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Malnutrition, Child clinical trials

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NCT ID: NCT05792514 Not yet recruiting - Malnutrition, Child Clinical Trials

The Reliable Nutritional Risk Screening Tools

Start date: September 1, 2023
Phase:
Study type: Observational

- assess the subjective global validity and reliability of using The Pediatric Yorkhil Malnutrition Score (PYMs) and merits of using the Screening Tool for Risk on Nutritional status and Growth (STRONGkids) as a nutrition screening tool - correlate it with the severity of their nutritional derangements in comparison to the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP)in hospitalized Egyptian children aged (2-5)years in Assiut University Children Hospital (AUCH).

NCT ID: NCT05791305 Recruiting - Obesity Clinical Trials

Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years

DBM
Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Background: Double burden of malnutrition is an emerging public health problem among children under-five years due to the inevitable consequences of nutritional transition. Addressing these two contrasting forms of malnutrition (undernutrition and overnutrition) simultaneously brings an enormous challenge to the food and nutrition policies of developing countries like Ethiopia. Children under five ages are more vulnerable to DBM, especially during the first year of their life due to high growth and inadequate diet. Hence, there has been a paradigm shift in thinking to reduce its effect on the health of children. However, interventions that are used to address these different kinds of malnutrition are implemented through different governance and still, they are isolated and disintegrated each other. Therefore, double-duty interventions can tackle the risk of both nutritional problems simultaneously in an integrated approach through nutrition behavior change communication. Objective: Therefore, the main aim of this pilot study is to assess the effect of selected double-duty interventions on the double burden of malnutrition among children under five years in Debre Berhan City, Ethiopia.

NCT ID: NCT05629624 Recruiting - Malnutrition, Child Clinical Trials

Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The study explores the impact of malnutrition at enrollment on executive function (EF) and emotional regulation (ER) in malnourished 1-year-old children and whether specially designed brain directed therapeutic feeds improve EF/ER outcomes at three years of age. The study will detect changes in EF and ER related to nutritional rehabilitation using specially designed ready to use therapeutic feeds (E-RUSF Nutriset) during the repletion phase and maintained for two years until age 3 with enhanced E-SQLNS (small quantity lipid based nutrient supplement) also modified to provide adequate brain directed micro and macronutrients. The investigators hypothesize that standard Bangladeshi designed B-RUSF and SQLNS (Nutriset) do not provide adequate nutrients to supply the brain during the rapid catch-up growth and subsequent early childhood growth phases of rehabilitation from Moderate Acute Malnutrition (MAM). The investigators predict that the children with moderately severe malnutrition treated with E-RUSF followed by 2 years of E-SQLNS will show an exuberance of connections (higher functional connectivity) than children receiving standard Bangladeshi rehabilitation feeds B-RUSF and SQLNS. This prediction is based on past work using EEG to examine the BEAN sample in Bangladesh, and differs from the sample in Boston, where the investigators anticipate that among healthy, normally nourished children, greater connectivity will be associated with better cognitive outcomes. The Core Toolkit will be deployed to the Bangladesh site to define its utility in prediction of executive dysfunction and emotional dysregulation in the context of low-income status, malnutrition and nutritional intervention. All nutritional intervention groups of malnourished children will also receive a set psychosocial stimulation curriculum that has been shown to be effective on severely malnourished children with therapeutic feedings.

