' phase with weekly fecal sample collection and a blood draw, treatment will be initiated. The treatment phase will be for 4 weeks, during which time each test product will be administered at the test center twice daily, separated by at least 6 hours. The amount of each serving actually ingested will be calculated by subtracting the leftover amount from the offered amount. Pre-weighed napkins will be provided; any food that is regurgitated, vomited or spilled will be swabbed, weighed and subtracted from the amount offered. Fecal samples will be collected weekly using established SOPs for rapid cryopreservation. A second blood draw will be performed at the end of the 4-week intervention period. There will be a 2- week post intervention phase during which 2 additional fecal samples will be collected (at the end of weeks 7 and 8) to assess changes in the microbiota that occur after cessation of treatment. Children will be monitored daily by trained FRAs for any side effects/adverse events (e.g. rash, urticaria due to food allergy, or any significant changes in clinical status). If any adverse events are observed, children will be treated using appropriate management practices at Dhaka Hospital. Fecal sample collection: Fecal samples will be collected weekly from each study participant during the course of the 8-week study, including during the 2 weeks prior to treatment, the four weeks of treatment, and the two weeks following cessation of treatment (11 samples/ child). Fecal samples will be used for culture-independent analysis of microbial composition using existing SOPs, and for subsequent culture-based initiatives to characterize growth promoting bacterial taxa (Raman et al., Science 2019, 365, eaau 4735; Gehrig et al., Science 2019; 365, eaau4732). Blood sample collection: 5 mL of blood will be collected from each child immediately prior to initiating treatment, and just after the 4-week period of treatment is complete. Plasma will be prepared immediately and frozen at -80C prior to proteomics analysis as previously described (Gehrig et al., Science 2019, 365, eaau4732; Chen et al., N Engl J Med 2021; 384:1517-1528). Additionally, status of different blood biomarkers (hormonal regulators of appetite and satiety, micronutrient status, and systemic inflammation) will also be assessed using the samples collected before and after the intervention Sample size estimate: The estimate is informed by fecal 16S rDNA datasets generated in a recent POC study in 12 to 18-month-old Bangladeshi children with moderate acute malnutrition (MAM) who had been treated with the ("reference") kitchen-prepared MDCF-2 formulation. This formulation repaired the microbiota of these children and produced an improvement in the rate of ponderal growth that was superior to that produced by the control Ready-to-Use Supplementary Food (RUSF; Chen et al., 2021). In this POC study, the investigators identified 209 bacterial taxa (Amplicon Sequence Variants; ASVs) that were present above 5 counts in at least 5% of the 939 fecal samples analyzed from 118 participants (Chen et al., 2021). The investigators calculated 95% confidence intervals (CI; mean ± 1.96 standard error) for the change (delta) in abundance of each of the 209 bacterial taxa ASVs between day 0 (pre-intervention) and 4 weeks of intervention for the 59 children who completed treatment in the MDCF-2 group of the POC study. The investigators used a bootstrapping approach with ASV data from 5000 subsets of children from the MDCF-2 group and 5000 subsets of children from the RUSF group and identified 121 ASVs whose mean changes in abundance fell within the 95% CI of the mean changes for the MDCF-2 participants, but not in children that had received RUSF, with 80% power using a subset (sample) size of 20 children per group ("MDCF-2-responsive ASVs"). Therefore, we will aim to have a minimum of 20 children per arm complete this pre-POC study. Taking into account potential drop-outs (15%), a minimum of 23 children will be recruited per arm. Analysis plan: To assess the comparability of microbiota repair elicited by alternative/shelf-stable test formulations of MDCF-2 and the reference kitchen-prepared formulation described in Chen et al (2021), the investigators sequence PCR amplicons generated from bacterial 16S rDNA genes present in DNA isolated from fecal samples collected from participants in the different study arms immediately prior to intervention (day 0) and at the end of intervention (day 28). ASV data will be processed using DADA2 (Callahan et al., 2016) and filtered as described in Chen et al. (2021). Using the same approach used for the POC study above, the investigators will calculate 95% confidence intervals of the mean change in abundance of each of the MDCF-2-responsive ASVs identified in this study, between day 0 and day 28, in children who received the reference MDCF-2 formulation, as well as the mean change for each of these ASVs in participants receiving the test formulations. A test formulation will be considered comparable in efficacy to the reference kitchen-prepared MDCF-2 if >70% of the MDCF-2-responsive ASVs identified in this study have mean changes in abundance (day 0 to day 28) for the test formulation that fall within the 95% CI of their mean changes in abundance in the reference MDCF-2 arm over the same time period. Another embodiment of the analysis of microbial community repair elicited by the reference MDCF-2 and test formulations will involve a comparison of their respective effects after 4 weeks of treatment on the abundances of metagenome-assembled genomes (MAGs) identified by shotgun sequencing of the same fecal DNA samples used to produce 16S rDNA amplicons. Exploratory outcomes will include the effects of the test formulations on features of the plasma and fecal proteomes, including MDCF-2-responsive proteins that are associated with various facets of healthy growth, CNS development and immune function, using approaches described in Chen et al., 2021.

