Active clinical trials for "Malnutrition"

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current weight-based dosing of RUTF for children with SAM.

The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of three new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the three ONS for 28 days alongside their routine diet.

The "digital divide" or gap in technological access and knowledge, for older adults has worsened during the COVID-19 pandemic, leading to disruptions in services like congregate meal programs funded by the Older Americans Act. Seven San Antonio congregate meal sites remained partially open biweekly to distribute meals but no longer offer in-person nutrition education, physical activity classes, and social activities. The proposed project will test the efficacy of digital nutrition intervention with at-risk older adults who attend congregate meal center in areas of high poverty and digital exclusion. The study is uses a stepped-wedge cluster clinical trial. Key community partners with the Department of Health Services Senior Services Division and Older Adult Technology Services (OATS) will participate in the planning phase, research design, and implementation of the study. The study aims are: To test the impact of a technology-based intervention on the primary outcomes of food security and diet quality; To determine the effect of the intervention on secondary outcomes of technology knowledge and usage, physical activity, and social isolation and loneliness; To examine the long-term impact and sustainability of technology use on food security, diet quality, physical activity, and social isolation. If successful, the impact of this program could be applied throughout the national OATS network and to similar CMPs to bridge the digital divide beyond the COVID-19 pandemic

The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.

The proposed work is based on the finding that one-third of the world is infected with the bacteria Mycobacterium tuberculosis (Mtb) and only 10% of these individuals develop TB. The study aims to identify factors that drive progression to disease and study signals (markers of the immune response) that detect who will progress to active TB and why this happens. Armed with these markers, the study will address how malnutrition and worms alter this signal profile to cause active TB. The work will be conducted in India, where there are 2.8 million TB cases each year - more than any other country - and where the government has committed to eliminating TB by 2035. Data suggest that malnutrition and parasites increase risk of TB disease so the investigators will feed malnourished household contacts and have those with parasites receive medication to treat these. Using this infrastructure, the investigators will evaluate the immunologic impact of feeding on TB pathogenesis. An additional aim is to understand the role of parasitic worms with the goal of determining the utility of low-cost ($.02 per dose) worm treatment as part of TB control efforts. Risk of developing TB will be evaluated for 120 household contacts of TB patients in the setting of their malnutrition and parasites. There are four study arms comprised of thirty participants each -- malnourished with parasite infection, malnourished with no parasite infection, well-nourished with parasite infection, and well-nourished with no parasite infection. Correlates of risk of disease will be assessed using blood messenger RNA/micro RNA (mRNA/miRNA) sequencing and T cell immune markers. The TB LION study will confirm that malnutrition and worms increase the risk of active TB and will provide the basis for effective interventions that could change the face of the TB pandemic and have a profound impact on the health of people worldwide. Participants in this study will be household contacts of tuberculosis index cases. The index cases in this study do not participate in the study once a household contact is established. All interventions and follow up are only being conducted within the household contact cohort. All intervention supplies, treatments, and biologics will be purchased internationally.

The study is a prospective community-cluster non-randomized trial that will evaluate the effectiveness of a program that will provide 30-day egg vouchers to mothers of 6 to 24 month-old children living in rural areas of Intibucá, Honduras.

Older adults have very specific food and nutrient requirements and often struggle to meet these needs due to poor appetite, reduced functionality and dexterity. Protein (both quality and quantity) is an important macronutrient in maintaining muscle in older adults which can help prevent falls, delay disease onset and help individuals maintain independence. Fortifying regular/ everyday foods with additional protein is one strategy to help older adults meet these increased protein needs. However, it is well established that protein is the most satiating of the nutrients we eat, yet less is known about how this is impacted by age and protein type. This study aims to test 2 protein fortified porridge recipes in older adults (and a control recipe) with outcomes focused on protein bioavailability, appetite and satiety responses.

Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (<2500 g at birth) or underweight (weight-for-age Z-score < -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight/underweight neonates, who are at the highest risk of adverse outcomes.

The intervention will focus on identifying risk factors for depression and anxiety and will quantitate the educational component of the POWER Obesity group intervention delivered by mental health professionals that are currently presenting for 30 min during the Monday session to address the root causes of obesity as well as to encourage positive lifestyle changes (e.g. sleep, diet, sun exposure, circadian rhythms, and addictions). The previously published hypothesis identifies triggers, that combined, could cause mental health problems. The 10 groups of triggers are: (1) Genetic, (2) Developmental, (3) Lifestyle, (4) Circadian Rhythm, (5) Addiction, (6) Nutrition, (7) Toxic, (8) Social/Complicated Grief, (9) Medical Condition, and (10) Frontal Lobe. Each of these factors will be dealt with in the lifestyle intervention. The project will be led by the assistant professor (in process) Francisco E Ramirez, MD with his mentor Theodore Friedman, MD, PhD supervising the project. Hypothesis: The investigators hypothesize that composite POWER Obesity group will have greater improvement in mental health compared to the dietitian-led group. Measuring outcomes: The intervention will take 1 year to recruit all the patients the investigators expect to have the 75 patients in the group intervention and 25 patients in the dietitian-led group. With these numbers, our preliminary power analysis suggests there will be a difference in the two groups with an alpha of .05 and 80% power. The investigators will add 3 tests to both arms of the study, 9-question Patient Health Questionnaire (PQ-9), Generalized Anxiety Disorder (GAD), and the Depression and Anxiety Assessment Test, in the POWER Obesity group at 0, 3, 6 months and 12 months of intervention.

This study seeks to promote consumption of locally sourced foods among school going children in Barbados. The study targets parents/care givers of school going children aged 18 years and below. Parents have been chosen as the target for this study because they shape the meals that their children consume through two primary routes; a) direct purchase of meal ingredients and b) political influence on school based meal programs. The study seeks to achieve this by first identifying the behavioral obstacles for consumption of locally sourced produce through exploratory and desk research and then designing interventions to address the obstacles.