NCT ID: NCT05603793 Enrolling by invitation - Anemia Clinical Trials

YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition

Adol Cohort
Start date: September 13, 2022
Phase:
Study type: Observational

More children will survive to adulthood today than at any other point in human history, as evidenced by the proportion of live births and absolute numbers. The present generation of young people who have lived to the age of five will reach adulthood around 2030 and will be the generation of the Sustainable Development Goals (SDGs). These children's health and nutrition as they grow from 5 to 19 years will have permanent ramifications on the development of the coming generation. The Comprehensive National Nutrition Survey was conducted between 2016 and 2018, indicating unacceptably high levels of malnutrition among Indian children and adolescents. It was discovered that one out of every five children aged 5 to 9 was stunted, indicating they were malnourished for their age. Undernourished girls are more likely to become short-statured mothers, giving birth to low-birth-weight and stunted newborns who are more prone to disease and linear growth failure. Evidence suggests that maternal short stature (less than 150 cm) predicts childhood growth failure and increases the risk of having a stunted baby by two years. The common genetic background and environmental influences that affect the mother during her early childhood and adolescence play a substantial role in the relationship between maternal stature and the linear growth of the child. This causes a cycle of undernutrition and poor growth that continues through generations and impacts the offspring's growth. Adolescence is a key period of physical and social development when the physiological, mental, and behavioural underpinnings of long-term health are established. The development of critical bone mass is crucial during this time because it lays the foundation for preserving bone mineral integrity later in life. During adolescence, over 40% of peak bone mass is achieved. Changes in body composition are also seen during early adolescence. These physiological processes are both nutritionally sensitive and predictive of their future health. Adolescent behaviour is also linked to 33 percent of sickness and 60 percent of premature deaths in adulthood. Because adolescence is also a critical period for the development of the ability to make independent decisions, follow them through, and achieve goals- enabling healthy social networks, is critical. This includes Social and Behavioural Change Communications, which can assist early adolescents create lifetime behaviour patterns, such as good nutrition and physical exercise choices. Investing in adolescent health and well-being pays off in three ways: during their adolescence, in their adulthood, and for their future offspring generations. Thus, young adolescence provides a "window of opportunity" for children to improve their nutritional health and outcomes. Therefore, this cohort aims to explore the trajectories of growth (including anthropometric measures, bone mass, and muscle mass and function) among rural young adolescents and its association with intergenerational nutritional status through a longitudinal study. A greater understanding of growth trajectories set in a longitudinal study would aid in the discovery of particular variables that influence the timing of young adolescents' growth and the factors associated with intergenerational nutritional status.

NCT ID: NCT05590351 Not yet recruiting - Malnutrition, Child Clinical Trials

Promotion of Exclusive Breast Feeding and Young Child Feeding Practices Through m-Health

Start date: August 2023
Phase: N/A
Study type: Interventional

Early life nutrition is the key modifiable determinant of child growth, development, survival and diseases of adult onset. Pakistan ranks highest for neonatal mortality rate (44.2/1000 live births (LBs)) globally. One third of under-five deaths (74.9/1000 LBs) are attributable to high prevalence of stunting (38%), underweight (23%) and wasting (7%), greatly related to feeding practices. Given the low prevalence of exclusively breast fed (EBF) (48%) and use of minimum acceptable diet (13%), mitigation of early life nutritional risk through promotion of EBF and Young Child Feeding Practices (YCFP) provides a critical window of opportunity for intervention. Secondary Care Hospitals (SCH) of the Aga Khan Health Services Pakistan provide essential maternal and child health services for low-middle income population. Babies born at these SCHs are followed up for vaccination, growth-monitoring and other services at the closely affiliated Family Health Centers (FHCs) run by Lady Health Visitors (LHVs). We aim to examine the effectiveness of a locally designed m-Health application for empowering mothers for child nutritional care as a potentially sustainable approach. The first six months of formative research would identify perceptions, barriers and facilitators for EBF and YCFP using self-determination behavioral theory, among multi-parous pregnant mothers enrolled at three SCHs of Karachi. A randomization trial would be conducted during next 18 months among near-term pregnant women who have access to smart-phones. A culturally appropriate mhealth application called first diet would be developed to provide personalized push messages delivered weekly by the LHVs. Non-intervention group will receive face-face nutritional counselling by the research staff at FHC following routine vaccination and growth-monitoring schedule. Mothers would followed-up from one month prior to expected delivery to child's first birthday. We expect 20% improvement in rates of EBF and YCFP with m-Health intervention. If proven effective, m-health would be incorporated in routine child care provision by LHVs.