    Phase

    N/A

    Span

    174 weeks

    Sponsor

    International Centre for Diarrhoeal Disease Research, Bangladesh

    Recruiting

  • Oncology, Undernutrition and Sensoriality: Links, Mechanisms and Levers for Action

    Phase

    N/A

    Span

    160 weeks

    Sponsor

    Centre Hospitalier Universitaire Dijon

    Recruiting

  • Impact of Undernutrition Definitions on Its Prevalence in Hospitalized Patients

    1. Rationale 1.1 Epidemiology and morbidity of undernutrition Undernutrition, whether related to disease, poverty, hunger, war or natural disasters, affects more than one billion people worldwide (1). In France, an empirical estimate suggests a prevalence of undernutrition among hospitalized patients next to 2 million or 30 to 50%. It should be underligned that undernutrition is very common in and out of hospital. It is widely accepted that undernutrition can be caused by a deficit in nutrient intake or malabsorption. However, it is now known that the presence of an inflammatory state during illness is associated with undernutrition (1). The inflammatory state leads to anorexia and decreased intake but also increases basal metabolic rate and muscle catabolism. Undernutrition is marked by a decrease in all markers of muscle mass (1). Thus, It is strongly associated with a decrease in the patient's functional capacity and an increase in morbidity and mortality and health care costs (1,4-6). 1.2 International consensus on the definition of undernutrition In 2019, the Global Leadership Initiative on Malnutrition (GLIM) published an international consensus report on the diagnostic criteria for undernutrition (1). The diagnostic criteria are numerous, and include aetiological criteria such as reduced food intake; inflammatory context; symptoms such as anorexia, weakness; phenotypic criteria such as weight loss, body mass index (BMI), fat to lean mass ratio, fluid retention and muscle function. Muscle mass is described as a major diagnostic criterion, since it is a direct indicator of protein catabolism linked to undernutrition, but also a reflection of patient functional impairment, as it is directly associated with functional capacity, autonomy and prognosis. Various measurement tools are suggested, such as bioelectrical impedancemetry, ultrasound or magnetic resonance imaging, giving the tool choice by the clinicians, depending on experience and local resources. Handgrip measurement is considered as a complementary measure. GLIM advises an assessment of the risk of undernutrition, using validated questionnaires such as the NRS (Nutritional Risk Screening) or the MNA-SF (Mini Nutritional Assessment-Short Form). 1.3 New definition of undernutrition in France The French National Authority for Health (HAS) revised the definition of undernutrition in adults (< 70 years) in 2019, which is very similar to, but differs in some important aspects, from the GLIM definition. It includes the use of aetiological and phenotypic criteria, and now includes the assessment of muscle strength, gait speed and bioelectrical impedancemetry. 1.4 Convergences and divergences between the international and French definitions In adults under 70 years of age, both the GLIM and the HAS recommend screening for undernutrition, but the HAS recommendations do not recommend the use of a precise tool for assessing the risk of undernutrition. The presence of at least one aetiological criterion and one phenotypic criterion is mandatory to make a diagnosis of undernutrition in both situations. The differences between the international consensus and the HAS recommendations concern the diagnostic criteria. 1.5 Assessment of muscle function Physiotherapists use different tools to assess different aspects of muscle function, such as strength or walking speed. Isometric grip strength is strongly correlated with lower limb muscle strength, and is a negative marker of mobility in case of weakness (14). A linear relationship has been observed between grip strength and patient disability as measured by the Katz independence scale. In addition, grip strength has been shown to be a good predictor of the patient's clinical condition (19). The measurement of grip strength, using a dedicated dynamometer, also has the advantage of being simple and reliable and has reference values adjusted for gender and BMI. Gait speed is another indicator used to assess muscle function. It is associated with lower limb strength and is a predictor of disability and mobility limitation (14). Usual walking speed is most often measured over a distance of 4 or 6 m and has reference values adjusted for gender and height (19). Dietitians are also involved in the assessment of muscle function by measuring body composition in terms of lean body mass and fat mass. They perform bioelectrical impedancemetry, which estimates the volumes of fat and lean body mass by measuring the resistance of biological tissues to a low-intensity, high-frequency sinusoidal electric current through electrodes (14). This measurement method is simple to use, inexpensive, reproducible and feasible in bedridden patients (14). It also correlates very well with MRI and reference values are obtained in a variety of adult populations (12,22). 