Active clinical trials for "Malnutrition"

Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle interventions to reduce obesity. Few studies have been translated into rural settings or among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for urban Latino families. The FI is a 12-week behavioral modification program grounded in social cognitive theory, designed to engage the whole family in lifestyle changes by developing knowledge and skills in physical activity and healthy eating, building skills in goal-setting and self-monitoring, and creating a supportive home environment. Researchers will engage community partners in formative research to adapt the current FI for rural Latino families. Two parallel delivery methods of the FI will be developed and tested: 1) in-person group setting at a community center (FI-IP) and 2) home-based delivered remotely with technology (FI-RT). Both will be designed to address the unique social, cultural and environmental factors facing rural Latino families. The FI-RT will take advantage of innovative modern technology and e-Learning to increase program availability, accessibility and participation in rural settings. Researchers will conduct a 3-arm randomized controlled trial (RCT) to compare effectiveness of the two delivery approaches on weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus control. The researchers will recruit 270 obese Latino adults (ages 21-65) with a child (ages 8-17) from three primary care practices in rural South Texas. These parent-child pairs will be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI-RT (n=90); or 3) control group (n=90). Primary specific aims are to: 1) Conduct community-engaged formative studies to transform the existing FI into two unique delivery methods (FI-IP and FI-RT) for use in a subsequent RCT in a rural Latino community; and 2) Conduct a RCT to evaluate the comparative effectiveness of FI-IP and FI-RT to address weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with adult participants in control group at immediate post intervention (3 months), after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's weight and energy balance behaviors.

Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, we demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, we propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.

The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.

It is well documented that zinc supplementation to low-income population results in the reduced incidence of childhood diarrhoea and pneumonia, and improves growth of stunted children. In Bangladesh, the risk of zinc deficiency is considered to be high and children could benefit greatly by improving their zinc intakes on a daily basis. Zinc supplementation at a national scale would be a formidable task. There is a need to find an alternative. It might be sustainable to improve intake of zinc through fortified staples, e.g. rice with increased amounts of zinc; in fact such biofortified rice has been developed through conventional breeding, which is designed to contain an amount of zinc that could meet at least 40% of the daily requirement. In the first round of the previously approved and completed studies, total absorbed zinc (TAZ) did not differ when diets containing zinc biofortified rice (ZnBfR) or conventional rice (CR) were compared. Thus, the current study is planned to repeat using a new variety of (ZnBfR) that is expected to have higher zinc content than the variety previously studied. Initially, a pilot study will be conducted in 4 participants using a modified isotope administration protocol such that the oral tracers will be given on two days each at half the original dose each day so as to provide a lower proportion of the total daily zinc intake as tracer solution. Hypotheses: Young children will have greater total absorbed zinc (TAZ) when they consume mixed diets containing ZnBfR than when they consume the same diets containing CR. TAZ will not differ in children who receive the ZnBfR-containing diet or the same diet containing CR plus sufficient additional zinc to match the zinc content of the ZnBfR diet. Objectives: To measure the amount of zinc absorbed from ZnBfR compared with the amount absorbed from CR and from CR fortified with added zinc, using the triple stable isotope tracer ratio technique in young children. To assess the intestinal function of the children, using a sugar permeability test (lactulose:mannitol test). (Pilot study) To verify that the modified tracer dose will provide adequate signal for assessing zinc absorption. Methods: To assess the potentials for biofortified rice in providing a good, bioavailable source of additional zinc, it is proposed here to measure zinc absorption from rice-based meals among Bangladeshi preschool children. The amount of zinc absorbed from ZnBfR compared to that absorbed from a conventional Bangladeshi rice (Diet-CR) (control) will be measured. Zinc absorbed from ZnBfR with that from zinc-fortified conventional rice (Diet-CR+Z) will also be compared. The study will be a cross-over, randomized, controlled clinical study. Initially, a pilot study will be conducted with a modified dose of zinc stable isotope among 4 children aged 36-59 months of either sex from a peri-urban community in Dhaka. Later on, 44 children aged 36-59 months of either sex will be recruited from the same community as mentioned before, and they will be individually randomized, in equal numbers, to one of the two comparison groups, A and B. During an initial one-day acclimatization period, the study children will receive the conventional rice based diet three times a day, to confirm that they will accept the study diets and adhere to the study procedures. On study days 2 and 4, in comparison group A, the study subjects will receive either the Diet-ZnBfR or Diet-CR based on the random assignments, and they will receive Diet-CR or Diet ZnBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4), Likewise, in comparison group B, the study subjects will receive either Diet-ZnBfR or Diet-CR+Z on days 2 and 4 based on the random assignments, and they will receive Diet-CR+Z or the Diet-ZnBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4). Zinc stable isotope tracer techniques will be used to measure the fractional absorption of zinc, in which tracer : tracee ratios will be measured in spot urine samples following administration of an intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided with test meals over a four-day period. Outcome measures/variables: Intake of total dietary zinc (TDZ) and phytate for each subject will be calculated during the clinical study. Fractional absorption of zinc (FAZ) will be determined from the isotopic ratios obtained in urine samples using the following equation, which shows, as an example, the calculation that will be used for zinc absorption from the diet traced with 67Zn: FAZ = 67Zn tracer:tracee ratio / 68Zn tracer:tracee ratio * (68Zn dose given IV / 67Zn dose given orally) Total absorbed zinc (TAZ) for each child will be calculated as follows: TAZ (mg/d) = TDZ (mg/d) * FAZ