NCT ID: NCT05571280 Active, not recruiting - Malnutrition, Child Clinical Trials

Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The severity of the stunting in the provinces of Huíla and Cunene, Angola, in children aged 6 to 59 months is considered to be very high, as defined by the World Health Organization (WHO) classification of 2018. Some of the strategies that present promising results in the fight against chronic malnutrition have been specific nutritional interventions and money transfers. Among these, those that have so far had a greater impact in reducing chronic malnutrition indicators are fortified foods and lipid-based nutrient supplementation in small amounts. The hypothesis of the study is that these interventions applied from pregnancy can significantly reduce chronic malnutrition, each of which may have different impacts. The study intends, therefore, to evaluate an intervention that aims to obtain the highest quality scientific evidence on the best package of sensitive and specific measures that reduce chronic malnutrition and mortality in children under 2 years of age, maintaining the fundamental premises of sustainability, cost-benefit ratio, and scalability for other regions of the country. To this end, it was designed a community trial randomized by clusters in which different strategies will be evaluated separately: - Standard Intervention (CONTROL Arm) The Standard package includes a series of actions carried out by Community and Health Development Agents (ADECOS), which are characterized by having demonstrated strong evidence of their effectiveness in the scientific literature, and are part of the WHO guidelines and national health guidelines in different countries, including Angola. - CONTROL+ NUT (Nutrients Arm): Standard Intervention plus nutritional supplementation - CONTROL+ TM (Money transfers Arm): Standard Intervention plus money transfers Study population: pregnant women with more than 16 years of age; however the target population of the interventions will be the household where the pregnant woman lives. The impacts of interventions on indicators of chronic malnutrition in children under 5 years of age belonging to the household will also be analyzed.

NCT ID: NCT05551819 Completed - Malnutrition, Child Clinical Trials

Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition

Start date: October 26, 2022
Phase: N/A
Study type: Interventional

This study will compare the acceptability a microbiome-directed food (MDF) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.

NCT ID: NCT05519254 Recruiting - Diarrhea Clinical Trials

Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

Start date: March 10, 2023
Phase: Phase 3
Study type: Interventional

Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or "ORS"). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the facility nutritionists and ready to return home. Participation in the study will entail providing information on the child's health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child's porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.

NCT ID: NCT05442424 Recruiting - Obesity Clinical Trials

Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii

KPRxHawaii
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Children living in food-insecure homes, defined as at some time during the last year their household not having enough food, money, or resources to feed the family experience low intake of fresh fruits and vegetables (FV), and a trajectory for increased risk of obesity and chronic diseases in adulthood. In Hawai'i, a higher proportion of Native Hawaiian (NH) and other Pacific Islander (OPI) children live in food-insecure households when compared with the state average (30% and 50%, respectively vs. 18%) and NHOPI adults suffer disproportionately from chronic disease. Produce prescription programs, provide vouchers to individuals to purchase fresh FV, are promising strategies to improve diet quality and reduce chronic disease risk among food insecure populations. The long-term objective of this research is to reduce nutrition-related health disparities via clinical-community based programming. The Keiki (child) Produce Prescription (KPRx) program was developed and implemented by enlisting University and community researchers and health care providers at the Waianae Coast Comprehensive Health Center (WCCHC). The current study builds on the community-academic partnership to achieve the following specific aim, to measure effectiveness of the KPRx on FV intake, gut microbiome composition, and health related biomarkers in 100 parent-child dyads in the context of household food insecurity from a predominantly NHOPI community in Hawai'i. A community based participatory research approach to carry out a randomized controlled trial that measures the effect of the KPRx on child diet and microbiome, and parent/caregiver diet and health-related biomarkers on 100 parent-child dyads in the context of household food insecurity will be conducted. The community-informed research study will provide data to inform local and state healthcare and nutrition assistance programming policies aimed at reducing food insecurity and health disparities among NHOPI and minority populations.

NCT ID: NCT05437068 Withdrawn - Malnutrition, Child Clinical Trials

Nutritional Supplementation in Children at Risk of Undernutrition

Start date: November 11, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.