1.6 Research hypothesis The investigators hypothesise that the prevalence of undernutrition in a population of patients hospitalised in diabetology-obesity, pneumology, oncology and gastro-nutrition, under 70 years of age is different according to the diagnostic criteria recommended by the French National Authority for Health or those recommended by the Global Leadership Initiative on Malnutrition. Moreover, these two definitions could have a different impact on patient morbidity and mortality. The choice of the method of assessment of muscle function could impact on this prevalence. 2. Objective 2.1 Main objective The main objective of this study is to compare the prevalence of global undernutrition based on the diagnostic criteria recommended by the French National Authority for Health with that based on the diagnostic criteria recommended by the Global Leadership Initiative on Malnutrition, in patients hospitalised in diabetology-obesity, pneumology, oncology and gastro-nutrition 2.2 Secondary objectives The secondary objectives will be, in patients hospitalised in diabetes-obesity, pneumology, oncology and gastro-nutrition units: - To compare the prevalence of severe undernutrition according to the HAS and GLIM diagnostic criteria; - To compare the morbi-mortality of moderate and severe undernutrition according to the HAS and GLIM diagnostic criteria: - Length of hospital stay ; - Mortality rate ; - Autonomy at discharge. - To compare the predictive capacity of muscle function assessment tools on undernutrition according to the HAS and GLIM diagnostic criteria. 3. Type of study This is a prospective, monocenter, obversational cohort study. The research will be conducted in accordance with the protocol. The duration of recruitment will be 20 months with follow-up of patients during their entire hospital stay in the care unit, i.e. approximately 30 days (average length of stay), i.e. a total duration of the study estimated at 21 months. The study will take place at the Forcilles Hospital, in diabetology-obesity, pneumology, oncology and gastro-nutrition units. 4. Usual assessment procedures 4.1 Nutritional assessment At the patient's admission, a nutrition assessment is carried out by the dietician following the recommendations issued by the French Association of Dieticians-Nutritionists (AFDN) and the HAS. The dietician collects all the data required to detect malnutrition, such as weight, height, BMI, albumin levels, as well as grip strength and walking speed (carried out by the care assistant and the physiotherapist). The dietician also looks for possible obstacles to feeding, such as dental condition, swallowing problems or digestive discomfort. The doctor looks for various pathologies affecting digestive absorption such as short stool syndromes, gastrectomies, pancreatic insufficiency etc. It also looks for factors of aggression such as cancer, chronic progressive diseases, infections etc. All of this data is used to estimate the patient's theoretical nutritional needs and to adapt the nutritional management. The dietician, in collaboration with the nurses' aides, monitors the patient's intake. 4.2 Anthropometric measurements When the patient is admitted, the nurses measure the patient's weight and height. If the patient can maintain the erect position, a conventional scale and a measuring rod are used for the measurements. If the patient cannot maintain this position, a weighing chair and a laser meter are used. In order to assess weight loss prior to hospitalisation, the previous weight is sought from a hospital report or other recent medical document. Contact with the attending physician is also made in order to obtain information about the patient's weight history. If this information is not available, the patient's previous weight is collected. 4.3 Biological measurements On admission, a biological sample is usually taken from patients at risk of undernutrition in order to measure pre-albumin, albumin and C-reactive protein (CRP). These elements make it possible to determine the severity of undernutrition when it is present, according to the diagnostic criteria of the HAS. 4.4 Muscle function measurements Measurement of grip strength ("Handgrip") 4.5 Gait speed measurement 5. Assessment procedure added by the research 5.1 Mini-Nutritional Assessment Short Version (MNA-SF) score 5.2 Bio-electrical impedance measurement 5.3 Diagnosis of undernutrition according to GLIM criteria The diagnosis of undernutrition will also be carried out in the framework of this research according to the GLIM criteria. It will be based on the search for at least 1 phenotypic criterion and 1 etiological criterion. Severe undernutrition will be based solely on phenotypic criteria. This diagnosis according to the GLIM definition will be made by one of the investigators not involved in the management of the patient. The patient's team will be blinded to these results so as not to influence the management of the patient. 