Currently, there is no accurate measurement of dietary intake. All current methodologies of assessing dietary intake have inaccuracy rates of 30 -70%. Accurate assessment of dietary intake is critical in understanding individual and population nutritional status and monitoring the effectiveness of public health interventions to maintain nutritional health. Estimating dietary intake in low and middle-income countries (LMICs) is remarkably challenging, albeit the high presence of malnutrition and the critical need for evidence-based data to inform policies and programmes on nutrition and health. This study aims to develop and validate a low-cost and robust system for accurate measurement of an individual's dietary intake in households in LMICs. This innovative system passively recognises food, records intake, and estimates nutrient content of food. The system will be validated in field trials in Ghana and Kenya.

Sarcopenia and malnutrition are two geriatric syndromes that are frequently seen in the elderly and have multifactorial etiology and severe clinical effects. However, the results vary widely due to the many methods and criteria used in the diagnosis and prevalence rates of both syndromes. In this study, it is aimed to investigate the relationship between the GLIM (Global Leadership Initiative on Malnutrition) criteria and various sarcopenia levels, which are newly defined worldwide and have the widest spectrum so far in describing malnutrition.

Last Mile Health (LMH) has partnered with the Liberian Ministry of Health (MOH) to support the design and implementation of the National Community Health Assistant Program (NCHAP). In collaboration with MOH, LMH is planning to conduct an impact evaluation in Grand Bassa to assess the effect of the National Community Health Assistant Program (NCHAP) on health outcomes, as well as to learn lessons around program operations and implementation. Our central hypothesis is that Community Health Assistants (CHAs) within the NCHAP will reduce under 5 mortality, as a result of expanding access to and uptake of health care utilization in remote communities. We will use a mixed effects discrete survival model, taking advantage of the staggered program implementation in Grand Bassa districts over a period of 4 years to compare the incidence of under-5 child mortality between the pre- and post-CHW program implementation periods.

"Adult safeguarding is everyone's responsibility". The Care Act 2014 makes safeguarding a legal duty. It provides local authorities and other agencies in England with a responsibility to protect adults with care and support needs from abuse and neglect. This is done most effectively when all relevant agencies work together. This is particularly important for people living with dementia, as they are at higher risk of abuse or neglect. Such abuse is most common in their own homes and care settings. Primary and social care professionals are likely to have regular contacts with older people, hence have opportunities for early identification and prevention of abuse. However, little is known about how primary care practitioners work in partnership with social care and other agencies to investigate and manage abuse. Aims: This project will outline how health professionals in primary care settings understand and respond to abuse and what their understandings of safeguarding law and policy are. It will also identify how social services departments assess and manage referrals relating to people living with dementia in primary care settings. Furthermore, the study will analyse the experiences of people with dementia and families who are at the centre of safeguarding Methods: This study has three phases. In phase 1, the investigators will synthesise current research and practice evidence to develop a theory of safeguarding conceptualisation and process. In phase 2, the investigators will analyse national statistics on safeguarding (NHS digital dataset), ageing and dementia data (English Longitudinal Study of Ageing) to understand patterns of reporting and how they vary across location, gender, ethnicity and time period. In phase 3, the investigators will interview GPs, social workers, safeguarding leads, independent advocates, people with dementia, family members, support workers, carers and other professionals who make or receive referrals via primary care. As part of phase 3 group discussions will also be conducted, in which professionals will come together to share their experiences, and will identify approaches for preventing abuse and collaboration amongst relevant agencies. Phase 3 will inform the development of complex case studies, drawing on data from phases 1 and 2. Impact: This study will help develop practice guidance for professionals, to aid multi-agency collaboration in safeguarding cases specific to dementia. This will be developed in consultation with the PPIE (Patient and Public Involvement and Engagement) members and practitioners. Videos will also be produced and plain English versions of case studies of complex safeguarding scenarios and strategies in consultation with safeguarding leads, law experts, training providers and other key stakeholders. Experts by experience (working with, caring for or living with dementia), will be able to guide the team with cultural nuances and appropriateness to ensure that the material developed is sensitive to all populations. An info graph/pictograph displaying signs of abuse, staying safe and what to do, aimed at people with dementia and family will be compiled. The investigators will liaise with national safeguarding leads so that this information can be displayed in GP clinics. Furthermore, the investigators will contact social responsibility personnel for supermarkets and discuss the potentials of wider circulation for displaying this information in stores.

The aim of this single-arm prospective, multicenter, cross-sectional study is to evaluate the nutritional status and body composition on tumor regression grade with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment. Results of this study will reveal whether nutritional status and body composition assessment based on bioelectrical impedance analysis will become a validated and objective tool to support clinical decisions in gastric cancer patients undergoing multimodal treatment.

The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions it aims to answer are: Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ? Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) and a locally available food (LAF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.