5 Statistical aspects 5.1 Calculation of the number of subjects required According to our internal epidemiological data, the prevalence of undernutrition according to the HAS definition was 34%. Taking into account the wider period of weight loss and the higher BMI threshold used by GLIM in its definition of undernutrition, the investigators estimate a higher prevalence of undernutrition. In the absence of data in the literature, the investigators estimate a prevalence of undernutrition according to the GLIM definition at 49%, and a difference of at least 15%. The investigators wish to highlight this discordance. With a risk α = 0.05 and a power of 80%, it will be necessary to include 260 patients. 5.2 General aspects Descriptive statistics will be based on means (+/- standard deviation) or medians [interquartile range] depending on the distribution of quantitative variables. Categorical variables will be described in terms of numbers and percentages. Univariate comparisons will use the usual statistical tests after checking the distribution of the variables (Chi2 or Fisher's test, t-test, anova or their non-parametric equivalents Wilcoxon and Kruskal-Wallis tests). Paired-sample tests will be used if necessary. Tests will be performed at the 5% significance level. The 95% confidence intervals will be provided for each estimate. Calculations will be made using IBM SPSS v21 and R software (version 3.6.1, http://www.R-project.org ). 5.3 Main objective The difference in the prevalence of global undernutrition between the HAS and GLIM groups will be compared using the McNemar test for comparison of proportions in matched samples. 5.4 Secondary objectives 5.4.1 Comparison of the prevalence of severe undernutrition The difference in the prevalence of severe undernutrition between the HAS and GLIM groups will be compared using the test described in the primary objective. 5.4.2 Comparison of morbidity and mortality Morbidity and mortality will be compared between the HAS and GLIM groups, for moderate and severe undernutrition, by comparing length of hospital stay, mortality and independence at discharge. Length of hospital stay There is a relationship between the incidence of mortality and all duration type variables. Length of stay will therefore be analysed using a competitive risk method, which allows for the fact that patients who die are no longer eligible for length of stay analysis (25). The estimator also provides the probability of in-hospital death, so that the probability of hospital discharge versus death can be assessed simultaneously at any time after inclusion in the study. Mortality rates Mortality rates will be estimated using the Kaplan and Meier method. Comparison of the 2 curves will be performed by a Logrank test. The mortality rates in the 2 groups will be estimated via the survival curves. ADL The ADL score will be compared between the 2 groups using the discrete numerical variable comparison tests described in the general aspects. 5.4.3 Comparison of muscle function assessment tools The impact of the choice of muscle function assessment tool will be assessed by comparing the prevalences of undernutrition diagnosed by each tool and by comparing the presence of reduced muscle mass by each tool. 6 Expected results in terms of scientific and professional advances The results of this study will make it possible to verify whether the GLIM definition increases the prevalence of undernutrition compared to that of the HAS. The use of one or other of the definitions could have an impact on the medical management of undernutrition. On the other hand, muscle function benefits from various assessment tools. These tools assess different aspects of the muscle, such as strength, functional performance or quantity. Muscle function has an important place in the new definitions of undernutrition, involving physiotherapists in addition to dieticians, nurses, care assistants and physicians in the screening for undernutrition. The different tools could lead to a different estimation of the reduction of muscle mass and thus a different prevalence of undernutrition. The results of our study will help to evaluate this and guide professionals in the choice of tools for assessing muscle function. 7 Expected benefits and risks for patients 7.1 Minimal risks and constraints added by the research All medical examinations and management are usually carried out with the exception of the MNA-SF questionnaire and bioelectrical impedancemetry, which will be carried out systematically in the patients included. The MNA-SF questionnaire is very quick (less than 5 minutes) and therefore causes very little inconvenience to the patient apart from an additional visit by a carer. Bioelectrical impedancemetry is a tool for assessing body composition using electrodes applied to the skin surface. The examination takes an average of 15 minutes, and is non-invasive and painless. The minimal stress is related to the placement of the electrode and the duration of the examination. 7.2 Expected benefits for the patient This study may highlight a difference in the prevalence of undernutrition according to the definitions and tools used. The results of this study will not provide direct benefits for the patient, but could allow the clinician to be more vigilant if undernutrition is underestimated, according to the criteria used in France. The benefit would then be a broader screening of undernutrition and would allow the adaptation of the patient's nutritional and rehabilitation management.

    Phase

    N/A

    Span

    200 weeks

    Sponsor

    Hopital Forcilles

    Recruiting

  • Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis

    The objective of NutriPEPA2 study is to demonstrate that the use of an adsorbent membrane (PEPA-Poly Ester Poly Arylate synthetic co-polymer membrane) decreases undernutrition (often associated with inflammation) and consequently morbidity, comparing one year mortality in patients with Chronic Kidney Disease (CKD), with severe Protein-Energy Wasting (PEW), treated with dialysis using a non-adsorbent synthetic membrane (Polysulfone or Polyethersulfone) versus an adsorbent membrane (PEPA).

    Phase

    N/A

    Span

    547 weeks

    Sponsor

    Theradial

    Recruiting

  • Evaluation of the Validity and Reliability of Muscle Ultrasound in the Detection of Undernutrition

    1. Rationale 1.1 Epidemiology and morbidity of undernutrition Undernutrition, whether related to disease, poverty, hunger, war or natural disasters, affects more than one billion people worldwide. In France, an empirical estimate suggests a prevalence of undernutrition among hospitalized patients of about 2 million or 30 to 50%. It should be noted that undernutrition is very common in and out of hospital. It is widely accepted that undernutrition can be caused by a deficit in nutrient intake or malabsorption. However, it is now known that the inflammatory state present during illness is associated with undernutrition. 1.2 International consensus on the definition of undernutrition In 2019, the Global Leadership Initiative on Malnutrition (GLIM) published an international consensus report on diagnostic criteria for undernutrition. The diagnostic criteria are numerous, and include etiological criteria such as reduced food intake; an inflammatory context; symptoms such as anorexia, fatigue; phenotypic criteria such as weight loss, body mass index (BMI), fat to lean mass ratio, fluid retention, and muscle function. GLIM has chosen to select the most relevant criteria among the etiological and phenotypic criteria: - Etiological criteria: reduced food intake and inflammatory state of the patient; - Phenotypic criteria: weight loss, BMI, and reduced muscle mass. The presence of at least one etiological criterion and one phenotypic criterion is mandatory to make the diagnosis of undernutrition. Muscle mass is described as a major diagnostic criterion, since it is on the one hand a direct indicator of protein catabolism related to undernutrition, but also a reflection of functional impairment in the patient, as it is directly associated with functional capacities, autonomy and prognosis. Different measurement tools are suggested, such as bioelectrical impedancemetry, ultrasound or magnetic resonance imaging, leaving the choice of tool to the clinicians, depending on experience and local resources. Handgrip measurement is considered a complementary measure. GLIM recommends an assessment of the risk of undernutrition, using validated questionnaires such as the NRS (Nutritional Risk Screening) or the MNA-SF (Mini Nutritional Assessment- Short Form). The degree of severity of undernutrition is only assessed on the basis of phenotypic criteria. 1.3 Roles of professionals in screening for undernutrition In general, and more particularly in the Forcilles hospital, dieticians play a major role in detecting undernutrition. They ensure a prospective watch on the patient's admission to the hospital, with the collection of indicators related to BMI and weight loss, in collaboration with the nurses and care assistants. They also carry out a dietary consultation to clarify the above criteria, to evaluate the reduction of intake and absorption, in collaboration with the physician, and the realization of body composition measurements, such as bio-electrical impedancemetry. The evolution of the definition of undernutrition, with an important place in the muscular and functional evaluation of the patient, implies new actors: the physiotherapist and the Adapted Physical Activity Teacher (APAT). Indeed, they have expertise in the evaluation of the patient's muscular function and functional capacities. As part of their diagnostic assessment, the physiotherapist is used to evaluating muscle function by dynamometry, as well as the patient's functional capacities by field tests or the use of scores. The EAPA also participates in the performance of field tests. The collaboration between dieticians, physiotherapists, EAPAs, nurses, care assistants and doctors thus makes it possible to meet the need to screen for undernutrition according to this new definition. 1.4 Assessment of muscle function Physical therapists and EAPAs use different tools to assess different aspects of muscle function, such as strength or walking speed in more functional tests. Isometric grip strength is strongly correlated with lower extremity muscle strength, and is a pejorative marker of mobility in weakness. It has been observed a linear relationship between grip strength and patient disability as measured by the Katz independence scale. In addition, grip strength has been shown to be a good predictor of the patient's clinical condition. The measurement of grip strength, using a dedicated dynamometer, also has the advantage of being simple and reproducible and has reference values adjusted for sex and BMI. Gait speed is another indicator used to assess muscle function. It is associated with lower limb strength and is a predictor of disability and mobility limitation. Usual walking speed is most often measured over a distance of 4 or 6 m and has reference values adjusted for sex and height. Dietitians also participate in the evaluation of muscle function by measuring body composition in terms of lean and fat mass. They perform bioelectrical impedancemetry, which allows estimation of body fat and lean mass volumes by measuring the resistance of biological tissues to a low-intensity, high-frequency sinusoidal electric current through electrodes. This measurement method is simple to use, inexpensive, reproducible and feasible in bedridden patients. It also correlates very well with MRI and reference values are obtained in various adult populations. 1.5 Muscle ultrasound and undernutrition Ultrasound is a reproducible method of muscle assessmen. It allows the assessment of muscle thickness or cross-sectional area of a muscle, the reduction of which is a marker of atrophy and is strongly correlated with its loss of strength and reference measurements. In addition, ultrasound can be used to assess muscle quality, particularly by evaluating the echogenicity of the muscle. Echogenicity increases with muscle damage, related to the presence of fatty infiltrate and fibrous tissue. Complementary measurements such as pennation angle, fascicular length or fibrillations allow to complete the description of the muscle state. Muscle ultrasonography is becoming increasingly used among the tools for assessing muscle function, especially in sarcopenia found in many pathological situations. Its use in the evaluation of the patient's nutritional status, as a tool for assessing muscle function, is developing in the ICU and is associated with an increase in the patient's comorbidities. Studies remain limited to a few patient populations, do not report clear cut-off values to define muscle pathological status, and require more precise definition of ultrasound measurement protocols. 1.6 Research hypothesis The investigators hypothesize that muscle ultrasound is reliable and valid in the evaluation of muscle function during the screening of undernutrition in a population of hospitalized patients in diabetology-obesity, pneumology, oncology and gastro-nutrition, under 70 years of age. 2. Objective 2.1 Main objective The main objective of this study is to evaluate the reliability and validity of muscle ultrasound in the context of screening for undernutrition in patients hospitalized in short-stay and follow-up care and rehabilitation of diabetology-obesity, pneumology, oncology and gastro-nutrition. 2.2 Secondary objectives The secondary objectives will be, in patients hospitalized in short stay and follow-up care and rehabilitation of diabetes-obesity, pneumology, oncology and gastro-nutrition: - Evaluate the correlation of muscle ultrasound with standard measures of muscle function; - To compare the diagnostic capacity of muscle function assessment tools on undernutrition; 3. Type of study: This is a prospective, monocentric, interventional cohort study. The research will be conducted in accordance with the protocol. The duration of the recruitment will be 20 months with a follow-up of the patients during their entire hospitalization in the care unit, i.e. approximately 30 days (average length of stay), i.e. a total duration of the study estimated at 21 months. The study will take place at the Forcilles Hospital, in diabetology-obesity, pneumology, oncology and gastro-nutrition units. 4. Description of the usual care 4.1 Usual course of treatment Patients admitted to short-stay and follow-up care and rehabilitation for diabetes-obesity, pneumology, oncology and gastro-nutrition benefit from medical, nursing and rehabilitation examinations and care. All of this care will not be modified within the framework of this protocol. Physiotherapists and dieticians provide their diagnostic assessment and rehabilitation on medical prescription. The EAPAs participate in the functional evaluation of the patient and carry out physical activities adapted to the patient, also on medical prescription. As part of the screening for undernutrition in our establishment, the dieticians ensure a prospective and systematic collection of the patient's weight and its evolution over the last few months, of his BMI and an evaluation of the food intake, within 48 hours of the patient's admission to the service. The estimation of the patient's intake is done in collaboration with the nursing assistant. 4.2 Nutritional assessment At the patient's admission, a dietetic evaluation is performed by the dietician following the recommendations issued by the French Association of Dieticians-Nutritionists and the HAS. The dietitian collects all the data needed to detect malnutrition, such as weight, height, BMI, albumin level, and grip strength and walking speed (performed by the caregiver and the physiotherapist or the EAPA). The dietician also looks for possible obstacles to feeding such as dental condition, swallowing problems or digestive discomfort The doctor looks for different pathologies impacting digestive absorption such as shortened or shortened stool syndromes, gastrectomies, pancreatic insufficiency etc. He also looks for factors of aggression such as cancers, chronic progressive diseases, infections etc. All these data allow us to estimate the theoretical nutritional needs of the patient and to adapt the nutritional management. A follow-up of the ingestations is carried out by the dietician in collaboration with the nurses' aides. 4.2.1 Anthropometric measurements When the patient is admitted, the ward's nurses and orderlies measure the patient's weight and height. When the patient can maintain the erect position, a conventional scale and a measuring rod are used for the measurements. If the patient cannot maintain this position, a weighing chair and a laser meter are used. In order to evaluate the weight loss before hospitalization, the previous weight is sought in a hospitalization report or another recent medical document. A contact with the attending physician is also made in order to obtain information concerning the patient's weight follow-up. When this information is not available, the previous weight given by the patient is collected. 4.2.2 Biological measurements On admission, a biological sample is usually taken from patients at risk of undernutrition in order to measure pre-albumin, albumin and C-reactive protein (CRP). 4.2.3 Measurements of muscle function Measurement of grip strength ("Handgrip") The gripping force is evaluated with the Jamar® hydraulic force gauge by the caregiver. Measurement of the walking speed ("Gait speed") Walking speed (m/s) is measured on a 4-meter course, in a corridor, by the EAPA or the physiotherapist. 5. Assessment procedure added by the research : Mini-Nutritional Assessment Short Version (MNA-SF) score, Bioelectrical impedancemetry and muscle ultrasound. 6 Statistical aspects 6.1 Calculation of the number of subjects needed Reproducibility of ultrasound With an expected intraclass correlation coefficient of at least ρ1 = 0.8, a minimum value ρ0 = 0.70 considered acceptable, a number of observations k= 2, a risk α= 0.05, and a power of 80%, it is necessary to include 118 patients for the study of intra- and inter-examiner reproducibility of ultrasound. Ultrasound Validity: With an expected sensitivity and specificity of at least 90% and 85%, respectively, an estimated prevalence of muscle impairment of 45% to 60% in our hospitalized patients, for a risk α= 0.05 and a maximum width of the confidence interval of 10%, it is necessary to include between 87 and 109 patients. Therefore, it will be necessary to include 118 patients to meet the primary objective of evaluating the validity and reliability of peripheral muscle ultrasound. 6.2 General aspects Descriptive statistics will be based on means (+/- standard deviation) or medians [interquartile range] depending on the distribution of quantitative variables. Qualitative variables will be described in terms of numbers and percentages. Univariate comparisons will use the usual statistical tests after verification of the distribution of the variables (Chi2 or Fisher's test, t-test, anova or their non-parametric equivalents Wilcoxon and Kruskal-Wallis tests). Paired sample tests will be used if necessary. Tests will be performed at the 5% significance level. The 95% confidence intervals will be provided for each estimate. The calculations will be done using SPSS v21 IBM and R software (version 3.6.1, http://www.R- project.org ). 6.3 Morbidity and mortality criteria 6.3.1 Length of hospitalization The length of stay is defined as the number of days of presence in the inclusion service, from the patient's admission to the final discharge. Temporary transfers to another hospital department for an examination or an intervention are not considered discharges. A special statistical treatment will be carried out on the length of hospital stay, given the impact of death on the length of stay. 6.3.2 Mortality Number of deaths out of the total number of patients included. A specific statistical treatment will be performed on the mortality rate. 6.3.3 Katz Activities Daily Living (ADL) Score The Katz ADL score is completed within 48 hours prior to (scheduled) hospital discharge by the patient's caregiver or nurse. The total score is out of 6. A score of less than 3 indicates major dependence, a score of 0 indicates total dependence. The Katz ADL score will be treated as a discrete numerical variable. 6.4 Analysis of the main objective Inter- and intra-examiner reliability will be assessed by calculating intra-class correlation coefficients. Validity will be assessed by calculating the areas under the ROC curve (Receiver Operating Characteristics) and calculating sensitivities, specificities, positive and negative predictive values. The reference test for the diagnosis of impaired muscle function is bioelectrical impedance. The cut-off values used for the diagnosis of impaired muscle function are those recommended by GLIM : Appendicular Skeletal Muscle Index (ASMI) < 7 kg/M2 in men and < 5.7 kg/m2 in women. 6.5 Secondary objectives 6.5.1 Correlation of muscle ultrasound with standard measures of muscle function Measures of association between quantitative variables will be performed using Pearson's or Spearman's correlation coefficients depending on the distribution of the data. Measures of association between qualitative variables will be performed using the Chi-square or Fisher test depending on the distribution of the data. The agreement between quantitative variables will be evaluated using the Bland-Altman method and that between qualitative variables using the Kappa coefficient. 6.5.2 Compare the diagnostic capacity of muscle function assessment tools on undernutrition The diagnostic capabilities of the different tools for measuring muscle function (Handgrip, gait speed, bioelectrical impedance and muscle ultrasound) will be compared by ROC curves. 6.5.3 Evaluate the association of muscle ultrasound measurements with patient morbidity and mortality Morbidity and mortality will be compared between the groups with and without ultrasound-determined muscle function impairment, comparing length of hospital stay, mortality, and independence at discharge. Length of hospitalization There is a relationship between the incidence of mortality and all of the length of stay variables. Length of stay will therefore be analyzed using a competitive risk method, which takes into account the fact that patients who die are no longer eligible for length of stay analysis. The estimator also provides the probability of in-hospital death, so the probability of hospital discharge versus death at any time after study inclusion can be assessed simultaneously. Mortality rate The estimation of mortality rates will be performed by the Kaplan and Meier method. Comparison of the 2 curves will be performed by a Logrank test. The mortality rates in the 2 groups will be estimated via the survival curves. ADL The ADL score will be compared between the 2 groups using the discrete numerical variable comparison tests described in the general aspects. 7. Expected results in terms of scientific and professional advances The results of this study will make it possible to verify whether ultrasound is a reliable and valid tool in the evaluation of peripheral muscle function in the context of screening for undernutrition. On the other hand, they will allow us to propose threshold values for the alteration of muscle function and to provide information on the ultrasound characteristics of the muscle in the undernourished patient and their association with the prognosis of the patient. The different tools could lead to a different estimation of the reduction of muscle mass and therefore a different prevalence of undernutrition. The results of our study will help to evaluate this and to guide professionals in the choice of tools to assess muscle function. 8 Expected benefits and risks for patients 8.1 Minimal risks and constraints added by the research All medical and paramedical examinations and management are usually performed except for the MNA-SF questionnaire, muscle ultrasound and bioelectrical impedancemetry, which will be performed systematically in the patients included. The MNA-SF questionnaire is very quick (less than 5 minutes) and therefore causes very little inconvenience to the patient apart from an additional visit by a caregiver. Bioelectrical impedancemetry is a tool for assessing body composition using electrodes applied to the skin surface. The examination lasts an average of 15 minutes and is non-invasive and painless. The minimal constraint is related to the placement of the electrode and the duration of the examination. The ultrasound is also non-invasive and painless. The 3 ultrasounds performed will last about 30m. The minimal constraint is related to the installation of the ultrasound probe and the duration of the examination. 8.2 Expected benefits for the patient Ultrasound is a relatively simple and inexpensive tool compared to other methods of measuring body composition (DEXA or MRI) and provides additional information on muscle quantity and quality compared to the usual tools for measuring muscle function (Handgrip, functional tests). The results of this study will make it possible to propose to the patient a reliable and valid evaluation tool, more easily available and less restrictive in the evaluation of the muscular quality during undernutrition. This could lead to a wider and more precise evaluation of this muscular impairment in order to propose more adapted therapeutic solutions (exercise training, weight training, nutrition).

    Phase

    N/A

    Span

    144 weeks

    Sponsor

    Hopital Forcilles

    Recruiting

  • Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes and at Risk of Undernutrition

    This is a randomized, double-blind, parallel, non-inferiority study. Eligible participants will be randomly allocated (at 1:1 ratio) to one of two groups: DSF1 (experimental group) or DSF2 (control group). Both groups will incorporate one serving of the DSF into their daily diet, in addition to receiving standard of care for diabetes. The total expected duration of the study is up to 104 days, including a run-in period of up to 14 days, followed by an intervention period of 90 days. At Day 1, participants will be randomized into one of the two groups (n = 50 per group): DSF1 or DSF2. Participants will start the intervention on Day 1 and complete the intervention on Day 90.

    Phase

    N/A

    Span

    57 weeks

    Sponsor

    Abbott Nutrition

    Recruiting

  • Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population

    The geriatric population is a population at risk, given the frequent and numerous comorbidities present. Undernutrition is one of these, which is frequently associated with sarcopenia, that is, a decrease in muscle strength. Its screening must be early to avoid complications (osteoporosis, fractures, infections ...) and given the cost it generates for society. However, the detection of undernutrition can sometimes be time-consuming and its criteria in default, such as in the presence of edema or obesity, for example. There is a score, the SARC-F, which allows to detect sarcopenia from a result greater than or equal to 4, but which does not allow direct detection of undernutrition. The primary objective is to evaluate the SARC-F score as a screening tool for undernutrition in a geriatric population, secondary objectives being to find a threshold value at this score, and also to estimate a prevalence of undernutrition in this population. It will be a cross-sectional exploratory study to evaluate a diagnostic tool, the SARC-F score, with comparison between cases and controls. The study will be conducted in a single center, a geriatric short-stay service. Participation in the study will be offered to any patient admitted to the geriatric ward, those who meet the inclusion criteria and do not have exclusion criteria will have to complete the SARC-F questionnaire during their stay, and to do the handgrip test and impedancemetry performed by a third party. Biological data (albumin, pre-albumin and C-Reactive Protein) and anthropometric data will be collected and analyzed to determine if the patient is malnourished or not, and the results of SARC-F will be compared between these 2 groups.

    Phase

    N/A

    Span

    70 weeks

    Sponsor

    University Hospital, Clermont-Ferrand

    Recruiting

    Healthy Volunteers

  • Exploring Food Rejection Dispositions as Potential Risk Factors for Undernutrition in Hospitalized Children Aged 2 to 8

    Phase

    N/A

    Span

    79 weeks

    Sponsor

    Hospices Civils de Lyon

    Recruiting

  • Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.

    Phase

    N/A

    Span

    170 weeks

    Sponsor

    Centre Hospitalier Universitaire, Amiens

    Recruiting

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